Calgary – October 12, 2026 -- XORTX Therapeutics (NASDAQ: XRTX) plans to submit an Investigational New Drug application to the U.S. FDA in the fourth quarter of 2026 for its XRx-026 gout program, and estimates the program addresses a US$700M annual market opportunity.
XORTX targets an NDA filing in about one year, contingent on funding
The IND describes the company's clinical development plan for XORLOTM, its proprietary oxypurinol formulation, and its intention to file a New Drug Application after completing the two-part XRX-OXY-102 clinical trial. The trial is designed to characterize the pharmacokinetics and efficacy information the FDA needs to evaluate a future NDA.
If the trial succeeds, XORTX expects to request a pre-NDA meeting with the FDA and prepare the NDA in parallel with pre-commercialization work. The company is targeting an NDA submission in approximately one year, subject to sufficient funding and timely trial completion. It also lists manufacture of a commercial supply of XORLOTM for the first year of marketing as a required step.
XORTX bases its US$700M annual estimate on febuxostat's peak sales
The market estimate rests on prior peak net sales for febuxostat, which once exceeded US$450 million in annual sales but now carries a boxed warning for cardiovascular risk. Oral xanthine oxidase inhibitors are the current standard of care for gout. About 3-5% of patients cannot tolerate allopurinol, which XORTX cites as the unmet need for XORLOTM.
XORTX says the market-size estimate relies on third-party data and the historical sales of other products, and that it could prove inaccurate.
U.S. gout burden covers 9.2 million patients and is projected to grow
About 44 million people in the United States have uric acid levels above the normal range, and 9.2 million of them live with gout. Global gout cases are expected to rise 70% over the next 25 years. The disease is associated with metabolic syndrome, myocardial infarction, Type 2 diabetes, chronic kidney disease and premature mortality.
Co-CEO Allen Davidoff called the planned filing "a defining step" for the program. XORTX also said it will provide further updates on its international development plans.
XORTX flags funding, clinical hold and FDA agreement as key risks
The company cited its need for additional capital, the risk that the IND is delayed or placed on clinical hold, and the risk that the FDA requires additional studies or does not agree with the proposed development plan. It also named reliance on third-party contract research organizations and contract manufacturers, and competition from existing and future gout therapies.