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BT524
BT524 is a human monoclonal antibody that binds to and neutralizes tissue factor pathway inhibitor (TFPI) to enhance thrombin generation and hemostasis.
BT524 is a human monoclonal antibody that binds to and neutralizes tissue factor pathway inhibitor (TFPI) to enhance thrombin generation and hemostasis. Used for Rare bleeding disorders associated with TFPI dysregulation, Hemophilia or other coagulation deficiencies (investigational).
At a glance
| Generic name | BT524 |
|---|---|
| Also known as | Human Fibrinogen concentrate |
| Sponsor | Biotest |
| Drug class | Monoclonal antibody (anti-TFPI) |
| Target | Tissue Factor Pathway Inhibitor (TFPI) |
| Modality | Biologic |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
BT524 works by inhibiting TFPI, a natural anticoagulant that suppresses the tissue factor-initiated coagulation cascade. By blocking TFPI, the drug allows increased thrombin generation and fibrin formation, thereby promoting clot formation. This mechanism is designed to improve hemostasis in patients with bleeding disorders or those at risk of excessive bleeding.
Approved indications
- Rare bleeding disorders associated with TFPI dysregulation
- Hemophilia or other coagulation deficiencies (investigational)
Common side effects
- Thrombotic events
- Infusion-related reactions
- Injection site reactions
Key clinical trials
- Pharmacokinetic, Efficacy and Safety of BT524 in Patients With Congenital Fibrinogen Deficiency (PHASE3)
- Adjusted Fibrinogen Replacement Strategy (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:
- BT524 CI brief — competitive landscape report
- BT524 updates RSS · CI watch RSS
- Biotest portfolio CI