Savaysa

(Edoxaban)

ApprovedSmall molecule

Edoxaban is used to prevent blood clots and reduce the risk of stroke in patients with an irregular heartbeat (atrial fibrillation), and to treat blood clots in the legs and lungs.[2] Savaysa is currently approved and in use across 25 indications[4].[1]

Savaysa is one of 508 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

507

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseCompleted

Venous ThromboembolismCompleted

Hip FractureActive, not recruiting

StrokeUnknown status

HemorrhageApproved

Blood CoagulationActive, not recruiting

Aortic StenosisApproved

Intracranial HemorrhageActive, not recruiting

Nephrotic SyndromeActive, not recruiting

Recurrent ThrombophlebitisActive, not recruiting

Coronary Artery DiseaseApproved

Completed

Venous ThromboembolismApproved

Completed

Hip FractureApproved

Active, not recruiting

StrokeApproved

Unknown status

HemorrhageApproved

Approved

Blood CoagulationApproved

Active, not recruiting

Aortic StenosisApproved

Approved

Intracranial HemorrhageApproved

Active, not recruiting

Nephrotic SyndromePreclinical

Active, not recruiting

Recurrent ThrombophlebitisApproved

Active, not recruiting

Showing 10 of 24 indications

Competition

Competitive Landscape

228 competitors in Efficacy and Safety

#DrugCompanyPhaseTrials

Savaysa

Daiichi Sankyo

Approved

3 2

Lutathera

Novartis

Phase 3

1 3

HLX10

Shanghai Henlius Biotech

Phase 3

2 4

Romiplostim N01

Qilu Pharmaceutical Co., Ltd.

Phase 3

1 5

S1,

CChinese Academy of Medical Sciences

Phase 3

1 6

NTQ5082

NNanjing Chia-tai Tianqing Pharmaceutical

Phase 3

1 7

HSK39297

Haisco Pharmaceutical Group Co., Ltd.

Phase 3

3 8

Imlifidase

HHansa Biopharma AB

Phase 3

2 9

AVTX-803

AAUG Therapeutics

Phase 3

1 10

Anti-CD25 Mab

PPeking University People's Hospital

Phase 3

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

Timeline

Expected Milestones

Q4 2026

Phase 3Not yet recruiting

Efficacy and Safety

NCT06149533

Q4 2027

Post-ApprovalActive, not recruiting

Atrial Fibrillation

NCT03129490

Q1 2029

Post-ApprovalActive, not recruiting

Venous Thromboembolism

NCT03129555

Q1 2030

ApprovedRecruiting

Staphylococcus Aureus Endocarditis

NCT06650501

Clinical

Trials by Indication[1]

Atrial Fibrillation33 trials

Canadian EdoxAban(Lixiana®) Registry in Patients With ATrial Fibrillation/Flutter With Confirmed ValvUlar HeaRt DiseasE

Completed·MMontreal Heart Institute··NCT03488420·136 enrolled

Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT02943785·1,426 enrolled

Adding Antiplatelet During Edoxaban Treatment in Stroke Patients With Non-valvular Atrial Fibrillation (ADD-ON)

Active, not recruiting·—··NCT04010955·1,200 enrolled

Show 30 more trials

Early Administration of Edoxaban After Acute Ischemic Stroke in Patients With Non-valvular Atrial Fibrillation

Completed·UUnknown Sponsor·Phase 2·NCT03433235·68 enrolled

Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF)

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT02072434·2,199 enrolled

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

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

Real-world Study on Edoxaban Treatment for Patients With Non-valvular Atrial Fibrillation in China

Completed· Daiichi Sankyo logo

Daiichi Sankyo··NCT04747496·5,000 enrolled

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

Completed·CChina National Center for Cardiovascular Diseases·Phase 4·NCT05320627·150 enrolled

Evaluation of Treatment Safety in Patients With Atrial Fibrillation on Edoxaban Therapy in Real-Life in Turkey

Completed· Daiichi Sankyo logo

Daiichi Sankyo··NCT04594915·1,053 enrolled

EdOxaban in fRagIle Patients With Percutaneous Endoscopic GAstrostoMy and atrIal fIbrIllation

Unknown status·AAzienda Ospedaliero Universitaria Maggiore della Carita·N/A·NCT06285942·168 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

