XORTX Outlines Anticipated FDA IND Submission For XRx-026 Gout Program

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, outlines its anticipated Investigational New Drug application ("IND") submission to the U.S. Food and Drug Administration (the "FDA") for the XRx-026 gout program. XORTX’s drug development plan is to seek FDA marketing approval for XRx-026 and provide patients with a new therapeutic option. The key steps the Company anticipates will be necessary to file a marketing application with the FDA include meetings with the agency, a two-part clinical study to characterize the pharmacokinetics and efficacy of the XORLO™ formulation of oxypurinol, and manufacture of a commercial supply of XORLO™ for the first year of marketing.Recent drug development team activities include preparation of a new IND for submission to the FDA in the fourth quarter of 2026. The application describes the Company’s clinical development plan and its intention to file a New Drug Application ("NDA") with the FDA following completion of the planned two-part XRX-OXY-102 clinical trial, which is being advanced based on positive and supportive prior clinical trial results and discussions with the FDA. The focus of the XRX-OXY-102 clinical trial is to characterize key information needed by the FDA in its evaluation of a future NDA filing by XORTX for marketing approval.If the XRX-OXY-102 clinical trial is successfully completed, 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. Based on prior peak net sales for febuxostat, XORTX estimates the XRx-026 program addresses an estimated US$700M market opportunity per annum.This planned submission is one part of XORTX’s broader regulatory strategy for XRx-026, and the Company looks forward to providing further updates on its international development plans.