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FVIII Replacement — Competitive Intelligence Brief
phase 2
Coagulation factor replacement
Factor VIII
Rare Disease
Small molecule
Live · refreshed every 30 min
Target snapshot
FVIII Replacement (FVIII Replacement) — Hoffmann-La Roche. Recombinant FVIII replacement to correct FVIII deficiency
Comparator set (6 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| FVIII Replacement TARGET | FVIII Replacement | Hoffmann-La Roche | phase 2 | Coagulation factor replacement | Factor VIII | |
| Moroctocog alfa (AF-CC) | Moroctocog alfa (AF-CC) | Pfizer | marketed | Recombinant coagulation factor VIII | Coagulation factor VIII | |
| Recombinant Human Coagulation FVIII | Recombinant Human Coagulation FVIII | Sinocelltech Ltd. | marketed | Coagulation factor replacement therapy | Coagulation Factor VIII | |
| OBIZUR | OBIZUR | Baxalta now part of Shire | marketed | Recombinant coagulation factor VIII | Coagulation factor VIII | |
| Recombinant Factor VIII (rAHF) | Recombinant Factor VIII (rAHF) | Baxalta now part of Shire | marketed | Recombinant clotting factor | Coagulation Factor VIII | |
| Coagulation Factor VIII | Coagulation Factor VIII | Beijing Children's Hospital | marketed | Coagulation factor replacement | Coagulation Factor VIII (antihemophilic factor) | |
| von Willebrand factor | von Willebrand factor | National Center for Research Resources (NCRR) | marketed | Coagulation factor replacement | Von Willebrand factor receptor (GPIb-IX-V complex on platelets); Factor VIII binding site |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
Sponsor landscape (Coagulation factor replacement class)
- Beijing Children's Hospital · 1 drug in this class
- Bioverativ Therapeutics Inc. · 1 drug in this class
- Hoffmann-La Roche · 1 drug in this class
- National Center for Research Resources (NCRR) · 1 drug in this class
- Takeda · 1 drug in this class
- Wyeth is now a wholly owned subsidiary of Pfizer · 1 drug in this class
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Cite this brief
Drug Landscape (2026). FVIII Replacement — Competitive Intelligence Brief. https://druglandscape.com/ci/fviii-replacement. Accessed 2026-05-13.
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