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XORTX plans to submit IND application for XRx-026 gout program in Q4 2026
XRTXXORTX Therapeutics Inc.
XORTX Therapeutics announced it plans to submit an Investigational New Drug (IND) application to the U.S. FDA for its XRx-026 gout program in the fourth quarter of 2026. The submission follows a planned two-part clinical trial, XRX-OXY-102, designed to characterize pharmacokinetics and efficacy using the company's proprietary XORLO formulation of oxypurinol. If successful, XORTX targets an NDA submission approximately one year later. The company estimates the U.S. market opportunity for this therapy at over USD$700 million annually based on prior peak sales data for febuxostat. XORTX Therapeutics is a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat gout and progressive kidney disease.