XORTX Plans FDA IND Submission for XRx-026 Gout Program

CALGARY, Alberta, Sept. 18, 2026 /CourierPR/ -- XORTX Therapeutics Inc. announced plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its XRx-026 gout program in the fourth quarter of 2026. The application will detail the Company’s clinical development plan and its intention to file a New Drug Application (NDA) following the completion of the planned two-part XRX-OXY-102 clinical trial. This trial aims to characterize the pharmacokinetics and efficacy of the XORLO™ formulation of oxypurinol, a potential alternative to current standard of care treatments.

XORTX’s drug development plan is to seek FDA marketing approval for XRx-026, providing patients with a new therapeutic option. The Company estimates that the XRx-026 program addresses an estimated US$700 million market opportunity per annum in the U.S. gout market. According to the release, approximately 44 million individuals in the United States have uric acid levels above the normal range, with 9.2 million living with gout. Gout is associated with severe pain, reduced quality of life, decreased physical function, increased healthcare costs, and lost economic productivity. It is also strongly linked to metabolic syndrome, myocardial infarction, Type 2 diabetes mellitus, chronic kidney disease, and premature mortality.

The XRx-026 program is developing XORLO™, the Company’s proprietary formulation of oxypurinol, to treat individuals with gout. Oral xanthine oxidase inhibitors (XOIs) are the current standard of care, but limitations remain: approximately 3-5% of patients cannot tolerate allopurinol, and febuxostat, while once achieving over US$450 million in annual sales, now carries a boxed warning for cardiovascular risk. XORLO™ is designed to address this unmet need by providing an alternative therapeutic option with a differentiated safety and efficacy profile.

The planned IND submission is one part of XORTX’s broader regulatory strategy for XRx-026. The Company anticipates requesting a pre-NDA meeting with the FDA and preparing an NDA submission, in parallel with pre-commercialization activities. Subject to the availability of sufficient funding and the timely completion of the XRX-OXY-102 clinical trial, XORTX is targeting an NDA submission in approximately one year.

XORTX is a pharmaceutical company with three clinically advanced products in development: its lead XRx-026 program for the treatment of gout, the XRx-008 program for autosomal dominant polycystic kidney disease (ADPKD), and the XRx-101 for acute kidney and other acute organ injury associated with respiratory virus infections. In addition, the Company is developing XRx-225, a pre-clinical stage program for Type 2 diabetic nephropathy, and the recently acquired VB4-P5 program, which targets both rare and prevalent forms of kidney disease. XORTX is dedicated to developing medications that improve the quality of life and health of individuals with gout and other important diseases.