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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.

3 Jun 2025Tier 3 MajorMethodology 0.1

Current score

+0.58

10 base · Major (tier 3 of 5, 10 pts)
× 0.5000 attribution · Material acceleration
× 0.7000 evidence · Peer review or independent validation
× 0.5500 realization · Experimentally validated
× 0.5000 durability
Event-level product before credit split: 0.96

First peer-reviewed Phase 2a of an AI-designed first-in-class small molecule is major (tier 3), not approved disease-modifying care (tier 4). Attribution is shared with human chemistry and clinical work (0.50). Peer-reviewed RCT. 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

+0.58

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

Secondary domains: Biology, Chemistry

Revision history

  • 13 Sep 2026 · 0.00 → 0.58

    Initial adjudicated seed score under methodology 0.1.