The candidate, KQTD-126, functions as a gut-restricted pan-TRK inhibitor. By targeting TRKA, TRKB, and TRKC receptors exclusively within the gastrointestinal tract, the drug aims to resolve chronic pain while bypassing the central nervous system, where traditional systemic inhibitors often trigger adverse neurological reactions. Preclinical data highlight the drug's potency, showing sub-nanomolar activity (IC50 < 1 nM) and a gut-to-blood exposure ratio exceeding 1,000:1.
In section Releases
XtalPi Files FDA Application for AI-Designed Chronic Pain Drug
With the submission of an Investigational New Drug application to the U.S. FDA, XtalPi has officially transitioned into a clinical-stage organization. The company’s lead candidate, KQTD-126, targets chronic intestinal pain in patients with IBS and IBD by utilizing a localized approach to avoid systemic neurological side effects.

To achieve this specific biological profile, XtalPi utilized its proprietary drug discovery platform, which integrates generative AI models with automated chemistry robotics. This closed-loop process allowed researchers to navigate complex chemical spaces, balancing target affinity with strict tissue distribution requirements. The submission represents the first program from XtalPi’s internal pipeline to reach this milestone, following the company’s recent interim results. The global market for IBS and IBD therapeutics is expected to reach $52.6 billion by 2030, underscoring the demand for long-term treatment options that address persistent abdominal pain.
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