Insilico Medicine (3696.HK), a clinical-stage biotech company leveraging generative artificial intelligence for drug discovery, has announced that its investigational compound ISM8969 has received investigational new drug (IND) approval from the U.S. Food and Drug Administration (FDA). The approval paves the way for a Phase I clinical trial evaluating ISM8969 as a potential treatment for Parkinson’s Disease. ISM8969 is an orally available, brain-penetrant NLRP3 inhibitor designed to target chronic neuroinflammation, a key driver in the progression of neurodegenerative disorders. NLRP3 activation leads to excessive release of pro-inflammatory molecules, contributing to neuronal damage. By inhibiting this pathway, ISM8969 aims to reduce inflammation and support neuronal health. Carol Satler, MD, PhD, Senior Vice President for Clinical Development, Non-Oncology at Insilico Medicine, highlighted the significance of the milestone: “NLRP3 has emerged as a central player in neuroinflammation and disease progression. ISM8969, designed through our AI-powered platform, possesses the unique ability to cross the blood-brain barrier and reach the central nervous system, offering a potential breakthrough in treating Parkinson’s Disease. We are excited to advance this novel therapy into human trials and drive a paradigm shift in AI-driven drug discovery.” ISM8969 was identified and optimized using Insilico’s Chemistry42, a comprehensive generative chemistry engine that integrates AI across multiple stages of drug design. The compound demonstrates a strong druggability profile, efficacy in both acute and chronic inflammatory disease models, and favorable pharmacokinetics. To accelerate global development, Insilico has entered a co-development partnership with Hygtia Therapeutics. Under the agreement, both companies hold equal 50% rights to research, develop, register, manufacture, and commercialize ISM8969 worldwide. Insilico is eligible to receive up to $66 million in upfront and milestone payments. This development underscores Insilico’s broader success in AI-driven drug discovery. The company has built a robust portfolio powered by its Pharma.AI platform, leading to collaborations with major pharmaceutical firms including Sanofi, Eli Lilly, Exelixis, and Menarini. Three key license-out deals have a combined maximum value of up to $2.1 billion. Insilico has dramatically shortened the drug discovery timeline—achieving preclinical candidate nomination in just 12 to 18 months on average, compared to the traditional 4.5 years. From 2021 to 2024, the company nominated 20 preclinical candidates, testing only 60 to 200 molecules per program. Headquartered globally and listed on the Hong Kong Stock Exchange since December 30, 2025, Insilico Medicine continues to pioneer AI and automation in drug development, with applications extending beyond medicine into advanced materials, agriculture, nutrition, and veterinary science. For more information, visit www.insilico.com.