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Dabigatran Etexilate Mesylate

FDA-approved product (capsule, oral), marketed as Dabigatran Etexilate Mesylate, Pradaxa.

Registered studies
14
Lab records
0
Pathogens at ≥40%
3 of 4

Chemical structure

Chemical structure of Dabigatran Etexilate Mesylate
A drawing shows what the molecule is, not what it does.

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Atrial fibrillation
  • Deep vein thrombosis
  • Pulmonary embolism
  • Recurrent thrombophlebitis
  • Stroke
  • Thrombotic disease
  • Total joint arthroplasty
  • Venous thromboembolism

Indications ChEMBL records as approved, from FDA and DailyMed labels. Label ↗

WHO therapeutic group
Direct thrombin inhibitors
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against E. coli, MRSA and M. tuberculosis. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA53.5% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli51.4% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae29.4% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis66.9% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.

A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.

Evidence

Clinical and experimental

Documented evidence

Clinical

14registered studies name this medicine, for any condition. See them below.

Experimental

No evidence found

No laboratory measurement against the four pathogens in the ChEMBL records loaded here.

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

Not yet docked: queued in the docking rundetails

KPC-2 carbapenemase ↗ (K. pneumoniae)

Not yet docked: queued in the docking rundetails

Enoyl-ACP reductase (InhA) ↗ (M. tuberculosis)

Not yet docked: queued in the docking rundetails

Dihydrofolate reductase ↗ (MRSA)

Not yet docked: queued in the docking rundetails

AutoDock Vina, one experimentally solved protein per pathogen. This project’s screening target is -7.0 kcal/mol, its own mark rather than a universal cutoff. A docking score is a structural hypothesis, not proof of binding, and requires experimental validation.

Other medicines to investigate

AI prediction · nothing measured

Other repurposing candidates: approved medicines besides Dabigatran Etexilate Mesylate with AI-predicted activity ≥40% against the chosen pathogen, leaving out existing antimicrobials. They are computational candidates for further investigation, not alternatives and not recommendations.

Sorted by AI-predicted activity, high to low. The order is not a ranking of which medicine is better.

Registered studies

A registration describes a study; it does not establish a positive result.

  • Timing to Restart Direct Oral Anticoagulants After Traumatic Intracranial Haemorrhage

    NCT06322953 · start 2025-03-10

    Registered record
    Registry ID
    NCT06322953
    Conditions
    Traumatic Intracranial Haemorrhage
    Interventions
    Direct-Acting Oral Anticoagulants (used as per local standard practice)
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2025-03-10
    Completion
    2028-07-31
    Enrolment
    1,084

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionTraumatic Intracranial Haemorrhage
    InterventionDirect-Acting Oral Anticoagulants (used as per local standard practice)
    PhasePhase 3
    Registry statusRecruiting
  • A Single Dose Bioequivalence Study of WD-1602 Versus Pradaxa® in Healthy Subjects Under Fed Condition

    NCT04592822 · start 2021-01-06

    Registered record
    Registry ID
    NCT04592822
    Conditions
    Anticoagulant
    Interventions
    WD-1602; Pradaxa®
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Unknown
    Start
    2021-01-06
    Completion
    2021-12-06
    Enrolment
    20

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAnticoagulant
    InterventionWD-1602; Pradaxa®
    PhasePhase 1
    Registry statusUnknown
  • A Study of the Effect of Quizartinib on the Pharmacokinetics of the P-gp Substrate Dabigatran Etexilate in Healthy Participants

    NCT04459585 · start 2020-08-28

    Registered record
    Registry ID
    NCT04459585
    Conditions
    Healthy Subjects; Drug-drug Interaction; Pharmacokinetics; Quizartinib
    Interventions
    Dabigatran Etexilate Mesylate; Quizartinib
    Study type
    INTERVENTIONAL
    Phase
    Early phase 1
    Registry status
    Completed
    Start
    2020-08-28
    Completion
    2020-10-20
    Enrolment
    20

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy Subjects; Drug-drug Interaction; Pharmacokinetics; Quizartinib
    InterventionDabigatran Etexilate Mesylate; Quizartinib
    PhaseEarly phase 1
    Registry statusCompleted
  • Bioequivalence Study of Two Dabigatran Etexilate Mesylate Capsules in Healthy Subjects

    NCT06876623 · start 2019-12-10

    Registered record
    Registry ID
    NCT06876623
    Conditions
    Bioequivalence of Dabigatran Etexilate Mesylate Capsules From Two Different Manufacturers in Healthy Chinese Subjects
    Interventions
    dabigatran etexilate mesylate capsules 150mg
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2019-12-10
    Completion
    2020-06-12
    Enrolment
    88

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBioequivalence of Dabigatran Etexilate Mesylate Capsules From Two Different Manufacturers in Healthy Chinese Subjects
    Interventiondabigatran etexilate mesylate capsules 150mg
    PhasePhase 1
    Registry statusCompleted
  • Treating Acute Pancreatitis With Dabigatran, a Pilot Study

    NCT03807856 · start 2019-06-24

    Registered record
    Registry ID
    NCT03807856
    Conditions
    Acute Pancreatitis
    Interventions
    Dabigatran Etexilate Mesylate; Standard of Care
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Terminated
    Start
    2019-06-24
    Completion
    2020-07-23
    Enrolment
    2

