elivaldogene autotemcel
Trade name: Eli-cel
Cell therapyapprovedOrphan Drug FDABreakthrough Therapy FDA
Approved
Sep 16, 2022
Clinical trial activity
1 trials · 1 clinical orgs · 1 marketing orgs
Phase 1
1
Phase 2
1
Phase 3
0
Phase 4
0
Earliest trial started Mar 24, 2025 (NCT06826196)
Timeline
2010s
- Apr 19, 2012
Orphan Drug Designation
2020s
- Sep 16, 2022
bluebird bio — Earliest FDA Approval
- Sep 16, 2022
bluebird bio — NDA Secondary Org
- Sep 16, 2022
bluebird bio — NDA Organization
- Jan 1, 2025
Earliest Phase 1 Sponsor(trial)
Indications
Approved for
Studied for
Mechanism of action
Approval history
- approvedAcceleratedBreakthroughSep 16, 2022
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Black box warning
Sources
- ChEMBLCHEMBL4594333 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06826196 | Phase 1/Phase 2 (Phase 2) | Mar 24, 2025 | Aldena Therapeutics |
Showing 1 of 1 trials
Page 1 / 1
Organizations
Research & Development (1)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Aldena Therapeutics | For profit | 1 | 1 | 1 | 2025 |
1 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| bluebird bio | For profit | NDA2 | Sep 16, 2022 |
| bluebird bio | For profit | NDA | Sep 16, 2022 |