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Kogenate (BAY 14-2222)
Kogenate is a recombinant human coagulation factor VIII that replaces deficient or dysfunctional factor VIII to restore blood clotting ability in hemophilia A patients.
Kogenate is a recombinant human 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) — treatment and prevention of bleeding episodes, Perioperative management in hemophilia A patients.
At a glance
| Generic name | Kogenate (BAY 14-2222) |
|---|---|
| Sponsor | Bayer |
| Drug class | Recombinant coagulation factor VIII |
| 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 von Willebrand factor to activate factor X. In hemophilia A, factor VIII is deficient or non-functional, leading to impaired thrombin generation and bleeding. Kogenate provides exogenous factor VIII to bypass this deficiency and restore normal hemostasis.
Approved indications
- Hemophilia A (congenital factor VIII deficiency) — treatment and prevention of bleeding episodes
- Perioperative management in hemophilia A patients
Common side effects
- Inhibitor development (anti-factor VIII antibodies)
- Injection site reactions
- Headache
- Fever
- Allergic reactions
Key clinical trials
- Extension at 10 Years of the: "Observational Study Evaluating Efficacy and Costs of Secondary Prophylaxis vs On-demand Therapy With Kogenate Bayer in Patients With Severe Haemophilia A."
- Comparison of Efficacy, Safety and Costs of Recombinant FVIII Products Between On-demand and Secondary Prophylaxis Groups in Haemophilia A Patients
- Patient Functioning and Well-being, Economic, and Clinical Impact of Hemophilia A and Its Treatment
- Trial to Evaluate the Pharmacokinetics and Safety Profile of BAY94-9027 Following Single and Multiple Dose Administration (PHASE1)
- Trial to Evaluate the Efficacy and Safety of a New Full Length Recombinant Human FVIII for Hemophilia A (PHASE3)
- Validation Study of a cOmputer Pharmacokinetic Tool to assIst in the Follow up Care of haeMophilia A Patients
- Russian Kogenate Pediatric Study (PHASE4)
- Prophylaxis Versus on Demand Treatment for Children With Hemophilia A (PHASE4)
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:
- Kogenate (BAY 14-2222) CI brief — competitive landscape report
- Kogenate (BAY 14-2222) updates RSS · CI watch RSS
- Bayer portfolio CI