Insilico Medicine Doses First Patient in World's First Phase III Trial of a Generative AI-Driven Drug

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Insilico Medicine has dosed the first patient with Rentosertib, also known as ISM001-055 or INS018_055, in GENESIS-IPF-3, the world's first Phase III clinical trial of a generative AI-driven innovative drug, at Peking Union Medical College Hospital, with Shanghai Pulmonary Hospital enrolling its first patient the same day. The 52-week prospective, multi-center, randomized, double-blind, placebo-controlled, parallel-group study is expected to enroll a total of 320 participants across 47 centers in China, with a primary endpoint of the annual rate of decline in forced vital capacity and a key secondary endpoint of time to first occurrence of any disease progression event. The trial is led by Professor Zuojun Xu of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences as Leading Principal Investigator, with Academician Nanshan Zhong of the Chinese Academy of Engineering and President Chang Chen of Shanghai Pulmonary Hospital as Co-Leading Principal Investigators. Insilico recently reported total revenue of approximately $106 million in the first half of 2026, a 287% year-over-year increase, and its first profitable half-year since listing, with an adjusted net profit exceeding $51 million, while the total contract value of transactions announced in 2026 reached approximately $7.3 billion, pushing the cumulative contract value of its major collaborations since 2021 to approximately $11 billion. Rentosertib, a potentially first-in-class small molecule targeting TNIK, received Orphan Drug Designation from the U.S. Food and Drug Administration for IPF in February 2023 and remains investigational, having not been approved by any regulatory authority.

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First patient dosed in the world's first Phase III trial of its generative AI-driven drug Rentosertib for IPF

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