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Open label fondaparinux
Fondaparinux selectively inhibits Factor Xa, a key enzyme in the coagulation cascade, thereby preventing thrombin generation and blood clot formation.
Fondaparinux selectively inhibits Factor Xa, a key enzyme in the coagulation cascade, thereby preventing thrombin generation and blood clot formation. Used for Acute deep vein thrombosis (DVT) treatment, Acute pulmonary embolism (PE) treatment, Prophylaxis of venous thromboembolism in patients undergoing hip fracture surgery, hip replacement surgery, or knee replacement surgery.
At a glance
| Generic name | Open label fondaparinux |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Factor Xa inhibitor |
| Target | Factor Xa |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Fondaparinux is a synthetic pentasaccharide that binds to antithrombin III and potentiates its inhibition of Factor Xa. By blocking Factor Xa activity, it interrupts the intrinsic and common pathways of the coagulation cascade, reducing thrombin generation and preventing thrombosis without directly inhibiting thrombin itself.
Approved indications
- Acute deep vein thrombosis (DVT)
- Acute pulmonary embolism (PE)
- Prophylaxis of venous thromboembolism in patients undergoing hip fracture surgery, hip replacement surgery, or knee replacement surgery
- Acute coronary syndrome (unstable angina and non-ST-segment elevation myocardial infarction)
Common side effects
- Bleeding (major and minor)
- Thrombocytopenia
- Injection site reactions
- Anemia
- Nausea
Key clinical trials
- Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (PHASE3)
- Thromboprophylaxis in Lower Limb Immobilisation (PHASE3)
- Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE) (PHASE3)
- Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE) (PHASE3)
- EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis (PHASE3)
- Safety and Pharmacokinetics Study of DU-176b Administered to Patients With Severe Renal Impairment Undergoing Orthopedic Surgery of The Lower Limbs (PHASE3)
- Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer (PHASE2)
- Fondaparinux Trial With Unfractionated Heparin (UFH) During Revascularization in Acute Coronary Syndromes (ACS) (PHASE4)
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:
- Open label fondaparinux CI brief — competitive landscape report
- Open label fondaparinux updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI