Clinical Trials

Edoxaban tosylate monohydrate is documented in 128 clinical trials across various development stages, ranging from Phase 1 to Phase 4 evaluation. Research actively explores its therapeutic utility in conditions such as non-valvular atrial fibrillation, venous catheter-related thrombosis, ischemic stroke, aortic valve stenosis, and liver cirrhosis, alongside assessing drug-drug interactions and postoperative bleeding. Clinical investigations are sponsored by pharmaceutical entities like Daiichi Sankyo and Astellas Pharma as well as academic institutions such as Radboud University Medical Center. Current trial recruitment statuses across global registries encompass recruiting, active not recruiting, completed, and withdrawn studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07454707 NOT_YET_RECRUITING
Stroke, Ischemic
Sunnybrook Health Sciences Centre
 2026-04 PHASE3
NCT07753200 RECRUITING
Atrial Fibrillation (AF); Coronary Arterial Disease (CAD)
Samsung Medical Center
 2026-07-20 PHASE4
NCT06900725 NOT_YET_RECRUITING
Elderly; Atrial Fibrillation (AF); Ischemic Stroke
National Taiwan University Hospital
 2025-04-01 PHASE2; PHASE3
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
NCT06864052 NOT_YET_RECRUITING
Stroke; Atrial Fibrillation
Ewha Womans University Seoul Hospital
 2025-03-01
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
NCT03129555 ACTIVE_NOT_RECRUITING
Deep Vein Thrombosis; Pulmonary Embolism
Herlev and Gentofte Hospital
 2023-04-01 PHASE4
NCT03950076 COMPLETED
Intracranial Hemorrhages; Atrial Fibrillation
Population Health Research Institute
 2019-09-20 PHASE4
NCT05035277 COMPLETED
Aortic Stenosis
Oslo University Hospital
 2021-12-04 PHASE3
NCT05869591 RECRUITING
Liver Cirrhosis
Centre Hospitalier Universitaire Vaudois
 2024-01-18 PHASE2
NCT06149533 NOT_YET_RECRUITING
Thrombosis, Venous; Cancer; Catheter Complications
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
 2023-11-30 PHASE3
NCT06449469 ACTIVE_NOT_RECRUITING
Aortic Valve Stenosis; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Valve Disease, Aortic
Rigshospitalet, Denmark
 2021-05-01
NCT03777631 UNKNOWN
Ischemic Stroke; Atrial Fibrillation Non-Rheumatic
Nippon Medical School
 2018-04-01 PHASE3
NCT07116239 NOT_YET_RECRUITING
Nephrotic Syndrome; Hypoalbuminemia
Peking University People's Hospital
 2025-09
NCT07113054 ACTIVE_NOT_RECRUITING
Healthy
Hyewon Chung
 2025-09-02 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
NCT03961334 UNKNOWN
Stroke, Ischemic
University of Zurich
 2019-12-05 PHASE3
NCT06285942 UNKNOWN
Atrial Fibrillation; Fragility
Azienda Ospedaliero Universitaria Maggiore della Carita
 2024-02-01
NCT03463317 COMPLETED
Atrial Fibrillation
Charite University, Berlin, Germany
 2018-02-28 PHASE4
NCT06930937 COMPLETED
Prevention of Stroke or Systemic Embolism; Deep Vein Thrombosis (DVT); Pulmonary Embolism (PE)
Humanis Saglık Anonim Sirketi
 2024-08-30
NCT05320627 COMPLETED
Non-Valvular Atrial Fibrillation
China National Center for Cardiovascular Diseases
 2022-03-30 PHASE4
NCT06372483 ACTIVE_NOT_RECRUITING
Coagulation Disorder
VarmX B.V.
 2024-02-21 PHASE1
NCT05339672 Recruiting
Drug-drug Interaction
Radboud University Medical Center|Astellas Pharma Inc
 2024-07-01 --
NCT05419583 COMPLETED
Myocardial Infarction Type 2
University of Edinburgh
 2022-11-14
NCT05122455 COMPLETED
SCAD; AMI
University of Sao Paulo
 2021-09-14 PHASE2; PHASE3
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
NCT05540587 UNKNOWN
Mitral Valve Stenosis; Atrial Fibrillation; Stroke; Systemic Embolism
Sung-Hwan Kim
 2022-05-20 PHASE2
NCT06326138 WITHDRAWN
Bariatric Surgery Candidate
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
 2024-03-11 PHASE1
NCT06326138 Withdrawn
Bariatric Surgery Candidate
Institut universitaire de cardiologie et de pneumologie de Québec University Laval
 2024-03-11 Phase 1
NCT05869591 Recruiting
Liver Cirrhosis
Centre Hospitalier Universitaire Vaudois
 2024-01-18 Phase 2
NCT05491460 UNKNOWN
Anticoagulant Therapy
Doasense GmbH
 2022-07-01 PHASE1
NCT03718559 COMPLETED
Atrial Fibrillation; Coronary Artery Disease; Stable Angina; Stable Chronic Angina
Gi-Byoung Nam
 2019-05-14 PHASE4
NCT06149533 Not yet recruiting
Thrombosis Venous|Cancer|Catheter Complications
Cancer Institute and Hospital Chinese Academy of Medical Sciences
 2023-11-30 Phase 3
NCT03840291 COMPLETED
Atrial Fibrillation; Left Atrial Appendage Thrombosis
Keimyung University Dongsan Medical Center
 2019-05-19 PHASE4
NCT05723510 COMPLETED
Healthy
HK inno.N Corporation
 2023-03-06 PHASE1
NCT03895502 COMPLETED
Venous Thrombosis; Neoplasms; Anticoagulant
Takeshi Morimoto
 2019-05-27 PHASE4
NCT04171726 UNKNOWN
Aortic Valve Stenosis
Erasmus Medical Center
 2019-08-01 PHASE3
NCT04730037 COMPLETED
CTEPH
Kyushu University
 2021-03-23 PHASE3
NCT05152420 COMPLETED
Coagulation Disorder
VarmX B.V.
 2021-10-29 PHASE1
NCT05804747 Recruiting
Atrial Fibrillation
Daiichi Sankyo|Daiichi Sankyo Korea Co. Ltd.
 2023-02-16 --
NCT04002011 WITHDRAWN
Anticoagulant-induced Bleeding
Laval University
 2022-03-09 PHASE2
NCT02618577 TERMINATED
Atrial High Rate Episodes
Atrial Fibrillation Network
 2016-02 PHASE3
NCT03148457 COMPLETED
Ischaemic Stroke
Insel Gruppe AG, University Hospital Bern
 2017-11-06
NCT04542408 COMPLETED
Covid19
Universitätsklinikum Hamburg-Eppendorf
 2020-11-12 PHASE3
NCT04516941 TERMINATED
SARS-CoV Infection; COVID-19
Insel Gruppe AG, University Hospital Bern
 2021-01-21 PHASE3
NCT02798471 COMPLETED
Venous Thromboembolism (VTE); Pulmonary Embolism; Deep Vein Thrombosis (DVT)
Daiichi Sankyo
 2017-03-27 PHASE3
NCT04072068 COMPLETED
Thromboembolism; Cancer
Gruppo Oncologico Italiano di Ricerca Clinica
 2019-06-27 PHASE4
NCT03395639 COMPLETED
Cardiac Disease
Daiichi Sankyo
 2018-05-15 PHASE3
NCT03494530 COMPLETED
Ischemic Stroke; Atrial Fibrillation; Hemorrhagic Transformation Stroke
University of Alberta
 2018-06-01 PHASE4
NCT03284827 COMPLETED
Aortic Valve Stenosis
Duk-Woo Park, MD
 2018-03-15 PHASE4
NCT02303431 COMPLETED
Deep Vein Thrombosis; Venous Thromboembolism
Daiichi Sankyo
 2014-11-05 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
NCT02943785 COMPLETED
Atrial Fibrillation
Daiichi Sankyo
 2017-03-21 PHASE3
NCT03489395 COMPLETED
Atrial Fibrillation
Raffaele De Caterina
 2018-01-30 PHASE2
NCT02744092 COMPLETED
Cancer; Venous Thromboembolism; Deep Vein Thrombosis (DVT); Pulmonary Embolism (PE); Blood Clot
Alliance Foundation Trials, LLC.
