KQTD-126 targets chronic abdominal pain associated with IBS and IBD
SHENZHEN, China and BOSTON, United States, Oct. 28, 2026 — XtalPi Holdings Limited (“XtalPi,” HKEX: 2228) today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for KQTD-126, an internally developed, gut-restricted pan-tropomyosin receptor kinase (pan-TRK) inhibitor. Following IND clearance, the company plans to initiate clinical trials in the near term to evaluate KQTD-126’s safety, tolerability, and pharmacokinetics.
The candidate is being developed to treat chronic abdominal pain associated with irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD). IBS is estimated to affect approximately 10%–15% of people worldwide, while more than 10 million people live with IBD. BCC Research estimated the broader global market for IBS and IBD therapies at US$33.3 billion in 2025, with growth to US$52.6 billion projected by 2030. [1]
Abdominal pain is a defining symptom of IBS and can persist in people with IBD even after intestinal inflammation is controlled. Patients need treatment options that provide sustained relief and are suitable for long-term use, yet available therapies do not fully address this need.
KQTD-126 targets the tropomyosin receptor kinase (TRK) family, TRKA, TRKB, and TRKC, which helps regulate sensory nerve activity and pain sensitization. Inhibiting these pathways offers a potential approach to reducing intestinal pain. However, TRK receptors also function in other tissues, including the central nervous system. KQTD-126’s gut-restricted design aims to preserve activity in the gastrointestinal tract while limiting systemic exposure and the associated risk of adverse effects.
Developing a molecule with this profile required potent TRK inhibition and high selectivity over other kinases. XtalPi combined AI-guided molecular design with robotic synthesis and experimental testing, using the resulting data to refine candidate structures through successive rounds of optimization.
In preclinical studies, KQTD-126 demonstrated sub-nanomolar pan-TRK inhibitory activity (IC₅₀ < 1 nM) and high kinase selectivity. Its gut tissue-to-blood exposure ratio exceeded 1,000:1, supporting its development as a locally acting treatment intended to limit systemic exposure and associated adverse effects.
For XtalPi, the program provides a concrete application of AI-guided design and robotic experimentation to a drug discovery challenge in which several molecular properties must be optimized together.
