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Drug

Etranacogene dezaparvovec

Approved medicine
ClassCoagulation factor IX exogenous proteinResearchOngoing clinical research

Also known as AAV5-hFIXco-Padua, Hemgenix.

Coagulation factor IX
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Etranacogene dezaparvovec
Aliases & brands
AAV5-hFIXco-PaduaHemgenix
RxNorm CUI
2626727
ChEMBL ID
CHEMBL5095451
ATC codes
B02BD16
UNII
Z5XCD5Q9RL
Primary mechanism
Coagulation factor IX exogenous protein
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

EXOGENOUS PROTEINCoagulation factor IX exogenous protein

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2023-02-20
Latest approval
2023-02-20
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2023-02-20Approval
Approval: Hemgenix (EMA)

Indication: Treatment of severe and moderately severe Haemophilia B (congenital Factor IX deficiency) in adult patients without a history of Factor IX inhibitors.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

1 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
1
registered trials across all phases
LATEST COMPLETION 2025
1
Late-stage (III+)
1
Completed
PHASE DISTRIBUTIONn = 1
Phase 31
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.