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Coagadex(R) — Competitive Intelligence Brief
phase 3
Recombinant clotting factor
Factor X (coagulation factor X)
Hematology
Biologic
Live · refreshed every 30 min
Target snapshot
Coagadex(R) (Coagadex(R)) — Kedrion S.p.A.. Coagadex is a recombinant human vitamin K-dependent clotting factor X that replaces deficient or dysfunctional Factor X to restore blood coagulation.
Comparator set (6 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| Coagadex(R) TARGET | Coagadex(R) | Kedrion S.p.A. | phase 3 | Recombinant clotting factor | Factor X (coagulation factor X) | |
| Afstyla® | Afstyla® | CSL Behring | marketed | Recombinant clotting factor VIII | 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 | |
| Recombinant factor IX | Recombinant factor IX | Baxalta now part of Shire | marketed | Recombinant clotting factor | Coagulation factor IX (F9) | |
| ReFacto | ReFacto | Wyeth is now a wholly owned subsidiary of Pfizer | marketed | Recombinant clotting factor | Factor VIII (antihemophilic factor) | |
| rFVIIIFc | rFVIIIFc | Bioverativ Therapeutics Inc. | marketed | Recombinant clotting factor (Factor VIII replacement therapy) | Factor VIII / FcRn (neonatal Fc receptor) | |
| Factor VIII (rFVIIIFc) | Factor VIII (rFVIIIFc) | Bioverativ Therapeutics Inc. | phase 3 | Recombinant clotting factor | Factor VIII / Intrinsic tenase complex |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
Sponsor landscape (Recombinant clotting factor class)
- Baxalta now part of Shire · 2 drugs in this class
- Bioverativ Therapeutics Inc. · 1 drug in this class
- Kedrion S.p.A. · 1 drug in this class
- Octapharma · 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). Coagadex(R) — Competitive Intelligence Brief. https://druglandscape.com/ci/coagadex-r. Accessed 2026-06-10.
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