{ "id": "AIBD-0006", "title": "Generative-AI-discovered TNIK inhibitor rentosertib shows FVC improvement in a 71-patient phase 2a IPF trial", "summary": "Phase 2a GENESIS-IPF trial in China: 60 mg daily rentosertib +98.4 mL FVC vs -20.3 mL placebo at 12 weeks; cohort-level, sponsor-run", "date_observed": "2024-08-08", "date_basis": "unassessed", "date_precision": "unassessed", "benefit_status": null, "source_collection": null, "source_entry": null, "account": "Rentosertib, a TNIK inhibitor designed with Insilico Medicine's generative-AI platform, was tested in a randomized, double-blind, placebo-controlled phase 2a trial (NCT05938920). It enrolled 71 patients with idiopathic pulmonary fibrosis at 21 sites in China from 19 July 2023 to 11 June 2024 (paper). The registry lists 22 locations, a start date of 19 June 2023 and study completion on 8 August 2024. The primary endpoint was safety. Treatment-emergent adverse events were similar across arms. Patients on 60 mg once daily showed a mean forced vital capacity change of +98.4 mL versus -20.3 mL on placebo over 12 weeks. Insilico sponsored the trial. Eleven authors are its employees and the first author is at Peking Union Medical College Hospital. Results appeared in Nature Medicine on 3 June 2025. The authors call for larger, longer trials.", "category": "general benefit", "unexpected": false, "purpose": "Rentosertib was designed as an antifibrotic treatment for idiopathic pulmonary fibrosis. The trial tested the safety and preliminary efficacy of exactly that intended benefit.", "system": "Insilico Medicine generative-AI drug discovery platform (target discovery and generative chemistry) that produced rentosertib (ISM001-055)", "model_version": "PandaOmics (Biology42) and Chemistry42, Insilico Pharma.AI platform", "developer": "Insilico Medicine", "deployer": "Insilico Medicine (trial sponsor) with 21 clinical centers in China", "location": null, "domain": "Pharmaceutical R&D / respiratory medicine", "segment": "Idiopathic pulmonary fibrosis", "benefit_type": "Improved Physical Health", "taxonomy_note": null, "registry_ids": {}, "ratings": [ { "group": "personal", "depth": null, "reason": "The FVC improvement is a cohort mean from a 71-patient, 12-week, sponsor-run phase 2a trial with safety as the primary endpoint." }, { "group": "societal", "depth": null, "reason": "Any wider benefit depends on confirmation in larger, longer trials, which the authors themselves say are warranted." } ], "ai_role": { "status": "assessed", "statement": "The AI role is upstream: generative-AI tools identified TNIK as a target and designed the molecule. Any clinical effect is pharmacological. The trial was not powered for efficacy and FVC was not the primary endpoint. An independent network meta-analysis ranks rentosertib favorably on FVC decline but reports a non-significant trend toward more serious adverse events." }, "evidence": [ { "kind": "peer-reviewed study", "citation": "Xu Z et al. (2025). A generative AI-discovered TNIK inhibitor for idiopathic pulmonary fibrosis: a randomized phase 2a trial. Nature Medicine 31:2602–2610. doi:10.1038/s41591-025-03743-2. Insilico Medicine sponsored the trial; eleven authors were employees, and sponsor-employed authors participated in trial design, collection, analysis, and interpretation.", "title": "A generative AI-discovered TNIK inhibitor for idiopathic pulmonary fibrosis: a randomized phase 2a trial", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC12353801/", "date": "2025-06-03", "written_by": "makers", "quote": "We observed increased forced vital capacity at the highest dosage with a mean change of +98.4 ml (95% confidence interval 10.9 to 185.9) for patients in the 60 mg rentosertib QD group, compared with −20.3 ml (95% confidence interval −116.1 to 75.6) for the placebo group." }, { "kind": "registry label", "citation": "Insilico Medicine Hong Kong Limited. ClinicalTrials.gov, NCT05938920, phase IIa trial of INS018_055 in idiopathic pulmonary fibrosis. Sponsor-supplied registration and results, first posted July 11, 2023; results first posted December 2, 2025.", "title": "Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)", "url": "https://clinicaltrials.gov/study/NCT05938920", "date": "2023-07-11", "written_by": "makers", "quote": "Percentage