tregzi Purple Book BLA 125868
- BLA number
- 125868
- Proprietary names
- tregzi
- Proper names
- allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq
- Applicant
- Orca Biosystems Inc.
- Center
- CBER
- First observed release
- 2026-07-01
- Latest observed release
- 2026-09-01
- Newest archive release
- 2026-09-01
- FDA patent list
- No patents listed in the captured FDA patent list; source updated 2025-06-11
- Coverage
- Present in newest release
Latest Known Product Presentations#
Product, Proprietary name, Proper name table| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | tregzi | allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq | 351(a) | >=1.0 10^6HSPC CELLS,0.9-3.510^6 TREG CELLS,0.9-6.910^6 TCON CELLS /PATIENT KG | Solution | Intravenous | Bag | Rx | Licensed | 2026-06-30 | |
Published Patent List#
No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2026-08-01 | U | 001 | tregzi | 351(a) | Rx | Orca Biosystems Inc. |
| 2026-07-01 | N | 001 | tregzi | 351(a) | Rx | Orca Biosystems Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2026-07-01 | 001 | tregzi | 351(a) | Rx | Licensed | 2026-06-30 |