United Therapeutics Says FDA Clears IND For The UKidney Xenotransplantation Clinical Trial

(RTTNews) - United Therapeutics Corp. (UTHR), a public benefit corporation, announced Monday that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application (IND) to initiate a clinical study of the company's investigational UKidney derived from a 10 gene-edited source pig.

This will be the first-ever human clinical trial of a xeno-organ intended to allow for potential registration through the submission of a Biologics License Application to the U.S. FDA.

The study will enroll an initial cohort of six end-stage renal disease (ESRD) patients, expanding to up to 50 participants, and is intended to support a Biologics License Application (BLA) with the FDA.

United Therapeutics expects the first xenotransplant in this trial to be performed around mid-year 2025.