United Therapeutics Announces FDA Clearance of Pig Transplantation Clinical Trial

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On Feb. 3, 2025, United Therapeutics, a public benefit corporation, announced 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.

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.

According to the American Kidney Fund, more than 557,000 patients in the U.S. are on dialysis to filter their blood when their kidneys are no longer able to do so. A 2009 study estimated that 52% of kidney transplant candidates who were at least 60 years of age when placed on the transplant waitlist die within five years before receiving a transplant. United Therapeutics believes that xenotransplantation offers a therapeutic alternative to dialysis.

United Therapeutics’ xenokidney, known by the proposed trade name UKidney, is an investigational xenokidney from a pig with 10 gene edits. Six human genes are added to the pig genome to facilitate immunological acceptance and compatibility of the organ in the human recipient, while four porcine genes are inactivated: three that contribute to porcine organ rejection in humans and one that can cause organ growth.

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