Pradaxa

(Dabigatran)

ApprovedSmall molecule

Dabigatran is a blood thinner used to prevent blood clots and reduce the risk of stroke in people with an irregular heartbeat, and to treat or prevent blood clots in the legs and lungs.[2] Pradaxa is currently approved and in use across 19 indications[4].[1]

Pradaxa is one of 372 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

371

Competitors

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseActive, not recruiting

Transient Ischemic AttackActive, not recruiting

Venous ThromboembolismActive, not recruiting

Cognitive ImpairmentActive, not recruiting

StrokeUnknown

Venous ThrombosisActive, not recruiting

HemorrhageActive, not recruiting

Paroxysmal Atrial FibrillationActive, not recruiting

Cerebral Arteriopathy, Autosomal Dominant, With Subcortical Infarcts and Leukoencephalopathy, Type 1Active, not recruiting

HematomaActive, not recruiting

Coronary Artery DiseasePreclinical

Active, not recruiting

Transient Ischemic AttackPhase 2

Active, not recruiting

Venous ThromboembolismPhase 3

Active, not recruiting

Cognitive ImpairmentApproved

Active, not recruiting

StrokePreclinical

Unknown

Venous ThrombosisPreclinical

Active, not recruiting

HemorrhagePhase 2

Active, not recruiting

Paroxysmal Atrial FibrillationPhase 3

Active, not recruiting

Cerebral Arteriopathy, Autosomal Dominant, With Subcortical Infarcts and Leukoencephalopathy, Type 1Phase 2

Active, not recruiting

HematomaPhase 3

Active, not recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

461 competitors in Stroke

#DrugCompanyPhaseTrials

Pradaxa

Boehringer Ingelheim

Approved

3 2

Activase

Roche

Preclinical

19 3

Folvite

Eli Lilly

Preclinical

1 4

Zometa

Pfizer

Preclinical

1 5

Proamatine

Takeda

Preclinical

—6

Botox

RRevance Therapeutics, Inc.

Preclinical

2 7

Alka-Seltzer

AAbbott

Preclinical

1 8

Zantac 150

CChattem

Preclinical

1 9

Haldol

DDePuy Orthopaedics

Preclinical

1 10

Periactin

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Recruiting

Venous Thrombosis

NCT07083609

Q1 2030

Post-ApprovalRecruiting

Bacteremia

NCT06650501

Q2 2030

N/AActive, not recruiting

Trial

NCT06449469

Clinical

Trials by Indication[1]

Atrial Fibrillation23 trials

Prevention of Silent Cerebral Thromboembolism by Oral Anticoagulation With Dabigatran After Pulmonary Vein Isolation for Atrial Fibrillation

Completed·GGeorg Nickenig·Phase 4·NCT02067182·200 enrolled

PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation

Completed·IImperial College London·Phase 3·NCT03996772·319 enrolled

Dabigatran Versus Warfarin After Mitral and/or Aortic Bioprosthesis Replacement and Atrial Fibrillation Postoperatively

Terminated·HHospital Ana Nery·Phase 2/3·NCT01868243·27 enrolled

Show 20 more trials

Replication Of An Early Evaluation Of 30-Day Readmissions Among Nonvalvular Atrial Fibrillation Patients Treated With Dabigatran, Rivaroxaban, Apixaban, or Warfarin In The U.S

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT02769078·14,201 enrolled

Dabigatran Versus Conventional Treatment for Prevention of Silent Cerebral Infarct in Atrial Fibrillation Associated With Valvular Disease

Completed·—·Phase 4·NCT02982850·120 enrolled

A Study to Learn About the Effects of Medicines That Help in Thinning the Blood in People With Atrial Fibrillation (AF) Between 2016 and 2020 in France

Completed· Pfizer logo

Pfizer··NCT05838664·2,140,403 enrolled

DAPPAR AF Dabigatran for Peri Procedural Anticoagulation During Radiofrequency Ablation of Atrial Fibrillation

Completed·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·Phase 4·NCT01468155·50 enrolled

Oral Anticoagulant Discontinuation, Adherence Patterns, Hospitalizations and Costs in Non-Valvular Atrial Fibrillation (NVAF) Patients

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT02792335·28,000 enrolled

Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France

Completed· Bayer logo

Bayer··NCT02864758·99,999 enrolled

Direct Oral Anticoagulants in Patients With Atrial Fibrillation (DOACs vs DOACs)

Completed·CCanadian Network for Observational Drug Effect Studies, CNODES··NCT03568916·227,579 enrolled

Management of Major Bleeding Events in Atrial Fibrillation Patients Using Pradaxa

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT02149303·191 enrolled

APIXABAN in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France SNIIRAM Study

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT02640222·321,501 enrolled

Predictive Factors for Response to New Oral Anticoagulants in the Treatment of Non-valvular Atrial Fibrillation..

