Xarelto

(Rivaroxaban)

ApprovedSmall molecule

Rivaroxaban is a blood thinner used to prevent dangerous blood clots that can cause strokes or serious bleeding, and to treat existing blood clots in the legs or lungs.[2] Xarelto is currently approved and in use across 55 indications[4].[1]

Xarelto is one of 724 small molecule programs targeting Total Joint Arthroplasty. It is currently in Approved.

Indications

415

Total Trials

Active Trials

723

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Total Joint ArthroplastyActive, not recruiting

Brain IschemiaActive, not recruiting

Thrombotic DiseaseActive, not recruiting

HemorrhageApproved

Aortic StenosisApproved

Hypertrophic CardiomyopathyApproved

Renal InsufficiencyActive, not recruiting

Ischemic StrokeNot yet recruiting

Atrial FibrillationRecruiting

CognitionActive, not recruiting

Total Joint ArthroplastyApproved

Active, not recruiting

Brain IschemiaPreclinical

Active, not recruiting

Thrombotic DiseaseApproved

Active, not recruiting

HemorrhageApproved

Approved

Aortic StenosisApproved

Approved

Hypertrophic CardiomyopathyApproved

Approved

Renal InsufficiencyPreclinical

Active, not recruiting

Ischemic StrokeApproved

Not yet recruiting

Atrial FibrillationApproved

Recruiting

CognitionApproved

Active, not recruiting

Showing 10 of 54 indications

Competition

Competitive Landscape

317 competitors in COVID-19

#DrugCompanyPhaseTrials

Xarelto

WWim Janssens

Approved

11 2

Calciferol

Benadryl

1 4

Achromycin V

WWyeth-Lederle Vaccines

Preclinical

—5

Biological Collection

AAssistance Publique - Hôpitaux de Paris

Preclinical

1 6

Blood Taken

HHospices Civils de Lyon

Preclinical

1 7

Antihypertensive Agents

NNational Heart, Lung, and Blood Institute (NHLBI)

Preclinical

1 8

Other Tkis

Bayer

Preclinical

1 9

Pfizer-COVID-19 Vaccine

Moderna

Preclinical

1 10

Immunosuppressive

Chiesi Farmaceutici S.p.A.

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Anticoagulation

NCT05035277

Post-ApprovalNot yet recruiting

Efficacy and Safety

NCT06476301

Post-ApprovalRecruiting

Membranous Nephropathy

NCT07404436

N/ARecruiting

Hematologic Malignancies

NCT07270263

Q1 2027

Recruiting

Anticoagulant

NCT06362343

Phase 1Recruiting

Cardiovascular

NCT06961630

Clinical

Trials by Indication[1]

Rivaroxaban37 trials

Non Inferiority Study of a Reduced Dose of Activated Charcoal on Rivaroxaban Pharmacokinetics.

Completed·—·Phase 1·NCT04767776·12 enrolled

Rivaroxaban Combined With DAPT Versus DAPT Alone After Drug-coated Balloon Angioplasty

Completed·HHenan Institute of Cardiovascular Epidemiology·N/A·NCT05750758·140 enrolled

Rivaroxaban Versus Warfarin in the Evaluation of Progression of Coronary Calcium

Completed·LLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center·Phase 4·NCT02376010·110 enrolled

Show 34 more trials

Phase 2 Study of Rivaroxaban Reversal by Ciraparantag as Measured by WBCT

Completed·AAMAG Pharmaceuticals, Inc.·Phase 2·NCT03172910·69 enrolled

Cancer Associated Thrombosis, a Pilot Treatment Study Using Rivaroxaban

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT02746185·159 enrolled

A Study to Assess the Effects of 2 Different Prothrombin Complex Concentrates on the Pharmacodynamics of Rivaroxaban in Healthy Adult Volunteers

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01656330·35 enrolled

Rivaroxaban Hypericum Trial

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 1·NCT03796377·12 enrolled

Rivaroxaban for Scheduled Work-up of DVT - The Ri-Schedule Study

Completed·OOstfold Hospital Trust·Phase 3·NCT02486445·625 enrolled

Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux

Completed·GGWT-TUD GmbH·Phase 3·NCT01499953·472 enrolled

Rivaroxaban for Slow Coronary Flow After PCI in STEMI

Not yet recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT07195812·60 enrolled

Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02846532·112 enrolled

Rivaroxaban in Mechanical Valves: RMV Study

No longer available·HHospital Ana Nery··NCT02894307

Rivaroxaban for Antiphospholipid Antibody Syndrome

Completed·SSt. Joseph's Healthcare Hamilton·Phase 4·NCT02116036·81 enrolled

Efficacy Comparison of Warfarin Versus Rivaroxaban CVT

Unknown status·IIsfahan University of Medical Sciences·Phase 1/2·NCT03747081·50 enrolled

Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran

Unknown status·YYokohama City University Medical Center·Phase 4·NCT02331602·200 enrolled

Bioequivalence Study of Rivaroxaban

Completed· Bayer logo

Bayer·Phase 1·NCT02537457·40 enrolled

A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02111564·12,024 enrolled

Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice (UK)

Completed· Bayer logo

Bayer··NCT01947998·50,299 enrolled

Real-world Dosing Patterns of Rivaroxaban in the United States

Completed· Bayer logo

Bayer··NCT03242278·12,507 enrolled

Pharmacokinetics Study of Oral Rivaroxaban in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01464450·55 enrolled

Rivaroxaban vs. Warfarin in CVT Treatment

Completed·—·Phase 3·NCT04569279·71 enrolled

Pharmacokinetics and Bioequivalence of Rivaroxaban Tablet in Healthy Chinese Volunteers

Completed·TThe Affiliated Hospital of Qingdao University·Phase 1·NCT04424381·72 enrolled

Rivaroxaban vs Warfarin for SPAF in Multi-morbid Patients

Completed· Bayer logo

Bayer··NCT03374540·78,517 enrolled

Bioequivalence Study of Rivaroxaban in Japanese Healthy Adult Male Subjects

Completed· Bayer logo

Bayer·Phase 1·NCT02537405·40 enrolled

A Trial to Learn How a New Liquid Form of Rivaroxaban Behaves and How Safe it is Compared to the Current Tablet Form of Rivaroxaban in Healthy Male Participants

Completed· Bayer logo

Bayer·Phase 1·NCT04720092·30 enrolled

A Trial to Learn How Much Rivaroxaban Gets Into the Blood When Taken in Different Forms and How Safe They Are in Healthy Men

Completed· Bayer logo

Bayer·Phase 1·NCT04727021·30 enrolled

Relative Bioavailability of Oral Suspension of Rivaroxaban Compared to Standard Tablet

Completed· Bayer logo

Bayer·Phase 1·NCT01853800·14 enrolled

Rivaroxaban Versus Low-molecular-weight Heparin for Preventing Thrombosis in Cancer Patients

Completed·—·Phase 1/2·NCT03282643·74 enrolled

Excretion of Rivaroxaban in Human Breast Milk

Recruiting·TThomas Jefferson University·Phase 1·NCT06831474·10 enrolled

Comparative Efficacy of Rivaroxaban and Enoxaparin in Post-Laparotomy DVT Prevention

Recruiting·—·Phase 4·NCT07243080·212 enrolled

Bioequivalence Study of Rivaroxaban 10 mg Film-coated Tablets

Completed·DDexa Medica Group·Phase 1·NCT06558058·28 enrolled

Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice (Germany)

Completed· Bayer logo

Bayer··NCT01947959·665,533 enrolled

Bioequivalence Study of Rivaroxaban 20 mg Film-coated Tablets

Completed·DDexa Medica Group·Phase 1·NCT06558045·26 enrolled

Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice (Sweden)

Completed· Bayer logo

Bayer··NCT02468102·99,999 enrolled

Analysis of the Potential Savings of Rivaroxaban Events Versus Vitamin K Antagonists Events

Completed· Bayer logo

Bayer··NCT03462446·249 enrolled

Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United States Cohort

Completed· Bayer logo

Bayer··NCT04979780·3,708 enrolled

Switching Study From Warfarin to Rivaroxaban

Completed· Bayer logo

Bayer·Phase 1·NCT01507051·96 enrolled

Atrial Fibrillation31 trials

RIvaroxaban for Valvular Heart diseasE and atRial Fibrillation Trial -RIVER Trial

