XtalPi Files FDA IND for First Gut-Restricted Pan-TRK Pain Drug
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Boston and Shenzhen – September 24, 2026 -- XtalPi Holdings Limited (HKEX: 2228) has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for KQTD-126, a potential first-in-class gut-restricted pan-tropomyosin receptor kinase (pan-TRK) inhibitor targeting chronic intestinal pain in irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD).
KQTD-126 marks XtalPi's first proprietary pipeline candidate to reach IND stage
The submission represents the inaugural IND filing from XtalPi's internally developed pipeline, which the company disclosed in its recent interim results. It confirms the company's transition from a discovery-services provider to a clinical-stage drug developer built on AI and robotics.