A clinical study of XRx-026 for the treatment of individuals who have gout and are intolerant to allopurinol
Latest Information Update: 08 May 2025
At a glance
- Drugs XRx 026 (Primary)
- Indications Gout
- Focus Adverse reactions
Most Recent Events
- 30 Apr 2025 According to a XORTX Therapeutics media release, company announced that the gout NDA may be filed in the H1 2026.
- 30 Apr 2025 According to a XORTX Therapeutics media release, company announced that it has received responses from the US Food and Drug Administration (the FDA) and clarified key steps for a new drug application (NDA) for the Companys novel proprietary formulation of oxypurinol for the treatment of gout. The Type B meeting conducted by the FDA, included review of chemistry, manufacturing, pharmacology, toxicology and clinical evidence to support the Companys XRx-026 program for the treatment of gout.
- 19 Mar 2025 According to a XORTX Therapeutics media release, company has prepared a Type B meeting review at the request of the FDA regarding the XRx-026 program for the treatment of gout.The purpose of this meeting will be to review the XRx-026 program and its readiness for submission of a New Drug Application to gain marketing approval for XORLO in the US using the FDA 505(b)2 development pathway. The Company believes that a Type B meeting will facilitate a broader discussion toward market approval.