Dabigatran Clinical Trials

Size	Price	Qty
5mg	USD 170
50mg	USD 970

Clinical Trials

Numerous clinical trials evaluate dabigatran from early phase 1 through phase 4 for conditions including venous thromboembolism, atrial fibrillation, postoperative hemorrhaging, aortic valve stenosis, and idiopathic pulmonary fibrosis. Sponsored by major pharmaceutical companies alongside academic research institutions, these studies currently span various recruitment statuses ranging from actively recruiting and completed to terminated or withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06650501	RECRUITING	Staphylococcus Aureus Endocarditis; Staphylococcus Aureus Septicemia; Staphylococcus Aureus Bacteremia; Staphylococcus Aureus Bloodstream Infection; S. Aureus Bacteremia; S. Aureus Bloodstream Infection	McGill University Health Centre/Research Institute of the McGill University Health Centre	2026-01-15	PHASE4
NCT07744386	NOT_YET_RECRUITING	Healthy Male Volunteers	Chiesi Farmaceutici S.p.A.	2026-10-27	PHASE1
NCT07746882	NOT_YET_RECRUITING	Stroke; Acute Ischemic Stroke	Second Affiliated Hospital, Zhejiang University, School of Medicine	2026-08-15	PHASE3
NCT06957366	RECRUITING	Atrial Fibrillation (AF); VTE	McMaster University	2025-04-01
NCT03129490	ACTIVE_NOT_RECRUITING	Atrial Fibrillation; Atrial Flutter	Herlev and Gentofte Hospital	2023-04-01	PHASE4
NCT05735639	RECRUITING	Venous Thromboembolism; Varicose Veins	Imperial College London	2024-01-22	PHASE4
NCT07629999	RECRUITING	Healthy Volunteers	Bristol-Myers Squibb	2026-07-13	PHASE1
NCT03129555	ACTIVE_NOT_RECRUITING	Deep Vein Thrombosis; Pulmonary Embolism	Herlev and Gentofte Hospital	2023-04-01	PHASE4
NCT07744802	NOT_YET_RECRUITING	Healthy Male Participants	Deciphera Pharmaceuticals, LLC	2026-09	PHASE1
NCT06551402	RECRUITING	Cerebral Venous Sinus Thrombosis	Kafrelsheikh University	2024-08-09	PHASE3
NCT04045093	ACTIVE_NOT_RECRUITING	Atrial Fibrillation; Mitral Stenosis	The University of Hong Kong	2020-10-22	PHASE4
NCT04695106	RECRUITING	Atrial Fibrillation; Antithrombotic Therapy; Acute Coronary Syndrome; Percutaneous Coronary Interventions	Medical University of Gdansk	2021-10-25	PHASE4
NCT07515339	WITHDRAWN	Chronic Kidney Disease	Bayer	2026-04-08	PHASE1
NCT06449469	ACTIVE_NOT_RECRUITING	Aortic Valve Stenosis; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Valve Disease, Aortic	Rigshospitalet, Denmark	2021-05-01
NCT06818279	NOT_YET_RECRUITING	Portal Vein Thrombosis; Liver Cirrhosis	Institute of Liver and Biliary Sciences, India	2025-01-31	PHASE2; PHASE3
NCT06273215	UNKNOWN	Diabetes	Peking University Third Hospital	2023-03-05	PHASE4
NCT07190430	ACTIVE_NOT_RECRUITING	Atopic Dermatitis	Pfizer	2025-10-03	PHASE1
NCT06945276	COMPLETED	COVID-19	National Institute of Allergy and Infectious Diseases (NIAID)	2025-05-13	PHASE1
NCT03568890	ACTIVE_NOT_RECRUITING	Left Atrial Appendage Closure; Thrombosis; Stroke; TIA; Bleeding	Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec	2018-09-01	PHASE4
NCT06791187	COMPLETED	Healthy	Boehringer Ingelheim	2025-01-23	PHASE1
NCT03961334	UNKNOWN	Stroke, Ischemic	University of Zurich	2019-12-05	PHASE3
NCT06693518	COMPLETED	SARS-CoV-2 Infections	Pfizer	2024-11-22	PHASE1
NCT03463317	COMPLETED	Atrial Fibrillation	Charite University, Berlin, Germany	2018-02-28	PHASE4
NCT06360055	UNKNOWN	Health	Peking University Third Hospital	2024-04-01
NCT06441916	UNKNOWN	Healthy Volunteer; Dabigatran; Bioequivalence Study	International Bio service	2024-09-25	PHASE1
NCT06504862	COMPLETED	Healthy	Boehringer Ingelheim	2024-08-20	PHASE1
NCT06551415	UNKNOWN	Cerebral Venous Sinus Thrombosis	Kafrelsheikh University	2021-08-01	PHASE3
NCT06329895	COMPLETED	Advanced Non-small Cell Lung Cancer; EGFR Mutation; HER2 Mutation; Healthy Volunteers	Bayer	2024-03-25	PHASE1
NCT05747768	UNKNOWN	Chronic Kidney Disease	Peking University Third Hospital	2022-07-15	PHASE4
NCT04684212	WITHDRAWN	Atrial Fibrillation; Left Atrial Appendage Thrombosis; CVA	Brian O'Neill MD	2024-06-01
NCT03996772	COMPLETED	Atrial Fibrillation; Intracerebral Hemorrhage	Imperial College London	2019-06-03	PHASE3
NCT06360055	Recruiting	Health	Peking University Third Hospital	2024-04-01	Not Applicable
NCT03539055	COMPLETED	Atrial Fibrillation; Device Related Thrombus; Left Atrial Appendage Thrombosis; Watchman LAA Closure Device	Vanderbilt University Medical Center	2018-09-01	PHASE4
NCT05491460	UNKNOWN	Anticoagulant Therapy	Doasense GmbH	2022-07-01	PHASE1
NCT05959447	COMPLETED	Cough; Healthy	Bellus Health Inc. - a GSK company	2023-07-26	PHASE1
NCT05966740	Recruiting	Venous Thromboembolism	Boehringer Ingelheim\|Children''s Hospital Acquired Thrombosis consortium	2023-10-31	--
NCT05788328	TERMINATED	Healthy	Pfizer	2023-03-27	PHASE1
NCT05715658	UNKNOWN	Nonvalvular Atrial Fibrillation; Health, Subjective	Dongyang Liu	2022-08-15
NCT05673889	COMPLETED	Healthy	Pfizer	2023-01-27	PHASE1
NCT04002011	WITHDRAWN	Anticoagulant-induced Bleeding	Laval University	2022-03-09	PHASE2
NCT05673889	Completed	Healthy	Pfizer\|Arvinas Estrogen Receptor Inc.	2023-01-27	Phase 1
NCT04688723	UNKNOWN	Coronary Artery Disease; Myocardial Ischemia; Myocardial Infarction; Atrial Fibrillation	Zuyderland Medisch Centrum	2020-12-23	PHASE4
NCT03148457	COMPLETED	Ischaemic Stroke	Insel Gruppe AG, University Hospital Bern	2017-11-06
NCT05438303	COMPLETED	Healthy Volunteers	AstraZeneca	2022-06-13	PHASE1
NCT05471817	COMPLETED	Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men; Hot Flashes; Healthy Volunteers	Bayer	2022-08-05	PHASE1
NCT05480475	COMPLETED	Healthy	Idorsia Pharmaceuticals Ltd.	2022-09-03	PHASE1
NCT05347979	COMPLETED	Cushing Syndrome; Neoplasms	Corcept Therapeutics	2022-05-25	PHASE1
NCT04433481	UNKNOWN	Liver Cirrhosis; Portal Vein Thrombosis	Institute of Liver and Biliary Sciences, India	2020-06-20
NCT05492318	COMPLETED	Drug-Drug Interaction; Heathy Volunteer	Italfarmaco	2022-03-21	PHASE1
NCT03752294	WITHDRAWN	Mild Cognitive Impairment; Mild Alzheimer's Disease	University of Rhode Island	2019-05	PHASE1
NCT05368805	COMPLETED	Metastatic Colorectal Cancer	Hutchmed	2022-03-02	PHASE1
NCT04157881	COMPLETED	Atrial Fibrillation; Venous Thromboembolism	Population Health Research Institute	2020-01-03	PHASE4
NCT05064800	COMPLETED	Healthy Participants	Pfizer	2021-09-21	PHASE1
NCT04809818	COMPLETED	Acute Ischemic Stroke	Lumosa Therapeutics Co., Ltd.	2021-03-21	PHASE1
NCT04749914	COMPLETED	Healthy	Eli Lilly and Company	2021-02-15	PHASE1
NCT03789695	UNKNOWN	Atrial Fibrillation; T2DM (Type 2 Diabetes Mellitus); Chronic Kidney Diseases	Irina Ermolaeva	2018-11-14	PHASE4
NCT03240120	UNKNOWN	Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism	The University of Hong Kong	2017-09-01	PHASE3
NCT04498741	COMPLETED	RSV Infection	Enanta Pharmaceuticals, Inc	2020-07-08	PHASE1
NCT04782076	COMPLETED	Healthy	Loxo Oncology, Inc.	2021-03-05	PHASE1
NCT03153150	COMPLETED	Intracranial Hemorrhages; Intracranial Hemorrhage, Hypertensive; Subarachnoid Hemorrhage; Subdural Hematoma; Intraventricular Hemorrhage; Atrial Fibrillation; Atrial Flutter; Small Vessel Cerebrovascular Disease; Microhaemorrhage	University of Edinburgh	2018-03-28	PHASE3
NCT04208061	COMPLETED	Healthy	Janssen Research & Development, LLC	2019-12-18	PHASE1
NCT03061006	COMPLETED	Dementia; Cognition Disorders; Cerebral Ischemic Events	Intermountain Health Care, Inc.	2017-03-30	PHASE4
NCT01994265	COMPLETED	Atrial Fibrillation	University of Sao Paulo	2014-11-07	PHASE4
NCT04192552	UNKNOWN	Atrial Fibrillation	McMaster University	2020-01-09
NCT03975062	UNKNOWN	Atrial Fibrillation	Ural State Medical University	2017-12-28	PHASE4
NCT03181386	COMPLETED	Atrial Fibrillation; Periodontal Disease; Hemorrhage	University of Sao Paulo General Hospital	2017-05-03	PHASE3
NCT02744092	COMPLETED	Cancer; Venous Thromboembolism; Deep Vein Thrombosis (DVT); Pulmonary Embolism (PE); Blood Clot	Alliance Foundation Trials, LLC.	2016-12-13
NCT04459585	COMPLETED	Healthy Subjects; Drug-drug Interaction; Pharmacokinetics; Quizartinib	Daiichi Sankyo Co., Ltd.	2020-08-28	EARLY_PHASE1
NCT02982850	COMPLETED	Atrial Fibrillation; Valve Heart Disease	Asan Medical Center	2016-12	PHASE4
NCT04257032	COMPLETED	Healthy	Boehringer Ingelheim	2020-02-13	PHASE1
NCT02067182	COMPLETED	Atrial Fibrillation; Cardioembolic Events; Oral Anticoagulation	Georg Nickenig	2015-08	PHASE4
NCT03807856	TERMINATED	Acute Pancreatitis	Mayo Clinic	2019-06-24	PHASE1
NCT03343704	COMPLETED	Hemorrhage	Boehringer Ingelheim	2018-03-26	PHASE3
NCT06876623	COMPLETED	Bioequivalence of Dabigatran Etexilate Mesylate Capsules From Two Different Manufacturers in Healthy Chinese Subjects	The Affiliated Hospital Of Guizhou Medical University	2019-12-10	PHASE1
NCT02596555	TERMINATED	Pulmonary Embolism	Prof. Stavros Konstantinides, MD	2016-01	PHASE4
NCT04092725	COMPLETED	Pharmacokinetics	Scynexis, Inc.	2019-09-09	PHASE1
NCT03536611	UNKNOWN	Atrial Fibrillation; Coronary Artery Disease	Shenyang Northern Hospital	2018-09-01	PHASE4
NCT04099732	COMPLETED	Healthy	Boehringer Ingelheim	2019-10-07	PHASE1
NCT02815670	COMPLETED	Hemorrhage	Boehringer Ingelheim	2016-09-07	PHASE3
NCT01895777	COMPLETED	Venous Thromboembolism	Boehringer Ingelheim	2013-09-25	PHASE3
NCT02197416	COMPLETED	Venous Thromboembolism; Secondary Prevention	Boehringer Ingelheim	2014-09-29	PHASE3
NCT02935855	COMPLETED	Diabetes	University of Pavia	2015-09	PHASE4
NCT03742336	COMPLETED	Healthy	Pfizer	2018-11-21	PHASE1
NCT03217448	UNKNOWN	Cerebral Venous Thrombosis	Capital Medical University	2017-10-30	PHASE3
NCT02295826	COMPLETED	Transient Ischemic Attack; Minor Ischemic Stroke	University of Alberta	2015-01	PHASE2
NCT03728101	COMPLETED	Healthy	Korea University Guro Hospital	2018-11-16	PHASE1
NCT02666157	UNKNOWN	Atrial Fibrillation	National Cheng-Kung University Hospital	2016-01	PHASE4
NCT03492437	COMPLETED	Healthy	Merck KGaA, Darmstadt, Germany	2018-05-17	PHASE1
NCT02239120	COMPLETED	Stroke; Secondary Prevention	Boehringer Ingelheim	2014-11-27	PHASE3
NCT03311841	COMPLETED	Renal Insufficiency	Merck Sharp & Dohme LLC	2018-03-01	PHASE1
NCT03183843	UNKNOWN	Mitral Valve Stenosis and Insufficiency; Atrial Fibrillation	Research Institute for Complex Problems of Cardiovascular Diseases, Russia	2016-06-29	PHASE4
NCT02913326	COMPLETED	Thromboembolism	Boehringer Ingelheim	2016-12-13	PHASE3
NCT03495739	UNKNOWN	Healthy	Huons Co., Ltd.	2018-02-01	PHASE1
NCT02426229	COMPLETED	Scleroderma; Interstitial Lung Disease	Medical University of South Carolina	2016-02	PHASE1
NCT02979561	UNKNOWN	Angiographically Confirmed Acute Massive Pulmonary Embolism Treated With Endovascular Mechanical Fragmentation and Thrombolytic Therapy	Meshalkin Research Institute of Pathology of Circulation	2016-10	PHASE4
NCT02723981	WITHDRAWN	Stable Angina; Unstable Angina; STEMI; NSTEMI; Coronary Disease	IHF GmbH - Institut für Herzinfarktforschung	2016-04	PHASE4
NCT02256683	TERMINATED	Atrial Fibrillation or Atrial Flutter; Thrombosis of Left Atrial Appendage	Johannes Gutenberg University Mainz	2014-07	PHASE2
NCT01661101	COMPLETED	Myocardial Injury After Noncardiac Surgery (MINS)	Population Health Research Institute	2013-01	PHASE3
NCT02646267	UNKNOWN	Atrial Fibrillation	The First Affiliated Hospital with Nanjing Medical University	2016-03	PHASE4
NCT02591225	UNKNOWN	Atrial Fibrillation; Left Atrial Thrombosis	University of Ulm	2015-10	PHASE4
NCT03237416	COMPLETED	Prostatic Neoplasms	Bayer	2017-08-02	PHASE1
NCT01675076	COMPLETED	Hematoma	Ottawa Heart Institute Research Corporation	2013-01	PHASE3
NCT03086356	COMPLETED	Healthy Volunteers	Boehringer Ingelheim	2017-05-10	PHASE1
NCT02544932	UNKNOWN	Atrial Fibrillation	Kyunghee University Medical Center	2015-10	PHASE3
NCT02885961	UNKNOWN	Idiopathic Pulmonary Fibrosis; IPF; Interstitial Lung Disease	University College, London	2016-08
