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Open-label Semuloparin sodium
Semuloparin sodium is a selective inhibitor of Factor Xa that prevents thrombin generation and blood clot formation.
Semuloparin sodium is a selective inhibitor of Factor Xa that prevents thrombin generation and blood clot formation. Used for Thromboprophylaxis in patients undergoing abdominal surgery, Thromboprophylaxis in patients with acute medical illness.
At a glance
| Generic name | Open-label Semuloparin sodium |
|---|---|
| Also known as | AVE5026 |
| Sponsor | Sanofi |
| Drug class | Low-molecular-weight heparin (LMWH); Factor Xa inhibitor |
| Target | Factor Xa |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Semuloparin is a low-molecular-weight heparin (LMWH) derivative that selectively inhibits Factor Xa, a key enzyme in the coagulation cascade. By blocking Factor Xa activity, it prevents the conversion of prothrombin to thrombin, thereby reducing thrombus formation. It is used for thromboprophylaxis in patients at high risk of venous thromboembolism.
Approved indications
- Thromboprophylaxis in patients undergoing abdominal surgery
- Thromboprophylaxis in patients with acute medical illness
Common side effects
- Bleeding
- Thrombocytopenia
- Injection site reactions
Key clinical trials
- Study of AVE5026 at Weight-adjusted Doses in Children With a Central Venous Line (PHASE2)
- Evaluation of AVE5026 as Compared to Placebo for the Extended Prophylaxis of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery (PHASE3)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |