NDAORALCAPSULEPriority Review
Approved
Oct 2010
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
18
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PRADAXA (dabigatran etexilate mesylate) is an oral, small-molecule direct thrombin inhibitor approved by the FDA in October 2010 for stroke and systemic embolism prevention in non-valvular atrial fibrillation, as well as treatment and prevention of deep vein thrombosis and pulmonary embolism in adults and pediatric patients. The drug works by competitively inhibiting both free and clot-bound thrombin, preventing fibrin formation and thrombus development. It represents an important alternative to warfarin in the anticoagulation treatment landscape.
$0.2BPart D
5.2 years to LOEMechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (18)
A Study in the United Sates That Looks at the Safety and Effectiveness of Pradaxa Pellets in Children Aged 3 Months to Less Than 12 Years Who Need Treatment of a Blood Clot or Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot
Started Apr 2024
6 enrolled
Venous Thromboembolism
A Single Dose Bioequivalence Study of WD-1602 Versus Pradaxa® in Healthy Subjects Under Fed Condition
Started Jan 2021
20 enrolled
Anticoagulant
Clinical Trial to Assess the Safety and Pharmacokinetics of RDG-17012 Capsule and Pradaxa® Capsule in Healthy Male Volunteers
Started Feb 2018
64 enrolled
Healthy
Japanese Pradaxa PMS, Long Term
Started Jul 2017
5,660 enrolled
Atrial Fibrillation
Pradaxa Tablet Proton Pump Inhibitor (PPI) Bioavailability (BA) Study in Japan
Started May 2017
36 enrolled
Non-alcoholic Fatty Liver Disease
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.