NCT03143166	COMPLETED	Non-alcoholic Fatty Liver Disease	Boehringer Ingelheim	2017-05-22	PHASE1
NCT03070171	COMPLETED	Healthy	Boehringer Ingelheim	2017-03-21	PHASE1
NCT02164864	COMPLETED	Atrial Fibrillation; Percutaneous Coronary Intervention	Boehringer Ingelheim	2014-07-22	PHASE3
NCT01896622	COMPLETED	HIV	National Institutes of Health Clinical Center (CC)	2013-06-18	PHASE1
NCT02945020	COMPLETED	Healthy	Janssen Research & Development, LLC	2016-11-10	PHASE1
NCT01468155	COMPLETED	Atrial Fibrillation	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	2011-07-13	PHASE4
NCT00562289	COMPLETED	Ischemic Stroke; Patent Foramen Ovale; Atrial Septal Aneurysm; Migraine	Assistance Publique - Hôpitaux de Paris	2007-12	PHASE3
NCT01976507	COMPLETED	Atrial Fibrillation; Atrial Flutter	Vanderbilt University Medical Center	2013-10	PHASE4
NCT02348723	COMPLETED	Atrial Fibrillation	Boehringer Ingelheim	2015-04-28	PHASE4
NCT02831660	COMPLETED	Hemorrhage	Boehringer Ingelheim	2016-07-22	PHASE3
NCT02313584	UNKNOWN	Atrial Fibrillation; Thromboembolism	Korea University	2014-12	PHASE3
NCT02361619	COMPLETED	Healthy Volunteers	Turku University Hospital	2015-02	PHASE1
NCT02104947	COMPLETED	Hemorrhage	Boehringer Ingelheim	2014-05-06	PHASE3
NCT02463591	UNKNOWN	Drug Action Reversal	University Medical Center Groningen	2015-01	PHASE2
NCT02710630	COMPLETED	Healthy	Boehringer Ingelheim	2016-03-22	PHASE1
NCT01083732	COMPLETED	Venous Thromboembolism	Boehringer Ingelheim	2010-03	PHASE2
NCT02568397	COMPLETED	Healthy	AstraZeneca	2015-10-31	PHASE1
NCT02223260	COMPLETED	Venous Thromboembolism	Boehringer Ingelheim	2014-09	PHASE2
NCT01773174	WITHDRAWN	Venous Thromboembolism	Boehringer Ingelheim	2013-01	PHASE2
NCT02389582	COMPLETED	Coronary Disease	University of Sao Paulo General Hospital	2014-05	PHASE4
NCT02331602	UNKNOWN	Atrial Fibrillation	Yokohama City University Medical Center	2013-07	PHASE4
NCT01896297	COMPLETED	Atrial Fibrillation	Boehringer Ingelheim	2013-07	PHASE4
NCT02872649	TERMINATED	Thrombosis; Bleeding	Daniel Zimpfer, MD	2013-01	PHASE2
NCT02524210	COMPLETED	Healthy	Centre Hospitalier Universitaire de Saint Etienne	2014-05	PHASE1
NCT01593150	COMPLETED	Atrial Fibrillation	Odense University Hospital	2011-11
NCT01361763	UNKNOWN	CADASIL	S. Andrea Hospital	2011-06	PHASE2
NCT01431456	COMPLETED	Venous Thromboembolism	Martini Hospital Groningen	2013-09	PHASE3
NCT01868243	TERMINATED	Primary Disease	Hospital Ana Nery	2013-08	PHASE2; PHASE3
NCT02028780	COMPLETED	Healthy	Boehringer Ingelheim	2014-01	PHASE1
NCT01493557	COMPLETED	Atrial Fibrillation	Boehringer Ingelheim	2011-12	PHASE4
NCT01578044	COMPLETED	Atrial Fibrillation	VA Office of Research and Development	2012-01
NCT01627665	COMPLETED	Healthy Volunteers	Assistance Publique - Hôpitaux de Paris	2011-10	PHASE2; PHASE3
NCT02102633	COMPLETED	Healthy	Pfizer	2014-05	PHASE1
