XtalPi files FDA application for intestinal pain drug candidate
Technology firm XtalPi submitted an Investigational New Drug application to the US Food and Drug Administration to initiate clinical trials for its gut restricted inhibitor KQTD 126
BOSTON and SHENZHEN, CHINA, Sept. 25, 2026 /PRNewswire/ -- XtalPi, an AI and robotics-focused drug and materials discovery firm, has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for KQTD-126. This candidate is a unique gut-restricted pan-tropomyosin receptor kinase (pan-TRK) inhibitor intended to address chronic intestinal pain linked to irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD).
IBS impacts roughly 10%-15% of the world's population, while over 10 million individuals suffer from IBD. Persistent abdominal pain is a significant concern for IBS sufferers, and even with existing treatments, there is a need for additional options that offer long-lasting pain relief and are safe for long-term use. The global IBS and IBD therapeutics market is expected to grow to US$52.6 billion by 2030, according to BCC Research.
KQTD-126 specifically targets the TRK family of receptors (TRKA, TRKB, and TRKC), which regulate nerve activity and pain signal amplification in the gut. While targeting these pathways can effectively manage this pain, traditional TRK inhibitors can cause serious neurological side effects due to their impact on other parts of the central nervous system.
XtalPi resolved this challenge by utilizing its AI models and automated chemistry robots to navigate the extensive chemical space and balance target affinity, kinase selectivity, and tissue distribution properties. Preclinical studies have demonstrated that KQTD-126 achieves pan-TRK inhibition at sub-nanomolar concentrations (IC₅₀).
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