XORTX plans FDA gout drug submission
- XORTX Therapeutics (NASDAQ:XRTX) plans to submit an IND application for its XRx-026 gout program in Q4 2026.
- The program uses the XORLO formulation of oxypurinol and is designed to advance toward potential FDA approval.
- XORTX plans a clinical trial evaluating pharmacokinetics and efficacy before a potential NDA submission.
XORTX Therapeutics (NASDAQ:XRTX) announced plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration in the fourth quarter of 2026 for its XRx-026 gout program using the XORLO formulation of oxypurinol.
The company said the development plan includes regulatory discussions with the FDA, a two-part XRX-OXY-102 clinical trial and manufacturing preparations for a first-year commercial supply of XORLO.
The planned XRX-OXY-102 study will evaluate pharmacokinetics and efficacy, and the company expects to request a pre-NDA meeting if the trial is completed successfully.
XORTX develops therapies targeting purine metabolism and related conditions, including kidney disease and gout, with XRx-026 focused on advancing oxypurinol as a potential gout treatment.
The company estimates that XRx-026 addresses an approximately $700 million annual U.S. gout market opportunity based on prior peak net sales of febuxostat, although timing depends on regulatory progress, funding and clinical trial outcomes.