Unknown status·FFundación de Investigación Biomédica - Hospital Universitario de La Princesa··NCT04297150·700 enrolled

Apixaban Drug Utilization Study In Stroke Prevention In Atrial Fibrillation (Spaf)

Completed· Pfizer logo

Pfizer··NCT03441633·51,690 enrolled

ReAHEAD: A Study to Find Out Whether Education Improves Adherence to Dabigatran in People With Atrial Fibrillation Who Are Younger Than 75 Years

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT04532528·897 enrolled

Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation Compared to Medical Therapy

Completed·—·Phase 4·NCT03463317·912 enrolled

Prospective Monitoring of Non-Vitamin K Oral Anticoagulants in Older Adults With Atrial Fibrillation and Frailty

Unknown status·—··NCT04878497·1,000,000 enrolled

ORal anticoaGulants in diAbetic and Nondiabetic Patients With nOn-valvular Atrial fibrillatioN (ORGANON)

Completed·UUniversity of Pavia·Phase 4·NCT02935855·300 enrolled

Study to Gather Information About the Safety of Oral Anticoagulation Drugs and How Well These Drugs Work in Real World for Patients With Non-valvular Atrial Fibrillation (Irregularly Heart Beats Which is Not Caused by a Heart Valve Problem)

Completed· Bayer logo

Bayer··NCT04249401·134,897 enrolled

A Real-World Comparison of Safety and Effectiveness of Novel Oral Anti-Coagulant (NOAC) Naïve and Warfarin Naïve Non-Valvular Atrial Fibrillation (NVAF) Patients With Medicare Advantage Coverage

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT03189069·36,000 enrolled

Real-World Comparative Observational Study in Non-Valvular Atrial Fibrillation Patients Using Oral Anticoagulants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT02754154·321,182 enrolled

This Study Uses the SITS Registry to Find Out When Patients With a Heart Rhythm Disorder (Atrial Fibrillation) Start Treatment With Dabigatran After They Had a Stroke

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT03258645·1,489 enrolled

ANTICOAGULANT TREATMENT PATTERNS AND OUTCOMES AMONG NON-VALVULAR ATRIAL FIBRILLATION PATIENTS WITH HIGH RISK OF GASTROINTESTINAL BLEEDING IN FRANCE: A RETROSPECTIVE COHORT ANALYSIS USING SNDS DATABASE

Completed· Pfizer logo

Pfizer··NCT05038228·1 enrolled

Anticoagulant6 trials

Dabigatran as an Alternative Anticoagulant in Patients With Left Ventricular Assist Device (LVAD)

Terminated·—·Phase 2·NCT02872649·16 enrolled

Replication of the RELY Anticoagulant Trial in Healthcare Claims Data

Completed·—··NCT04593043·78,140 enrolled

Pleotropic Effect of New Oral Anticoagulants

Unknown status·KKyunghee University Medical Center·Phase 3·NCT02544932·55 enrolled

Show 3 more trials

Replication of the RECOVER-II Anticoagulant Trial in Healthcare Claims Data

Completed·—··NCT04735523·5,350 enrolled

Use of Direct Oral Anticoagulants in UK

Completed· Bayer logo

Bayer··NCT03119116·31,336 enrolled

Start or STop Anticoagulants Randomised Trial (SoSTART)

Completed·UUniversity of Edinburgh·Phase 3·NCT03153150·203 enrolled

Interaction6 trials

A Drug Drug Interaction (DDI) Study of Selpercatinib and Dabigatran in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT04782076·36 enrolled

Drug-Drug Interaction Study Between EDP-938, Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects

