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Recombinant Human Coagulation FVIII
Recombinant human coagulation factor VIII replaces deficient or dysfunctional Factor VIII to restore the intrinsic coagulation pathway and enable normal blood clot formation.
Recombinant human coagulation factor VIII replaces deficient or dysfunctional Factor VIII to restore the intrinsic coagulation pathway and enable normal blood clot formation. Used for Hemophilia A (Factor VIII deficiency), Prevention and treatment of bleeding episodes in hemophilia A patients.
At a glance
| Generic name | Recombinant Human Coagulation FVIII |
|---|---|
| Also known as | SCT800 |
| Sponsor | Sinocelltech Ltd. |
| Drug class | Coagulation factor replacement therapy |
| Target | Coagulation Factor VIII |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
Factor VIII is a critical cofactor in the intrinsic coagulation cascade that works with Factor IX to activate Factor X, ultimately leading to thrombin generation and fibrin clot formation. This recombinant product is produced using cell culture technology and is used to treat patients with Factor VIII deficiency or dysfunction. By restoring Factor VIII activity, the drug corrects the bleeding tendency characteristic of hemophilia A.
Approved indications
- Hemophilia A (Factor VIII deficiency)
- Prevention and treatment of bleeding episodes in hemophilia A patients
Common side effects
- Inhibitor development (anti-Factor VIII antibodies)
- Injection site reactions
- Allergic reactions
- Thrombotic events
Key clinical trials
- Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery (PHASE4)
- SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors (PHASE4)
- A Study of Recombinant Von Willebrand Factor (rVWF) in Chinese Participants With Von Willebrand Disease (vWD) (PHASE3)
- Prophylaxis Regimen for Hemophilia A Patients (PHASE4)
- Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study (PHASE4)
- Drug Use Investigation of Kovaltry in Hemophilia A Patients
- A Study of Vonicog Alfa (rVWF) in Children With Severe Von Willebrand Disease (vWD) (PHASE3)
- Treatment of Hemophilia A Patients With FVIII Inhibitors
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 Human Coagulation FVIII CI brief — competitive landscape report
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- Sinocelltech Ltd. portfolio CI