XORTX Therapeutics Initiates IND Preparation For XRx-026, Focused On Treatment Of Gout

Author: Benzinga Newsdesk | September 03, 2025 06:09am

XORTX Therapeutics Inc. ("XORTX" or the "Company") (NASDAQ:XRTX, TSXV:XRTX, Frankfurt: ANU))), a late stage clinical pharmaceutical company focused on developing innovative therapies to treat gout and progressive kidney disease, today announced the initiation of Investigational New Drug ("IND") preparation for its lead program, XRx-026, focused on the treatment of gout. In support of this milestone, XORTX has engaged Allucent, a global contract research organization specializing in regulatory and clinical development.

Preparation of the IND will include a comprehensive review of non-clinical, pharmacologic, toxicological, and regulatory progress, and will incorporate the clinical development plan and protocol for a pharmacologic characterization study of XORLO™, the Company's proprietary formulation of oxypurinol, in fed and fasted states. XORTX anticipates submission of the IND in the second half of 2025.

The submission of the IND follows the Type B meeting that was held in April 2025 with the U.S. Food and Drug Administration (the "FDA"), where the FDA provided guidance on the path toward a New Drug Application ("NDA") for XORLO™. The FDA outlined four critical requirements prior to NDA submission:

1. Filing of an IND;
2. Preparation of clinical and commercial drug supply with supporting stability data;
3. A pharmacologic study characterizing absorption of XORLO™ in fasted versus fed individuals; and
4. Compilation of data from steps 2 and 3 above, then submission of the NDA.

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