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Dabigatran etexilate (DE) (dabigatran-etexilate-de)
Dabigatran etexilate (DE) as oral capsule
Dabigatran etexilate is a direct thrombin inhibitor anticoagulant approved to reduce stroke risk in patients with atrial fibrillation and to treat venous thromboembolism. Unlike warfarin, it works by directly blocking thrombin without requiring INR monitoring, offering a more predictable anticoagulant effect with fixed dosing.
At a glance
| Generic name | dabigatran-etexilate-de |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | Dabigatran etexilate (DE) as oral capsule |
| Target | Multidrug and toxin extrusion protein 1, Multidrug and toxin extrusion protein 2, Ribosyldihydronicotinamide dehydrogenase [quinone] |
| Therapeutic area | Cardiovascular |
| Phase | discontinued |
Mechanism of action
Dabigatran etexilate is an anticoagulant medication that prevents blood clots by targeting a specific protein in your blood called thrombin. Thrombin is a key enzyme that acts like the final trigger in the clotting cascade—it converts fibrinogen into fibrin, which forms the structural meshwork of blood clots. By directly inhibiting thrombin, dabigatran essentially stops this final step of clot formation before it can happen. When you take dabigatran etexilate, it's quickly converted in your body to its active form, dabigatran. This active form circulates in your bloodstream and continuously blocks thrombin molecules, preventing them from doing their job. This makes your blood less likely to form dangerous clots in the heart, veins, or arteries. The medication is particularly useful in conditions like atrial fibrillation, where irregular heartbeats create stagnant blood flow that promotes clot formation. A major advantage of dabigatran compared to older anticoagulants like warfarin is that it works predictably without requiring frequent blood tests or dietary restrictions. You take it at a fixed dose, and it provides consistent anticoagulation. However, because it works so directly and powerfully, careful monitoring for bleeding risk is still important, and it cannot be used in certain patient populations or with specific medications.
Approved indications
- Deep vein thrombosis
- Prevention of Thromboembolism with Chronic Atrial Fibrillation
- Prevention of deep vein thrombosis
- Prevention of stroke
- Prevention of systemic embolism
- Pulmonary embolism
Pipeline indications
- Healthy — discontinued
Common side effects
Key clinical trials
- VH3739937 Phase 1 Multiple Ascending Dose (MAD) Study in Healthy Volunteers Including Relative Bioavailability (RBA), Optional Food Effect (FE), and Drug-drug Interaction (DDI) (PHASE1)
- Assessment of the Incidence of Hemorrhagic and Ischemic Events in Post-angioplasty in Anticoagulated Coronary Patients with Atrial Fibrillation
- A Drug-Drug Interaction Study to Estimate the Effect of PF-07081532 on the Pharmacokinetics of Dabigatran and Rosuvastatin in Overweight or Obese Adult Participants (PHASE1)
- Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United States Cohort
- A Study in Europe Based on Medical Records That Looks at the Safety of Dabigatran in Children Below 2 Years of Age Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot
- RE-COVERY DVT/PE: Global Study on Treatment Secondary Prevention of Acute Venous Thromboembolism
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:
- Dabigatran etexilate (DE) CI brief — competitive landscape report
- Dabigatran etexilate (DE) updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI