Drug

Edoxaban

Approved · EMA

Emerging researchLate-stage development

Also known as Savaysa.

RxNorm1599538 ChEMBLCHEMBL1269025 ATCB01AF03UNIINDU3J18APO

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation

Clinical trial2026-06-05Completed · ClinicalTrials.gov

Pharmacokinetics and Pharmacodynamics Assessment of Apixaban and Edoxaban in Patients with Child a or B Liver Cirrhosis

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

A Randomized, Multicenter, Open-Label, Control, Clinical Trial to Evaluate the Efficacy and Safety of Edoxaban on Prevention of Catheter-related Thrombosis (CRT) in Cancer Patients

Clinical trial2026-05-30Primary completion · ClinicalTrials.gov

EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF)

Clinical trial2026-05-13Primary completion · ClinicalTrials.gov

Prospective Study on the Impact of Different Anti-thrombotic Therapies on Subclinical Leaflet Thickening and Its Temporal Dynamics in Transcatheter Bioprosthetic Aortic Valves (NOTION-4)

Clinical trial2026-04-01Primary completion · ClinicalTrials.gov

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

Clinical trial2026-03-20Results expected Q1 2030 · ClinicalTrials.gov

Randomized Trial to Evaluate the Efficacy and Safety of Very Low Dose Anticoagulant Therapy Added to Standard-Care Single Antiplatelet Therapy for Prevention of Recurrent Strokes in Patients With Ischemic Stroke Aged 75+ Years

Clinical trial2026-03-06Results expected Q4 2031 · ClinicalTrials.gov

Steady-state Pharmacokinetics and Pharmacodynamics of Edoxaban in Adults With Nephrotic Syndrome: A Non-randomized Open-label, Parallel Arm and Single-center Study

Clinical trial2026-02-01Primary completion · ClinicalTrials.gov

A Clinical Trial to Evaluate the Effect of Grapefruit Juice on the Pharmacokinetics and Pharmacodynamics of Edoxaban in Healthy Adults

Clinical trial2025-09-24Primary completion · ClinicalTrials.gov

Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes.

Research2023-08-25The New England journal of medicine

Edoxaban for the Treatment of Cancer-Associated Venous Thromboembolism.

Research2017-12-12The New England journal of medicine

Approval: Roteas (EMA)

Regulatory2017-04-19EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Edoxaban

Aliases & brands

Savaysa

RxNorm CUI

1599538

ChEMBL ID

CHEMBL1269025

ATC codes

B01AF03

UNII

NDU3J18APO

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2017-04-19

Latest approval

2017-04-19

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2017-04-19Approval

Approval: Roteas (EMA)

Indication: Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure,… Show full indication

Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

63 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 63

Phase 18Phase 210Phase 2 / 34Phase 320Phase 415Phase N / A6

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

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

RecruitingPH IVMcGill University Health Centre/Research Institute of the McGill University Health Centren=3002030

The Danish Non-vitamin K Antagonist Oral Anticoagulation Study. A Cluster Randomized Study Comparing Safety and Efficacy of Edoxaban, Apixaban, Rivaroxaban and Dabigatran for Oral Anticoagulation in Patients With Venous Thromboembolism.

Active, not recruitingPH IVKey trialHerlev and Gentofte Hospitaln=5,0002029

Active, not recruitingPH IVKey trialHerlev and Gentofte Hospitaln=11,0002027

EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF)

Active, not recruitingPH IVPopulation Health Research Instituten=9482026

Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation at High Risk of Stroke and Bleeding Compared to Medical Therapy: a Prospective Randomized Clinical Trial

CompletedPH IVCharite University, Berlin, Germanyn=9122024

Recent completions

Trials that read out recently, adding to the completed evidence base.

AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation

CompletedPH IIIOslo University Hospitaln=3602026

Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation at High Risk of Stroke and Bleeding Compared to Medical Therapy: a Prospective Randomized Clinical Trial

CompletedPH IVCharite University, Berlin, Germanyn=9122024

Population Pharmacokinetics of Edoxaban in Chinese Patients With Non-Valvular Atrial Fibrillation

CompletedPH IVChina National Center for Cardiovascular Diseasesn=1502024

Resolution of Thrombi in Left Atrial Appendage With Edoxaban

CompletedPH IVKeimyung University Dongsan Medical Centern=362024

Effects of Edoxaban on Platelet Aggregation in Patients With Stable Coronary Artery Disease

CompletedPH II/IIIUniversity of Sao Paulon=612024

PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation (PRESTIGE-AF)

CompletedPH IIIImperial College Londonn=3192024

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20182023

Most influential

Edoxaban for the Treatment of Cancer-Associated Venous Thromboembolism.

The New England journal of medicine · 2018 · 1,036 cites

Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes.

The New England journal of medicine · 2023 · 283 cites

Related diseases

1 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas

Hemorrhage2

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Dalteparin

Studied across 3 of the same disease areas as Edoxaban in the shared literature.

3 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.