Completed·HHospital do Coracao·Phase 2·NCT02303795·1,005 enrolled

A Real-World Comparison of Safety and Effectiveness of Novel Oral Anti-Coagulant (NOAC) Naïve and Warfarin Naïve Non-Valvular Atrial Fibrillation (NVAF) Patients With Medicare Advantage Coverage

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT03189069·36,000 enrolled

Real-World Comparative Observational Study in Non-Valvular Atrial Fibrillation Patients Using Oral Anticoagulants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT02754154·321,182 enrolled

Show 28 more trials

Tooth Extraction in Patients With Atrial Fibrillation in Use of New Oral Anticoagulants

Completed·UUniversity of Sao Paulo General Hospital·Phase 3·NCT03181386·60 enrolled

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

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

COmparison of Bleeding Risk Between Rivaroxaban and Apixaban in Patients With Atrial Fibrillation

Recruiting·OOttawa Hospital Research Institute·Phase 4·NCT04642430·3,018 enrolled

Apixaban Drug Utilization Study In Stroke Prevention In Atrial Fibrillation (Spaf)

Completed· Pfizer logo

Pfizer··NCT03441633·51,690 enrolled

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

Completed·—·Phase 4·NCT03463317·912 enrolled

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

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

A Study Exploring Two Treatment Strategies in Patients With Atrial Fibrillation Who Undergo Catheter Ablation Therapy

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01729871·253 enrolled

Predictive Value of Infarction Volume on Hemorrhagic Transformation in Ischemic Stroke/TIA With Non-valve Atrial Fibrillation(NVAF) Patients Using Rivaroxaban

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University··NCT03772457·400 enrolled

Rivaroxaban Monotherapy After CYP2C19 Genotype Testing in Patients With Atrial Fibrillation and Percutaneous Coronary Intervention

Unknown status·JJ.P.S Henriques·Phase 4·NCT06103266·50 enrolled

BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status

Completed· Bayer logo

Bayer·Phase 2·NCT00779064·36 enrolled

Clinical Trial to Evaluate Efficacy and Safety of Rivaroxaban 15mg and 20mg in Patients With Non-valvular Atrial Fibrillation

Recruiting·KKorea University Anam Hospital·Phase 4·NCT06187311·940 enrolled

Replication Of An Early Evaluation Of 30-Day Readmissions Among Nonvalvular Atrial Fibrillation Patients Treated With Dabigatran, Rivaroxaban, Apixaban, or Warfarin In The U.S

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT02769078·14,201 enrolled

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· Pfizer logo

Pfizer··NCT05838664·2,140,403 enrolled

Direct Oral Anticoagulants in Patients With Atrial Fibrillation (DOACs vs DOACs)

Completed·CCanadian Network for Observational Drug Effect Studies, CNODES··NCT03568916·227,579 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

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

Satisfaction/Quality of Life With Rivaroxaban in SPAF (Stroke Prevention in Atrial Fibrillation) Indication

Completed· Bayer logo

Bayer··NCT01805531·411 enrolled

Study to Learn More About the Benefits and Side-effects of Drugs Rivaroxaban and Apixaban Compared to the Drug Warfarin for Stroke Prevention in Patients With Rapid and Irregular Heartbeat Which is Not Due to a Heart-valve Fault (Non-valvular Atrial Fibrillation) in the UK Routine Clinical Practice

Completed· Bayer logo

Bayer··NCT03847181·45,164 enrolled

Xarelto on Prevention of Stroke and Noncentral Nervous System Systemic Embolism in Treatment-naïve Asian Patients With Non-valvular Atrial Fibrillation

Completed· Bayer logo

Bayer··NCT03284762·1,216 enrolled

Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latinamerica and EMEA Region

Completed· Bayer logo

Bayer··NCT01800006·2,101 enrolled

A Nationwide Observational Study Looking at Effectiveness and Bleeding Complications of NOACs vs. VKA in Non-valvular Atrial Fibrillation Patients.

