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Drug

Damoctocog alfa pegol

Approved medicine
ClassCoagulation factor VIII exogenous proteinResearchOngoing clinical research
Also known as Damoctocog pegol alfa, Damoctocog pegol alpha, Jivi, Damoctocog alfa-pegol+3 more

Damoctocog pegol alfa, Damoctocog pegol alpha, Jivi, Damoctocog alfa-pegol, Damoctocog alpha pegol, antihemophilic factor (recombinant) pegylated (damoctocog alfa pegol), damoctocog alfa pegol (antihemophilic factor (recombinant) pegylated).

RxNorm2055655ChEMBLCHEMBL5315069UNIIBY4TSK952Y
Coagulation factor VIII
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
Damoctocog alfa pegol
Aliases & brands
Damoctocog pegol alfaDamoctocog pegol alphaJiviDamoctocog alfa-pegolDamoctocog alpha pegolantihemophilic factor (recombinant) pegylated (damoctocog alfa pegol)damoctocog alfa pegol (antihemophilic factor (recombinant) pegylated)
RxNorm CUI
2055655
ChEMBL ID
CHEMBL5315069
UNII
BY4TSK952Y
Primary mechanism
Coagulation factor VIII exogenous protein
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Coagulation factor VIII
F8 · P00451
EXOGENOUS PROTEINCoagulation factor VIII 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
2018-11-22
Latest approval
2018-11-22
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2018-11-22Approval
Approval: Jivi (EMA)

Indication: Treatment and prophylaxis of bleeding in previously treated patients (PTPs) ≥ 7 years of age with haemophilia A (congenital factor VIII deficiency).

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 2022
1
Late-stage (III+)
1
Completed
PHASE DISTRIBUTIONn = 1
Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Post-marketing Investigation (PMI) to Assess Safety and Efficacy of Jivi (BAY 94-9027) Treatment in Participants With Hemophilia A

CompletedPH IVBayern=322022

Recent completions

Trials that read out recently, adding to the completed evidence base.

Post-marketing Investigation (PMI) to Assess Safety and Efficacy of Jivi (BAY 94-9027) Treatment in Participants With Hemophilia A

CompletedPH IVBayern=322022
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.