Japan plans to launch its first clinical trials for xenotransplantation using genetically engineered pig organs in early 2028 [1].

This initiative seeks to provide a critical alternative for patients facing a severe shortage of human organ donors within the country [1, 2].

Researchers from a Japanese biotech venture and Hokkaido University Hospital are preparing the trials. The primary focus will be the transplantation of pig kidneys into human patients [1, 2]. According to the project guidelines, the target patient age range for these initial trials will be 55 to 65 years [2].

"We aim to start the first clinical trial of pig‑kidney xenotransplantation in early 2028," Prof. Hiroshi Horita said [2].

Japan is following a global trend of xenotransplantation research. The U.S. conducted a successful pig-kidney transplant in 2022 on a 62-year-old man [3]. Dr. Bartley of Massachusetts General Hospital said the procedure marked the first successful pig-kidney xenotransplant in the U.S. [3].

Other advancements have occurred in Asia. In 2024, a medical team in Guangxi, China, performed transplants involving two kidneys, and one liver from pigs into human patients [4].

These procedures rely on genetic engineering to prevent the human immune system from rejecting the animal organ. The upcoming Japanese trials will test these modifications in a domestic clinical setting to determine the long-term viability of the organs [1, 2].

“"We aim to start the first clinical trial of pig‑kidney xenotransplantation in early 2028."”

The move toward xenotransplantation in Japan reflects a systemic effort to decouple organ availability from the limited pool of human donors. By targeting a specific age demographic (55–65), researchers can better control variables and monitor the efficacy of genetically modified organs before expanding the trial to a broader population. Success in these trials would align Japan with the U.S. and China in establishing a scalable, biological solution to end-stage organ failure.