Completed·EEnanta Pharmaceuticals, Inc·Phase 1·NCT04498741·89 enrolled

Drug Interaction Study Between Bosutinib And Dabigatran

Completed· Pfizer logo

Pfizer·Phase 1·NCT02102633·27 enrolled

Show 3 more trials

A Study to Evaluate Safety and PK of Multiple Doses of LT3001 Drug Product and Drug-drug Interaction in Healthy Subjects

Completed·LLumosa Therapeutics Co., Ltd.·Phase 1·NCT04809818·65 enrolled

Phase 1 Study on Bioavailability, Food Effect, and Drug-Drug Interaction of ALG-097558 Tablets in Healthy Volunteers

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT06945276·51 enrolled

Dabigatran in an Interaction Probe Drug Cocktail

Completed·TTurku University Hospital·Phase 1·NCT02361619·16 enrolled

Venous Thromboembolism4 trials

Direct Oral Anticoagulants and Venous Thromboembolism

Completed·CCanadian Network for Observational Drug Effect Studies, CNODES··NCT02833987·59,525 enrolled

Safety of DAbigatran and RIvaroxaban Versus NAdroparin in the Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery

Completed·MMartini Hospital Groningen·Phase 3·NCT01431456·148 enrolled

Treatment Patterns and Bleeding Risk of Anticoagulants in Patients With Venous Thromboembolism in Korea

Completed· Pfizer logo

Pfizer··NCT05022563·55,759 enrolled

Show 1 more trial

Anticoagulation in Patients With Venous Thromboembolism and Cancer

Active, not recruiting· Pfizer logo

Pfizer··NCT04618913·1 enrolled

Tics3 trials

Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 Administered Alone or With Dabigatran Etexilate

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01688830·157 enrolled

Study of PF-04965842 Effect on Dabigatran Pharmacokinetics in Healthy Participants

Completed· Pfizer logo

Pfizer·Phase 1·NCT03742336·20 enrolled

Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 (Idarucizumab) Administered Alone or With Dabigatran Etexilate in Japanese Healthy Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02028780·80 enrolled

36 more indications

Stroke3 trials

Dabigatran Study in the Early Phase of Stroke. New Neuroimaging Markers and Biomarkers Study (SEDMAN STUDY)

Unknown status·HHospital Mutua de Terrassa··NCT02742480·500 enrolled

MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention

Unknown status·UUniversity of Zurich·Phase 3·NCT03961334·620 enrolled

Canadian Pradaxa Acute Stroke Safety Study

Completed·UUniversity of Alberta··NCT02415855·101 enrolled

Portal vein thrombosis2 trials

Efficacy and Safety of Dabigatran in Patients With Cirrhosis and Portal Vein Thrombosis

Unknown status·IInstitute of Liver and Biliary Sciences, India·N/A·NCT04433481·84 enrolled

Compare the Efficacy and Safety of Dabigatran and Enoxaparin in Patients With Portal Vein Thrombosis With Cirrhosis

Not yet recruiting·IInstitute of Liver and Biliary Sciences, India·Phase 2/3·NCT06818279·120 enrolled

Platelet Aggregation2 trials

Impact of Dabigatran and Phenprocoumon on ADP Induced Platelet Aggregation in Patients With Atrial Fibrillation

Completed·DDeutsches Herzzentrum Muenchen·Phase 4·NCT01339819·70 enrolled

Impact of Dabigatran and Phenprocoumon on Clopidogrel Mediated ADP Induced Platelet Aggregation in Patients With Atrial Fibrillation

Terminated·DDeutsches Herzzentrum Muenchen·Phase 4·NCT01352702·46 enrolled

Effectiveness2 trials

Comparative Effectiveness and Safety Between Warfarin and Dabigatran

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT03254134·22,490 enrolled

Real-world Comparative Effectiveness of Dabigatran Versus Vitamin K Antagonist

Completed· Bayer logo

Bayer··NCT02687867·56,039 enrolled

Complication2 trials

Complications and Antiplatelet and Anticoagulant Therapy in Vascular Surgery.

