US EditionFirst AI-Designed Drug Nears Final Trials Before Approval
Rentosertib, designed using artificial intelligence, showed lung function improvement in a Phase II trial with 71 patients and is moving rapidly toward Phase 3 trials.
- After publication in Nature Medicine, Insilico Medicine’s Rentosertib is likely to enter Phase 3 trials within the coming year, based on industry projections.
- Given that traditional drug development timelines cost about $2 billion, AI accelerates candidate nomination by shortening preclinical phases to 12–18 months, according to Insilico’s Pharma.AI.
- The GENESIS‑IPF Phase IIa trial enrolled 71 patients across 22 sites in China, showing the 60 mg QD group gained +98.4 mL in FVC and biomarker analyses validated TNIK inhibition.
- Insilico Medicine has begun discussions with regulatory authorities and is scaling through partnerships, including a potential $100 million deal with Eli Lilly and a HK IPO that raised US$293 million, to support global expansion.
- VCs invested $2.7 billion in AI drug startups through Q3 2025, and Precedence Research projects AI investment to reach $2.51 billion in 2026 and $16.49 billion by 2034, although experts caution AI’s limited role in late-stage trials.
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A generative AI-discovered TNIK inhibitor for idiopathic pulmonary fibrosis: a randomized phase 2a trial - Nature Medicine
Despite substantial progress in artificial intelligence (AI) for generative chemistry, few novel AI-discovered or AI-designed drugs have reached human clinical trials. Here we present the results of the first phase 2a multicenter, double-blind, randomized, placebo-controlled trial testing the safety and efficacy of rentosertib (formerly ISM001-055), a first-in-class AI-generated small-molecule inhibitor of TNIK, a first-in-class target in idiopa…
AI-powered R&D acceleration: Insilico Medicine and Hisun Pharma nominate a preclinical candidate just 8 months after forming a strategic collaboration
January 2, 2026 – Insilico Medicine (“Insilico”, 03696.HK), a clinical-stage biotechnology company driven by generative artificial intelligence (AI), announced the milestone in its collaboration with Hisun Pharmaceutical Co., Ltd. (“Hisun” 600267.SH). Leveraging its proprietary Pharma.AI platform, Insilico successfully nominated a preclinical candidate (PCC) just 8 months after the two parties entered a strategic collaboration. The collaboratio
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