{ "id": "AIBD-0262", "title": "Zasocitinib, computationally designed by Nimbus with Schrodinger's platform, beats deucravacitinib in phase 3; FDA priority review", "summary": "Takeda reports 36.5% complete skin clearance with zasocitinib versus 13.9% with deucravacitinib at week 16. The contribution of AI to discovery is not separately measured.", "date_observed": "2026-09-30", "date_basis": "unassessed", "date_precision": "unassessed", "benefit_status": null, "source_collection": null, "source_entry": null, "account": "Takeda reported that zasocitinib produced complete skin clearance in 36.5% of its LATITUDE Atlas group, versus 13.9% with deucravacitinib, at week 16. The September 30, 2026 announcement gives analysis groups of 301 and 303 participants. The sponsor’s registration lists 606 enrolled participants and has no posted results. The earlier Nimbus-funded phase 2b trial treated 259 participants and found a dose response against placebo, including complete clearance in 33% at the 30 mg dose. Nimbus and Schrödinger developed the molecule with computational structure-based design. Schrödinger describes free-energy calculations and virtual screening, while a Takeda scientist separately describes the approach as AI-assisted. These accounts do not isolate the effect of AI from the wider discovery process. Takeda reported that the FDA granted priority review and that the EMA accepted its application in September 2026. These were application milestones, not approvals. Takeda’s February 2023 closing announcement states an approximately $4 billion upfront acquisition payment, with additional contingent milestones. That transaction is not a valuation of the benefit attributable to AI.", "category": "benefit created", "unexpected": false, "purpose": "Design a selective oral allosteric TYK2 inhibitor for plaque psoriasis and other immune-mediated diseases", "system": "Schrodinger physics-based computational drug-design platform with machine learning, used by Nimbus Therapeutics to discover NDI-034858 (TAK-279, zasocitinib)", "model_version": "FEP+", "developer": "Schrodinger (platform); Nimbus Therapeutics (compound)", "deployer": "Takeda (clinical development, LATITUDE phase 3 program)", "location": "United States (Nimbus, Boston; Takeda Development Center Americas, Cambridge, MA); phase 2b at 55 sites in the US and Canada; phase 3 sites unverified", "domain": "Health; drug discovery", "segment": "Adults with moderate-to-severe plaque psoriasis", "benefit_type": "Improved Physical Health", "taxonomy_note": null, "registry_ids": {}, "ratings": [ { "group": "personal", "depth": 3, "reason": "Trial participants achieved complete skin clearance at higher rates. PASI 100 was 36.5% vs 13.9% at week 16 in LATITUDE Atlas, and 33% at 30 mg in phase 2b." }, { "group": "organizational", "depth": 2, "reason": "Takeda reported acceptance of its application for FDA priority review in September 2026 after acquiring the program for approximately $4 billion upfront. Application acceptance is not regulatory confirmation of efficacy or an estimate of AI-created value." }, { "group": "societal", "depth": null, "reason": "No approval or population-level outcome as of 20 October 2026." } ], "ai_role": { "status": "assessed", "statement": "The original developer accounts describe computational structure-based design, free-energy calculations, and virtual screening. Takeda’s Warren Winkelman calls the approach AI-assisted. Physics-based computation alone does not establish an AI contribution. The discovery paper and developer accounts do not provide a controlled estimate of AI’s contribution to clinical efficacy, discovery speed, or the acquisition price." }, "evidence": [ { "kind": "press release", "citation": "Takeda. Zasocitinib demonstrates superior efficacy to deucravacitinib in LATITUDE Atlas. 2026-09-30. Original sponsor announcement of EADV 2026 late-breaking results, citing Stein Gold et al., LB-312, session D3T01.3.", "title": "Zasocitinib demonstrates superior efficacy to deucravacitinib in LATITUDE Atlas", "url": "https://www.takeda.com/newsroom/newsreleases/2026/zasocitinib-superior-efficacy/", "date": "2026-09-30", "written_by": "makers", "quote": null }, { "kind": "peer-reviewed study", "citation": "Armstrong AW, Gooderham M, Lynde C, et al.. Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) in Psoriasis: A Randomized Clinical Trial. 2024-08-21. JAMA Dermatology 160(10). doi:10.1001/jamadermatol.2024.2701. Nimbus funded the trial and participated in design, analysis, and interpretation.", "title": "Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) in Psoriasis: A Randomized Clinical Trial", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11339701/", "date": "2024-08-21", "written_by": "makers", "quote": null }, { "kind": "dataset", "citation": "Takeda; ClinicalTrials.gov. NCT06973291: LATITUDE Atlas. 2025-05-15. Sponsor-submitted registration; first posted May 15, 2025, updated May 1, 2026. No posted results.", "title": "NCT06973291: LATITUDE Atlas", "url": "https://clinicaltrials.gov/study/NCT06973291", "date": "2025-05-15", "written_by": "makers", "quote": null }, { "kind": "report", "citation": "Schrödinger. Design of a highly selective, allosteric, picomolar TYK2 inhibitor using novel FEP+ strategies. n.d. Original developer account; JH2 program section concerns TAK-279.", "title": "Design of a highly selective, allosteric, picomolar TYK2 inhibitor using novel FEP+ strategies", "url": "https://www.schrodinger.com/design-of-a-highly-selective-allosteric-picomolar-tyk2-inhibitor-using-novel-fep-strategies/", "date": null, "written_by": "makers", "quote": null }, { "kind": "news report", "citation": "Drug Target Review, interview with Takeda’s Warren Winkelman. Inside Zasocitinib: A New Model for TYK2 Inhibition in Immune-Mediated Diseases. 2025-09-26. A firsthand sponsor account of the AI-assisted design claim, rather than independent verification.", "title": "Inside Zasocitinib: A New Model for TYK2 Inhibition in Immune-Mediated Diseases", "url": "https://www.drugtargetreview.com/inside-zasocitinib-a-new-model-for-tyk2-inhibition-in-immune-mediated-diseases/677029.article", "date": "2025-09-26", "written_by": "makers", "quote": null }, { "kind": "press release", "citation": "Takeda. FDA Grants Priority Review to Zasocitinib for Moderate-to-Severe Plaque Psoriasis. 2026-09-14. Sponsor reports FDA priority review and EMA application acceptance; no approval reported.", "title": "FDA Grants Priority Review to Zasocitinib for Moderate-to-Severe Plaque Psoriasis", "url": "https://www.takeda.com/newsroom/newsreleases/2026/fda-priority-review-zasocitinib-psoriasis/", "date": "2026-09-14", "written_by": "makers", "quote": null }, { "kind": "press release", "citation": "Takeda. Takeda Completes Acquisition of Nimbus Therapeutics’ TYK2 Program Subsidiary. 2023-02-08. Closing announcement. Approximately $4 billion upfront, subject to closing adjustments, with contingent milestones.", "title": "Takeda Completes Acquisition of Nimbus Therapeutics’ TYK2 Program Subsidiary", "url": "https://www.takeda.com/newsroom/newsreleases/2023/takeda-completes-acquisition-of-nimbus-therapeutics-tyk2-program-subsidiary/", "date": "2023-02-08", "written_by": "makers", "quote": null } ], "replication": { "produced_by": [ "Computational structure-based design and laboratory testing of a selective allosteric TYK2 inhibitor", "Sponsor-led randomized clinical trials against placebo and deucravacitinib" ], "must_hold": [ "Phase 3 efficacy and safety confirmed in regulatory review", "Independent documentation of the computational platform's contribution to the molecule" ], "echoes": [ { "date": "2024-08-21", "setting": "Phase 2b RCT, 47 US and 8 Canadian centers, 259 treated patients", "model_version": null, "outcome": "recurred", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11339701/" }, { "date": "2026-09-14", "setting": "FDA acceptance of the NDA under priority review", "model_version": null, "outcome": "unknown", "source": "https://www.takeda.com/newsroom/newsreleases/2026/fda-priority-review-zasocitinib-psoriasis/" } ] }, "paired_incident": null, "headline": "Nimbus's zasocitinib beats deucravacitinib in phase 3 trial", "metric": "PASI 100 36.5% vs 13.9% for deucravacitinib at week 16", "comparator": { "against": "deucravacitinib (Sotyktu), the active comparator in the LATITUDE Atlas phase 3 trial", "before": "13.9% of those receiving deucravacitinib (n = 303)", "after": "36.5% of patients (n = 301) achieving PASI 100 at week 16", "basis": "measured", "quote": "36.5% of patients treated with zasocitinib (n=301) achieved complete skin clearance … versus 13.9% in the deucravacitinib group", "url": "https://www.takeda.com/newsroom/newsreleases/2026/zasocitinib-superior-efficacy/" }, "later": { "status": "unknown", "date": "2026-09-14", "note": "Takeda reported FDA priority review with a decision expected in the first quarter of 2027 and EMA acceptance of the application. These sponsor announcements do not establish approval.", "quote": null, "url": "https://www.takeda.com/newsroom/newsreleases/2026/fda-priority-review-zasocitinib-psoriasis/" }, "value": { "amount": "$4 billion", "what": "Approximately $4 billion upfront for acquisition of the TYK2 program subsidiary, subject to closing adjustments; a transfer rather than an estimate of AI-created value.", "who": "Nimbus (seller), paid by Takeda", "estimate": false, "quote": "Takeda will pay Nimbus approximately 4 billion USD upfront", "url": "https://www.takeda.com/newsroom/newsreleases/2023/takeda-completes-acquisition-of-nimbus-therapeutics-tyk2-program-subsidiary/" }, "developer_country": "United