XORTX plans Health Canada filing to launch XRx-026 gout trial in Canada
XRTX•XORTX plans to file a Health Canada clinical trial application for XRx-026 and conduct the first part of a two-part study in Canada. The study will evaluate XORLO, its oxypurinol formulation, and support a future U.S. FDA new drug application.
1. Planned Canadian trial
XORTX outlined plans to file a Health Canada clinical trial application for XRx-026, extending its international regulatory strategy for gout. The planned two-part XRX-OXY-102 study will evaluate XORLO, its oxypurinol formulation; the Canadian first part is intended to speed delivery of key clinical data, and the study will further characterize the commercial tablet form. XORTX said partner interest had increased across jurisdictions, but no agreements had been signed.
