omidubicel
Trade name: Omisirge
Cell therapyapprovedOrphan Drug FDABreakthrough Therapy FDA
Approved
Apr 17, 2023
Clinical trial activity
1 trials · 2 clinical orgs · 1 marketing orgs
Phase 1
0
Phase 2
1
Phase 3
1
Phase 4
0
Earliest trial started Jun 15, 2020 (NCT04260698)
Timeline
2010s
- May 23, 2018
Orphan Drug Designation
2020s
- Jan 1, 2020
Gamida Cell — Earliest Phase 3 Sponsor(trial)
- Apr 17, 2023
Gamida Cell — Earliest FDA Approval
- Apr 17, 2023
Gamida Cell — NDA Organization
Indications
Approved for
Studied for
Mechanism of action
- Unspecified targetOTHER
Somatic cell supplemental therapy
Cryopreserved nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood.
- Stem CellSupplementation
Stem Cell supplementation
Approval history
- approvedBreakthroughApr 17, 2023
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL4298190 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04260698 | Phase 3 | Jun 15, 2020 | Duke University, Gamida Cell |
Showing 1 of 1 trials
Page 1 / 1
Organizations
Research & Development (2)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Duke University | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Gamida Cell | For profit | 1 | 1 | 1 | 2020 |
2 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Gamida Cell | For profit | NDA | Apr 17, 2023 |