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Intravenous infusions of Xyntha
Xyntha is a recombinant coagulation factor VIII that replaces deficient or dysfunctional factor VIII to restore blood clotting ability in hemophilia A patients.
Xyntha is a recombinant coagulation factor VIII that replaces deficient or dysfunctional factor VIII to restore blood clotting ability in hemophilia A patients. Used for Hemophilia A (congenital factor VIII deficiency) for control and prevention of bleeding episodes, Perioperative management in hemophilia A patients undergoing surgery.
At a glance
| Generic name | Intravenous infusions of Xyntha |
|---|---|
| Also known as | Xyntha (Moroctocog-alfa (AF-CC) |
| Sponsor | Pfizer |
| Drug class | Recombinant coagulation factor VIII |
| Target | Coagulation factor VIII |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
Xyntha is a recombinant human coagulation factor VIII produced using a modified Chinese hamster ovary cell line. It functions as a cofactor in the intrinsic coagulation pathway, working with factor IX to activate factor X and initiate the cascade leading to thrombin generation and fibrin clot formation. In hemophilia A patients who lack functional factor VIII, intravenous infusion of Xyntha restores the ability to form stable blood clots.
Approved indications
- Hemophilia A (congenital factor VIII deficiency) for control and prevention of bleeding episodes
- Perioperative management in hemophilia A patients undergoing surgery
Common side effects
- Inhibitor development (factor VIII antibodies)
- Hypersensitivity reactions
- Headache
- Fever
- Injection site reactions
Key clinical trials
- Evaluation of the Safety and Efficacy of Hemophilia A Gene Therapy Drugs (PHASE2, 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)
- A Study of Recombinant Von Willebrand Factor (rVWF) in Chinese Participants With Von Willebrand Disease (vWD) (PHASE3)
- Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Participants With Hemophilia A Previously Treated With FVIII Products (PHASE3)
- A Study of Vonicog Alfa (rVWF) in Children With Severe Von Willebrand Disease (vWD) (PHASE3)
- A Study of BAX 888 in Male Adults With Severe Hemophilia A (PHASE1, PHASE2)
- Study to Evaluate the Efficacy and Safety of PF-07055480 / Giroctocogene Fitelparvovec Gene Therapy in Moderately Severe to Severe Hemophilia A Adults (PHASE3)
- Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A (PHASE3)
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
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