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Xyntha (xyntha)
Xyntha is a marketed drug by Pfizer Inc. for Hemophilia A. It is a recombinant coagulation factor VIII, replacing the deficient protein in patients. This treatment helps prevent bleeding episodes and improve quality of life. Xyntha's clinical differentiation lies in its high efficacy and safety profile. Its commercial significance is substantial, with a large patient population. Pipeline developments are focused on improving treatment outcomes and reducing side effects. Xyntha's mechanism involves replacing the deficient coagulation factor VIII protein.
At a glance
| Generic name | xyntha |
|---|---|
| Sponsor | Pfizer |
| Drug class | Recombinant protein therapy |
| Target | Coagulation factor VIII |
| Therapeutic area | Rare Disease |
| Phase | FDA-approved |
Approved indications
- Hemophilia A
Common side effects
- Headache
- Arthralgia
- Pyrexia
- Cough
- Diarrhea
- Vomiting
- Asthenia
Serious adverse events
- Factor VIII inhibitors
- Anti-FVIII antibodies
Drug interactions
- Aspirin
- Warfarin
- NSAIDs
- Anticoagulants
- Antiplatelets
- Selective serotonin reuptake inhibitors (SSRIs)
- Serotonin-norepinephrine reuptake inhibitors (SNRIs)
- Thrombolytics
- Heparin
- Low molecular weight heparin
- Fibrinolytics
- Dipyridamole
Key clinical trials
- Long-term Study Evaluating Joint Health in People With Haemophilia A Receiving Real-world Prophylactic Treatment With Efanesoctocog Alfa (PHASE4)
- A 48-Month Study to Evaluate Long-Term Effectiveness of Elocta on Joint Health
- Phase 3 Study for Efficacy and Safety Outcomes Data in Japanese Patients With Severe Hemophilia A (PHASE3)
- Study to Test the Safety and How Well Patients With Severe Hemophilia A Respond to Treatment With BAY 2599023 (DTX 201), a Drug Therapy That Delivers a Healthy Version of the Defective Factor VIII Gene Into the Nucleus of Liver Cells Using an Altered, Non-infectious Virus (AAV) as a "Shuttle" (PHASE1, PHASE2)
- An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A
- A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease (PHASE3)
- An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
- Evaluation of the Safety and Efficacy of Hemophilia A Gene Therapy Drugs (PHASE2, 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
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Xyntha CI brief — competitive landscape report
- Xyntha updates RSS · CI watch RSS
- Pfizer portfolio CI