 2016-12-13
NCT04121767 COMPLETED
Atrial Fibrillation; Anticoagulants and Bleeding Disorders
Samsung Medical Center
 2017-12-01
NCT03570281 UNKNOWN
Correction of Cancer-related Coagulopathy With Novel Oral Anticoagulant (Edoxaban)
Samsung Medical Center
 2018-06-15 PHASE2; PHASE3
NCT03433235 COMPLETED
Acute Ischemic Stroke
Jong Sung Kim
 2018-06-19 PHASE2
NCT03757481 COMPLETED
Post Thrombotic Syndrome; Deep Vein Thrombosis; Chronic Thromboembolic Pulmonary Hypertension
University Hospital, Montpellier
 2018-01-01
NCT03244319 COMPLETED
MV(Mitral Valve) Repair
Yonsei University
 2017-12-01 PHASE3
NCT03310021 COMPLETED
Bleeding
Portola Pharmaceuticals
 2017-08-28 PHASE2
NCT02866175 COMPLETED
Atrial Fibrillation
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
 2017-02-24 PHASE3
NCT02935855 COMPLETED
Diabetes
University of Pavia
 2015-09 PHASE4
NCT03666650 COMPLETED
Blood Coagulation Disorder
Turku University Hospital
 2018-11-26 PHASE4
NCT03088072 UNKNOWN
Non-Valvular Atrial Fibrillation; Left Atrial Appendage Closure
Scripps Health
 2017-03-23 PHASE4
NCT02964949 COMPLETED
Atrial Fibrillation
Daiichi Sankyo
 2017-01-24
NCT02942576 COMPLETED
Atrial Fibrillation
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
 2017-03-21 PHASE3
NCT02339415 COMPLETED
Inflammation; Coagulation; HIV Infection
Hennepin Healthcare Research Institute
 2015-07 PHASE2
NCT02567461 COMPLETED
Coronary Artery Disease
University of Florida
 2016-03 PHASE4
NCT03083704 COMPLETED
Bleeding
Portola Pharmaceuticals
 2017-02-26 PHASE1
NCT02073682 COMPLETED
Venous Thromboembolism (VTE); Deep Vein Thrombosis (DVT); Pulmonary Embolism (PE); Cancer
Daiichi Sankyo
 2015-07-16 PHASE3
NCT02561897 TERMINATED
Atrial Fibrillation
Electrophysiology Research Foundation
 2015-12 PHASE4
NCT02072434 COMPLETED
Atrial Fibrillation
Daiichi Sankyo
 2014-03-25 PHASE3
NCT02207257 COMPLETED
Anticoagulation Reversal
Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
 2014-03 PHASE2
NCT03551743 COMPLETED
Healthy Volunteers
Portola Pharmaceuticals
 2012-12 PHASE2
NCT02221102 UNKNOWN
Ischemia; Stroke; Cerebral Infarction
Xijing Hospital
 2013-12 PHASE2; PHASE3
NCT01802775 COMPLETED
Peripheral Arterial Disease
Daiichi Sankyo
 2013-02-06 PHASE2
NCT02047565 COMPLETED
Bleeding
Daiichi Sankyo
 2013-10 PHASE1
NCT01662908 COMPLETED
Deep Vein Thrombosis; Venous Thrombosis
Daiichi Sankyo
 2012-08 PHASE2
NCT01826266 COMPLETED
Anticoagulant Reversal; Reversal of Edoxaban Induced Anticoagulation
Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
 2013-07 PHASE1
NCT00986154 COMPLETED
Venous Thromboembolism; Deep Vein Thrombosis (DVT); Pulmonary Embolism (PE); Thromboembolism; Venous Thrombosis
Daiichi Sankyo
 2009-10 PHASE3
NCT00781391 COMPLETED
Stroke; Atrial Fibrillation; Embolism
Daiichi Sankyo
 2008-11 PHASE3
NCT01181167 COMPLETED
Prevention; Venous Thromboembolism
Daiichi Sankyo Co., Ltd.
 2009-05 PHASE3
NCT01181102 COMPLETED
Venous Thromboembolism
Daiichi Sankyo Co., Ltd.
 2009-03 PHASE3
NCT01181141 COMPLETED
Venous Thromboembolism
Daiichi Sankyo Co., Ltd.
 2008-10 PHASE3
NCT00504556 COMPLETED
Atrial Fibrillation; Thromboembolism
Daiichi Sankyo
 2007-06 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-03-06)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Edoxaban selectively binds to and inhibits factor Xa with high affinity, preventing the conversion of prothrombin to thrombin within the coagulation cascade and suppressing thrombin-mediated platelet activation and fibrin clot formation. By halting downstream systemic clot formation, this potent anticoagulant effectively reduces the risk of stroke and thromboembolism in clinical settings such as atrial fibrillation and catheter-related venous thrombosis.

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>).

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Note: Technical data last updated: Sep 1, 2026.