DABIGATRAN ETEXILATE MESYLATE
Dabigatran etexilate mesylate helps patients with non-valvular atrial fibrillation by lowering the risk of stroke and systemic embolism. It also treats deep venous thrombosis and pulmonary embolism in adults and children aged 8 to 18 who have already received initial injectable blood thinners. Additionally, it is used to prevent blood clots in adults following hip replacement surgery and to reduce the risk of these conditions returning in patients who were previously treated.
How DABIGATRAN ETEXILATE MESYLATE Works
This drug works by acting as a competitive, direct thrombin inhibitor. By blocking thrombin, it prevents the conversion of fibrinogen into fibrin, which stops blood clots from forming. It targets both free and clot-bound thrombin while also stopping platelets from clumping together.
Details
- Status
- Discontinued
- First Approved
- 2020-03-11
- Routes
- ORAL
- Dosage Forms
- CAPSULE
Companies
DABIGATRAN ETEXILATE MESYLATE Approval History
What DABIGATRAN ETEXILATE MESYLATE Treats
6 indicationsDABIGATRAN ETEXILATE MESYLATE is approved for 6 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Stroke
- Systemic Embolism
- Atrial Fibrillation
- Deep Vein Thrombosis
- Pulmonary Embolism
- Venous Thromboembolism
DABIGATRAN ETEXILATE MESYLATE Boxed Warning
(A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, and (B) SPINAL/EPIDURAL HEMATOMA WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, and (B) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete boxed warning (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS: Premature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events. To red...
WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, and (B) SPINAL/EPIDURAL HEMATOMA WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, and (B) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete boxed warning (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS: Premature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events. To reduce this risk, consider coverage with another anticoagulant if PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy ( 2.6 , 2.7 , 2.8 , 5.1 ). (B) SPINAL/EPIDURAL HEMATOMA: Epidural or spinal hematomas may occur in patients treated with PRADAXA who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis ( 5.3 ). Monitor patients frequently for signs and symptoms of neurological impairment and if observed, treat urgently. Consider the benefits and risks before neuraxial intervention in patients who are or who need to be anticoagulated ( 5.3 ). (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS Premature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events. If anticoagulation with PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.6 , 2.7 , 2.8) and Warnings and Precautions (5.1) ]. (B) SPINAL/EPIDURAL HEMATOMA Epidural or spinal hematomas may occur in patients treated with PRADAXA who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epid
DABIGATRAN ETEXILATE MESYLATE Target & Pathway
ProTarget
The central enzyme in blood coagulation that converts fibrinogen to fibrin, forming blood clots. Direct thrombin inhibitors prevent clot formation and are used to prevent stroke and treat blood clots.
DABIGATRAN ETEXILATE MESYLATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in DABIGATRAN ETEXILATE MESYLATE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DABIGATRAN ETEXILATE MESYLATE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to DABIGATRAN ETEXILATE MESYLATE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02945020 | CR108164 64294178HPC1003 | Ph 1 | completed | A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Participants |
| NCT03807856 | 18-004345 | Ph 1 | terminated | Treating Acute Pancreatitis With Dabigatran, a Pilot Study |
| NCT01976507 results posted | 121204 | Ph 4 | completed | Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DABIGATRAN ETEXILATE MESYLATE FDA Label Details
Indications & Usage
DABIGATRAN ETEXILATE MESYLATE is indicated for the treatment of Stroke; Systemic Embolism; Atrial Fibrillation; Deep Vein Thrombosis; Pulmonary Embolism; Venous Thromboembolism.
WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, and (B) SPINAL/EPIDURAL HEMATOMA WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, and (B) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete boxed ...
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PRADAXA
Full clinical data, patents, trials, and competitive landscape for dabigatran etexilate mesylate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.