XORLO

XORTX Plans Q4 2026 FDA IND Filing for XRx-026 Gout Drug

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.

XORTX Plans Health Canada Trial Filing for Gout Drug XRx-026

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.