Cambridge – – September 15, 2026 -- Insilico Medicine (HKEX: 3696) has dosed the first patient in GENESIS-IPF-3, a Phase III trial of Rentosertib, marking what the company calls the world's first late-stage clinical study of a drug candidate discovered and developed using generative AI.
Peking and Shanghai hospitals simultaneously enroll first patients
The dosing occurred at Peking Union Medical College Hospital, with Shanghai Pulmonary Hospital enrolling its own first patient on the same day. Professor Zuojun Xu of Peking Union Medical College Hospital serves as Leading Principal Investigator, with Academician Nanshan Zhong and President Chang Chen of Shanghai Pulmonary Hospital as Co-Leading PIs.
Trial targets 320 IPF patients across 47 Chinese centers over 52 weeks
The randomized, double-blind, placebo-controlled study (NCT07687459, CTR20262475) will measure the annual rate of decline in forced vital capacity as its primary endpoint, with time to first disease progression event as a key secondary measure. Xu noted that TNIK, the AI-identified drug target, had no prior link to fibrosis research, calling it evidence that AI is opening discovery paths distinct from traditional research. He estimated three to four years from Phase III initiation to potential regulatory approval under favorable conditions.
Phase IIa data showed dose-dependent lung function improvements
Insilico has documented Rentosertib's development through peer-reviewed publications: a 2024 Nature Biotechnology paper on AI-driven discovery, a 2025 Nature Medicine study reporting Phase IIa results with dose-dependent efficacy trends, and a 2026 Nature Biotechnology study showing reduced biological age across six independent aging clock models following dosing. The FDA granted Rentosertib Orphan Drug Designation for IPF in February 2023. IPF affects approximately 5 million people globally and carries a median survival of three to four years, with no current therapy able to reverse the disease.
Carol Satler, MD, PhD, Senior Vice President for Clinical Development, Non-Oncology at Insilico Medicine, said AI has enabled faster, lower-cost drug discovery that could reshape the field.
Revenue jumps 287% as licensing deals push contract value to $11 billion
Insilico reported approximately $106 million in total revenue for the first half of 2026, a 287% year-over-year increase, alongside its first profitable half-year since listing with adjusted net profit exceeding $51 million. The results were driven by out-licensing and R&D collaborations with Eli Lilly, Servier, Takeda, SK Biopharmaceuticals, Qilu Pharmaceutical, Hygtia Therapeutics, CMS, and Tenacia. Total contract value of transactions announced in 2026 reached approximately $7.3 billion, pushing cumulative collaboration value since 2021 to roughly $11 billion.
Company nominates nine development candidates in nine months
Insilico nominated nine development candidates within the first nine months of 2026, a company record for annual pipeline productivity, while achieving eight clinical milestones across proprietary and co-developed programs. The company also launched benchmarks and foundation models designed to evaluate AI systems across drug discovery tasks, which it says outperform existing internal tools.