Last reviewed · How we verify
Pradaxa (Dabigatran etexilate)
Dabigatran etexilate is a direct thrombin inhibitor that blocks the final step of the coagulation cascade by directly binding to and inhibiting thrombin.
Dabigatran etexilate is a direct thrombin inhibitor that blocks the final step of the coagulation cascade by directly binding to and inhibiting thrombin. Used for Atrial fibrillation for stroke and systemic embolism prevention, Treatment of deep vein thrombosis and pulmonary embolism, Prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery.
At a glance
| Generic name | Pradaxa (Dabigatran etexilate) |
|---|---|
| Sponsor | Bayer |
| Drug class | Direct thrombin inhibitor (anticoagulant) |
| Target | Thrombin (Factor IIa) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Dabigatran etexilate is a prodrug that is rapidly converted to dabigatran in the body. Dabigatran directly and reversibly inhibits both free and clot-bound thrombin, preventing the conversion of fibrinogen to fibrin and thereby blocking thrombus formation. This direct mechanism of action provides predictable anticoagulation without requiring monitoring of coagulation parameters.
Approved indications
- Atrial fibrillation for stroke and systemic embolism prevention
- Treatment of deep vein thrombosis and pulmonary embolism
- Prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery
Common side effects
- Bleeding (major and minor)
- Dyspepsia
- Gastrointestinal bleeding
- Abdominal pain
- Headache
Key clinical trials
- Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure (PHASE4)
- FENOX Trial (Comparative Effectiveness of Fexuprazan Co-therapy in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants) (NA)
- PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years (PHASE3)
- Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia (PHASE4)
- Anticoagulation in Patients With Venous Thromboembolism and Cancer
- High Gastrointestinal Bleed Risk Outcomes in Patients With Non-valvular Atrial Fibrillation (NVAF) in France
- A Study to Evaluate Safety and PK of Multiple Doses of LT3001 Drug Product and Drug-drug Interaction in Healthy Subjects (PHASE1)
- SNAP AF-52: Dose Appropriateness and Adherence to Oral Anticoagulation in Adults ≥65 With Atrial Fibrillation in Primary Care (Ordu, Türkiye)
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:
- Pradaxa (Dabigatran etexilate) CI brief — competitive landscape report
- Pradaxa (Dabigatran etexilate) updates RSS · CI watch RSS
- Bayer portfolio CI