eGenesis Receives FDA Clearance for Gene-Edited Pig Kidney Trial in End-Stage Kidney Disease Patients

Massachusetts-headquartered biotech eGenesis announced on Monday that the US FDA has cleared its clinical trial application to evaluate gene-edited pig kidneys in patients with end-stage kidney disease (ESKD).

The company, which is developing human-compatible engineered organs to address the global organ shortage, has received clearance for a Phase 1/2/3 clinical study that will evaluate the safety and efficacy of EGEN-2784 at 24 weeks post-transplantation.

The trial will specifically evaluate EGEN-2784 in patients with ESKD who are age 50 or older, dialysis-dependent, and on a waiting list for a kidney transplant.

Multiplex gene-edited pig kidneys

EGEN-2784 is eGenesis’ lead candidate for kidney transplantation. It is a pig kidney that undergoes three types of gene edits that are designed to improve compatibility and support long-term function in human recipients.

These edits are introduced via multiplexed CRISPR-Cas gene editing and include: elimination of three glycan antigens to prevent hyperacute immune rejection, insertion of seven human transgenes to regulate immune response, reduce inflammation, improve coagulation compatibility and regulate complement activation, and inactivation of endogenous retroviruses within the pig genome to enhance safety. Without genetic modification, a pig kidney would be immediately rejected by the human immune system.

IND approval follows positive data from three-patient expanded access study

At the beginning of 2025, eGenesis initiated a three-patient FDA-authorised Expanded Access study that allowed three patients to receive an EGEN-2784 kidney. According to the official press release, the first patient from that study has surpassed seven months kidney function and a second patient has been successfully transplanted.

Tim Andrews, 67, who received an EGEN-2784 kidney on January 25, 2025, at Massachusetts General Hospital, recently surpassed seven months post-transplant, making him the world’s longest-living recipient of a genetically-engineered pig-derived organ. Prior to his transplant, Mr. Andrews required dialysis for more than two years. Since the transplant, he continues to live dialysis-free.

On June 14, 2025, Bill Stewart, 54 became the second patient in the expanded access study to receive an EGEN-2784 kidney. Before his transplant, he underwent dialysis three times weekly for more than two years and faced a long wait for a kidney transplant. He was discharged from hospital on June 21st and no longer requires dialysis for the first time in over two years. Prior to transplanation with EGEN-2784, Stewart underwent a unique immunosuppression regimen described in a press release published at that time.

See the full official press release about eGenesis' IND approval for EGEN-2784 here.

Stay tuned for more updates

We will continue to update you the EGEN-2784 trial as new details emerge. In the meantime, you can find all of our coverage on clinical-stage gene editing programmes here.

For a complete overview of current gene editing clinical trials, check out CRISPR Medicine News' Clinical Trials Database.