States", "deployer_country": "Japan", "unrated_because": null, "brief_notes": null, "brief": null, "revisions": [ { "date": "2026-10-20", "change": "Record drafted from the cited sources.", "source": null, "editor": "AIBD" }, { "date": "2026-10-21", "change": "Benefit type set to Improved Physical Health under Trustible's full taxonomy of 23 types; it was Improved Knowledge Discovery among the six first used.", "source": "https://trustible.ai/post/a-framework-for-measuring-the-benefits-of-ai/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Added what the benefit is measured against, the model version, the value as stated from the cited sources.", "source": "https://www.hcplive.com/view/eadv-2026-zasocitinib-tops-deucravacitinib-for-pasi-100-in-plaque-psoriasis; https://www.schrodinger.com/design-of-a-highly-selective-allosteric-picomolar-tyk2-inhibitor-using-novel-fep-strategies/; https://www.biopharmadive.com/news/nimbus-takeda-tyk2-inhibitor-drug-deal/638614/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Country of the developer and the deployer added from the organization's own site or a registry.", "source": "https://en.wikipedia.org/wiki/Schr%C3%B6dinger,_Inc.; https://www.takeda.com/who-we-are/company-information/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Prose pass: a rating reason, account, the system's part rewritten in shorter sentences with abbreviations expanded; facts, figures and quotations unchanged.", "source": null, "editor": "AIBD" }, { "date": "2026-10-21", "change": "Notes about which sources could be read were reworded for readers; facts, figures and quotations unchanged.", "source": null, "editor": "AIBD" }, { "date": "2026-10-24", "change": "Replaced derivative trial, regulatory, and transaction reporting with the original sponsor documents. Corrected the phase 2b trial’s interested authorship and online publication date.", "source": "https://www.takeda.com/newsroom/newsreleases/2026/zasocitinib-superior-efficacy/", "editor": "AIBD" } ], "confidence": "claimed", "shade": "low", "claim_status": "The makers' claim", "claim_basis": "Sources: the makers' peer-reviewed study, the makers' report, the makers' news report, the makers' dataset and three press releases from the makers. The cited evidence includes no independent source and no finding by a regulator or court.", "profile": { "case_id": "AIBD-0262", "catalog_version": "1.0.0", "source_fingerprint": "8369c6c4cda4d1bd2c6dd8c07efdcac14d89ef7bf6cb027a2dbdc322d0061e9e", "collection_refs": [ { "collection_id": "aibd", "version": "snapshot-8bf7cfec9cb185aa" }, { "collection_id": "aibd", "version": "2026-10-25" }, { "collection_id": "fructus", "version": "2026-10-25" }, { "collection_id": "viator", "version": "2026-10-25" } ], "source_ids": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "families": { "strategic assessments": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "record_ids": [] }, "evaluations": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "record_ids": [] }, "monetary observations": { "state": "value_present", "value": { "kind": "identifiers", "identifiers": [ "AIBD-0262-legacy-value", "DIV-0036" ], "role": "Existing monetary observations and Fructus statements with matched AIBD case links; each statement retains its own review and eligibility status" }, "provenance": { "kind": "curatorial", "basis": "Linked to the current Fructus dataset by its validated case identifier. Eligible statements can supply unanswered monetary questions without a new source review or a finding of net benefit.", "record_fields": [], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial", "record_ids": [ "AIBD-0262-legacy-value", "DIV-0036" ] }, "institutional decisions": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "record_ids": [] } }, "fields": { "actors[]": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "developer": "Schrodinger (platform); Nimbus Therapeutics (compound)", "deployer": "Takeda (clinical development, LATITUDE phase 3 program)" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "developer", "deployer" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "actors[].ownership_control": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "ai_contribution": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "ai_role": { "status": "assessed", "statement": "The original developer accounts describe computational structure-based design, free-energy calculations, and virtual screening. Takeda’s Warren Winkelman calls the approach AI-assisted. Physics-based computation alone does not establish an AI contribution. The discovery paper and developer accounts do not provide a controlled estimate of AI’s contribution to clinical efficacy, discovery speed, or the acquisition price." } } }, "provenance": { "kind": "curatorial", "basis": "Updated affected case fields after the dated primary-source review. Unrelated requirement assessments retain their existing status.", "record_fields": [ "ai_role" ], "source_refs": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "reviewed_on": "2026-10-24" }, "review_state": "record_mapped", "coverage": "partial" }, "ai_relationship": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "category": "benefit created", "ai_role": { "status": "assessed", "statement": "The original developer accounts describe computational structure-based design, free-energy calculations, and virtual screening. Takeda’s Warren Winkelman calls the approach AI-assisted. Physics-based computation alone does not establish an AI contribution. The discovery paper and developer accounts do not provide a controlled estimate of AI’s contribution to clinical efficacy, discovery speed, or the acquisition price." } } }, "provenance": { "kind": "curatorial", "basis": "Updated affected case fields after the dated primary-source review. Unrelated requirement assessments retain their existing status.", "record_fields": [ "category", "ai_role" ], "source_refs": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "reviewed_on": "2026-10-24" }, "review_state": "record_mapped", "coverage": "partial" }, "assessments[].alternatives": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "assessments[].assessor_date": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "assessments[].depth": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "ratings": [ { "group": "personal", "depth": 3, "reason": "Trial participants achieved complete skin clearance at higher rates. PASI 100 was 36.5% vs 13.9% at week 16 in LATITUDE Atlas, and 33% at 30 mg in phase 2b." }, { "group": "organizational", "depth": 2, "reason": "Takeda reported acceptance of its application for FDA priority review in September 2026 after acquiring the program for approximately $4 billion upfront. Application acceptance is not regulatory confirmation of efficacy or an estimate of AI-created value." }, { "group": "societal", "reason": "No approval or population-level outcome as of 20 October 2026." } ] } }, "provenance": { "kind": "curatorial", "basis": "Updated affected case fields after the dated primary-source review. Unrelated requirement assessments retain their existing status.", "record_fields": [ "ratings" ], "source_refs": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "reviewed_on": "2026-10-24" }, "review_state": "record_mapped", "coverage": "partial" }, "assessments[].display_confidence": { "state": "value_present", "value": { "kind": "structured", "data": { "confidence": "low", "evidence_word": "claimed", "claim_status": "The makers' claim", "basis": "Sources: the makers' peer-reviewed study, the makers' report, the makers' news report, the makers' dataset and three press releases from the makers. The cited evidence includes no independent source and no finding by a regulator or court.", "interpretation": "Existing display rule preserved; the richer outcome-specific confidence question still needs review." } }, "provenance": { "kind": "curatorial", "basis": "Derived from the existing case display properties; not a new evidentiary judgment.", "record_fields": [], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "assessments[].rationale": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "ratings": [ { "group": "personal", "depth": 3, "reason": "Trial participants achieved complete skin clearance at higher rates. PASI 100 was 36.5% vs 13.9% at week 16 in LATITUDE Atlas, and 33% at 30 mg in phase 2b." }, { "group": "organizational", "depth": 2, "reason": "Takeda reported acceptance of its application for FDA priority review in September 2026 after acquiring the program for approximately $4 billion upfront. Application acceptance is not regulatory confirmation of efficacy or an estimate of AI-created value." }, { "group": "societal", "reason": "No approval or population-level outcome as of 20 October 2026." } ] } }, "provenance": { "kind": "curatorial", "basis": "Updated affected case fields after the dated primary-source review. Unrelated requirement assessments retain their existing status.", "record_fields": [ "ratings" ], "source_refs": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "reviewed_on": "2026-10-24" }, "review_state": "record_mapped", "coverage": "partial" }, "assessments[].rubric_version": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "assessments[].status_basis": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "assessments[].target": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "ratings": [ { "group": "personal", "depth": 3, "reason": "Trial participants achieved complete skin clearance at