fidanacogene elaparvovec
Trade name: BEQVEZ
Gene therapyapprovedOrphan Drug FDABreakthrough Therapy FDA
Approved
Apr 25, 2024
Clinical trial activity
1 trials · 2 clinical orgs · 0 marketing orgs
Phase 1
1
Phase 2
1
Phase 3
0
Phase 4
0
Earliest trial started Sep 1, 2015 (NCT02484092)
Timeline
2010s
- Jan 1, 2015
Earliest Phase 1 Sponsor(trial)
- Sep 21, 2015
Orphan Drug Designation
2020s
- Apr 25, 2024
Earliest FDA Approval
Indications
Approved for
Studied for
Mechanism of action
- Coagulation factor IXSupplementation
F9 supplementation
Approval history
- approvedBreakthroughApr 25, 2024
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Also known as
- spk-9001
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT02484092 | Phase 1/Phase 2 (Phase 2) | Sep 1, 2015 | Pfizer, Spark Therapeutics |
Showing 1 of 1 trials
Page 1 / 1
Organizations
Research & Development (2)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Pfizer | For profit | 1 | 0 | 1 | 2015 |
| Spark Therapeutics | For profit | 1 | 1 | 1 | 2015 |
2 organizations
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