We received from XORTX Therapeutics Inc. amd we are glad to publish the following press release:
“XORTX Announces Planned FDA IND Submission for XRx-026 Gout Program Using XORLO™, Targeting USD$700M+ U.S. Gout Market Opportunity
Investigational New Drug application planned for submission to the U.S. FDA in the fourth quarter of 2026, advancing the Company’s regulatory path toward NDA filing for gout program XRx-026 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.
“Our planned IND submission to the FDA next quarter is a defining step for the XRx-026 program,” stated Allen Davidoff, Co-Chief Executive Officer of XORTX, who added, “It reflects the strength of our prior clinical results and moves us closer to potentially offering gout patients a differentiated treatment option.”
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.
About Hyperuricemia and Gout
In the United States, approximately 44 million individuals have uric acid levels above the normal range, with 9.2 million individuals living with gout1. Gout is associated with severe pain, reduced quality of life2, decreased physical function3, increased healthcare costs4, and lost economic productivity5. It is also strongly associated with metabolic syndrome5, myocardial infarction6,7, Type 2 diabetes mellitus8, chronic kidney disease9, and premature mortality6,10,11. Importantly, the global prevalence of gout is increasing, with cases expected to increase 70% over the next 25 years*.
About the XRx-026 Program and XORLO™
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 >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. Advancement of XRx-026 through NDA filing is a strategic priority for XORTX.”.
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