higher rates. PASI 100 was 36.5% vs 13.9% at week 16 in LATITUDE Atlas, and 33% at 30 mg in phase 2b." }, { "group": "organizational", "depth": 2, "reason": "Takeda reported acceptance of its application for FDA priority review in September 2026 after acquiring the program for approximately $4 billion upfront. Application acceptance is not regulatory confirmation of efficacy or an estimate of AI-created value." }, { "group": "societal", "reason": "No approval or population-level outcome as of 20 October 2026." } ] } }, "provenance": { "kind": "curatorial", "basis": "Updated affected case fields after the dated primary-source review. Unrelated requirement assessments retain their existing status.", "record_fields": [ "ratings" ], "source_refs": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "reviewed_on": "2026-10-24" }, "review_state": "record_mapped", "coverage": "partial" }, "availability": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "brief": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "case_kind": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "case_links[]": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "claims[].evidence_links": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "claims[].evidence_strength": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "claims[].missingness": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "claims[].proposition": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "cross_border_flows[]": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "decisions[].action_outcome": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "family": "institutional decisions" }, "decisions[].grounds": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "family": "institutional decisions" }, "decisions[].institution_task": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "family": "institutional decisions" }, "decisions[].success_criterion": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "family": "institutional decisions" }, "deployment_stage": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "economics[].amount": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "value": { "amount": "$4 billion", "what": "Approximately $4 billion upfront for acquisition of the TYK2 program subsidiary, subject to closing adjustments; a transfer rather than an estimate of AI-created value.", "who": "Nimbus (seller), paid by Takeda", "estimate": false, "quote": "Takeda will pay Nimbus approximately 4 billion USD upfront", "url": "https://www.takeda.com/newsroom/newsreleases/2023/takeda-completes-acquisition-of-nimbus-therapeutics-tyk2-program-subsidiary/" } } }, "provenance": { "kind": "curatorial", "basis": "Updated affected case fields after the dated primary-source review. Unrelated requirement assessments retain their existing status.", "record_fields": [ "value" ], "source_refs": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "reviewed_on": "2026-10-24" }, "review_state": "record_mapped", "coverage": "partial" }, "economics[].costs[]": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "economics[].counterfactual": { "state": "value_present", "value": { "kind": "structured", "data": { "answer": "No estimate of the transaction value without AI-assisted design is supplied.", "monetary_statements": [ { "id": "DIV-0036", "title": "Payment for Nimbus’s TYK2 program", "monetary_role": "commercial_transaction", "financial_type": "commercial_receipt", "amount_basis": "transaction", "net_benefit_established": false, "source_review_status": "primary_source_checked", "curation_status": "curated", "observations": [ { "id": "primary", "relationship": "primary", "amount": { "source_text": "US$4 billion", "value": "4000000000", "qualifier": "exact", "currency": "USD", "currency_basis": "explicit", "price_basis": "Nominal source amount; price year not separately stated." }, "period": "Acquisition closed February 8, 2023; payment is reported in the fiscal-2023 annual securities report filed June 26, 2024.", "unit": "One acquisition’s upfront consideration.", "realization": "paid", "accounting_boundary": "Gross acquisition consideration, not drug revenue, seller profit, clinical benefit, or newly created societal wealth.", "source_review_status": "primary_source_checked", "sources": [ { "url": "https://assets-dam.takeda.com/image/upload/Global/Investor/ASR/Y2023/E_FY23_ASR.pdf", "title": "Takeda annual securities report for the year ended March 31, 2024", "quote": "we paid Nimbus USD 4.0 billion upfront following the closing of the transaction", "date": "2024-06-26", "primary": true, "written_by": "deployer", "reviewed_at": "2026-10-23", "review_method": "full_text", "locator": "Printed page 50, material contracts" } ] } ] } ] } }, "provenance": { "kind": "curatorial", "basis": "Mapped from eligible Fructus statements DIV-0036. Each statement retains its source review status. The mapping performs no new source review or currency conversion and does not establish additional value from AI.", "record_fields": [], "source_refs": [ "https://assets-dam.takeda.com/image/upload/Global/Investor/ASR/Y2023/E_FY23_ASR.pdf" ] }, "review_state": "record_mapped", "coverage": "partial" }, "economics[].currency_price_basis": { "state": "value_present", "value": { "kind": "structured", "data": { "answer": "USD, stated in the source. Nominal source amount; price year not separately stated.", "monetary_statements": [ { "id": "DIV-0036", "title": "Payment for Nimbus’s TYK2 program", "monetary_role": "commercial_transaction", "financial_type": "commercial_receipt", "amount_basis": "transaction", "net_benefit_established": false, "source_review_status": "primary_source_checked", "curation_status": "curated", "observations": [ { "id": "primary", "relationship": "primary", "amount": { "source_text": "US$4 billion", "value": "4000000000", "qualifier": "exact", "currency": "USD", "currency_basis": "explicit", "price_basis": "Nominal source amount; price year not separately stated." }, "period": "Acquisition closed February 8, 2023; payment is reported in the fiscal-2023 annual securities report filed June 26, 2024.", "unit": "One acquisition’s upfront consideration.", "realization": "paid", "accounting_boundary": "Gross acquisition consideration, not drug revenue, seller profit, clinical benefit, or newly created societal wealth.", "source_review_status": "primary_source_checked", "sources": [ { "url": "https://assets-dam.takeda.com/image/upload/Global/Investor/ASR/Y2023/E_FY23_ASR.pdf", "title": "Takeda annual securities report for the year ended March 31, 2024", "quote": "we paid Nimbus USD 4.0 billion upfront following the closing of the transaction", "date": "2024-06-26", "primary": true, "written_by": "deployer", "reviewed_at": "2026-10-23", "review_method": "full_text", "locator": "Printed page 50, material contracts" } ] } ] } ] } }, "provenance": { "kind": "curatorial", "basis": "Mapped from eligible Fructus statements DIV-0036. Each statement retains its source review status. The mapping performs no new source review or currency conversion and does not establish additional value from AI.", "record_fields": [], "source_refs": [ "https://assets-dam.takeda.com/image/upload/Global/Investor/ASR/Y2023/E_FY23_ASR.pdf" ] }, "review_state": "record_mapped", "coverage": "partial" }, "economics[].gross_net": { "state": "value_present", "value": { "kind": "structured", "data": { "answer": "Gross acquisition consideration, not drug revenue, seller profit, clinical benefit, or newly created societal wealth.", "monetary_statements": [ { "id": "DIV-0036", "title": "Payment for Nimbus’s TYK2 program", "monetary_role": "commercial_transaction", "financial_type": "commercial_receipt", "amount_basis": "transaction", "net_benefit_established": false, "source_review_status": "primary_source_checked", "curation_status": "curated", "observations": [ { "id": "primary", "relationship": "primary", "amount": { "source_text": "US$4 billion", "value": "4000000000", "qualifier": "exact", "currency": "USD", "currency_basis": "explicit", "price_basis": "Nominal source amount; price year not separately stated." }, "period": "Acquisition closed February 8, 2023; payment is reported in the fiscal-2023 annual securities report filed June 26, 2024.", "unit": "One acquisition’s upfront consideration.", "realization": "paid", "accounting_boundary": "Gross acquisition consideration, not drug revenue, seller profit, clinical benefit, or newly created societal wealth.", "source_review_status": "primary_source_checked", "sources": [ { "url": "https://assets-dam.takeda.com/image/upload/Global/Investor/ASR/Y2023/E_FY23_ASR.pdf", "title": "Takeda annual securities report for the year ended March 31, 2024", "quote": "we paid Nimbus USD 4.0 billion upfront following the closing of the transaction", "date": "2024-06-26", "primary": true, "written_by": "deployer", "reviewed_at": "2026-10-23", "review_method": "full_text", "locator": "Printed page 50, material contracts" } ] } ] } ] } }, "provenance": { "kind": "curatorial", "basis": "Mapped from eligible Fructus statements DIV-0036. Each statement retains its source review status. The mapping performs no new source review or currency conversion and does not establish additional value from AI.", "record_fields": [], "source_refs": [ "https://assets-dam.takeda.com/image/upload/Global/Investor/ASR/Y2023/E_FY23_ASR.pdf" ] }, "review_state": "record_mapped", "coverage": "partial" }, "economics[].measure_type": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "value": { "amount": "$4 billion", "what": "Approximately $4 billion upfront for