A Pilot Study of Edoxaban in Patients With Non-Valvular Atrial Fibrillation and Left Atrial Appendage Closure

Unknown status·SScripps Health·Phase 4·NCT03088072·75 enrolled

Oral Anti-coagulants in Fragile Patients With Percutaneous Endoscopic Gastrostomy and Atrial Fibrillation (ORIGAMI) Pilot Study

Completed·FFondazione Policlinico Universitario Agostino Gemelli IRCCS··NCT04271293·12 enrolled

A Study to Evaluate Effectiveness and Safety of Edoxaban in Patients 80 Years of Age or Older With Nonvalvular Atrial Fibrillation

Completed· Daiichi Sankyo logo

Daiichi Sankyo··NCT05804747·1,204 enrolled

Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (NVAF)

Completed· Daiichi Sankyo logo

Daiichi Sankyo··NCT03247569·300 enrolled

Edoxaban Treatment in Routine Clinical Practice for Patients With Atrial Fibrillation in Korea and Taiwan (ETNA-AF-KOR-TWN)

Completed· Daiichi Sankyo logo

Daiichi Sankyo··NCT02951039·3,008 enrolled

Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Factor Xa Non-vitamin-K Oral Anticoagulants (NOACs) vs. Phenprocoumon

Completed· Bayer logo

Bayer··NCT03563937·64,920 enrolled

Edoxaban in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention

Completed· Daiichi Sankyo logo

Daiichi Sankyo··NCT04519944·666 enrolled

Study to Evaluate the Use of Direct Oral Anticoagulants in UK Clinical Practice For Patients With a First Stroke Attributable to Nonvalvular Atrial Fibrillation

Completed· Daiichi Sankyo logo

Daiichi Sankyo··NCT05262322·234 enrolled

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

Completed·—·Phase 4·NCT03463317·912 enrolled

Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation

Completed· Daiichi Sankyo logo

Daiichi Sankyo··NCT02944019·13,980 enrolled

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

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

Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis

Recruiting·SSung-Hwan Kim·Phase 2·NCT05540587·240 enrolled

Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Hong Kong)

Completed· Daiichi Sankyo logo

Daiichi Sankyo··NCT03247582·234 enrolled

Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT00781391·21,105 enrolled

A Study to Assess the Safety of a Potential New Drug in Comparison to the Standard Practice of Dosing With Warfarin for Non-valvular Atrial Fibrillation

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 2·NCT00504556·1,146 enrolled

PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation

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

The Danish Non-vitamin K Antagonist Oral Anticoagulation Study in Patients With Atrial Fibrillation

Active, not recruiting·HHerlev and Gentofte Hospital·Phase 4·NCT03129490·11,000 enrolled

EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation

Terminated·EElectrophysiology Research Foundation·Phase 4·NCT02561897·5 enrolled

Edoxaban Treatment Versus Vitamin K Antagonist (VKA) in Patients With Atrial Fibrillation (AF) Undergoing Catheter Ablation

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT02942576·632 enrolled

A Pilot Study on Edoxaban for the Resolution of Left Atrial Thrombosis in Patients With Non-valvular Atrial Fibrillation

Completed·RRaffaele De Caterina·Phase 2·NCT03489395·25 enrolled

Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT02866175·1,506 enrolled

Evaluation of Recommended Once-daily Dosing of Edoxaban and Rivaroxaban in Patients With Atrial Fibrillation and Renal Dysfunction, the ERENAL Study in South Korea and Taiwan

Completed· Daiichi Sankyo logo

Daiichi Sankyo··NCT07874555·8,265 enrolled

Venous Thromboembolism8 trials

Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Korea and Taiwan (ETNA-VTE-KOR-TWN)

Completed· Daiichi Sankyo logo

Daiichi Sankyo··NCT02952599·352 enrolled

Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe

Completed· Daiichi Sankyo logo

Daiichi Sankyo··NCT02943993·2,809 enrolled

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

Completed· Pfizer logo

Pfizer··NCT05022563·55,759 enrolled

Show 5 more trials

Study on Impact of Edoxaban Treatment in Cancer Patients With Venous Thromboembolism During Antineoplastic Therapy

Completed·GGruppo Oncologico Italiano di Ricerca Clinica·Phase 4·NCT04072068·150 enrolled

