Fidanacogene elaparvovec clinical trials
How each study uses fidanacogene elaparvovec is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
Approvals
The first approval found in each region, with its record
- United States
- 25 Apr 2024 · BEQVEZ · BLA 125786 (FDA, Purple Book)
- European Union
- 24 Jul 2024 · Beqvez (previously Durveqtix) · EMEA/H/C/004774 (EMA; now withdrawn)
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Development codes
- SPK-9001
- 1
Studies by the year they started
4 studies that test it; most in 2012 (1)
| Year | Studies |
|---|---|
| 2012 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2019 | 1 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 4 · Other 0
Studies
Open first, then newest update. How each study uses fidanacogene elaparvovec is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 4
- A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia BActive, not recruitingPhase 3PfizerNCT03861273Written as PF-06838435/ fidanacogene elaparvovec
- Long-term Safety and Efficacy Study and Dose-Escalation Substudy of PF 06838435 in Individuals With Hemophilia BTerminatedPhase 2PfizerNCT03307980Written as PF-06838435 (formerly SPK-9001)
- A Gene Therapy Study for Hemophilia BCompletedPhase 2PfizerNCT02484092Written as SPK-9001
- Hemophilia B Gene Therapy With AAV8 VectorTerminatedPhase 1Spark Therapeutics, Inc.NCT01620801Written as AAV8-hFIX19
Codes
What other systems call fidanacogene elaparvovec · ClinicalTrials.gg INT002140
- MeSH (NLM) C000731812fidanacogene elaparvovecOne source NLM
- UNII (FDA) 413EU9081YFIDANACOGENE ELAPARVOVECConfirmed FDA, NLM
- NCI Thesaurus C171800Fidanacogene ElaparvovecOne source FDA
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C000731812 | fidanacogene elaparvovec | One source NLM |
| UNII (FDA) | 413EU9081Y | FIDANACOGENE ELAPARVOVEC | Confirmed FDA, NLM |
| NCI Thesaurus | C171800 | Fidanacogene Elaparvovec | One source FDA |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.