acquisition of the TYK2 program subsidiary, subject to closing adjustments; a transfer rather than an estimate of AI-created value.", "who": "Nimbus (seller), paid by Takeda", "estimate": false, "quote": "Takeda will pay Nimbus approximately 4 billion USD upfront", "url": "https://www.takeda.com/newsroom/newsreleases/2023/takeda-completes-acquisition-of-nimbus-therapeutics-tyk2-program-subsidiary/" } } }, "provenance": { "kind": "curatorial", "basis": "Updated affected case fields after the dated primary-source review. Unrelated requirement assessments retain their existing status.", "record_fields": [ "value" ], "source_refs": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "reviewed_on": "2026-10-24" }, "review_state": "record_mapped", "coverage": "partial" }, "economics[].period_unit": { "state": "value_present", "value": { "kind": "structured", "data": { "answer": "Acquisition closed February 8, 2023; payment is reported in the fiscal-2023 annual securities report filed June 26, 2024. One acquisition’s upfront consideration.", "monetary_statements": [ { "id": "DIV-0036", "title": "Payment for Nimbus’s TYK2 program", "monetary_role": "commercial_transaction", "financial_type": "commercial_receipt", "amount_basis": "transaction", "net_benefit_established": false, "source_review_status": "primary_source_checked", "curation_status": "curated", "observations": [ { "id": "primary", "relationship": "primary", "amount": { "source_text": "US$4 billion", "value": "4000000000", "qualifier": "exact", "currency": "USD", "currency_basis": "explicit", "price_basis": "Nominal source amount; price year not separately stated." }, "period": "Acquisition closed February 8, 2023; payment is reported in the fiscal-2023 annual securities report filed June 26, 2024.", "unit": "One acquisition’s upfront consideration.", "realization": "paid", "accounting_boundary": "Gross acquisition consideration, not drug revenue, seller profit, clinical benefit, or newly created societal wealth.", "source_review_status": "primary_source_checked", "sources": [ { "url": "https://assets-dam.takeda.com/image/upload/Global/Investor/ASR/Y2023/E_FY23_ASR.pdf", "title": "Takeda annual securities report for the year ended March 31, 2024", "quote": "we paid Nimbus USD 4.0 billion upfront following the closing of the transaction", "date": "2024-06-26", "primary": true, "written_by": "deployer", "reviewed_at": "2026-10-23", "review_method": "full_text", "locator": "Printed page 50, material contracts" } ] } ] } ] } }, "provenance": { "kind": "curatorial", "basis": "Mapped from eligible Fructus statements DIV-0036. Each statement retains its source review status. The mapping performs no new source review or currency conversion and does not establish additional value from AI.", "record_fields": [], "source_refs": [ "https://assets-dam.takeda.com/image/upload/Global/Investor/ASR/Y2023/E_FY23_ASR.pdf" ] }, "review_state": "record_mapped", "coverage": "partial" }, "economics[].realization": { "state": "value_present", "value": { "kind": "structured", "data": { "answer": "Paid.", "monetary_statements": [ { "id": "DIV-0036", "title": "Payment for Nimbus’s TYK2 program", "monetary_role": "commercial_transaction", "financial_type": "commercial_receipt", "amount_basis": "transaction", "net_benefit_established": false, "source_review_status": "primary_source_checked", "curation_status": "curated", "observations": [ { "id": "primary", "relationship": "primary", "amount": { "source_text": "US$4 billion", "value": "4000000000", "qualifier": "exact", "currency": "USD", "currency_basis": "explicit", "price_basis": "Nominal source amount; price year not separately stated." }, "period": "Acquisition closed February 8, 2023; payment is reported in the fiscal-2023 annual securities report filed June 26, 2024.", "unit": "One acquisition’s upfront consideration.", "realization": "paid", "accounting_boundary": "Gross acquisition consideration, not drug revenue, seller profit, clinical benefit, or newly created societal wealth.", "source_review_status": "primary_source_checked", "sources": [ { "url": "https://assets-dam.takeda.com/image/upload/Global/Investor/ASR/Y2023/E_FY23_ASR.pdf", "title": "Takeda annual securities report for the year ended March 31, 2024", "quote": "we paid Nimbus USD 4.0 billion upfront following the closing of the transaction", "date": "2024-06-26", "primary": true, "written_by": "deployer", "reviewed_at": "2026-10-23", "review_method": "full_text", "locator": "Printed page 50, material contracts" } ] } ] } ] } }, "provenance": { "kind": "curatorial", "basis": "Mapped from eligible Fructus statements DIV-0036. Each statement retains its source review status. The mapping performs no new source review or currency conversion and does not establish additional value from AI.", "record_fields": [], "source_refs": [ "https://assets-dam.takeda.com/image/upload/Global/Investor/ASR/Y2023/E_FY23_ASR.pdf" ] }, "review_state": "record_mapped", "coverage": "partial" }, "economics[].recipient_payer": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "value": { "amount": "$4 billion", "what": "Approximately $4 billion upfront for acquisition of the TYK2 program subsidiary, subject to closing adjustments; a transfer rather than an estimate of AI-created value.", "who": "Nimbus (seller), paid by Takeda", "estimate": false, "quote": "Takeda will pay Nimbus approximately 4 billion USD upfront", "url": "https://www.takeda.com/newsroom/newsreleases/2023/takeda-completes-acquisition-of-nimbus-therapeutics-tyk2-program-subsidiary/" } } }, "provenance": { "kind": "curatorial", "basis": "Updated affected case fields after the dated primary-source review. Unrelated requirement assessments retain their existing status.", "record_fields": [ "value" ], "source_refs": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "reviewed_on": "2026-10-24" }, "review_state": "record_mapped", "coverage": "partial" }, "economics[].return_payback": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "economics[].valuation_method": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "evaluations[].ai_uplift": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "family": "evaluations" }, "evaluations[].comparator": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "family": "evaluations" }, "evaluations[].design": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "family": "evaluations" }, "evaluations[].effect": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "family": "evaluations" }, "evaluations[].exposure": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "family": "evaluations" }, "evaluations[].id": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "family": "evaluations" }, "evaluations[].measurement_method": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "family": "evaluations" }, "evaluations[].metric": { "state": "not_assessed", "provenance": { "kind": "legacy_record", "basis": "Mapped from the existing case description without a new external source review.", "record_fields": [ "metric" ], "source_refs": [] }, "review_state": "not_assessed", "coverage": "partial", "family": "evaluations", "display": { "answer": "PASI 100 36.5% vs 13.9% for deucravacitinib at week 16", "editor_note": "" } }, "evaluations[].reproduction_materials": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "family": "evaluations" }, "evaluations[].setting_sample": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "family": "evaluations" }, "evaluations[].uncertainty_limitations": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "family": "evaluations" }, "external_references[]": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "follow_up[]": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "later": { "status": "unknown", "date": "2026-09-14", "note": "Takeda reported FDA priority review with a decision expected in the first quarter of 2027 and EMA acceptance of the application. These sponsor announcements do not establish approval.", "url": "https://www.takeda.com/newsroom/newsreleases/2026/fda-priority-review-zasocitinib-psoriasis/" } } }, "provenance": { "kind": "curatorial", "basis": "Updated affected case fields after the dated primary-source review. Unrelated requirement assessments retain their existing status.", "record_fields": [ "later" ], "source_refs": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "reviewed_on": "2026-10-24" }, "review_state": "record_mapped", "coverage": "partial" }, "human_oversight": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "id": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "id": "AIBD-0262" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "id" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "infrastructure_dependencies[]": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "outcomes[].beneficiaries": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "outcomes[].beneficiary_count": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "outcomes[].benefit_type": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "benefit_type": "Improved Physical Health" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "benefit_type" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "outcomes[].claim": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "account": "Takeda reported that zasocitinib produced complete skin clearance in 36.5% of its LATITUDE Atlas group, versus 13.9% with deucravacitinib, at week 16. The September 30, 2026 announcement gives analysis groups of 301 and 303 participants. The sponsor’s registration lists 606 enrolled participants and has no posted results. The earlier Nimbus-funded phase 2b trial treated 259 participants and found a dose response against placebo, including complete clearance in 33% at the 30 mg dose. Nimbus and Schrödinger developed the molecule with computational structure-based design. Schrödinger describes free-energy calculations and virtual screening, while a Takeda scientist separately describes the approach as AI-assisted. These accounts do not isolate the effect of AI from the wider discovery process. Takeda reported that the FDA granted priority review and that the EMA accepted its application in September 2026. These were application milestones, not approvals. Takeda’s February 2023 closing announcement states an approximately $4 billion upfront acquisition payment, with additional contingent milestones. That transaction is not a valuation of the benefit attributable to AI.", "benefit_type": "Improved Physical Health" } }, "provenance": { "kind": "curatorial", "basis": "Updated affected case fields after the dated primary-source review. Unrelated requirement assessments retain their existing status.", "record_fields": [ "account", "benefit_type" ], "source_refs": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "reviewed_on": "2026-10-24" }, "review_state": "record_mapped", "coverage": "partial" }, "outcomes[].distribution": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "outcomes[].duration": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "outcomes[].id": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "outcomes[].stakeholder_group": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "ratings": [ { "group": "personal", "depth": 3, "reason": "Trial participants achieved complete skin clearance at higher rates. PASI 100 was 36.5% vs 13.9% at week 16 in LATITUDE Atlas, and 33% at 30 mg in phase 2b." }, { "group": "organizational", "depth": 2, "reason": "Takeda reported acceptance of its application for FDA priority review in September 2026 after acquiring the program for approximately $4 billion upfront. Application acceptance is not regulatory confirmation of efficacy or an estimate of AI-created value." }, { "group": "societal", "reason": "No approval or population-level outcome as of 20 October 2026." } ] } }, "provenance": { "kind": "curatorial", "basis": "Updated affected case fields after the dated primary-source review. Unrelated requirement assessments retain their existing status.", "record_fields": [ "ratings" ], "source_refs": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "reviewed_on": "2026-10-24" }, "review_state": "record_mapped", "coverage": "partial" }, "outcomes[].status": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "outcomes[].tradeoffs": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "outcomes[].unexpected": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "unexpected": false, "purpose": "Design a selective oral allosteric TYK2 inhibitor for plaque psoriasis and other immune-mediated diseases" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "unexpected", "purpose" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "places[]": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "location": "United States (Nimbus, Boston; Takeda Development Center Americas, Cambridge, MA); phase 2b at 55 sites in the US and Canada; phase 3 sites unverified", "developer_country": "United States", "deployer_country": "Japan" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "location", "developer_country", "deployer_country" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "purpose": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "purpose": "Design a selective oral allosteric TYK2 inhibitor for plaque psoriasis and other immune-mediated diseases" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "purpose" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "record_dates": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "date_observed": "2026-09-30", "revisions": [ { "date": "2026-10-20", "change": "Record drafted from the cited sources.", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Benefit type set to Improved Physical Health under Trustible's full taxonomy of 23 types; it was Improved Knowledge Discovery among the six first used.", "source": "https://trustible.ai/post/a-framework-for-measuring-the-benefits-of-ai/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Added what the benefit is measured against, the model version, the value as stated from the cited sources.", "source": "https://www.hcplive.com/view/eadv-2026-zasocitinib-tops-deucravacitinib-for-pasi-100-in-plaque-psoriasis; https://www.schrodinger.com/design-of-a-highly-selective-allosteric-picomolar-tyk2-inhibitor-using-novel-fep-strategies/; https://www.biopharmadive.com/news/nimbus-takeda-tyk2-inhibitor-drug-deal/638614/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Country of the developer and the deployer added from the organization's own site or a registry.", "source": "https://en.wikipedia.org/wiki/Schr%C3%B6dinger,_Inc.; https://www.takeda.com/who-we-are/company-information/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Prose pass: a rating reason, account, the system's part rewritten in shorter sentences with abbreviations expanded; facts, figures and quotations unchanged.", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Notes about which sources could be read were reworded for readers; facts, figures and quotations unchanged.", "editor": "AIBD" }, { "date": "2026-10-24", "change": "Replaced derivative trial, regulatory, and transaction reporting with the original sponsor documents. Corrected the phase 2b trial’s interested authorship and online publication date.", "source": "https://www.takeda.com/newsroom/newsreleases/2026/zasocitinib-superior-efficacy/", "editor": "AIBD" } ] } }, "provenance": { "kind": "curatorial", "basis": "Updated affected case fields after the dated primary-source review. Unrelated requirement assessments retain their existing status.", "record_fields": [ "date_observed", "revisions" ], "source_refs": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "reviewed_on": "2026-10-24" }, "review_state": "record_mapped", "coverage": "partial" }, "replication.attempts[]": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "replication": { "produced_by": [ "Computational structure-based design and laboratory testing of a selective allosteric TYK2 inhibitor", "Sponsor-led randomized clinical trials against placebo and deucravacitinib" ], "must_hold": [ "Phase 3 efficacy and safety confirmed in regulatory review", "Independent documentation of the computational platform's contribution to the molecule" ], "echoes": [ { "date": "2024-08-21", "setting": "Phase 2b RCT, 47 US and 8 Canadian centers, 259 treated patients", "outcome": "recurred", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11339701/" }, { "date": "2026-09-14", "setting": "FDA acceptance of the NDA under priority review", "outcome": "unknown", "source": "https://www.takeda.com/newsroom/newsreleases/2026/fda-priority-review-zasocitinib-psoriasis/" } ] } } }, "provenance": { "kind": "curatorial", "basis": "Updated affected case fields after the dated primary-source review. Unrelated requirement assessments retain their existing status.", "record_fields": [ "replication" ], "source_refs": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "reviewed_on": "2026-10-24" }, "review_state": "record_mapped", "coverage": "partial" }, "replication.conditions": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "replication": { "produced_by": [ "Computational structure-based design and laboratory testing of a selective allosteric TYK2 inhibitor", "Sponsor-led randomized clinical trials against placebo and deucravacitinib" ], "must_hold": [ "Phase 3 efficacy and safety confirmed in regulatory review", "Independent documentation of the computational platform's contribution to the molecule" ], "echoes": [ { "date": "2024-08-21", "setting": "Phase 2b RCT, 47 US and 8 Canadian centers, 259 treated patients", "outcome": "recurred", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11339701/" }, { "date": "2026-09-14", "setting": "FDA acceptance of the NDA under priority review", "outcome": "unknown", "source": "https://www.takeda.com/newsroom/newsreleases/2026/fda-priority-review-zasocitinib-psoriasis/" } ] } } }, "provenance": { "kind": "curatorial", "basis": "Updated affected case fields after the dated primary-source review. Unrelated requirement assessments retain their existing status.", "record_fields": [ "replication" ], "source_refs": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "reviewed_on": "2026-10-24" }, "review_state": "record_mapped", "coverage": "partial" }, "revision_history[]": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "revisions": [ { "date": "2026-10-20", "change": "Record drafted from the cited sources.", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Benefit type set to Improved Physical Health under Trustible's full taxonomy of 23 types; it was Improved Knowledge Discovery among the six first used.", "source": "https://trustible.ai/post/a-framework-for-measuring-the-benefits-of-ai/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Added what the benefit is measured against, the model version, the value as stated from the cited sources.", "source": "https://www.hcplive.com/view/eadv-2026-zasocitinib-tops-deucravacitinib-for-pasi-100-in-plaque-psoriasis; https://www.schrodinger.com/design-of-a-highly-selective-allosteric-picomolar-tyk2-inhibitor-using-novel-fep-strategies/; https://www.biopharmadive.com/news/nimbus-takeda-tyk2-inhibitor-drug-deal/638614/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Country