First AI-designed drug reaches Phase III

Insilico Medicine's rentosertib remains under study in GENESIS-IPF-3, reportedly the first Phase III trial of a generative-AI-designed drug: a 320-participant, 52-week idiopathic pulmonary fibrosis study with clinically relevant endpoints. The drug remains investigational; no AI-designed drug has received FDA approval, and biomarker or aging-clock findings do not establish efficacy, safety, disease modification, or systemic age reversal.