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BT524 (Part II)
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 Severe bleeding or hemostatic support in patients with coagulopathies.
At a glance
| Generic name | BT524 (Part II) |
|---|---|
| Also known as | Human Fibrinogen Concentrate |
| Sponsor | Biotest |
| Drug class | Monoclonal antibody (anti-TFPI) |
| Target | Tissue Factor Pathway Inhibitor (TFPI) |
| Modality | Small molecule |
| 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, which promotes clot formation and hemostasis. This mechanism is intended to improve bleeding control in patients with severe bleeding disorders or those requiring hemostatic support.
Approved indications
- Severe bleeding or hemostatic support in patients with coagulopathies
Common side effects
- Thrombotic events
- Infusion-related reactions
Key clinical trials
- Pharmacokinetic, Efficacy and Safety of BT524 in Patients With Congenital Fibrinogen Deficiency (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 |