Active, not recruiting·PPetrovsky National Research Centre of Surgery··NCT07358416·500 enrolled

NOACs in Oral and Maxillofacial Surgery: Impact on Post-operative Complications

Completed·MMalmö University··NCT04662515·216 enrolled

Female1 trial

Relative Bioavailability of Single Oral Doses of Dabigatran Etexilate With or Without Oral Administration of Verapamil in Two Different Dosages in Healthy Male and Female Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02171533·40 enrolled

Alzheimer's Disease1 trial

A Novel Therapeutic Target for Alzheimer's Disease in Men and Women 50-85 Years of Age.

Withdrawn·UUniversity of Rhode Island·Phase 1·NCT03752294

Injury1 trial

Management of Myocardial Injury After Noncardiac Surgery Trial

Completed·PPopulation Health Research Institute·Phase 3·NCT01661101·1,754 enrolled

ART1 trial

PF-07321332/Ritonavir and Ritonavir on Dabigatran Study in Healthy Participants

Completed· Pfizer logo

Pfizer·Phase 1·NCT05064800·24 enrolled

Idiopathic Pulmonary Fibrosis1 trial

The Coagulation Cascade in Idiopathic Pulmonary Fibrosis

Unknown status·UUniversity College, London·N/A·NCT02885961·12 enrolled

Atorvastatin1 trial

Relative Bioavailability of Dabigatran and Atorvastatin in Healthy Male and Female Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02171039·24 enrolled

Rivaroxaban1 trial

Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran

Unknown status·YYokohama City University Medical Center·Phase 4·NCT02331602·200 enrolled

Venous thrombosis1 trial

Treatment Outcomes of Direct Oral Anticoagulants in Cerebral Venous Thrombosis in Vietnam

Recruiting·HHieu Trung Dinh··NCT07083609·69 enrolled

Pulmonary Embolism1 trial

Low Molecular Weight Heparin for 72 Hours Followed by Dabigatran for Acute Intermediate-Risk Pulmonary Embolism.

Terminated·PProf. Stavros Konstantinides, MD·Phase 4·NCT02596555·400 enrolled

Paroxysmal atrial fibrillation1 trial

Investigation on Appropriate Duration of Dabigatran Use After Catheter Ablation for Paroxysmal Atrial Fibrillation in Patients With Low Thromboembolic Risk

Unknown status·KKorea University·Phase 3·NCT02313584·464 enrolled

Cohort Study1 trial

Non-interventional, Retrospective Cohort Study to Explore OAC Treatment in Korea

Completed· Pfizer logo

Pfizer··NCT03572972·64,684 enrolled

High Risk1 trial

Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events

Completed·OOttawa Heart Institute Research Corporation·Phase 3·NCT01675076·663 enrolled

Heavy Menstrual Bleeding1 trial

Prospective Comparison of Incidence of Heavy Menstrual Bleeding in Women Treated With Direct Oral Anticoagulants

Completed·CCardioangiologisches Centrum Bethanien··NCT04477837·84 enrolled

Percutaneous Coronary Intervention1 trial

Randomized, Open Label Study of Dabigatran Etexilate in Elective Percutaneous Coronary Intervention

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT00818753·53 enrolled

Transient Ischemic Attack1 trial

Dabigatran Following Transient Ischemic Attack and Minor Stroke

Completed·UUniversity of Alberta·Phase 2·NCT02295826·300 enrolled

Bacteremia1 trial

Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia

Recruiting·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·Phase 4·NCT06650501·300 enrolled

Total Hip Arthroplasty1 trial

Comparison of Blood Loss Following Total Hip Arthroplasty With the Use of Three Thromboprophylactic Regimes: Dabigatran, Enoxaparin and Rivaroxaban.

Unknown status·CCentre of Postgraduate Medical Education·N/A·NCT02085824·60 enrolled

Prevention1 trial

Secondary Prevention of Venous Thrombo Embolism (VTE).

