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Insilico Medicine Receives IND Approval from FDA for ISM8969, an AI-empowered Potential Best-in-class NLRP3 Inhibitor
Insilico Medicine (3696.HK), a clinical-stage drug discovery and development company driven by generative artificial intelligence (AI), today announced that ISM8969, an orally available NLRP3 inhibitor targeting inflammation and neurodegenerative disorders, has recently received investigational new drug (IND) clearance from the U.S. Food and Drug Administration (FDA), intended for the treatment of Parkinson's Disease.
About this update from Insilico Medicine Cayman Topco
[{"type":"list","items":[{"val":[{"type":"text","content":"Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) paves the way for ISM8969 clinical study in the United States. The Phase I clinical trial aims to evaluate safety, tolerability, and pharmacokinetics profiles.","length":248,"tagName":"p"}]},{"val":[{"type":"text","content":"ISM8969 is a novel oral therapeutic candidate developed through Insilico's Pharma.AI, with best-in-class potential, unique brain penetrant traits, and favorable druggability profiles demonstrated in preclinical studies.","length":223,"tagName":"p"}]},{"val":[{"type":"text","content":"Insilico Medicine has entered into a co-development collaboration agreement with Hygtia Therapeutics, with both parties each holding 50% of the global rights and interests to the program. In return, Insilico is eligible to receive up to $66 million in upfront and milestone payments.","length":283,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":754,"olType":false},{"type":"text","content":"CAMBRIDGE, Mass., Jan. 23, 2026 /PRNewswire/ -- Insilico Medicine (3696.HK), a clinical-stage drug discovery and development company driven by generative artificial intelligence (AI), today announced that ISM8969, an orally available NLRP3 inhibitor targeting inflammation and neurodegenerative disorders, has recently received investigational new drug (IND) clearance from the U.S. Food and Drug Administration (FDA), intended for the treatment of Parkinson's Disease.","length":473,"tagName":"p"},{"type":"text","content":"The Phase I clinical trial plans to evaluate the safety, tolerability, and pharmacokinetics of ISM8969 in healthy volunteers, and to identify the optimal dose level(s) to be recommended for further investigation.","length":212,"tagName":"p"},{"type":"text","content":""NLRP3 has emerged as a key contributor to chronic neuroinflammation and disease progression in neurodegenerative disorders. A novel NLRP3 inhibitor, ISM8969 with the desired brain penetrant property made possible via our AI-powered design process, offers the potential to advance Parkinson's Disease treatment to the next generation," says Carol Satler, MD, PhD, Senior Vice President for Clinical Development, Non-Oncology, Insilico Medicine. "We are excited to get the greenlight from FDA to advance this novel...