• U.S. Food and Drug Administration (FDA) approval of the Investigational New Drug (IND) application for ISM8969 clears the path for its clinical study in the United States. The Phase I clinical trial will assess safety, tolerability, and pharmacokinetic profiles.
• ISM8969 is a new oral therapeutic candidate created using Insilico’s Pharma.AI platform, showing potential as a best-in-class agent, unique ability to cross the blood-brain barrier, and strong druggability profiles in preclinical testing.
• Insilico Medicine has signed a co-development partnership with Hygtia Therapeutics, where both companies hold 50% of the global rights and interests in the program. Insilico is entitled to receive up to $66 million in upfront and milestone payments.

CAMBRIDGE, Mass., Jan. 23, 2026 — Insilico Medicine (3696.HK), a clinical-stage drug discovery and development firm powered by generative artificial intelligence (AI), today revealed that ISM8969—an oral NLRP3 inhibitor focused on inflammation and neurodegenerative conditions—has obtained investigational new drug (IND) approval from the U.S. Food and Drug Administration (FDA) for the treatment of Parkinson’s disease. 

The Phase I clinical trial will evaluate ISM8969’s safety, tolerability, and pharmacokinetics in healthy participants, and determine the optimal dose level(s) for future research.

“NLRP3 has become a critical driver of chronic neuroinflammation and disease advancement in neurodegenerative disorders. ISM8969—a new NLRP3 inhibitor with the desired brain-penetrating capability enabled by our AI-driven design process—has the potential to take Parkinson’s disease treatment to the next level,” stated Carol Satler, MD, PhD, Senior Vice President of Non-Oncology Clinical Development at Insilico Medicine. “We’re thrilled to receive FDA approval to move this novel therapy into human trials, and we aim to create a true paradigm shift through AI breakthroughs in new drug discovery.” 

Overactivation of NLRP3 leads to excessive production of pro-inflammatory cytokines and chemokines, causing ongoing inflammation and tissue harm. By blocking NLRP3, ISM8969 seeks to regulate this pathological inflammation, promoting neuronal survival and function in patients with neurodegenerative diseases. In December 2024, ISM8969 was designated as an oral, potential best-in-class preclinical candidate targeting NLRP3.

Notably, ISM8969 was discovered and refined using Insilico’s Chemistry42—a full generative chemistry platform with multiple tools spanning drug design and discovery stages. Most importantly, its ability to cross the blood-brain barrier and directly access the central nervous system (CNS) gives ISM8969 a unique edge in treating CNS disorders like Parkinson’s disease, in addition to a balanced druggability profile and effectiveness against inflammation in both inflammatory and chronic disease mouse models.

To speed up ISM8969’s global development, Insilico Medicine has entered a co-development partnership with Hygtia Therapeutics. Under the deal, Insilico provides Hygtia with worldwide rights to research, develop, register, manufacture, and commercialize ISM8969, with both companies holding 50% of the global rights and interests in the program. In exchange, Insilico can receive up to $66 million in upfront and milestone payments.

Leveraging its Pharma.AI-powered comprehensive portfolio, Insilico has formed dozens of partnerships with top global pharmaceutical firms such as Sanofi, Lilly, Exelixis, and Menarini. Three major license-out agreements have a combined maximum total contract value of up to $2.1 billion.

Using cutting-edge AI and automation technologies, Insilico has greatly enhanced the efficiency of preclinical drug development, setting a for AI-driven drug R&D. While traditional early-stage drug discovery usually takes an average of 4.5 years, Insilico nominated 20 preclinical candidates from 2021 to 2024, with an average timeline from project start to preclinical candidate (PCC) nomination of just 12 to 18 months per program—using only 60 to 200 synthesized and tested molecules per program.

About Insilico Medicine

Insilico Medicine is a leading global biotech company focused on integrating AI and automation technologies to speed up drug discovery, drive life sciences innovation, and extend healthy lifespan for people worldwide. The firm was listed on the Hong Kong Stock Exchange’s Main Board on December 30, 2025, under stock code 03696.HK.

Through combining AI, automation, and deep in-house drug discovery expertise, Insilico delivers innovative drug solutions for unmet needs like fibrosis, oncology, immunology, pain, and obesity/metabolic disorders. Insilico also applies Pharma.AI to diverse industries including advanced materials, agriculture, nutritional products, and veterinary medicine. For more details, please visit

SOURCE Insilico Medicine