XRx-026

September 18, 2026: XORTX Therapeutics (NASDAQ: XRTX) said it plans to submit an IND to the FDA in Q4 2026 for XRx-026, its gout program based on XORLO, a proprietary oxypurinol formulation. The IND is intended to support the planned two-part XRX-OXY-102 clinical trial, which the company says will characterize pharmacokinetics and efficacy and provide information needed for a future NDA review.

The company said the IND outlines its clinical development plan and its intention to file an NDA after completing XRX-OXY-102, citing prior positive and supportive clinical trial results and FDA discussions, though no specific data were disclosed. If XRX-OXY-102 is successfully completed, XORTX expects to request a pre-NDA meeting and prepare an NDA in parallel with pre-commercial activities, including manufacturing commercial supply for the first year of marketing.

Upcoming catalysts: planned IND submission in Q4 2026, then XRX-OXY-102 trial initiation/completion, followed by a pre-NDA meeting and an NDA submission targeted in approximately one year, subject to funding and timely trial completion.