Core Viewpoint - XORTX Therapeutics Inc. is launching a late-stage program, XRx-026, aimed at treating gout in patients intolerant to allopurinol, with plans to discuss New Drug Application (NDA) filing with the FDA in the first half of 2025 [1][2][3] Company Overview - XORTX is a late-stage clinical pharmaceutical company focused on innovative therapies for progressive kidney disease, with three clinically advanced products: XRx-008 for ADPKD, XRx-026 for allopurinol intolerant gout, and XRx-101 for acute kidney injury related to COVID-19 [6] Clinical Development - The clinical development of XORLO, a proprietary formulation of oxypurinol, has progressed sufficiently, leading to the initiation of discussions with the FDA regarding the XRx-026 program and potential orphan drug designation [2][3][10] Market Opportunity - In North America, approximately 3.5 million individuals suffer from gout, with 3-5% unable to tolerate allopurinol, creating a significant market opportunity for alternative treatments [5] - Febuxostat, an alternative XOI, peaked at approximately US$450 million in sales but has seen a decline due to safety concerns, highlighting the need for a new treatment option like XRx-026 [5] Health Context - Hyperuricemia affects about 14% of the global population, with 1-2% diagnosed with gout, and lowering uric acid levels is strongly correlated with improved health outcomes [4]
XORTX Adds Late Stage Gout Program to Pipeline