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00329238·2,867 enrolled

Length of Stay1 trial

Length of Stay in NVAF Patients Hospitalized and Initiated With Dabigatran or Warfarin in Japan

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT02631057·4,313 enrolled

Knee Replacement Surgery1 trial

Pradaxa (Dabigatran Etexilate) VTE Prevention After Elective Total Hip or Knee Replacement Surgery

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT01153698·167 enrolled

Antithrombotic1 trial

Reversal of the Antithrombotic Action of New Oral Anticoagulants

Unknown status·GGines Escolar·Phase 4·NCT01478282·10 enrolled

Direct Oral Anticoagulants (DOACs)1 trial

Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer

Completed·AAlliance Foundation Trials, LLC.·N/A·NCT02744092·811 enrolled

Anticoagulation1 trial

Validation of a Novel Dabigatran Based Peri-Operative Bridging Anticoagulation Protocol for Patients on Chronic Warfarin Therapy

Withdrawn·NNova Scotia Health Authority·N/A·NCT01810237

After Cardiac Surgery1 trial

DOAC Versus VKA After Cardiac Surgery

Withdrawn·LLaval University·Phase 2·NCT04002011

Dual Antiplatelet Therapy1 trial

Pharmacodynamic Effects of Dabigatran in Patients on Dual Antiplatelet Therapy

Completed·UUniversity of Florida·N/A·NCT01852162·35 enrolled

Children1 trial

Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT02223260·8 enrolled

CADASIL1 trial

Safety Study of Dabigatran in CADASIL

Unknown status·SS. Andrea Hospital·Phase 2·NCT01361763·50 enrolled

Coronary Artery Disease1 trial

Effects of Low Molecular Weight Heparin Versus Dabigatran on Platelet Aggregation in Patients With Stable Coronary Artery Disease

Completed·UUniversity of Sao Paulo General Hospital·Phase 4·NCT02389582·29 enrolled

Trial1 trial

The Nordic Aortic Valve Intervention Trial 4 (NOTION-4)

Active, not recruiting·RRigshospitalet, Denmark·N/A·NCT06449469·352 enrolled

Cognitive impairment1 trial

Cognitive Impairment Related to Atrial Fibrillation Prevention Trial

Completed·UUniversity of Sao Paulo·Phase 4·NCT01994265·200 enrolled

Unspecified5 trials

Medical Need of OAC Reversal

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT03254147·53,969 enrolled

Dabigatran Versus Warfarin With NVAF Who Undergo PCI

Unknown status·SShenyang Northern Hospital·Phase 4·NCT03536611·1,120 enrolled

Use of Public Health Surveillance Models in the French National Health System Database

Completed·—··NCT02904499·814,446 enrolled

Show 2 more trials

Effect of Inhibitors of the Proton Pump on Intestinal Transporters

Completed·—·Phase 1·NCT02524210·12 enrolled

NOAC Portuguese Real World Study

Withdrawn· Pfizer logo

Pfizer··NCT04808934

Sources

References

[1]
ClinicalTrials.gov — 88 trial records for Dabigatran. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Pradaxa drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Dabigatran compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Dabigatran. EMBL-EBI & Wellcome Sanger Institute.
[5]
SEC EDGAR — Boehringer Ingelheim company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Thrombin Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Boehringer Ingelheim

Pradaxa

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q1 2030

Q2 2030

Trials by Indication[1]

Atrial Fibrillation23 trials

Anticoagulant6 trials

Interaction6 trials

Venous Thromboembolism4 trials

Tics3 trials

Stroke3 trials

Portal vein thrombosis2 trials

Platelet Aggregation2 trials

Effectiveness2 trials

Complication2 trials

Female1 trial

Alzheimer's Disease1 trial

Injury1 trial

ART1 trial

Idiopathic Pulmonary Fibrosis1 trial

Atorvastatin1 trial

Rivaroxaban1 trial

Venous thrombosis1 trial

Pulmonary Embolism1 trial

Paroxysmal atrial fibrillation1 trial

Cohort Study1 trial

High Risk1 trial

Heavy Menstrual Bleeding1 trial

Percutaneous Coronary Intervention1 trial

Transient Ischemic Attack1 trial

Bacteremia1 trial

Total Hip Arthroplasty1 trial

Prevention1 trial

Length of Stay1 trial

Knee Replacement Surgery1 trial

Antithrombotic1 trial

Direct Oral Anticoagulants (DOACs)1 trial

Anticoagulation1 trial

After Cardiac Surgery1 trial

Dual Antiplatelet Therapy1 trial

Children1 trial

CADASIL1 trial

Coronary Artery Disease1 trial

Trial1 trial

Cognitive impairment1 trial

Unspecified5 trials

References

Drug Info

Quick Facts

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