United Therapeutics Corporation Announces FDA Clearance to Proceed with UHeart Xenotransplantation Clinical Trial
United Therapeutics received FDA clearance to begin the EXPRESS clinical trial for UHeart, a gene-edited pig heart intended for human transplantation. The study is designed as a seamless Phase 1/2/3 trial, starting with an initial cohort of two participants at a single center. Data from the first recipient will be reviewed by the FDA before the second transplant proceeds. UHeart features 10 genetic edits—six human genes added and four porcine genes inactivated—to reduce rejection risk.
Key figures
- Drug Name
- UHeart
- Phase Of Trial
- Phase 1/2/3
- Gene edits
- 10
- Human genes added
- 6
- Initial cohort size
- 2
- Follow up period weeks
- 24
- Porcine genes knocked out
- 4
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