XORTX Commences Gout Program NDA Discussions with the FDA

Provided By GlobeNewswire

Last update: Feb 24, 2025

● Type C Meeting Requested to Accelerate XRx-026 for Gout to NDA ●

CALGARY, Alberta, Feb. 24, 2025 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANUA), a late stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease and gout, announces that it has submitted a Type C meeting request with the US Food and Drug Administration (the “FDA”) regarding the Company’s XRx-026 program for the treatment of gout. Development of XORLO^™ ¹, the Company’s proprietary drug formulation of oxypurinol, has advanced to the point where a Type C meeting and discussion with the FDA is warranted. The purpose of this meeting is to review the XRx-026 program and its readiness for submission of a New Drug Application (“NDA”) to gain marketing approval for XORLO^™ in the US using the FDA’s 505(b)2 development pathway.