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Eptacog Alfa (EPTACOG ALFA (ACTIVATED))
Eptacog Alfa (generic name: EPTACOG ALFA (ACTIVATED)) is a Recombinant protein drug developed by Novo Nordisk. It is currently FDA-approved (first approved 1996) for Factor VII deficiency, Glanzmann's thrombasthenia, Hereditary factor IX deficiency disease.
Eptacog Alfa is a recombinant human protein that belongs to the class of exogenous proteins and targets coagulation factor VII. It is used to treat various bleeding disorders, including acquired and congenital bleeding disorders, as well as post-partum hemorrhage and traumatic bleeding.
At a glance
| Generic name | EPTACOG ALFA (ACTIVATED) |
|---|---|
| Sponsor | Novo Nordisk |
| Modality | Recombinant protein |
| Therapeutic area | Rare Disease |
| Phase | FDA-approved |
| First approval | 1996 |
Approved indications
- Factor VII deficiency
- Glanzmann's thrombasthenia
- Hereditary factor IX deficiency disease
- Hereditary factor VIII deficiency disease
Common side effects
Key clinical trials
- An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
- SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis (PHASE3)
- Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial (PHASE3)
- SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors (PHASE4)
- Comparative Outcomes of PCC and Recombinant Activated Factor VIIa in Trauma-Associated Massive Transfusion
- Treatment of Hemophilia A Patients With FVIII Inhibitors
- Factor IX as Adjunctive Therapy to Emicizumab (EMIX) (EARLY_PHASE1)
- Anti-αIIbβ3 Immunization in Glanzmann Thrombasthenia: Prevalence and Associated Risk Factors: Thrombasthenia Anti-αIIbβ3 Antibodies Study (TAAS) (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Eptacog Alfa CI brief — competitive landscape report
- Eptacog Alfa updates RSS · CI watch RSS
- Novo Nordisk portfolio CI
Frequently asked questions about Eptacog Alfa
What is Eptacog Alfa?
What is Eptacog Alfa used for?
Who makes Eptacog Alfa?
What is the generic name of Eptacog Alfa?
When was Eptacog Alfa approved?
What development phase is Eptacog Alfa in?
Related
- Manufacturer: Novo Nordisk — full pipeline
- Therapeutic area: All drugs in Rare Disease
- Indication: Drugs for Factor VII deficiency
- Indication: Drugs for Glanzmann's thrombasthenia
- Indication: Drugs for Hereditary factor IX deficiency disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing