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.
Preclinical data show sub-nanomolar potency and a 1,000:1 gut-to-blood exposure ratio
KQTD-126 achieved pan-TRK inhibition (targeting TRKA, TRKB, and TRKC) at concentrations below 1 nM (IC50 < 1 nM) while maintaining high selectivity over other kinases. The candidate demonstrated a gut tissue-to-blood exposure ratio exceeding 1,000:1, confining pharmacological activity to the gastrointestinal tract and limiting systemic exposure.
Design addresses a known safety gap in systemic TRK inhibitors
TRK receptors regulate nerve activity and pain-signal amplification in the gut, but they also operate throughout the central nervous system. Traditional systemic TRK inhibitors therefore carry a high risk of neurological side effects, restricting their use for chronic, long-term pain management. XtalPi positions KQTD-126 as the industry's first gut-restricted pan-TRK inhibitor developed specifically to avoid this liability while still delivering sustained pain relief.
AI-robotics closed-loop process resolved competing chemical design constraints
Achieving the target's biological profile required navigating a large chemical space to balance target affinity, kinase selectivity, and tissue-distribution properties. XtalPi applied its generative and predictive AI models integrated with automated chemistry robots in a closed-loop cycle of computational design, automated synthesis, empirical screening, and molecular refinement to iterate across structural variants.
Market opportunity spans a $52.6 billion IBS/IBD therapeutics segment by 2030
IBS affects an estimated 10%-15% of the global population, and more than 10 million people live with IBD, according to the source material. Chronic abdominal pain remains a major burden for IBS patients and can persist in some IBD patients even when standard anti-inflammatory therapies control the underlying disease. BCC Research projects the global IBS and IBD therapeutics market will reach $52.6 billion by 2030, underscoring the commercial scale of unmet need for pain therapies suitable for long-term use.