Terminated· Bayer logo

Bayer··NCT03715725·70,000 enrolled

A Study Using Electronic Health Information to Learn About Rivaroxaban Compared to Warfarin in Participants With Non-valvular Atrial Fibrillation (NVAF) and Diabetes

Completed· Bayer logo

Bayer··NCT04509193·116,049 enrolled

A Study to Evaluate the Safety and Effectiveness of Rivaroxaban (Xarelto) for Prevention of Stroke and Systemic Embolism in Indian Patients With Non-valvular Atrial Fibrillation (NVAF)

Completed· Bayer logo

Bayer··NCT03887780·504 enrolled

Study Aims to Collect Information in Routine Clinical Practice in Italy About the Number of Patients Suffering From Irregularly Heart Beats Which Are Not Caused by a Heart Valve Problem (Non-valvular Atrial Fibrillation, NVAF) Who Stopped or Changed Rivaroxaban Treatment

Completed· Bayer logo

Bayer··NCT04174859·812 enrolled

Xarelto on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-valvular Atrial Fibrillation

Completed· Bayer logo

Bayer··NCT03746301·924 enrolled

Study to Gather Information on the Kidney Function of Patients With Non-valvular Atrial Fibrillation (Irregularly Heart Beats Which is Not Caused by a Heart Valve Problem) Treated With Rivaroxaban or Vitamin K Antagonists

Completed· Bayer logo

Bayer··NCT04297072·25,000 enrolled

Clinical Outcomes Among Non-valvular Atrial Fibrillation Patients With Renal Dysfunction

Completed· Bayer logo

Bayer··NCT03359876·16,000 enrolled

Venous Thromboembolism16 trials

Monotherapy Anticoagulation To Expedite Home Treatment of Venous Thromboembolism

Completed·IIndiana University··NCT03404635·1,300 enrolled

Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy

Completed·UUniversity of Padova·Phase 2·NCT01629381·500 enrolled

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

Completed· Pfizer logo

Pfizer··NCT05022563·55,759 enrolled

Show 13 more trials

Study of Prophylactic Effect of Rivaroxaban on Venous Thromboembolism in AECOPD

Unknown status·HHuashan Hospital·N/A·NCT03277001·438 enrolled

Rivaroxaban for the Prevention of Venous Thromboembolism in Asian Patients With Cancer

Completed·SSeoul National University Hospital·Phase 4·NCT01989845·127 enrolled

Venous Thromboembolism in Renally Impaired Patients and Direct Oral Anticoagulants

Terminated·—·Phase 3·NCT02664155·203 enrolled

An Observational Study Called H2H-OSCAR-US to Learn More About How Well Rivaroxaban Works and How Safe it is Compared to Apixaban Under Real World Conditions in People in the US With Cancer Who Have Problems Due to Formation of Blood Clots in the Veins (Venous Thromboembolism)

Completed· Bayer logo

Bayer··NCT05461807·2,437 enrolled

Study to Gather Information How Often Venous Thromboembolism Occurs in Prostate Cancer Patients in Sweden and How This Condition is Treated With Blood Thinners

Completed· Bayer logo

Bayer··NCT03965741·97,765 enrolled

A Randomized Phase II Open Label Study to Compare the Safety and Efficacy of Subcutaneous Dalteparin Versus Direct Oral Anticoagulants for Cancer-associated Venous Thromboembolism

Unknown status·—·Phase 2·NCT03139487·176 enrolled

Once - Daily Oral Direct Factor Xa Inhibitor Rivaroxaban In The Long-Term Prevention Of Recurrent Symptomatic Venous Thromboembolism In Patients With Symptomatic Deep-Vein Thrombosis Or Pulmonary Embolism. The Einstein-Extension Study

Completed· Bayer logo

Bayer·Phase 3·NCT00439725·1,197 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

Treatment of Venous Thromboembolism (VTE) With Either Rivaroxaban or Current Standard of Care Therapy

Completed· Bayer logo

Bayer··NCT02210819·1,987 enrolled

A Study to Learn About Venous Thromboembolism (VTE) Treatment With Rivaroxaban in Japanese Patients Using a Claims Database