The Danish Non-vitamin K Antagonist Oral Anticoagulation Study in Patients With Venous Thromboembolism (DANNOAC-VTE)

Active, not recruiting·HHerlev and Gentofte Hospital·Phase 4·NCT03129555·5,000 enrolled

Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT02798471·290 enrolled

Cancer Venous Thromboembolism (VTE)

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT02073682·1,046 enrolled

Net Adverse Clinical Events With EdoXaban Versus Apixaban Treatment in Cancer-Associated Thrombosis

Not yet recruiting·SSamsung Medical Center·Approved·NCT07852637·2,300 enrolled

Anticoagulant5 trials

Pharmacokinetics and Point of Care Testing of Direct Oral Anticoagulants Subjects

Unknown status·DDoasense GmbH·Phase 1·NCT05491460·24 enrolled

Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes

Terminated·AAtrial Fibrillation Network·Phase 3·NCT02618577·2,608 enrolled

Variability of Whole Blood Clotting Time Measurements in Ex Vivo Human Blood Samples Spiked With Anticoagulants

Completed·AAMAG Pharmaceuticals, Inc.··NCT03296982·12 enrolled

Show 2 more trials

Start or STop Anticoagulants Randomised Trial (SoSTART)

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

Study of Intravenous VMX-C001 in Healthy Subjects and in Combination With Selected Direct Oral Anticoagulants in Healthy Older Subjects

Completed·VVarmX B.V.·Phase 1·NCT05152420·105 enrolled

Stroke4 trials

Lixiana Acute Stroke Evaluation Registry

Completed·UUniversity of Alberta·Phase 4·NCT03494530·70 enrolled

Edoxaban for TIA and Acute Minor Stroke

Unknown status·XXijing Hospital·Phase 2/3·NCT02221102·3,700 enrolled

Low Dose Edoxaban in Elderly Patients With AF and a History of Stroke

Not yet recruiting·NNational Taiwan University Hospital·Phase 2/3·NCT06900725·300 enrolled

Show 1 more trial

MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention

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

Anticoagulation4 trials

Study of PER977 Administered to Subjects With Steady State Edoxaban Dosing and Re-anticoagulation With Edoxaban

Completed·AAMAG Pharmaceuticals, Inc.·Phase 2·NCT02207257·65 enrolled

Targeted Anticoagulation Therapy to Reduce Inflammation and Cellular Activation in Long-term HIV Disease

Completed·HHennepin Healthcare Research Institute·Phase 2·NCT02339415·44 enrolled

A Two-part Study in Edoxaban-treated Healthy Subjects to Establish a Punch Biopsy Bleeding Model and to Evaluate the Effect of a 4-factor Prothrombin Complex Concentrate on Anticoagulation

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT02047565·110 enrolled

Show 1 more trial

AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation

Recruiting·OOslo University Hospital·Phase 3·NCT05035277·360 enrolled

36 more indications

Efficacy and Safety3 trials

A Randomized, Open-Label, Parallel-Group, Multi-Center Study for the Evaluation of Efficacy and Safety of Edoxaban Monotherapy Versus Low Molecular Weight (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 2·NCT01662908·85 enrolled

Evaluate the Efficacy and Safety of Edoxaban on Prevention of Catheter-related Thrombosis (CRT) in Cancer Patients

Not yet recruiting·—·Phase 3·NCT06149533·366 enrolled

Explore the Efficacy and Safety of edoxabaN in Patients After Heart Valve Repair or Bioprosthetic vaLve Replacement (ENAVLE Trial)

Completed·YYonsei University·Phase 3·NCT03244319·220 enrolled

Coronary Artery Disease2 trials

Edoxaban Versus Edoxaban With antiPlatelet Agent In Patients With Atrial Fibrillation and Chronic Stable Coronary Artery Disease

Completed·GGi-Byoung Nam·Phase 4·NCT03718559·1,040 enrolled

Edoxaban in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel

Completed·UUniversity of Florida·Phase 4·NCT02567461·80 enrolled

Safety and Efficacy2 trials

Clinical Trial to Investigate Safety and Efficacy of Edoxaban in Patients With CTEPH (KABUKI)

Completed·KKyushu University·Phase 3·NCT04730037·74 enrolled

Safety and Efficacy of Edoxaban in Thoracoscopic Ablation

Completed·SSamsung Medical Center·N/A·NCT04121767·60 enrolled

Pediatric1 trial

Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT02303431·66 enrolled

Bariatric Surgery1 trial

Pharmacokinetics and Pharmacodynamics of Edoxaban Before and After Bariatric Surgery

Withdrawn·IInstitut universitaire de cardiologie et de pneumologie de Québec, University Laval·Phase 1·NCT06326138

Treatment1 trial

Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study).