NCT01352702	TERMINATED	Coronary Heart Disease; Atrial Fibrillation; Acute Coronary Syndrome; Atherosclerosis	Deutsches Herzzentrum Muenchen	2011-05	PHASE4
NCT01769703	COMPLETED	Transient Ischemic Attack; Minor Ischemic Stroke	University of Alberta	2012-02	PHASE2
NCT01955720	COMPLETED	Hemorrhage	Boehringer Ingelheim	2013-09	PHASE1
NCT02044367	COMPLETED	Healthy	Boehringer Ingelheim	2014-01	PHASE1
NCT02085824	UNKNOWN	Hip Osteoarthritis; Blood Loss	Centre of Postgraduate Medical Education	2012-07
NCT01852162	COMPLETED	Coronary Artery Disease	University of Florida	2012-02
NCT01711853	COMPLETED	Renal Insufficiency, Chronic	Boehringer Ingelheim	2012-10	PHASE1
NCT01546883	TERMINATED	Atrial Fibrillation	University of Utah	2012-02	PHASE4
NCT01688830	COMPLETED	Healthy	Boehringer Ingelheim	2012-09	PHASE1
NCT01810237	WITHDRAWN	Venous Thromboses	Nova Scotia Health Authority	2013-03
NCT01505881	TERMINATED	Thromboembolism; Heart Valve Prosthesis	Boehringer Ingelheim	2011-12	PHASE2
NCT01734772	COMPLETED	Healthy	Boehringer Ingelheim	2012-11	PHASE1
NCT01452347	TERMINATED	Heart Valve Diseases	Boehringer Ingelheim	2011-10	PHASE2
NCT01812200	COMPLETED	Atrial Fibrillation; Acute Coronary Syndrome	Medical University of Vienna	2012-10	PHASE4
NCT01184989	COMPLETED	Arthroplasty, Replacement; Prevention of Venous Thromboembolism; Moderate Renal Impairment (CrCl 30-50 mL/Min)	Boehringer Ingelheim	2010-08	PHASE4
NCT01478282	UNKNOWN	Thrombosis; Anticoagulant-induced Bleeding; Anticoagulant Overdosage; Hemorrhage	Gines Escolar	2012-01	PHASE4
NCT00808067	COMPLETED	Atrial Fibrillation	Boehringer Ingelheim	2008-11	PHASE3
NCT01590823	COMPLETED	Blood Coagulation Disorders	Nova Scotia Health Authority	2012-07	PHASE1
NCT01595854	COMPLETED	Healthy	Boehringer Ingelheim	2012-05	PHASE1
NCT01339819	COMPLETED	Atrial Fibrillation	Deutsches Herzzentrum Muenchen	2011-04	PHASE4
NCT00844415	COMPLETED	Venous Thromboembolism	Boehringer Ingelheim	2009-06-01	PHASE2
NCT01379300	COMPLETED	Thrombosis	Merck Sharp & Dohme LLC	2011-05	PHASE1
NCT01385683	COMPLETED	Healthy	Centre Hospitalier Universitaire de Saint Etienne	2011-06	PHASE1
NCT00680186	COMPLETED	Thromboembolism	Boehringer Ingelheim	2008-04	PHASE3
NCT01306162	COMPLETED	Healthy	Boehringer Ingelheim	2011-02	PHASE1
NCT01241539	COMPLETED	Cardiovascular Diseases; Kidney Failure, Chronic	Boehringer Ingelheim	2010-11	PHASE1
NCT01290757	COMPLETED	Healthy	Boehringer Ingelheim	2011-01	PHASE1
NCT01210755	COMPLETED	Venous Thromboembolism	University Hospital, Grenoble	2010-11	PHASE4
NCT00558259	COMPLETED	Venous Thromboembolism	Boehringer Ingelheim	2007-11	PHASE3
NCT00329238	COMPLETED	Thromboembolism	Boehringer Ingelheim	2006-05	PHASE3
NCT00818753	COMPLETED	Heart Catheterization	Boehringer Ingelheim	2009-01	PHASE2
NCT02171572	COMPLETED	Healthy	Boehringer Ingelheim	2009-10	PHASE1
NCT00621855	COMPLETED	Coronary Disease	Boehringer Ingelheim	2008-03	PHASE2
NCT00657150	COMPLETED	Venous Thromboembolism	Boehringer Ingelheim	2008-03	PHASE3
