FDA clears IND application for UKidney xenotransplant clinical trial

United Therapeutics/UKidney

United Therapeutics announced FDA clearance of its Investigational New Drug (IND) application for the UKidney xenotransplant clinical trial. The study will enroll an initial cohort of six end-stage renal disease patients, with potential expansion to 50 participants, and is designed to support a future Biologics License Application.

• Initial cohort of 6 ESRD patients; expansion to 50 planned.
• First xenotransplant clinical trial expected to begin mid-2025.
• Data will support BLA submission to FDA.