Dabigatran

Generic Name: Dabigatran

Brand Names: Dabigatran Etexilate Leon Farma, Dabigatran Etexilate Accord, Pradaxa

Drug Type: Small Molecule

Chemical Formula: C_₂₅H_₂₅N_₇O_₃

CAS Number: 211914-51-1

Unique Ingredient Identifier: I0VM4M70GC

Background: Dabigatran is the active form of the orally bioavailable prodrug dabigatran etexilate.

Clinical Trials

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

Phase 1

Recruiting

Conditions: COVID-19

Interventions: Drug: ALG-097558
Drug: Itraconazole
Drug: Dabigatran
Other: Placebo

First Posted Date: 2025-04-25

Last Posted Date: 2025-05-20

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 51

Registration Number: NCT06945276

Locations: 🇺🇸
Dr. Vince Clinical Research, Overland Park, Kansas, United States

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

Phase 2

Not yet recruiting

Conditions: Portal Vein Thrombosis
Liver Cirrhosis

Interventions: Drug: Enoxaparin
Drug: Dabigatran

First Posted Date: 2025-02-10

Last Posted Date: 2025-02-10

Lead Sponsor: Institute of Liver and Biliary Sciences, India

Target Recruit Count: 120

Registration Number: NCT06818279

Locations: 🇮🇳
Institute of Liver & Biliary Sciences (ILBS), New Delhi, Delhi, India

Dabigatran for the Adjunctive Treatment of Staphylococcus Aureus Bacteremia

Phase 4

Not yet recruiting

Conditions: Staphylococcus Aureus Endocarditis
Staphylococcus Aureus Septicemia
Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bloodstream Infection
S. Aureus Bacteremia
S. Aureus Bloodstream Infection

Interventions: Drug: Dabigatran
Drug: Apixaban
Drug: edoxaban
Drug: Rivaroxaban

First Posted Date: 2024-10-21

Last Posted Date: 2024-10-21

Lead Sponsor: Emily McDonald

Target Recruit Count: 300

Registration Number: NCT06650501

Locations: 🇨🇦
McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital), Montreal, Quebec, Canada

Dabigatran Versus Apixaban in Cerebral Venous Thrombosis

Phase 3

Recruiting

Conditions: Cerebral Venous Sinus Thrombosis

Interventions: Drug: Apixaban 5MG
Drug: Dabigatran Etexilate 150mg

First Posted Date: 2024-08-13

Last Posted Date: 2024-08-13

Lead Sponsor: Kafrelsheikh University

Target Recruit Count: 200

Registration Number: NCT06551415

Locations: 🇪🇬
Kafr Elsheikh University Hospital, Kafr Ash Shaykh, Egypt

Dabigatran Versus Rivaroxaban in Cerebral Venous Thrombosis

Phase 3

Recruiting

Conditions: Cerebral Venous Sinus Thrombosis

Interventions: Drug: Rivaroxaban 20 MG Oral Tablet
Drug: Dabigatran Etexilate 150mg

First Posted Date: 2024-08-13

Last Posted Date: 2024-08-13

Lead Sponsor: Kafrelsheikh University

Target Recruit Count: 200

Registration Number: NCT06551402

Locations: 🇪🇬
Kafr Elsheikh University Hospital, Kafr Ash Shaykh, Egypt

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

Not Applicable

Active, not recruiting

Conditions: Heart Diseases
Cardiovascular Diseases
Aortic Valve Stenosis
Heart Valve Diseases
Valve Disease, Aortic

Interventions: Drug: Rivaroxaban
Drug: Acetylsalicylic acid
Drug: Edoxaban
Drug: Clopidogrel
Drug: Dabigatran
Drug: Apixaban
Drug: Warfarin

First Posted Date: 2024-06-10

Last Posted Date: 2025-04-06

Lead Sponsor: Rigshospitalet, Denmark

Target Recruit Count: 352

Registration Number: NCT06449469

Locations: 🇩🇰
Aarhus University Hospital, Skejby, Aarhus, Denmark
🇩🇰
Rigshospitalet, Copenhagen, Denmark

Bioequivalence Study of Dabigatran Etexilate Capsules 150 mg in Healthy Thai Volunteers Under Fasting Conditions

Phase 1

Not yet recruiting

Conditions: Dabigatran
Healthy Volunteer
Bioequivalence Study

Interventions: Drug: Dabigatran Etexilate Capsules 150 mg

First Posted Date: 2024-06-04

Last Posted Date: 2024-06-06

Lead Sponsor: International Bio service

Target Recruit Count: 60

Registration Number: NCT06441916

Population Pharmacokinetic Study of the Effect of Polymorphisms in the ABCB1 and CES1 Genes on the Pharmacokinetics of Dabigatran

Not yet recruiting

Conditions: Combined Analysis of Polymorphisms and Dabigatran Pharmacokinetic Parameters

First Posted Date: 2024-04-29

Last Posted Date: 2024-04-29

Lead Sponsor: The Affiliated Hospital Of Guizhou Medical University

Target Recruit Count: 30

Registration Number: NCT06387407

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

Conditions: Atrial Fibrillation

Interventions: Drug: rivaroxaban
Drug: dabigatran
Drug: VKA
Drug: No OAC
Drug: apixaban

First Posted Date: 2023-05-01

Last Posted Date: 2024-05-17

Lead Sponsor: Pfizer

Target Recruit Count: 3691397

Registration Number: NCT05838664

Locations: 🇫🇷
Pfizer Investigational Site, Paris, France

A Drug-Drug Interaction Study to Estimate the Effect of PF-07081532 on the Pharmacokinetics of Dabigatran and Rosuvastatin in Overweight or Obese Adult Participants

Phase 1

Terminated

Conditions: Healthy

Interventions: Drug: Dabigatran etexilate (DE)
Drug: Rosuvastatin
Drug: PF-07081532

First Posted Date: 2023-03-28

Last Posted Date: 2024-11-15

Lead Sponsor: Pfizer

Target Recruit Count: 16

Registration Number: NCT05788328

Locations: 🇺🇸
Qps-Mra, Llc, South Miami, Florida, United States

Drug Development Updates

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