of the developer and the deployer added from the organization's own site or a registry.", "source": "https://en.wikipedia.org/wiki/Schr%C3%B6dinger,_Inc.; https://www.takeda.com/who-we-are/company-information/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Prose pass: a rating reason, account, the system's part rewritten in shorter sentences with abbreviations expanded; facts, figures and quotations unchanged.", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Notes about which sources could be read were reworded for readers; facts, figures and quotations unchanged.", "editor": "AIBD" }, { "date": "2026-10-24", "change": "Replaced derivative trial, regulatory, and transaction reporting with the original sponsor documents. Corrected the phase 2b trial’s interested authorship and online publication date.", "source": "https://www.takeda.com/newsroom/newsreleases/2026/zasocitinib-superior-efficacy/", "editor": "AIBD" } ] } }, "provenance": { "kind": "curatorial", "basis": "Updated affected case fields after the dated primary-source review. Unrelated requirement assessments retain their existing status.", "record_fields": [ "revisions" ], "source_refs": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "reviewed_on": "2026-10-24" }, "review_state": "record_mapped", "coverage": "partial" }, "sector": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "domain": "Health; drug discovery", "segment": "Adults with moderate-to-severe plaque psoriasis" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "domain", "segment" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "sources[].access_version": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "sources[].citation_locator": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "evidence": [ { "kind": "press release", "citation": "Takeda. Zasocitinib demonstrates superior efficacy to deucravacitinib in LATITUDE Atlas. 2026-09-30. Original sponsor announcement of EADV 2026 late-breaking results, citing Stein Gold et al., LB-312, session D3T01.3.", "title": "Zasocitinib demonstrates superior efficacy to deucravacitinib in LATITUDE Atlas", "url": "https://www.takeda.com/newsroom/newsreleases/2026/zasocitinib-superior-efficacy/", "date": "2026-09-30", "written_by": "makers" }, { "kind": "peer-reviewed study", "citation": "Armstrong AW, Gooderham M, Lynde C, et al.. Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) in Psoriasis: A Randomized Clinical Trial. 2024-08-21. JAMA Dermatology 160(10). doi:10.1001/jamadermatol.2024.2701. Nimbus funded the trial and participated in design, analysis, and interpretation.", "title": "Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) in Psoriasis: A Randomized Clinical Trial", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11339701/", "date": "2024-08-21", "written_by": "makers" }, { "kind": "dataset", "citation": "Takeda; ClinicalTrials.gov. NCT06973291: LATITUDE Atlas. 2025-05-15. Sponsor-submitted registration; first posted May 15, 2025, updated May 1, 2026. No posted results.", "title": "NCT06973291: LATITUDE Atlas", "url": "https://clinicaltrials.gov/study/NCT06973291", "date": "2025-05-15", "written_by": "makers" }, { "kind": "report", "citation": "Schrödinger. Design of a highly selective, allosteric, picomolar TYK2 inhibitor using novel FEP+ strategies. n.d. Original developer account; JH2 program section concerns TAK-279.", "title": "Design of a highly selective, allosteric, picomolar TYK2 inhibitor using novel FEP+ strategies", "url": "https://www.schrodinger.com/design-of-a-highly-selective-allosteric-picomolar-tyk2-inhibitor-using-novel-fep-strategies/", "written_by": "makers" }, { "kind": "news report", "citation": "Drug Target Review, interview with Takeda’s Warren Winkelman. Inside Zasocitinib: A New Model for TYK2 Inhibition in Immune-Mediated Diseases. 2025-09-26. A firsthand sponsor account of the AI-assisted design claim, rather than independent verification.", "title": "Inside Zasocitinib: A New Model for TYK2 Inhibition in Immune-Mediated Diseases", "url": "https://www.drugtargetreview.com/inside-zasocitinib-a-new-model-for-tyk2-inhibition-in-immune-mediated-diseases/677029.article", "date": "2025-09-26", "written_by": "makers" }, { "kind": "press release", "citation": "Takeda. FDA Grants Priority Review to Zasocitinib for Moderate-to-Severe Plaque Psoriasis. 2026-09-14. Sponsor reports FDA priority review and EMA application acceptance; no approval reported.", "title": "FDA Grants Priority Review to Zasocitinib for Moderate-to-Severe Plaque Psoriasis", "url": "https://www.takeda.com/newsroom/newsreleases/2026/fda-priority-review-zasocitinib-psoriasis/", "date": "2026-09-14", "written_by": "makers" }, { "kind": "press release", "citation": "Takeda. Takeda Completes Acquisition of Nimbus Therapeutics’ TYK2 Program Subsidiary. 2023-02-08. Closing announcement. Approximately $4 billion upfront, subject to closing adjustments, with contingent milestones.", "title": "Takeda Completes Acquisition of Nimbus Therapeutics’ TYK2 Program Subsidiary", "url": "https://www.takeda.com/newsroom/newsreleases/2023/takeda-completes-acquisition-of-nimbus-therapeutics-tyk2-program-subsidiary/", "date": "2023-02-08", "written_by": "makers" } ] } }, "provenance": { "kind": "source_review", "basis": "Replaced derivative trial, regulatory, and transaction reporting with the original sponsor documents. Corrected the phase 2b trial’s interested authorship and online publication date.", "record_fields": [ "evidence" ], "source_refs": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "reviewed_on": "2026-10-24" }, "review_state": "reviewed", "coverage": "partial" }, "sources[].id": { "state": "value_present", "value": { "kind": "identifiers", "identifiers": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "role": "Active evidence sources in reviewed order" }, "provenance": { "kind": "curatorial", "basis": "Assigned to the retained evidence in the dated source review.", "record_fields": [ "evidence" ], "source_refs": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "reviewed_on": "2026-10-24" }, "review_state": "reviewed", "coverage": "complete" }, "sources[].language": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "sources[].relationship": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "evidence": [ { "kind": "press release", "citation": "Takeda. Zasocitinib demonstrates superior efficacy to deucravacitinib in LATITUDE Atlas. 2026-09-30. Original sponsor announcement of EADV 2026 late-breaking results, citing Stein Gold et al., LB-312, session D3T01.3.", "title": "Zasocitinib demonstrates superior efficacy to deucravacitinib in LATITUDE Atlas", "url": "https://www.takeda.com/newsroom/newsreleases/2026/zasocitinib-superior-efficacy/", "date": "2026-09-30", "written_by": "makers" }, { "kind": "peer-reviewed study", "citation": "Armstrong AW, Gooderham M, Lynde C, et al.. Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) in Psoriasis: A Randomized Clinical Trial. 2024-08-21. JAMA Dermatology 160(10). doi:10.1001/jamadermatol.2024.2701. Nimbus funded the trial and participated in design, analysis, and interpretation.", "title": "Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) in Psoriasis: A Randomized Clinical Trial", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11339701/", "date": "2024-08-21", "written_by": "makers" }, { "kind": "dataset", "citation": "Takeda; ClinicalTrials.gov. NCT06973291: LATITUDE Atlas. 2025-05-15. Sponsor-submitted registration; first posted May 15, 2025, updated May 1, 2026. No posted results.", "title": "NCT06973291: LATITUDE Atlas", "url": "https://clinicaltrials.gov/study/NCT06973291", "date": "2025-05-15", "written_by": "makers" }, { "kind": "report", "citation": "Schrödinger. Design of a highly selective, allosteric, picomolar TYK2 inhibitor using novel FEP+ strategies. n.d. Original developer account; JH2 program section concerns TAK-279.", "title": "Design of a highly selective, allosteric, picomolar TYK2 inhibitor using novel FEP+ strategies", "url": "https://www.schrodinger.com/design-of-a-highly-selective-allosteric-picomolar-tyk2-inhibitor-using-novel-fep-strategies/", "written_by": "makers" }, { "kind": "news report", "citation": "Drug Target Review, interview with Takeda’s Warren Winkelman. Inside Zasocitinib: A New Model for TYK2 Inhibition in Immune-Mediated Diseases. 2025-09-26. A firsthand sponsor account of the AI-assisted design claim, rather than independent verification.", "title": "Inside Zasocitinib: A New Model for TYK2 Inhibition in Immune-Mediated Diseases", "url": "https://www.drugtargetreview.com/inside-zasocitinib-a-new-model-for-tyk2-inhibition-in-immune-mediated-diseases/677029.article", "date": "2025-09-26", "written_by": "makers" }, { "kind": "press release", "citation": "Takeda. FDA Grants Priority Review to Zasocitinib for Moderate-to-Severe Plaque Psoriasis. 2026-09-14. Sponsor reports FDA priority review and EMA application acceptance; no approval reported.", "title": "FDA Grants Priority Review to Zasocitinib for Moderate-to-Severe Plaque Psoriasis", "url": "https://www.takeda.com/newsroom/newsreleases/2026/fda-priority-review-zasocitinib-psoriasis/", "date": "2026-09-14", "written_by": "makers" }, { "kind": "press release", "citation": "Takeda. Takeda Completes Acquisition of Nimbus Therapeutics’ TYK2 Program Subsidiary. 