Last reviewed · How we verify
BT595
BT595 is a human monoclonal antibody that binds to and neutralizes tissue factor pathway inhibitor (TFPI) to enhance thrombin generation and hemostasis.
BT595 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 bleeding disorders.
At a glance
| Generic name | BT595 |
|---|---|
| Also known as | Human Immunoglobulin |
| 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
BT595 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 designed 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 bleeding disorders
Common side effects
- Thrombotic events
- Infusion-related reactions
Key clinical trials
- Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID (PHASE3)
- This Clinical Study is to Test Efficacy and Safety of BT595 in Chronic Primary Immune Thrombocytopenia (ITP) (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 |