Completed· Bayer logo

Bayer··NCT04923139·2,627 enrolled

A Non-interventional Study on Xarelto for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Patients With Active Cancer

Completed· Bayer logo

Bayer··NCT02742623·528 enrolled

Special Drug Use Investigation of Xarelto for Venous Thromboembolism (VTE)

Completed· Bayer logo

Bayer··NCT02558465·2,540 enrolled

Direct Oral Anticoagulants and Venous Thromboembolism

Completed·CCanadian Network for Observational Drug Effect Studies, CNODES··NCT02833987·59,525 enrolled

Deep Vein Thrombosis7 trials

Rivaroxaban for the Prevention of Deep Vein Thrombosis in Patients With Left Iliac Vein Compression - The PLICTS Study

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 3·NCT04067505·224 enrolled

Prophylactic vs Therapeutic Anticoagulation in Symptomatic Isolated Distal Deep Vein Thrombosis

Unknown status·SShanghai Zhongshan Hospital·Phase 3·NCT04967573·480 enrolled

Rivaroxaban With Diosmin in Long-term Treatment of Deep Vein Thrombosis

Completed·PPirogov Russian National Research Medical University·Phase 4·NCT03413618·90 enrolled

Show 4 more trials

Treatment of an Acute Deep Vein Thrombosis (DVT) With Either Rivaroxaban or Current Standard of Care Therapy

Completed· Bayer logo

Bayer··NCT01619007·5,145 enrolled

Belgian Real Life Non-interventional Study (NIS) in Patients Treated With Xarelto Following an Acute Deep Vein Thrombosis (DVT)

Completed· Bayer logo

Bayer··NCT01855100·131 enrolled

Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis - The EINSTEIN DVT Study

Completed· Bayer logo

Bayer·Phase 3·NCT00440193·3,449 enrolled

Chemoprophylaxis With Rivaroxaban for Lower Limb Deep Vein Thrombosis in Colorectal Cancer

Unknown status·—·Phase 4·NCT05303818·68 enrolled

Anticoagulation6 trials

Anticoagulation With Rivaroxaban in Cardioversion -The ARC Study

Completed·CCook County Health·Phase 4·NCT01747746·33 enrolled

Clinical Outcomes Between Anticoagulation and DAPT Therapy in AF Patients Successfully Undergoing LAAO

Unknown status·SShanghai Zhongshan Hospital·Phase 4·NCT04135677·826 enrolled

Anticoagulation Using Rivaroxaban on Top of Aspirin in Intracranial Atherosclerotic Stenosis

Unknown status·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2/3·NCT05700266·1,180 enrolled

Show 3 more trials

Rivaroxaban and Vitamin K Antagonists for the Anticoagulation for the Implantation of Vena Cava Filters

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 3·NCT04066764·200 enrolled

AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation

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

Anticoagulation for Advanced Cirrhotic Patients After TIPS

Unknown status·—·N/A·NCT03005444·254 enrolled

70 more indications

Pulmonary Embolism6 trials

Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism

Recruiting·DDrahomir Aujesky·Phase 4·NCT04263038·276 enrolled

Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement

Completed·—·Phase 4·NCT02810704·18,883 enrolled

XENITH: Rivaroxaban for Pulmonary Embolism Managed With Catheter Directed Thrombolysis

Terminated·SSusan Smyth·Phase 4·NCT02506985·10 enrolled

Show 3 more trials

Xarelto for Real Life Anticoagulation in Pulmonary Embolism (PE) in China

Completed· Bayer logo

Bayer··NCT03410706·288 enrolled

Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.