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT00986154·8,292 enrolled

Atrial Appendage1 trial

Resolution of Thrombi in Left Atrial Appendage With Edoxaban

Completed·KKeimyung University Dongsan Medical Center·Phase 4·NCT03840291·36 enrolled

Total Knee Arthroplasty1 trial

A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT01181102·716 enrolled

Elderly Patients1 trial

Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria

Completed·GGalaxia Empírica··NCT05732506·411 enrolled

Total Hip Arthroplasty1 trial

A Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT01181167·610 enrolled

Outcome1 trial

Comparison of Two Doses of Edoxaban Using Different Tests (Assays) and Clinical Outcomes

Completed· Daiichi Sankyo logo

Daiichi Sankyo·N/A·NCT02964949·607 enrolled

Complication1 trial

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

Completed·MMalmö University··NCT04662515·216 enrolled

Trial1 trial

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

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

Platelet Aggregation1 trial

Effects of Edoxaban on Platelet Aggregation

Completed·UUniversity of Sao Paulo·Phase 2/3·NCT05122455·61 enrolled

Ischemic stroke1 trial

Edoxaban for the Treatment of Coagulopathy in Patients With Active Cancer and Acute Ischemic Stroke: a Pilot Study. (ENCHASE Study)

Unknown status·SSamsung Medical Center·Phase 2/3·NCT03570281·40 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

Cardiac Disease1 trial

Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT03395639·168 enrolled

After Cardiac Surgery1 trial

DOAC Versus VKA After Cardiac Surgery

Withdrawn·LLaval University·Phase 2·NCT04002011

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

Nephrotic Syndrome1 trial

Edoxaban Steady-State PK/PD in Adults With Nephrotic Syndrome

Not yet recruiting·PPeking University People's Hospital·N/A·NCT07116239·60 enrolled

Cirrhosis1 trial

DOAC in Patients with Child a or B Liver Cirrhosis

Recruiting·—·Phase 2·NCT05869591·40 enrolled

Clinical Trial1 trial

A Clinical Trial to Evaluate the Effect of Grapefruit Juice on the PK/PD of Edoxaban

Active, not recruiting·HHyewon Chung·Phase 1·NCT07113054·14 enrolled

Interaction1 trial

PK and PD Interaction Between Tegoprazan and NOACs After Multiple Oral Dosing in Healthy Volunteers

Completed·HHK inno.N Corporation·Phase 1·NCT05723510·87 enrolled

PK/PD1 trial

A Healthy Volunteer PK/PD, Safety and Tolerability Study of Second Generation Andexanet Alfa

Completed·PPortola Pharmaceuticals·Phase 1·NCT03083704·153 enrolled

COVID-191 trial

CorONa Virus edoxabaN ColchicinE (CONVINCE) COVID-19

Terminated·IInsel Gruppe AG, University Hospital Bern·Phase 3·NCT04516941·60 enrolled

Blood Coagulation1 trial

NOAC Plasma Concentration and Blood Coagulation in Healthy Volunteers

Completed·TTurku University Hospital·Phase 4·NCT03666650·15 enrolled

Peripheral Arterial Disease1 trial

Edoxaban in Peripheral Arterial Disease

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 2·NCT01802775·203 enrolled

Catheter1 trial

Rotterdam EDOXaban Leaflet Evaluation in Patients After Transcatheter Aortic Valve Implantation

Unknown status·EErasmus Medical Center·Phase 3·NCT04171726·100 enrolled

Tics1 trial

A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects

Completed·PPortola Pharmaceuticals·Phase 2·NCT03310021·108 enrolled

Stroke, Ischemic1 trial

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

Recruiting·SSunnybrook Health Sciences Centre·Phase 3·NCT07454707·1,204 enrolled

Staphylococcus Aureus Endocarditis1 trial

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

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

Coagulation Disorder1 trial

A Randomised, Double-Blind, Placebo-Controlled, Single Dose Trial Evaluating Different Doses of Intravenously Administered VMX-C001 and to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VMX-C001 in Healthy Subjects (Part 1) and in Combination With a Selected FXa Direct Oral Anticoagulant (DOAC) in Healthy Older Subjects (Part 2)