2023-02-08. Closing announcement. Approximately $4 billion upfront, subject to closing adjustments, with contingent milestones.", "title": "Takeda Completes Acquisition of Nimbus Therapeutics’ TYK2 Program Subsidiary", "url": "https://www.takeda.com/newsroom/newsreleases/2023/takeda-completes-acquisition-of-nimbus-therapeutics-tyk2-program-subsidiary/", "date": "2023-02-08", "written_by": "makers" } ] } }, "provenance": { "kind": "source_review", "basis": "Replaced derivative trial, regulatory, and transaction reporting with the original sponsor documents. Corrected the phase 2b trial’s interested authorship and online publication date.", "record_fields": [ "evidence" ], "source_refs": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "reviewed_on": "2026-10-24" }, "review_state": "reviewed", "coverage": "partial" }, "sources[].upstream_sources": { "state": "value_present", "value": { "kind": "structured", "data": { "origins": [ { "source_refs": [ "AIBD-0262-source-0001" ], "url": "https://www.takeda.com/newsroom/newsreleases/2026/zasocitinib-superior-efficacy/", "title": "Zasocitinib demonstrates superior efficacy to deucravacitinib in LATITUDE Atlas", "published_on": "2026-09-30", "relationship": "makers", "citation": "Takeda. Zasocitinib demonstrates superior efficacy to deucravacitinib in LATITUDE Atlas. 2026-09-30. Original sponsor announcement of EADV 2026 late-breaking results, citing Stein Gold et al., LB-312, session D3T01.3." }, { "source_refs": [ "AIBD-0262-source-0002" ], "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11339701/", "title": "Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) in Psoriasis: A Randomized Clinical Trial", "published_on": "2024-08-21", "relationship": "makers", "citation": "Armstrong AW, Gooderham M, Lynde C, et al.. Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) in Psoriasis: A Randomized Clinical Trial. 2024-08-21. JAMA Dermatology 160(10). doi:10.1001/jamadermatol.2024.2701. Nimbus funded the trial and participated in design, analysis, and interpretation." }, { "source_refs": [ "AIBD-0262-source-0003" ], "url": "https://clinicaltrials.gov/study/NCT06973291", "title": "NCT06973291: LATITUDE Atlas", "published_on": "2025-05-15", "relationship": "makers", "citation": "Takeda; ClinicalTrials.gov. NCT06973291: LATITUDE Atlas. 2025-05-15. Sponsor-submitted registration; first posted May 15, 2025, updated May 1, 2026. No posted results." }, { "source_refs": [ "AIBD-0262-source-0004" ], "url": "https://www.schrodinger.com/design-of-a-highly-selective-allosteric-picomolar-tyk2-inhibitor-using-novel-fep-strategies/", "title": "Design of a highly selective, allosteric, picomolar TYK2 inhibitor using novel FEP+ strategies", "relationship": "makers", "citation": "Schrödinger. Design of a highly selective, allosteric, picomolar TYK2 inhibitor using novel FEP+ strategies. n.d. Original developer account; JH2 program section concerns TAK-279." }, { "source_refs": [ "AIBD-0262-source-0005" ], "url": "https://www.drugtargetreview.com/inside-zasocitinib-a-new-model-for-tyk2-inhibition-in-immune-mediated-diseases/677029.article", "title": "Inside Zasocitinib: A New Model for TYK2 Inhibition in Immune-Mediated Diseases", "published_on": "2025-09-26", "relationship": "makers", "citation": "Drug Target Review, interview with Takeda’s Warren Winkelman. Inside Zasocitinib: A New Model for TYK2 Inhibition in Immune-Mediated Diseases. 2025-09-26. A firsthand sponsor account of the AI-assisted design claim, rather than independent verification." }, { "source_refs": [ "AIBD-0262-source-0006" ], "url": "https://www.takeda.com/newsroom/newsreleases/2026/fda-priority-review-zasocitinib-psoriasis/", "title": "FDA Grants Priority Review to Zasocitinib for Moderate-to-Severe Plaque Psoriasis", "published_on": "2026-09-14", "relationship": "makers", "citation": "Takeda. FDA Grants Priority Review to Zasocitinib for Moderate-to-Severe Plaque Psoriasis. 2026-09-14. Sponsor reports FDA priority review and EMA application acceptance; no approval reported." }, { "source_refs": [ "AIBD-0262-source-0007" ], "url": "https://www.takeda.com/newsroom/newsreleases/2023/takeda-completes-acquisition-of-nimbus-therapeutics-tyk2-program-subsidiary/", "title": "Takeda Completes Acquisition of Nimbus Therapeutics’ TYK2 Program Subsidiary", "published_on": "2023-02-08", "relationship": "makers", "citation": "Takeda. Takeda Completes Acquisition of Nimbus Therapeutics’ TYK2 Program Subsidiary. 2023-02-08. Closing announcement. Approximately $4 billion upfront, subject to closing adjustments, with contingent milestones." } ], "excluded_republications": [ { "url": "https://www.hcplive.com/view/eadv-2026-zasocitinib-tops-deucravacitinib-for-pasi-100-in-plaque-psoriasis", "title": "EADV 2026: Zasocitinib Tops Deucravacitinib for PASI 100 in Plaque Psoriasis", "published_on": "2026-09-30", "relationship": "Retained as source history; replaced by the original evidence or omitted because no distinct evidence is used for the revised claims", "previous_source_ref": "AIBD-0262-source-0002" }, { "url": "https://pharmaphorum.com/news/fda-decide-takedas-psoriasis-blockbuster-hope-q1", "title": "FDA to decide on Takeda's psoriasis blockbuster hope in Q1", "published_on": "2026-09-15", "relationship": "Retained as source history; replaced by the original evidence or omitted because no distinct evidence is used for the revised claims", "previous_source_ref": "AIBD-0262-source-0003" }, { "url": "https://www.genengnews.com/topics/artificial-intelligence/schrodingers-equation-physics-machine-learning-drug-discovery/", "title": "Schrodinger's Equation: Physics + Machine Learning = Drug Discovery", "published_on": "2023-08-18", "relationship": "Retained as source history; replaced by the original evidence or omitted because no distinct evidence is used for the revised claims", "previous_source_ref": "AIBD-0262-source-0005" }, { "url": "https://www.biopharmadive.com/news/nimbus-takeda-tyk2-inhibitor-drug-deal/638614/", "title": "Takeda to pay $4B for Nimbus' TYK2 drug", "published_on": "2022-12-13", "relationship": "Retained as source history; replaced by the original evidence or omitted because no distinct evidence is used for the revised claims", "previous_source_ref": "AIBD-0262-source-0006" } ], "independent_evaluations_of_reported_results": 0, "lead_source_ref": "AIBD-0262-source-0001", "retained_source_order": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "ordering_basis": "The source that directly supports the central case leads. Additional sources contribute the specific evidence or limitations described in claim_lineage.", "claim_lineage": [ { "claim": "Phase 3 complete-clearance comparison", "source_chain": [ { "url": "https://www.takeda.com/newsroom/newsreleases/2026/zasocitinib-superior-efficacy/", "locator": "Late-breaking LATITUDE Atlas results; reference to Stein Gold et al., EADV 2026 LB-312, session D3T01.3", "role": "Original sponsor results announcement", "access_status": "Full relevant text reviewed", "published_on": "2026-09-30" }, { "url": "https://eadv.org/congress/", "locator": "EADV 2026, Vienna, September 30–October 3; abstract LB-312", "role": "Underlying conference presentation", "access_status": "The complete original presentation/poster was not obtained" } ], "limitations": [ "301 plus 303 reported analysis participants differs from 606 enrolled; the reviewed announcement does not resolve that difference", "No independent replication or AI attribution experiment" ], "source_ref": "AIBD-0262-source-0001" }, { "claim": "Phase 2b clinical efficacy and trial funding", "source_chain": [ { "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11339701/", "locator": "Results, Figure 2, Funding/Support, and Role of the Funder/Sponsor", "role": "Original trial paper, full article reviewed through Europe PMC XML", "access_status": "Full relevant text reviewed", "published_on": "2024-08-21" } ], "limitations": [ "Nimbus funded and participated in the study; Takeda approved the manuscript", "Supplement 1 protocol, Supplement 2 analysis plan, Supplement 3 eResults, and Supplement 4 data-sharing statement were identified, but their files could not be retrieved" ], "source_ref": "AIBD-0262-source-0002" }, { "claim": "Phase 3 design and enrollment", "source_chain": [ { "url": "https://clinicaltrials.gov/study/NCT06973291", "locator": "Study overview, design, enrollment, dates, and results status; API https://clinicaltrials.gov/api/v2/studies/NCT06973291", "role": "Original sponsor registration", "access_status": "Full relevant text reviewed" } ], "limitations": [ "Registry entry is not an independent regulatory finding; no posted results" ], "source_ref": "AIBD-0262-source-0003" }, { "claim": "Computational discovery and AI attribution", "source_chain": [ { "url": "https://www.schrodinger.com/design-of-a-highly-selective-allosteric-picomolar-tyk2-inhibitor-using-novel-fep-strategies/", "locator": "JH2 program and FEP+ strategy sections", "role": "Original developer account", "access_status": "Full relevant text reviewed" }, { "url": "https://www.drugtargetreview.com/inside-zasocitinib-a-new-model-for-tyk2-inhibition-in-immune-mediated-diseases/677029.article", "locator": "Warren Winkelman interview and reference 1", "role": "Firsthand sponsor explanation", "access_status": "Full relevant text reviewed", "published_on": "2025-09-26" }, { "url": "https://doi.org/10.1021/acs.jmedchem.3c00600", "locator": "Leit et al., Discovery of a Potent and Selective Tyrosine Kinase 2 Inhibitor: TAK-279, J Med Chem 66(15):10473–10496", "role": "Original discovery study", "access_status": "Abstract and supporting-information listing identified; complete ACS paper and supplements were inaccessible", "published_on": "2023-07-10" } ], "limitations": [ "The 