of Participants Who Had at Least 1 Treatment-emergent Adverse Event (TEAE)" }, { "kind": "peer-reviewed study", "citation": "Xu J, Liu X, Liang X, Cai X, Qian W (2026). Comparative efficacy and safety of monotherapy and combination pharmacotherapies for idiopathic pulmonary fibrosis: a network meta-analysis of randomized controlled trials. BMC Pulmonary Medicine.", "title": "Comparative efficacy and safety of monotherapy and combination pharmacotherapies for idiopathic pulmonary fibrosis: a network meta-analysis of randomized controlled trials", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13330183/", "date": "2026-05-11", "written_by": "independent", "quote": "Rentosertib exhibited a non-significant trend toward a higher risk of SAEs compared with placebo (OR = 1.42, 95% CI: 0.72–2.77)." }, { "kind": "peer-reviewed study", "citation": "Khairil L, Benny KHS, Jerry J, Khatib FM, Che Ramli MD, Kumar S (2026). AI in Drug Discovery: Clinical Failures, Regulatory Reality, and the Validation Crisis Behind the Hype. Pharmaceuticals.", "title": "AI in Drug Discovery: Clinical Failures, Regulatory Reality, and the Validation Crisis Behind the Hype", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13304925/", "date": "2026-06-10", "written_by": "independent", "quote": "AI-discovered TNIK inhibitor showed dose-dependent FVC improvement (~trend up to ~100 mL) with acceptable safety." }, { "kind": "peer-reviewed study", "citation": "Magrì T, Richeldi L (2026). Contemporary Concise Review 2025: Interstitial Lung Disease. Respirology.", "title": "Contemporary Concise Review 2025: Interstitial Lung Disease", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13634690/", "date": "2026-09-07", "written_by": "independent", "quote": "Rentosertib, a first-in-class AI-generated small-molecule inhibitor of TNIK, a first-in-class target in idiopathic pulmonary fibrosis (IPF) discovered using generative AI." }, { "kind": "news report", "citation": "Hornick I (2025). Q&A: AI-established drug 'breakthrough in the treatment of IPF'. Healio. (Interviewees: Zuojun Xu, Peking Union Medical College; Alex Zhavoronkov, Insilico CEO.)", "title": "Q&A: AI-established drug 'breakthrough in the treatment of IPF'", "url": "https://www.healio.com/news/pulmonology/20250707/qa-aiestablished-drug-breakthrough-in-the-treatment-of-ipf", "date": "2025-07-07", "written_by": "independent", "quote": "The current phase 2a clinical results are encouraging, but they are based on a small sample size, and we look forward to seeing how it performs in phase 3 clinical trials." }, { "kind": "press release", "citation": "Insilico Medicine. Insilico Initiates Phase III Clinical Trial for Rentosertib, Its AI-Empowered TNIK Inhibitor for Idiopathic Pulmonary Fibrosis. 7 July 2026.", "title": "Insilico Initiates Phase III Clinical Trial for Rentosertib, Its AI-Empowered TNIK Inhibitor for Idiopathic Pulmonary Fibrosis", "url": "https://insilico.com/news/xmjsn4l091-insilico-initiates-phase-iii-clinical-tr", "date": "2026-07-07", "written_by": "makers", "quote": null } ], "replication": { "produced_by": [ "Generative-AI target identification (TNIK) and molecule design by the sponsor", "Sponsor-run 12-week, double-blind phase 2a trial at Chinese centers with safety as the primary endpoint" ], "must_hold": [ "The FVC signal must be confirmed in a larger, longer, geographically diverse phase 3 trial", "Hepatic adverse events and the serious-adverse-event trend must remain acceptable" ], "echoes": [] }, "paired_incident": null, "headline": "Insilico's rentosertib improves FVC in a phase 2a IPF trial", "metric": "mean forced vital capacity change of +98.4 mL versus -20.3 mL on placebo over 12 weeks", "comparator": { "against": "placebo", "before": "−20.3 ml (95% confidence interval −116.1 to 75.6) for the placebo group", "after": "+98.4 ml (95% confidence interval 10.9 to 185.9) for patients in the 60 mg rentosertib QD group", "basis": "measured", "quote": "We observed increased forced vital capacity at the highest dosage with a mean change of +98.4 ml (95% confidence interval 10.9 to 185.9) for patients in the 60 mg rentosertib QD group, compared with −20.3 ml (95% confidence interval −116.1 to 75.6) for the placebo group.", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC12353801/" }, "later": { "status": "scaled", "date": "2026-07-07", "note": "Insilico announced a 320-patient, 47-center, 52-week phase III trial of rentosertib in China on 7 July 2026, moving the drug past the 71-patient phase 2a stage.", "quote": "The prospective, randomized, double-blind, placebo-controlled, parallel-group Phase III study is expected to enroll a total of 320 participants across 47 centers in China. The primary endpoint is the annual rate of decline in forced vital capacity (FVC) over 52 weeks.", "url": "https://insilico.com/news/xmjsn4l091-insilico-initiates-phase-iii-clinical-tr" }, "value": null, "developer_country": "United States", "deployer_country": "United States", "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": "2026-10-20", "change": "Healio quote replaced with Xu's verbatim sentence; Nature Medicine quote replaced with the abstract sentence giving +98.4 ml versus −20.3 ml; account now separates the paper's conduct period and 21 sites from the registry's 19 June 2023 start, 22 locations and 8 August 2024 completion; Nature Medicine citation now states the sponsor-employed authors' role and the corresponding authors, on which basis the source stays independent.", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC12353801/ ; https://www.healio.com/news/pulmonology/20250707/qa-aiestablished-drug-breakthrough-in-the-treatment-of-ipf ; https://clinicaltrials.gov/study/NCT05938920", "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, what happened since, the model version from the cited sources.", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC12353801/; https://insilico.com/news/xmjsn4l091-insilico-initiates-phase-iii-clinical-tr; https://insilico.com/news/xmjsn4l091-insilico-initiates-phase-iii-clinical-tr", "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/Insilico_Medicine; https://en.wikipedia.org/wiki/Insilico_Medicine", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Prose pass: a rating reason, account, purpose, the system's part rewritten in shorter sentences with abbreviations expanded; facts, figures and quotations unchanged.", "source": null, "editor": "AIBD" }, { "date": "2026-10-25", "change": "Reviewed the specified original sources; corrected their authorship, document types, and support for the reported benefit.", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC12353801/", "editor": "AIBD" } ], "confidence": "studied", "shade": "high", "claim_status": "Independently studied", "claim_basis": "Sources: three independent peer-reviewed studies, one independent news report, the makers' peer-reviewed study, the makers' press release and a registry entry. The cited evidence includes no finding by a regulator or court.", "profile": { "case_id": "AIBD-0006", "catalog_version": "1.0.0", "source_fingerprint": "4feab4514c129b7e2e4ddc159c19579f9244619ac153adbd20701b97329ce132", "collection_refs": [ { "collection_id": "aibd", "version": "snapshot-8bf7cfec9cb185aa" }, { "collection_id": "aibd", "version": "2026-10-25" } ], "source_ids": [ "AIBD-0006-source-0001", "AIBD-0006-source-0002", "AIBD-0006-source-0003", "AIBD-0006-source-0004", "AIBD-0006-source-0005", "AIBD-0006-source-0006", "AIBD-0006-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": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "record_ids": [] }, "institutional decisions": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "record_ids": [] } }, "fields": { "actors[]": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "developer": "Insilico Medicine", "deployer": "Insilico Medicine (trial sponsor) with 21 clinical centers in China" } }, "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 AI role is upstream: generative-AI tools identified TNIK as a target and designed the molecule. Any clinical effect is pharmacological. The trial was not powered for efficacy and FVC was not the primary endpoint. An independent network meta-analysis ranks rentosertib favorably on FVC decline but reports a non-significant trend toward more serious adverse events." } } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "ai_role" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "ai_relationship": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "category": "general benefit", "ai_role": { "status": "assessed", "statement": "The AI role is upstream: generative-AI tools identified TNIK as a target and designed the molecule. Any clinical effect is pharmacological. The trial was not powered for efficacy and FVC was not the primary endpoint. 