XtalPi (HKEX: 2228), a Boston- and Shenzhen-based AI and robotics-driven drug discovery company, submitted an Investigational New Drug application to the US FDA for KQTD-126, a gut-restricted pan-TRK inhibitor being developed for chronic intestinal pain associated with irritable bowel syndrome and inflammatory bowel disease. The filing is XtalPi’s first IND submission from its proprietary drug pipeline.
KQTD-126 inhibits TRKA, TRKB, and TRKC, receptors involved in nerve signaling and pain amplification in the gut. The compound is designed to remain largely confined to intestinal tissue in an effort to avoid the neurological effects associated with systemic TRK inhibition. In preclinical studies, XtalPi reported sub-nanomolar pan-TRK activity and a gut tissue-to-blood exposure ratio exceeding 1,000:1.
XtalPi said KQTD-126 was designed using a closed-loop platform combining generative and predictive AI models with automated chemistry and experimental screening to optimize potency, kinase selectivity, and tissue distribution. The IND marks a step beyond the company’s historical focus on providing drug discovery technology and services to external partners, bringing an internally developed asset toward clinical testing.
XtalPi has also built a substantial external-partnering business around the platform. Its collaborations include a USD 250 million AI and robotics drug discovery agreement with Eli Lilly signed in 2023, followed by a separate USD 345 million bispecific antibody collaboration through subsidiary Ailux in 2025. XtalPi also expanded a longstanding collaboration with Pfizer in 2025 and entered a multi-target drug discovery collaboration with DoveTree with potential aggregate value of up to approximately USD 6 billion.