4,000-molecule/46-synthesis example in the developer case concerns the older JH1 program, not TAK-279", "An independent causal contribution of AI was not quantified" ], "source_ref": "AIBD-0262-source-0004" }, { "claim": "Regulatory application milestones", "source_chain": [ { "url": "https://www.takeda.com/newsroom/newsreleases/2026/fda-priority-review-zasocitinib-psoriasis/", "locator": "FDA priority review, Q1 2027 target, and EMA application acceptance", "role": "Original sponsor announcement", "access_status": "Full relevant text reviewed", "published_on": "2026-09-14" } ], "limitations": [ "Underlying agency correspondence was not public in the reviewed material; no drug approval established" ], "source_ref": "AIBD-0262-source-0006" }, { "claim": "Acquisition consideration", "source_chain": [ { "url": "https://www.takeda.com/newsroom/newsreleases/2023/takeda-completes-acquisition-of-nimbus-therapeutics-tyk2-program-subsidiary/", "locator": "Closing announcement and upfront/contingent consideration", "role": "Original buyer statement", "access_status": "Full relevant text reviewed", "published_on": "2023-02-08" }, { "url": "https://www.nimbustx.com/2022/12/13/takeda-to-acquire-nimbus-therapeutics-highly-selective-allosteric-tyk2-inhibitor-to-address-multiple-immune-mediated-diseases/", "locator": "Transaction terms", "role": "Earlier original seller announcement", "access_status": "Full relevant text reviewed", "published_on": "2022-12-13" } ], "limitations": [ "Approximately $4 billion, subject to closing adjustments; contingent payments are separate", "An acquisition transfer does not measure AI-created social or economic value" ], "source_ref": "AIBD-0262-source-0007" } ], "limitations": [ "Phase 3 presentation, discovery-paper full text, and phase 2b supplementary files remain unavailable" ] } }, "provenance": { "kind": "source_review", "basis": "Replaced derivative trial, regulatory, and transaction reporting with the original sponsor documents. Corrected the phase 2b trial’s interested authorship and online publication date.", "record_fields": [ "evidence" ], "source_refs": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "reviewed_on": "2026-10-24" }, "review_state": "reviewed", "coverage": "partial", "display": { "answer": "The phase 3 presentation, full discovery paper, and phase 2b supplements were inaccessible.", "editor_note": "" } }, "strategic_assessments[]": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "family": "strategic assessments" }, "summary": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "summary": "Takeda reports 36.5% complete skin clearance with zasocitinib versus 13.9% with deucravacitinib at week 16. The contribution of AI to discovery is not separately measured.", "account": "Takeda reported that zasocitinib produced complete skin clearance in 36.5% of its LATITUDE Atlas group, versus 13.9% with deucravacitinib, at week 16. The September 30, 2026 announcement gives analysis groups of 301 and 303 participants. The sponsor’s registration lists 606 enrolled participants and has no posted results. The earlier Nimbus-funded phase 2b trial treated 259 participants and found a dose response against placebo, including complete clearance in 33% at the 30 mg dose. Nimbus and Schrödinger developed the molecule with computational structure-based design. Schrödinger describes free-energy calculations and virtual screening, while a Takeda scientist separately describes the approach as AI-assisted. These accounts do not isolate the effect of AI from the wider discovery process. Takeda reported that the FDA granted priority review and that the EMA accepted its application in September 2026. These were application milestones, not approvals. Takeda’s February 2023 closing announcement states an approximately $4 billion upfront acquisition payment, with additional contingent milestones. That transaction is not a valuation of the benefit attributable to AI." } }, "provenance": { "kind": "curatorial", "basis": "Updated affected case fields after the dated primary-source review. Unrelated requirement assessments retain their existing status.", "record_fields": [ "summary", "account" ], "source_refs": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "reviewed_on": "2026-10-24" }, "review_state": "record_mapped", "coverage": "partial" }, "systems[].autonomy_permissions": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "systems[].component_role": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "systems[].deployment_configuration": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "systems[].inputs_outputs": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "systems[].model_name": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "systems[].model_version": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "model_version": "FEP+" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "model_version" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial", "display": { "answer": "Exact release not established.", "editor_note": "" } }, "systems[].product_name": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "system": "Schrodinger physics-based computational drug-design platform with machine learning, used by Nimbus Therapeutics to discover NDI-034858 (TAK-279, zasocitinib)" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "system" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "systems[].provider": { "state": "value_present", "value": { "kind": "structured", "data": { "application_developer": "Schrodinger (platform); Nimbus Therapeutics (compound)" } }, "provenance": { "kind": "legacy_record", "basis": "Mapped from the existing case description without a new external source review.", "record_fields": [ "developer" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "taxonomy_crosswalks[]": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "title": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "title": "Zasocitinib, computationally designed by Nimbus with Schrodinger's platform, beats deucravacitinib in phase 3; FDA priority review", "headline": "Nimbus's zasocitinib beats deucravacitinib in phase 3 trial" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "title", "headline" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "version": { "state": "value_present", "value": { "kind": "identifiers", "identifiers": [ "8369c6c4cda4d1bd2c6dd8c07efdcac14d89ef7bf6cb027a2dbdc322d0061e9e" ], "role": "SHA-256 of normalized original case data" }, "provenance": { "kind": "curatorial", "basis": "Deterministic content version after the October 24, 2026 primary-source review.", "record_fields": [], "source_refs": [], "reviewed_on": "2026-10-24" }, "review_state": "record_mapped", "coverage": "complete" }, "workflow": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "account": "Takeda reported that zasocitinib produced complete skin clearance in 36.5% of its LATITUDE Atlas group, versus 13.9% with deucravacitinib, at week 16. The September 30, 2026 announcement gives analysis groups of 301 and 303 participants. The sponsor’s registration lists 606 enrolled participants and has no posted results. The earlier Nimbus-funded phase 2b trial treated 259 participants and found a dose response against placebo, including complete clearance in 33% at the 30 mg dose. Nimbus and Schrödinger developed the molecule with computational structure-based design. Schrödinger describes free-energy calculations and virtual screening, while a Takeda scientist separately describes the approach as AI-assisted. These accounts do not isolate the effect of AI from the wider discovery process. Takeda reported that the FDA granted priority review and that the EMA accepted its application in September 2026. These were application milestones, not approvals. Takeda’s February 2023 closing announcement states an approximately $4 billion upfront acquisition payment, with additional contingent milestones. That transaction is not a valuation of the benefit attributable to AI.", "replication": { "produced_by": [ "Computational structure-based design and laboratory testing of a selective allosteric TYK2 inhibitor", "Sponsor-led randomized clinical trials against placebo and deucravacitinib" ], "must_hold": [ "Phase 3 efficacy and safety confirmed in regulatory review", "Independent documentation of the computational platform's contribution to the molecule" ], "echoes": [ { "date": "2024-08-21", "setting": "Phase 2b RCT, 47 US and 8 Canadian centers, 259 treated patients", "outcome": "recurred", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11339701/" }, { "date": "2026-09-14", "setting": "FDA acceptance of the NDA under priority review", "outcome": "unknown", "source": "https://www.takeda.com/newsroom/newsreleases/2026/fda-priority-review-zasocitinib-psoriasis/" } ] } } }, "provenance": { "kind": "curatorial", "basis": "Updated affected case fields after the dated primary-source review. Unrelated requirement assessments retain their existing status.", "record_fields": [ "account", "replication" ], "source_refs": [ "AIBD-0262-source-0001", "AIBD-0262-source-0002", "AIBD-0262-source-0003", "AIBD-0262-source-0004", "AIBD-0262-source-0005", "AIBD-0262-source-0006", "AIBD-0262-source-0007" ], "reviewed_on": "2026-10-24" }, "review_state": "record_mapped", "coverage": "partial" } }, "summary": { "total": 91, "addressed": 91, "known": 39, "reviewed": 4, "record_mapped": 35, "not_assessed": 52, "complete": false, "by_state": { "value_present": 39, "not_reported": 0, "unresolved": 0, "not_assessed": 52, "not_applicable": 0, "withheld": 0, "source_unavailable": 0 } } } }