Calgary – October 12, 2026 -- XORTX Therapeutics (NASDAQ: XRTX) plans to run the first part of its two-part XRX-OXY-102 gout study in Canada, a move it expects to speed delivery of the clinical data needed for a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA).
XORTX prepares Health Canada filing in parallel with FDA track
The company has outlined an anticipated Clinical Trial Application (CTA) to Health Canada for its XRx-026 gout program. The study evaluates XORLO, XORTX's proprietary formulation of oxypurinol, a xanthine oxidase inhibitor. Drug development teams have been preparing the CTA in parallel with the planned FDA NDA submission.
The application sets out the clinical development plan for XRx-026 and the company's intention to pursue regulatory approval in Canada alongside the U.S. filing. Part one of XRX-OXY-102 builds on previously reported positive clinical results for XORLO and extends characterization of the commercial tablet form.
Co-CEO Davidoff ties Canadian trial to capital efficiency
Co-Chief Executive Officer Dr. Allen Davidoff said the approach should make more efficient use of the company's capital, personnel and time. He said it could also accelerate patient access to XORLO and raise the overall value of the program for shareholders.
Commercialization partner inquiries rise, no agreements signed
XORTX reported increased inquiries from potential commercialization partners in several jurisdictions as XRx-026 has advanced. The company has not entered into any agreement with any such party and cautioned that discussions may not result in a transaction.
XORLO targets patients intolerant to allopurinol
Oral xanthine oxidase inhibitors are the current standard of care for hyperuricemia-associated gout, with allopurinol the recommended first-line therapy. About 3-5% of patients cannot tolerate allopurinol. Febuxostat, an alternative inhibitor, once reached annual peak net sales above US$450 million but now carries a boxed warning for cardiovascular risk, which has substantially reduced its use and sales. XORTX positions XORLO as an alternative with a differentiated safety and efficacy profile.
In the United States, roughly 44 million people have uric acid levels above the normal range and 9.2 million live with gout. Gout cases are expected to rise 70% over the next 25 years, according to a third-party study cited by the company.