The upcoming study will involve 320 patients across 47 centers in China, evaluating the drug's efficacy and safety over a 52-week period. Led by Professor Zuojun Xu of Peking Union Medical College Hospital, the trial aims to determine if the positive signals observed in Phase IIa—where the 60 mg daily dose showed a mean forced vital capacity improvement of 98.4 mL—can translate into meaningful clinical benefits for patients suffering from irreversible lung scarring.
In section Releases
Insilico Medicine Launches Phase III Trial for AI-Designed IPF Drug
Insilico Medicine has initiated a Phase III clinical trial for Rentosertib, a first-in-class oral inhibitor targeting TNIK to treat idiopathic pulmonary fibrosis. This marks a milestone for the company, as the drug—discovered and optimized entirely through generative AI—advances into late-stage testing to address a severe, progressive lung disease.
Rentosertib represents a departure from traditional drug development. Rather than screening known targets, Insilico used its Pharma.AI platform to link TNIK to fibrotic and inflammatory pathways, leveraging an aging-biology-informed hypothesis. The program’s journey, from target identification via the PandaOmics engine to molecular design using Chemistry42, has been documented in peer-reviewed journals including Nature Biotechnology and Nature Medicine. This transition to Phase III underscores a shift in the biotech industry, where AI is increasingly moving beyond simple acceleration to the creation of novel therapeutic candidates for complex, age-related conditions.
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