HYMPAVZI (marstacimab-hncq)
HYMPAVZI (marstacimab-hncq) is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis in adult and pediatric patients 12 years of age and older. It is used to prevent or reduce the frequency of bleeding episodes in individuals with hemophilia A or hemophilia B who do not have factor VIII or factor IX inhibitors. The therapy provides a prophylactic approach for managing congenital factor VIII or factor IX deficiencies.
How HYMPAVZI Works
Marstacimab-hncq is a human monoclonal antibody that targets the Kunitz domain 2 of tissue factor pathway inhibitor (TFPI). By binding to this specific domain, the drug neutralizes TFPI activity, which normally serves as the primary inhibitor of the extrinsic coagulation cascade. This neutralization prevents TFPI from inactivating the protease functions of the factor Xa/VIIa/TF complex, thereby enhancing thrombin generation and promoting blood coagulation.
Details
- Status
- Prescription
- First Approved
- 2024-10-11
- PDUFA Date
- 2026-06-29 (34d)
- Patent Cliff
- 2031
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
HYMPAVZI Approval History
What HYMPAVZI Treats
2 indicationsHYMPAVZI is approved for 2 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hemophilia A
- Hemophilia B
HYMPAVZI Target & Pathway
ProTarget
A key enzyme in the blood clotting cascade that converts prothrombin to thrombin. Inhibiting Factor Xa prevents clot formation, reducing risk of stroke in atrial fibrillation and treating/preventing venous thromboembolism.
HYMPAVZI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
HYMPAVZI FDA Label Details
Indications & Usage
FDA Label (PDF)HYMPAVZI is indicated for the treatment of Hemophilia A; Hemophilia B.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.