FDA Greenlights Pig Kidney Transplants: A Game-Changer for Organ Shortages.
Two American biotech firms—United Therapeutics and eGenesis—have secured approval from the U.S. Food and Drug Administration (FDA) to begin clinical trials using genetically modified pig kidneys in human transplants. This milestone pushes the long-pursued science of xenotransplantation closer to becoming a real solution for the country’s critical organ shortage.
Right now, more than 100,000 people in the U.S. are waiting for transplants, with kidney patients making up the vast majority—over 90,000. The demand far exceeds the supply, leaving many to endure grueling dialysis treatments for years while hoping for a viable donor. Pig organs, engineered to be more compatible with human bodies, could shift that grim reality.
United Therapeutics announced its approval publicly, stating that it will enroll six patients with end-stage kidney failure in its first trial phase, with the initial transplant expected by mid-2025. If the results are promising, the study could expand to 50 participants. Leigh Peterson, the company’s executive vice president, called the green light from the FDA a major breakthrough in their push to widen access to transplantable organs.
eGenesis, which received its FDA clearance in December, is taking a slightly different approach. Their trial will involve just three patients—specifically those who have little to no chance of receiving a donor kidney within the next five years.
Xenotransplantation—the concept of using animal organs in human bodies—has been a scientific aspiration for decades. Early attempts, particularly those using primate organs, failed due to severe immune rejection. But modern advancements in gene editing have changed the game, allowing scientists to tweak pig DNA in ways that reduce the risk of rejection and improve compatibility. Pigs are also practical donors because they reproduce quickly, grow fast, and are already widely bred for human consumption.
United Therapeutics confirmed that all patients in the upcoming trial will be monitored for life, not just for kidney function and survival rates, but also for potential zoonotic infections—diseases that could transfer from pigs to humans.
As of now, only one living person has successfully received and maintained a pig kidney transplant. Towana Looney, a 53-year-old Alabama woman, was given a genetically modified pig kidney by United Therapeutics on November 25, 2024. She has now lived with the organ for 71 days, surpassing the previous record held by David Bennett, who received a pig heart in 2022 and survived for 60 days.
While these cases are still exceptions, they highlight what could soon become a medical revolution—one that offers hope to thousands of patients stuck in the long, uncertain wait for a second chance at life.