NCT02173717	COMPLETED	Healthy	Boehringer Ingelheim	2009-06	PHASE1
NCT02171598	COMPLETED	Healthy	Boehringer Ingelheim	2009-02	PHASE1
NCT02170675	COMPLETED	Healthy	Boehringer Ingelheim	2009-06	PHASE1
NCT00291330	COMPLETED	Thromboembolism	Boehringer Ingelheim	2006-02	PHASE3
NCT02171611	COMPLETED	Healthy	Boehringer Ingelheim	2009-03	PHASE1
NCT02171624	COMPLETED	Healthy	Boehringer Ingelheim	2009-03	PHASE1
NCT00262600	COMPLETED	Atrial Fibrillation; Stroke	Boehringer Ingelheim	2005-12	PHASE3
NCT00157248	TERMINATED	Atrial Fibrillation; Stroke	Boehringer Ingelheim	2003-12	PHASE2
NCT02171559	COMPLETED	Healthy	Boehringer Ingelheim	2008-08	PHASE1
NCT02171481	COMPLETED	Healthy	Boehringer Ingelheim	2008-05	PHASE1
NCT02171585	COMPLETED	Healthy	Boehringer Ingelheim	2008-06	PHASE1
NCT02171533	COMPLETED	Healthy	Boehringer Ingelheim	2008-06	PHASE1
NCT02171520	COMPLETED	Healthy	Boehringer Ingelheim	2008-05	PHASE1
NCT02171546	TERMINATED	Healthy	Boehringer Ingelheim	2007-11	PHASE1
NCT00246025	COMPLETED	Arthroplasty, Replacement, Knee; Venous Thrombosis	Boehringer Ingelheim	2005-10	PHASE2
NCT01136408	COMPLETED	Atrial Fibrillation	Boehringer Ingelheim	2005-11	PHASE2
NCT02171039	COMPLETED	Healthy	Boehringer Ingelheim	2006-06	PHASE1
NCT02171052	COMPLETED	Healthy	Boehringer Ingelheim	2006-06	PHASE1
NCT02171468	COMPLETED	Healthy	Boehringer Ingelheim	2006-05	PHASE1
NCT02171013	COMPLETED	Healthy	Boehringer Ingelheim	2006-04	PHASE1
NCT00168818	COMPLETED	Thromboembolism; Arthroplasty, Replacement, Hip	Boehringer Ingelheim	2004-11	PHASE3
NCT02171507	COMPLETED	Healthy	Boehringer Ingelheim	2006-05	PHASE1
NCT00152971	COMPLETED	Arthroplasty, Replacement, Knee; Thromboembolism	Boehringer Ingelheim	2004-11	PHASE3
NCT02171026	COMPLETED	Healthy	Boehringer Ingelheim	2006-04	PHASE1
NCT02170987	COMPLETED	Healthy	Boehringer Ingelheim	2006-03	PHASE1
NCT00168805	COMPLETED	Arthroplasty, Replacement, Knee; Thromboembolism	Boehringer Ingelheim	2004-11	PHASE3
NCT02182024	COMPLETED	Renal Insufficiency	Boehringer Ingelheim	2005-04	PHASE1
NCT02171455	COMPLETED	Healthy	Boehringer Ingelheim	2006-01	PHASE1
NCT02170571	COMPLETED	Hepatic Insufficiency	Boehringer Ingelheim	2005-07	PHASE1
NCT01227629	COMPLETED	Atrial Fibrillation	Boehringer Ingelheim	2003-09	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-03-20)

Check the Dabigatran product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dabigatran functions as a potent, reversible, and competitive direct thrombin inhibitor, binding specifically to the active site of thrombin to block the conversion of fibrinogen into fibrin and prevent thrombin-mediated platelet activation. By suppressing thrombus formation and blood coagulation cascades, this mechanism provides direct therapeutic efficacy in clinical settings, particularly in reducing the risk of stroke in patients with atrial fibrillation and preventing venous thromboembolism.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).