Last reviewed · How we verify
Pradaxa (dabigatran etexilate)
Direct thrombin inhibitor that blocks both free and clot-bound thrombin, providing anticoagulation without routine monitoring.
Dabigatran (Pradaxa) was the first DOAC, developed by Boehringer Ingelheim and approved in 2010. It offers anticoagulation without INR monitoring and has a specific reversal agent (Praxbind). Available generically in some markets.
At a glance
| Generic name | dabigatran etexilate |
|---|---|
| Also known as | Pradaxa |
| Sponsor | Generic (originally Boehringer Ingelheim) |
| Drug class | Direct oral anticoagulant (DOAC) — direct thrombin inhibitor |
| Target | Multidrug and toxin extrusion protein 1, Multidrug and toxin extrusion protein 2, Ribosyldihydronicotinamide dehydrogenase [quinone] |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 2010-10-19 (United States) |
| Annual revenue | 1200 |
Mechanism of action
Dabigatran was the first direct oral anticoagulant (DOAC) approved, directly inhibiting thrombin without the need for INR monitoring required by warfarin. The RE-LY trial showed non-inferiority to warfarin for stroke prevention in AF. It has a specific reversal agent (idarucizumab/Praxbind) for emergency situations.
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
Common side effects
- Gastrointestinal adverse reactions
- Bleeding
- Dyspepsia
- Nausea
- Upper abdominal pain
- Diarrhea
Serious adverse events
- Major bleeding
- Intracranial hemorrhage
- Gastrointestinal hemorrhage
- Thrombotic events
- Thromboembolic events
Key clinical trials
- A Prospective, Randomized, Controlled, Analyst-blinded, Parallel Group Study to Investigate the Effect of Antithrombotic Triple Therapy With Ticagrelor and Acetylsalicylic Acid in Combination With Dab (Phase 4)
- Efficacy and Safety of Non-vitamin K Oral Anticoagulants and Vitamin K Oral Anticoagulants on Some Metabolic and Coagulation Parameters in Diabetic and Nondiabetic Patients With First Diagnosis of Non (Phase 4)
- Relative Bioavailability of Dabigatran After Administration of Different Dosage Forms of Multiple Doses of 150 mg Dabigatran Etexilate (Hard Capsule, Granules Resolved in Reconstitution Solution, Pell (Phase 1)
- Observational Cohort Study to Evaluate the Safety and Efficacy of Pradaxa (Dabigatran Etexilate) for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surg (N/A)
- Safety, Pharmacokinetics and Pharmacodynamics After Single Rising Oral Doses of 50, 150 and 350 mg BIBR 1048 MS as Capsules in Healthy Subjects of Japanese and Caucasian Origin. Double-blind at Each D (Phase 1)
- Uninterrupted Versus Interrupted Anticoagulation in Atrial Fibrillation Ablation - Cerebral Thromboemboli and Neurocognitive Performance (Phase 4)
- Optimizing Antithrombotic Care in Patients With AtriaL fibrillatiON and Coronary stEnt (OAC-ALONE) Study (Phase 4)
- BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery (Phase 2)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Pradaxa CI brief — competitive landscape report
- Pradaxa updates RSS · CI watch RSS
- Generic (originally Boehringer Ingelheim) portfolio CI