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It enrolled 71 patients with idiopathic pulmonary fibrosis at 21 sites in China from 19 July 2023 to 11 June 2024 (paper). The registry lists 22 locations, a start date of 19 June 2023 and study completion on 8 August 2024. The primary endpoint was safety. Treatment-emergent adverse events were similar across arms. Patients on 60 mg once daily showed a mean forced vital capacity change of +98.4 mL versus -20.3 mL on placebo over 12 weeks. Insilico sponsored the trial. Eleven authors are its employees and the first author is at Peking Union Medical College Hospital. Results appeared in Nature Medicine on 3 June 2025. 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No new source review is claimed.", "record_fields": [ "model_version", "system", "ai_role" ], "source_refs": [] }, "review_state": "record_mapped", "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": "PandaOmics (Biology42) and Chemistry42, Insilico Pharma.AI platform" } }, "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": "Insilico Medicine generative-AI drug discovery platform (target discovery and generative chemistry) that produced rentosertib (ISM001-055)" } }, "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": "Insilico Medicine" } }, "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": "Generative-AI-discovered TNIK inhibitor rentosertib shows FVC improvement in a 71-patient phase 2a IPF trial", "headline": "Insilico's rentosertib improves FVC in a phase 2a IPF 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": [ "4feab4514c129b7e2e4ddc159c19579f9244619ac153adbd20701b97329ce132" ], "role": "SHA-256 of normalized original case data" }, "provenance": { "kind": "curatorial", "basis": "Deterministic content version assigned by the local migration.", "record_fields": [], "source_refs": [] }, "review_state": "record_mapped", "coverage": "complete" }, "workflow": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "account": "Rentosertib, a TNIK inhibitor designed with Insilico Medicine's generative-AI platform, was tested in a randomized, double-blind, placebo-controlled phase 2a trial (NCT05938920). It enrolled 71 patients with idiopathic pulmonary fibrosis at 21 sites in China from 19 July 2023 to 11 June 2024 (paper). The registry lists 22 locations, a start date of 19 June 2023 and study completion on 8 August 2024. The primary endpoint was safety. Treatment-emergent adverse events were similar across arms. Patients on 60 mg once daily showed a mean forced vital capacity change of +98.4 mL versus -20.3 mL on placebo over 12 weeks. Insilico sponsored the trial. Eleven authors are its employees and the first author is at Peking Union Medical College Hospital. Results appeared in Nature Medicine on 3 June 2025. The authors call for larger, longer trials.", "replication": { "produced_by": [ "Generative-AI target identification (TNIK) and molecule design by the sponsor", "Sponsor-run 12-week, double-blind phase 2a trial at Chinese centers with safety as the primary endpoint" ], "must_hold": [ "The FVC signal must be confirmed in a larger, longer, geographically diverse phase 3 trial", "Hepatic adverse events and the serious-adverse-event trend must remain acceptable" ], "echoes": [] } } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "account", "replication" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" } }, "summary": { "total": 91, "addressed": 91, "known": 31, "reviewed": 2, "record_mapped": 29, "not_assessed": 60, "complete": false, "by_state": { "value_present": 31, "not_reported": 0, "unresolved": 0, "not_assessed": 60, "not_applicable": 0, "withheld": 0, "source_unavailable": 0 } } } }