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FDA grants orphan drug designation to pegrizeprument for the prevention of allograft rejection in heart transplant recipients
On April 22, 2026, the U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) to pegrizeprument, a novel investigational maintenance immunosuppressive agent, for the prevention of heart allograft rejection in heart transplant recipients. This follows the ODD granted for the prevention of allograft rejection in liver transplant recipients.
Pegrizeprument is a pegylated monoclonal antibody fragment being developed for the prevention of acute rejection in solid organ transplant recipients. Pegrizeprument binds to and blocks CD28-mediated effector T-cell costimulation without blocking CTLA-4, a costimulatory protein on T cells that helps regulate immune responses.
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