United Therapeutics performed the first clinical xenotransplant of its UKidney™ pig kidney in the EXPAND trial at NYU Langone Health. The procedure used a genetically engineered pig kidney with ten gene edits, including six human genes to promote immune tolerance and four porcine genes knocked out to reduce rejection risk.
The EXPAND study is a multicenter, open‑label safety and efficacy trial that will follow patients for 24 weeks after transplant. Participants are aged 55‑70, have end‑stage renal disease, have been on hemodialysis for at least six months, and undergo rigorous cross‑match testing to assess immunological compatibility.
United Therapeutics received FDA clearance for its investigational new drug application for the UKidney xenotransplantation trial in February 2025, and the first transplant in the trial was performed in early November 2025. The company’s public‑benefit mission is to expand access to transplantable organs, and the milestone is a key step toward addressing the chronic shortage of human donor kidneys, which leaves more than 90,000 patients on the U.S. waiting list.
The company has reported record total revenues of $794 million for Q1 2025 and $800 million for Q3 2025, reflecting growth across its therapeutic portfolio. United Therapeutics’ “Revolution” strategy aims to increase revenue from approximately $3 billion to $16 billion through new product launches, including xenotransplantation technologies.
United Therapeutics is not alone in the field; eGenesis is also preparing to launch a pig kidney clinical trial. The xenotransplantation market is projected to reach $21.98 billion by 2029, underscoring the strategic importance of United Therapeutics’ progress.
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