On Sept. 8, 2025, eGenesis announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a clinical trial evaluating EGEN-2784, a genetically engineered porcine-derived kidney, in patients with end stage kidney disease (ESKD).

The IND supports a Phase 1/2/3 study designed to assess the safety, tolerability, and efficacy of EGEN-2784 at 24 weeks post-transplant in patients with ESKD who are age 50 or older, dialysis-dependent, and on the kidney transplant waitlist.

EGEN-2784 is eGenesis’ lead candidate for kidney transplantation. The product carries three classes of genetic modifications designed to improve compatibility and support long-term function in human recipients: 1) Elimination of three glycan antigens to prevent hyperacute immune rejection 2) Insertion of seven human transgenes to regulate immune response, reduce inflammation, improve coagulation compatibility and regulate complement activation 3) Inactivation of endogenous retroviruses within the porcine genome to enhance safety. eGenesis is the only company developing organs with all three classes of edits to optimally address safety and efficacy.