Prademagene zamikeracel
Trade name: Zevaskyn
Cell therapyapprovedOrphan Drug FDABreakthrough Therapy FDA
Approved
Apr 28, 2025
Clinical trial activity
1 trials · 2 clinical orgs · 0 marketing orgs
Phase 1
0
Phase 2
1
Phase 3
1
Phase 4
0
Earliest trial started Jan 10, 2020 (NCT04227106)
Timeline
2010s
- May 24, 2017
Orphan Drug Designation
2020s
- Jan 1, 2020
Earliest Phase 3 Sponsor(trial)
- Apr 28, 2025
Earliest FDA Approval
Indications
Approved for
Mechanism of action
- UnclearUnclear
Unclear unclear
Approval history
- approvedBreakthroughApr 28, 2025
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL4594312 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04227106 | Phase 3 | Jan 10, 2020 | Abeona Therapeutics, Stanford University |
Showing 1 of 1 trials
Page 1 / 1
Organizations
Research & Development (2)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Abeona Therapeutics | For profit | 1 | 1 | 1 | 2020 |
| Stanford University | Academic/Hospital | 1 | 0 | 1 | 2020 |
2 organizations
Page 1 / 1