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAcute Pancreatitis
    InterventionDabigatran Etexilate Mesylate; Standard of Care
    PhasePhase 1
    Registry statusTerminated
  • Clinical Trial to Assess the Safety and Pharmacokinetics of RDG-17012 Capsule and Pradaxa® Capsule in Healthy Male Volunteers

    NCT03495739 · start 2018-02-01

    Registered record
    Registry ID
    NCT03495739
    Conditions
    Healthy
    Interventions
    RDG-17012 Capsule; Dabigatran Etexilate Mesylate 150 MG Oral Capsule
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Unknown
    Start
    2018-02-01
    Completion
    2018-12-01
    Enrolment
    64

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy
    InterventionRDG-17012 Capsule; Dabigatran Etexilate Mesylate 150 MG Oral Capsule
    PhasePhase 1
    Registry statusUnknown
  • A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Participants

    NCT02945020 · start 2016-11-10

    Registered record
    Registry ID
    NCT02945020
    Conditions
    Healthy
    Interventions
    Dabigatran etexilate mesylate; Odalasvir (ODV); Simeprevir (SMV)
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2016-11-10
    Completion
    2017-01-20
    Enrolment
    15

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy
    InterventionDabigatran etexilate mesylate; Odalasvir (ODV); Simeprevir (SMV)
    PhasePhase 1
    Registry statusCompleted
  • What is the Optimal antiplatElet and Anticoagulant Therapy in Patients With Oral Anticoagulation Undergoing revasculariSaTion 2.

    NCT02635230 · start 2014-06

    Registered record
    Registry ID
    NCT02635230
    Conditions
    Atrial Fibrillations; Heart Valve Prostheses; Acute Coronary Syndromes; Coronary Artery Diseases; Stroke; Bleeding; Myocardial Infarction
    Interventions
    Combination of chronic oral anticoagulation and a P2Y12 inhibitor with or without aspirin.
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Unknown
    Start
    2014-06
    Completion
    2022-01
    Enrolment
    2,200

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAtrial Fibrillations; Heart Valve Prostheses; Acute Coronary Syndromes; Coronary Artery Diseases +3 more
    InterventionCombination of chronic oral anticoagulation and a P2Y12 inhibitor with or without aspirin.
    PhaseNot recorded
    Registry statusUnknown
  • Drug Interaction Study Between Bosutinib And Dabigatran

    NCT02102633 · start 2014-05

    Registered record
    Registry ID
    NCT02102633
    Conditions
    Healthy
    Interventions
    Dabigatran; Bosutinib; Dabigatran
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2014-05
    Completion
    2014-06
    Enrolment
    27

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy
    InterventionDabigatran; Bosutinib; Dabigatran
    PhasePhase 1
    Registry statusCompleted
  • Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism

    NCT01976507 · start 2013-10

    Registered record
    Registry ID
    NCT01976507
    Conditions
    Atrial Fibrillation; Atrial Flutter
    Interventions
    dabigatran etexilate mesylate
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2013-10
    Completion
    2016-12
    Enrolment
    101

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAtrial Fibrillation; Atrial Flutter
    Interventiondabigatran etexilate mesylate
    PhasePhase 4
    Registry statusCompleted
  • SPARK: Safety Study of Pradaxa in Atrial Fibrillation Patients by Regulatory Requirement of Korea

    NCT01774370 · start 2013-01-14

    Registered record
    Registry ID
    NCT01774370
    Conditions
    Atrial Fibrillation
    Interventions
    Pradaxa (Dabigatran etexilate mesilate)
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2013-01-14
    Completion
    2017-02-17
    Enrolment
    3,182

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAtrial Fibrillation
    InterventionPradaxa (Dabigatran etexilate mesilate)
    PhaseNot recorded
    Registry statusCompleted
  • Pharmacokinetics, Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 2 Years of Age

    NCT01773174 · start 2013-01

    Registered record
    Registry ID
    NCT01773174
    Conditions
    Venous Thromboembolism
    Interventions
    dabigatran etexilate
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Withdrawn
    Start
    2013-01
    Completion
    2015-12
    Enrolment
    0

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionVenous Thromboembolism
    Interventiondabigatran etexilate
    PhasePhase 2
    Registry statusWithdrawn
  • Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age

    NCT01083732 · start 2010-03

    Registered record
    Registry ID
    NCT01083732
    Conditions
    Venous Thromboembolism
    Interventions
    dabigatran etexilate
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2010-03
    Completion
    2016-02
    Enrolment
    18

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionVenous Thromboembolism
    Interventiondabigatran etexilate
    PhasePhase 2
    Registry statusCompleted
  • Safety and Tolerability of Dabigatran Etexilate in Adolescents

    NCT00844415 · start 2009-06-01

    Registered record
    Registry ID
    NCT00844415
    Conditions
    Venous Thromboembolism
    Interventions
    dabigatran etexilate
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2009-06-01
    Completion
    Not recorded
    Enrolment
    9

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionVenous Thromboembolism
    Interventiondabigatran etexilate
    PhasePhase 2
    Registry statusCompleted