Insilico Medicine Doses First Patient in Phase III Trial of AI-Designed Drug Rentosertib

On September 10, Insilico Medicine announced that the first patient had been enrolled and dosed in the Phase III clinical trial of Rentosertib (ISM001-055/INS018_055) at Peking Union Medical College Hospital in Beijing. The first patient was also enrolled at Shanghai Pulmonary Hospital on the same day. Insilico Medicine is a Shanghai-based AI-driven drug discovery company.

The Phase III trial is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of once-daily oral Rentosertib over 52 weeks. According to the company, Rentosertib is the world's first drug candidate to enter Phase III clinical trials with both an AI-discovered target (TNIK) and an AI-designed molecule. Its Phase IIa study showed a dose-dependent trend of lung function improvement, and the candidate has received orphan drug designation from the U.S. FDA as well as breakthrough therapy designation from China's NMPA.

Zheshang Securities noted that AI drug development has moved from "algorithm narrative" to "clinical payoff", with wet-lab experiments remaining the rate-limiting step in drug R&D; AI-driven efficiency will drive stronger demand for molecular validation.