XtalPi (HKEX:2228), an AI- and robotics-driven drug and materials discovery company, announced on Thursday the submission of an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for KQTD-126.

The candidate is a potential first-in-class gut-restricted pan-tropomyosin receptor kinase (pan-TRK) inhibitor designed to treat chronic intestinal pain associated with irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD).

KQTD-126 targets the TRK family of receptors (TRKA, TRKB, and TRKC), which directly regulate nerve activity and pain-signal amplification in the gut.

In preclinical studies, KQTD-126 demonstrated sub-nanomolar potency alongside a gut-to-blood exposure ratio exceeding 1,000:1, confining pharmacological activity to the gastrointestinal tract to limit systemic exposure.

KQTD-126 is the first programme in XtalPi's proprietary pipeline to reach an IND submission since the portfolio was unveiled in the company's recent interim results.