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Recombinant Activated Factor VII
Recombinant Activated Factor VII is a Coagulation factor Small molecule drug developed by Hoffmann-La Roche. It is currently in Phase 3 development for Hemophilia A or B with inhibitors, Factor VII deficiency, Bleeding episodes in patients with coagulation disorders. Also known as: NovoSeven RT, Novo Nordisk, Bagsvaerd, Denmark, NovoSeven.
Recombinant Activated Factor VII (rFVIIa) directly activates the extrinsic coagulation pathway to promote thrombin generation and hemostasis.
Recombinant activated factor VII is a protein-based treatment used to address various bleeding disorders, including intracerebral hemorrhage, congenital bleeding disorders, and hemophilia A. It works by interacting with coagulation factor IX to facilitate blood clotting.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Hoffmann-La Roche is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Recombinant Activated Factor VII |
|---|---|
| Also known as | NovoSeven RT, Novo Nordisk, Bagsvaerd, Denmark, NovoSeven |
| Sponsor | Hoffmann-La Roche |
| Drug class | Coagulation factor |
| Target | Tissue Factor (TF); Factor X |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
rFVIIa is a recombinant version of human coagulation Factor VIIa that binds to tissue factor (TF) on cell surfaces, initiating the extrinsic pathway of blood coagulation. This complex catalyzes the conversion of Factor X to Factor Xa, which then generates thrombin and ultimately leads to fibrin clot formation. It is used to bypass deficiencies or inhibitors in the intrinsic coagulation pathway.
Approved indications
- Hemophilia A or B with inhibitors
- Factor VII deficiency
- Bleeding episodes in patients with coagulation disorders
Common side effects
- Thrombosis
- Arterial thromboembolism
- Venous thromboembolism
- Injection site reactions
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)
- 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
- Eptacog Beta in Glanzmann's (HeT_LFB-Strength-Study_FID531) (PHASE2)
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:
- Recombinant Activated Factor VII CI brief — competitive landscape report
- Recombinant Activated Factor VII updates RSS · CI watch RSS
- Hoffmann-La Roche portfolio CI
Frequently asked questions about Recombinant Activated Factor VII
What is Recombinant Activated Factor VII?
How does Recombinant Activated Factor VII work?
What is Recombinant Activated Factor VII used for?
Who makes Recombinant Activated Factor VII?
Is Recombinant Activated Factor VII also known as anything else?
What drug class is Recombinant Activated Factor VII in?
What development phase is Recombinant Activated Factor VII in?
What are the side effects of Recombinant Activated Factor VII?
What does Recombinant Activated Factor VII target?
Related
- Drug class: All Coagulation factor drugs
- Target: All drugs targeting Tissue Factor (TF); Factor X
- Manufacturer: Hoffmann-La Roche — full pipeline
- Therapeutic area: All drugs in Hematology
- Indication: Drugs for Hemophilia A or B with inhibitors
- Indication: Drugs for Factor VII deficiency
- Indication: Drugs for Bleeding episodes in patients with coagulation disorders
- Also known as: NovoSeven RT, Novo Nordisk, Bagsvaerd, Denmark, NovoSeven
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing