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Eptacog alfa (NovoSeven)
Eptacog alfa is a recombinant Factor VIIa that bypasses upstream coagulation defects by directly activating Factor X on the tissue factor pathway to initiate thrombin generation and hemostasis.
Eptacog alfa is a recombinant Factor VIIa that bypasses upstream coagulation defects by directly activating Factor X on the tissue factor pathway to initiate thrombin generation and hemostasis. Used for Hemophilia A with inhibitors, Hemophilia B with inhibitors, Factor VII deficiency.
At a glance
| Generic name | Eptacog alfa (NovoSeven) |
|---|---|
| Sponsor | Novo Nordisk A/S |
| Drug class | Recombinant coagulation factor |
| Target | Tissue factor (TF) / Factor X |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
Eptacog alfa (recombinant human Factor VIIa) binds to tissue factor on cell surfaces and directly activates Factor X to Factor Xa, bypassing the need for upstream factors VIII and IX. This allows patients with deficiencies or inhibitors in the intrinsic pathway to generate thrombin and form stable clots. It is particularly useful in hemophilia A and B patients with inhibitors who cannot use conventional factor replacement therapy.
Approved indications
- Hemophilia A with inhibitors
- Hemophilia B with inhibitors
- Factor VII deficiency
- Glanzmann thrombasthenia with refractoriness to platelet transfusions
- Acquired hemophilia
Common side effects
- Thrombotic events (deep vein thrombosis, pulmonary embolism, myocardial infarction)
- Injection site reactions
- Fever
- Headache
- Hypertension
Key clinical trials
- A Research Study to See How Safe is Eptacog Alfa When Used to Stop Heavy Bleeding in Women After Giving Birth in India (PHASE4)
- 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)
- A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia (PHASE3)
- Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2 (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
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 |
|---|---|
| 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 (NovoSeven) CI brief — competitive landscape report
- Eptacog alfa (NovoSeven) updates RSS · CI watch RSS
- Novo Nordisk A/S portfolio CI