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Dabigatran etexilate (Pradaxa)

Dabigatran etexilate (Pradaxa) is a Direct thrombin inhibitor (DTI) Small molecule drug developed by Bayer. It is currently FDA-approved for Atrial fibrillation for stroke and systemic embolism prevention, Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), Prophylaxis of DVT and PE following hip replacement surgery. Also known as: Pradaxa.

Dabigatran etexilate is a prodrug that converts to dabigatran, a direct thrombin inhibitor that blocks the final step of the coagulation cascade.

Dabigatran etexilate, also known as Pradaxa, is a small molecule medication used to treat conditions such as Atrial Fibrillation and Ischemic Stroke. It works by inhibiting thrombin, a key enzyme in the blood clotting process.

At a glance

Mechanism of action

Dabigatran etexilate is rapidly converted by esterase enzymes in the blood to its active form, dabigatran. Dabigatran directly inhibits thrombin (Factor IIa), a key serine protease responsible for converting fibrinogen to fibrin and amplifying the coagulation cascade. By blocking thrombin activity, it prevents clot formation without requiring antithrombin III as a cofactor, unlike warfarin and heparin-based anticoagulants.

Approved indications

• Atrial fibrillation for stroke and systemic embolism prevention
• Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE)
• Prophylaxis of DVT and PE following hip replacement surgery

Common side effects

• Bleeding (major and minor)
• Dyspepsia/gastrointestinal discomfort
• Gastritis
• 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

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Dabigatran etexilate (Pradaxa) CI brief — competitive landscape report
• Dabigatran etexilate (Pradaxa) updates RSS · CI watch RSS
• Bayer portfolio CI

Frequently asked questions about Dabigatran etexilate (Pradaxa)

Related

• Drug class: All Direct thrombin inhibitor (DTI) drugs
• Target: All drugs targeting Thrombin (Factor IIa)
• Manufacturer: Bayer — full pipeline
• Therapeutic area: All drugs in Cardiovascular
• Indication: Drugs for Atrial fibrillation for stroke and systemic embolism prevention
• Indication: Drugs for Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE)
• Indication: Drugs for Prophylaxis of DVT and PE following hip replacement surgery
• Also known as: Pradaxa

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing