United Therapeutics Corporation announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a clinical study of its investigational UKidney. This clearance enables the commencement of a Phase 1/2/3 trial in end-stage renal disease (ESRD) patients.
The study will initially enroll six ESRD patients, with plans to expand to up to 50 participants, and is designed to support a Biologics License Application (BLA) with the FDA. The UKidney is derived from a 10 gene-edited source pig, engineered for immune acceptance and function.
United Therapeutics expects the first xenotransplant in this trial to be performed around mid-year 2025. This regulatory approval represents a significant step forward in the company's mission to expand the availability of transplantable organs and offer a therapeutic alternative to dialysis for a large patient population.
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