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Benefit Ledger · verified · Medicine & Health

Rentosertib, an AI-designed TNIK inhibitor, posts Phase 2a IPF results

Insilico Medicine’s rentosertib (ISM001-055), discovered with generative models, met a Phase 2a safety endpoint in 71 IPF patients; the 60 mg daily arm showed a mean FVC gain of 98.4 ml versus a 20.3 ml decline on placebo.

Tier 2 NotableMethodology 0.2
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Current score

+0.17

3 base · Notable (tier 2 of 5, 3 pts)
× 0.5000 attribution · Material acceleration
× 0.7000 evidence · Peer review or substantial independent validation
× 0.5500 realization · Experimentally validated
× 0.5000 durability · Medium-term
Event-level product before credit split: 0.29

A peer-reviewed Phase 2a of an AI-designed first-in-class small molecule is Notable (tier 2) until Phase 3, approval, or a documented patient-outcome effect. Attribution is shared with human chemistry and clinical work (0.50). Peer review raises evidence, not the base tier. Realization is Phase 2a, not approval. Durability uncertain pending larger trials.

What happened

Nature Medicine published the randomized Phase 2a trial on 3 June 2025 after November 2024 topline results. The 12-week China multicenter study reported similar treatment-emergent adverse-event rates across arms, with discontinuations mainly for liver toxicity or diarrhea. FVC improvement at the highest dose is a secondary signal in a small sample and does not establish an approved therapy. Earlier Nature Biotechnology (2024) described AI-based target and molecule design on Insilico’s Pharma.AI stack.

Model attribution

+0.17

Pharma.AI

Used for TNIK target nomination and generative chemistry leading to rentosertib.

Company and papers attribute design to generative AI plus substantial medicinal chemistry and clinical execution.

Attribution 0.5000 · Credit share 60% · Insilico Medicine

Claims

  • Rentosertib was discovered using Insilico’s generative AI platform and completed a randomized Phase 2a IPF trial.

    attribution · supported

  • The 60 mg QD arm showed a mean FVC increase of 98.4 ml versus placebo decline of 20.3 ml over 12 weeks.

    outcome · supported

  • Rentosertib is an approved IPF therapy.

    outcome · disputed

Sources

primary sources

independent sources

Secondary domains: Biology, Chemistry

Revision history

  • 13 Sep 2026 · 0.00 → 0.58

    Initial adjudicated seed score under methodology 0.1.

  • 14 Sep 2026 · 0.58 → 0.17

    Methodology 0.2: Phase 2a is Notable until Phase 3, approval, or a documented patient-outcome effect.

  • 17 Sep 2026 · 0.17 → 0.17

    Methodology 0.2: Phase 2a is Notable until Phase 3, approval, or a documented patient-outcome effect.

  • 18 Sep 2026 · 0.17 → 0.17

    Ingest update: added a follow-up source.

  • 18 Sep 2026 · 0.17 → 0.17

    Methodology 0.2: Phase 2a is Notable until Phase 3, approval, or a documented patient-outcome effect.

  • 19 Sep 2026 · 0.17 → 0.17

    Methodology 0.2: Phase 2a is Notable until Phase 3, approval, or a documented patient-outcome effect.

  • 21 Sep 2026 · 0.17 → 0.17

    Methodology 0.2: Phase 2a is Notable until Phase 3, approval, or a documented patient-outcome effect.

  • 6 Oct 2026 · 0.17 → 0.17

    Methodology 0.2: Phase 2a is Notable until Phase 3, approval, or a documented patient-outcome effect.

  • 7 Oct 2026 · 0.17 → 0.17

    Methodology 0.2: Phase 2a is Notable until Phase 3, approval, or a documented patient-outcome effect.

  • 11 Oct 2026 · 0.17 → 0.17

    Methodology 0.2: Phase 2a is Notable until Phase 3, approval, or a documented patient-outcome effect.

  • 11 Oct 2026 · 0.17 → 0.17

    Methodology 0.2: Phase 2a is Notable until Phase 3, approval, or a documented patient-outcome effect.

  • 21 Oct 2026 · 0.17 → 0.17

    Methodology 0.2: Phase 2a is Notable until Phase 3, approval, or a documented patient-outcome effect.

  • 24 Oct 2026 · 0.17 → 0.17

    Methodology 0.2: Phase 2a is Notable until Phase 3, approval, or a documented patient-outcome effect.

  • 27 Oct 2026 · 0.17 → 0.17

    Methodology 0.2: Phase 2a is Notable until Phase 3, approval, or a documented patient-outcome effect.

  • 28 Oct 2026 · 0.17 → 0.17

    Methodology 0.2: Phase 2a is Notable until Phase 3, approval, or a documented patient-outcome effect.

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