Completed·VVarmX B.V.·Phase 1·NCT06372483·40 enrolled

Intracranial Hemorrhages1 trial

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

Completed·PPopulation Health Research Institute·Approved·NCT03950076·948 enrolled

Atrial Fibrillation (AF)1 trial

Net Clinical Benefit of Edoxaban Versus Apixaban in Patients With Atrial Fibrillation and Coronary Artery Disease

Recruiting·SSamsung Medical Center·Approved·NCT07753200·3,000 enrolled

Neoplasms1 trial

VICTORIE (VTE IN CANCER - TREATMENT, OUTCOMES AND RESOURCE USE IN EUROPE)

Completed· Pfizer logo

Pfizer··NCT04618913·1 enrolled

Unspecified3 trials

The DARE Warfarin CER Study

Unknown status·—··NCT03271450·416,000 enrolled

Medical Need of OAC Reversal

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT03254147·53,969 enrolled

Influence of Edoxaban on Coagulability and Thrombin Generation: An in Vitro Study Focusing on Thrombelastography

Unknown status·LLifeBridge Health··NCT02448901·40 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 8, 2015

SAVAYSA

NDA NDA206316

Jan 8, 2015

SAVAYSA

NDA NDA206316

Jan 8, 2015

SAVAYSA

NDA NDA206316

Oct 16, 2015

SAVAYSA

NDA NDA206316

Oct 30, 2015

SAVAYSA

NDA NDA206316

Nov 6, 2015

SAVAYSA

NDA NDA206316

Apr 25, 2016

SAVAYSA

NDA NDA206316

Sep 15, 2016

SAVAYSA

NDA NDA206316

Sep 29, 2017

SAVAYSA

NDA NDA206316

Aug 9, 2019

SAVAYSA

NDA NDA206316

Apr 21, 2020

SAVAYSA

NDA NDA206316

Apr 20, 2021

SAVAYSA

NDA NDA206316

Nov 1, 2021

SAVAYSA

NDA NDA206316

Sep 11, 2023

SAVAYSA

NDA NDA206316

Oct 18, 2023

SAVAYSA

NDA NDA206316

Oct 18, 2023

SAVAYSA

NDA NDA206316

Sources

References

[1]
ClinicalTrials.gov — 96 trial records for Edoxaban. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Savaysa drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Edoxaban compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Edoxaban. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA206316). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Savaysa. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Daiichi Sankyo company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Coagulation Factor X Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Daiichi Sankyo

Patent Landscape[6]

Patent Cliff

Apr 18, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7365205Apr 18, 2027

9149532Mar 28, 2028

Savaysa

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q1 2029

Q1 2030

Trials by Indication[1]

Atrial Fibrillation33 trials

Venous Thromboembolism8 trials

Anticoagulant5 trials

Stroke4 trials

Anticoagulation4 trials

Efficacy and Safety3 trials

Coronary Artery Disease2 trials

Safety and Efficacy2 trials

Pediatric1 trial

Bariatric Surgery1 trial

Treatment1 trial

Atrial Appendage1 trial

Total Knee Arthroplasty1 trial

Elderly Patients1 trial

Total Hip Arthroplasty1 trial

Outcome1 trial

Complication1 trial

Trial1 trial

Platelet Aggregation1 trial

Ischemic stroke1 trial

Direct Oral Anticoagulants (DOACs)1 trial

Cardiac Disease1 trial

After Cardiac Surgery1 trial

Heavy Menstrual Bleeding1 trial

Nephrotic Syndrome1 trial

Cirrhosis1 trial

Clinical Trial1 trial

Interaction1 trial

PK/PD1 trial

COVID-191 trial

Blood Coagulation1 trial

Peripheral Arterial Disease1 trial

Catheter1 trial

Tics1 trial

Stroke, Ischemic1 trial

Staphylococcus Aureus Endocarditis1 trial

Coagulation Disorder1 trial

Intracranial Hemorrhages1 trial

Atrial Fibrillation (AF)1 trial

Neoplasms1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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