XORTX Outlines Anticipated Health Canada Clinical Trial Application for XRx-026 for Gout
Key Highlights
- ➤XORTX plans Health Canada CTA filing for XRx-026 gout program
- ➤Canadian XRX-OXY-102 trial aims to accelerate clinical data for FDA NDA
- ➤XORLO formulation advances toward regulatory approval in Canada and United States
- ➤XORTX reports increased commercialization interest but has signed no agreements
Expert Statements
Allen Davidoff, Co-Chief Executive Officer of XORTX
“Advancing our Clinical Trial Application with Health Canada is expected to enable more efficient clinical plan execution and extends our regulatory strategy for XRx-026 globally”
Allen Davidoff, Co-Chief Executive Officer of XORTX
“Gout is a growing global burden, and approaches that make more efficient use of our capital, personnel and time are expected to accelerate the availability of XORLO™ to patients wherever the need exists. This, in turn, is anticipated to enhance the overall value of the XRx-026 program for the Company and its shareholders.”
● Clinical Trial Application planned for filing with Health Canada, extending the Company’s international regulatory strategy for gout program XRx-026 ●
CALGARY, Alberta, Oct. 08, 2026 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. (“XORTX” or the “Company”) (NASDAQ: XRTX), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat gout and progressive kidney disease, is pleased to provide an outline of its anticipated Clinical Trial Application (“CTA”) submission to Health Canada for the XRx-026 gout program. The filing supports the Company’s planned two-part clinical study, XRX-OXY-102, evaluating XORLO(TM), the Company’s proprietary formulation of oxypurinol, a xanthine oxidase inhibitor, for the treatment of gout. Conducting the first part of the XRX-OXY-102 clinical study in Canada is expected to enable the Company to accelerate the delivery of key clinical data in support of its planned New Drug Application (“NDA”) filing with the U.S. Food and Drug Administration (the “FDA”) for marketing approval.
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