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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq
Trade Name: Tregzi
Date Designated: 01/30/2024
Orphan Designation: Prevention of graft-versus-host disease and/or death in patients undergoing hematopoietic stem cell transplant.
Orphan Designation Status: Designated/Approved
Orca Biosystems, Inc.
3400 Business Drive, Suite C
Sacramento, California 94025
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq
Trade Name: Tregzi
Marketing Approval Date: 06/30/2026
Approved Labeled Indication: for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease-free survival, in the treatment of adults with hematological malignancies
Exclusivity End Date: TBD  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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