etuvetidigene autotemcel
Trade name: Waskyra
Cell therapyapprovedOrphan Drug FDA
Approved
Dec 9, 2025
Clinical trial activity
1 trials · 2 clinical orgs · 0 marketing orgs
Phase 1
0
Phase 2
1
Phase 3
0
Phase 4
0
Earliest trial started Jan 21, 2019 (NCT03837483)
Timeline
2010s
- Apr 30, 2010
Orphan Drug Designation
- Jan 1, 2019
Earliest Phase 2 Sponsor(trial)
2020s
- Dec 9, 2025
Earliest FDA Approval
Indications
Approved for
Mechanism of action
- Stem CellSupplementation
Stem Cell supplementation
Approval history
- approvedDec 9, 2025
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT03837483 | Phase 2 | Jan 21, 2019 | Orchard Therapeutics Limited, The Foundation Institute San Raffaele G. Giglio of Cefalù |
Showing 1 of 1 trials
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Organizations
Research & Development (2)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Orchard Therapeutics Limited | For profit | 1 | 1 | 1 | 2019 |
| The Foundation Institute San Raffaele G. Giglio of Cefalù | Academic/Hospital | 1 | 0 | 1 | 2019 |
2 organizations
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