The first generative-AI-discovered drug entered Phase III in September 2026 — no AI-discovered drug has yet been approved anywhere.

Insilico dosed the first patient in GENESIS-IPF-3 (320 patients, 47 Chinese sites, 52-week FVC primary endpoint) for rentosertib in idiopathic pulmonary fibrosis after a Phase IIa signal published in Nature Medicine (2025).

What would change this

A positive 52-week FVC result, then regulatory approval, then patients treated outside a trial — each step moves it closer; approval alone does not make it a "because" entry.

Sources

• primaryClinicalTrials.gov NCT07687459 (Phase 3, rentosertib in IPF)clinicaltrials.gov
• secondaryInsilico: first patient dosed in GENESIS-IPF-3insilico.com

Editor's notes

Registry (read 2026-10-23): randomized, double-blind, placebo-controlled Phase 3; 320 planned; actual start 9 September 2026; 47 sites, all in China; primary outcome annual FVC decline over 52 weeks; primary completion estimated 30 October 2029; recruiting. what_would_change not met.

Related

• An AI-optimized antibody for severe asthma is in Phase 3 — no AI-designed antibody has been approved.

History

• Oct 23, 2026Updated sources: the ClinicalTrials.gov record (NCT07687459) is the primary and the Insilico release is retyped as secondary; the registry matches the summary's size, sites and endpoint.
• Oct 22, 2026Added.

Cite this entry