Completed· Bayer logo

Bayer·Phase 3·NCT00362232·3,148 enrolled

Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study

Completed· Bayer logo

Bayer·Phase 3·NCT00439777·4,833 enrolled

Anticoagulant5 trials

Replication of the EINSTEIN-PE Anticoagulant Trial in Healthcare Claims Data

Completed·—··NCT04879407·98,947 enrolled

The Study of Monitoring and Dosing Guidance of Direct Oral Anticoagulants Based on Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics

Recruiting·PPeking Union Medical College Hospital··NCT06362343·300 enrolled

International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants

Recruiting·SStéphane Zuily··NCT04262492·500 enrolled

Show 2 more trials

Prediction of the COBRRA AF Anticoagulant Trial in Healthcare Claims Data

Completed·—··NCT05256797·353,980 enrolled

Use of Direct Oral Anticoagulants in UK

Completed· Bayer logo

Bayer··NCT03119116·31,336 enrolled

Acute Coronary Syndrome5 trials

A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02293395·3,037 enrolled

Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Patients With Acute Coronary Syndromes (The ATLAS ACS TIMI 46 Trial)

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00402597·3,490 enrolled

Antithrombotic Therapy in Acute Coronary Syndromes and Coronary Artery Ectasia

Unknown status·IInstituto Nacional de Cardiologia Ignacio Chavez·Phase 2·NCT05233124·60 enrolled

Show 2 more trials

To Assess the Efficacy and Safety of Dual Anticoagulants i.e. Rivaroxaban Plus Aspirin and Clopidogrel Plus Aspirin in Patients Suffering From an Acute Coronary Syndrome

Unknown status·SSarmad Zahoor·Phase 4·NCT05573958·90 enrolled

Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial.

Terminated·IImperial College London·N/A·NCT04333407·320 enrolled

Venous thrombosis4 trials

Prevention of Recurrence After Thrombolysis in Acute Iliofemoral Venous Thrombosis (PRAIS) Study

Unknown status·SSeoul National University Hospital·N/A·NCT01986192·72 enrolled

Study of Rivaroxaban for CeREbral Venous Thrombosis

Completed·UUniversity of British Columbia·Phase 2·NCT03178864·55 enrolled

Satisfaction/Quality of Life With Rivaroxaban in DVT (Deep Venous Thrombosis) Indication

Completed· Bayer logo

Bayer··NCT01805544·113 enrolled

Show 1 more trial

Oral Rivaroxaban in Children With Venous Thrombosis

Completed· Bayer logo

Bayer·Phase 2·NCT01684423·64 enrolled

Total Knee Replacement3 trials

Switching Drug Therapy for the Prevention of Blood Clot Formation From Enoxaparin to Rivaroxaban After Orthopedic Surgery for Either Total Hip or Total Knee Replacement

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01094886·56 enrolled

Study to Observe Safety of Xarelto in VTE Prophlylaxis After Elective TKR (Total Knee Replacement) or THR (Total Hip Replacement)

Withdrawn· Bayer logo

Bayer··NCT01523418

Dose-confirmatory Bridging Study in Total Knee Replacement

Completed· Bayer logo

Bayer·Phase 3·NCT01206972·302 enrolled

COVID-193 trials

Efficacy and Safety of Apixaban in COVID-19 Coagulopathy Patients With Respiratory Severity Under Critical Care

Unknown status·SScotmann Pharmaceuticals·Phase 2·NCT05088928·40 enrolled

Effect of Anticoagulation Therapy on Clinical Outcomes in COVID-19

Terminated·—·Phase 2·NCT04416048·111 enrolled

Effect of Prophylactic and Therapeutic Anticoagulants in Egyptian Patients With COVID-19

Completed·—··NCT04736901·90 enrolled

Heavy Menstrual Bleeding2 trials

RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding

Completed·IIndiana University·Phase 2/3·NCT02829957·19 enrolled

Prospective Comparison of Incidence of Heavy Menstrual Bleeding in Women Treated With Direct Oral Anticoagulants

Completed·CCardioangiologisches Centrum Bethanien··NCT04477837·84 enrolled

Complication2 trials

Complications and Antiplatelet and Anticoagulant Therapy in Vascular Surgery.

Active, not recruiting·PPetrovsky National Research Centre of Surgery··NCT07358416·500 enrolled

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

Completed·MMalmö University··NCT04662515·216 enrolled

Intermittent Claudication2 trials

Influence of Rivaroxaban for Intermittent Claudication and Exercise Tolerance in Patients With Symptomatic PAD

Unknown status·PPoznan University of Medical Sciences··NCT04305028·100 enrolled

Rivaroxaban 2.5 mg BID and Aspirin for Intermittent Claudication in PAD Patients

Completed·SScience Valley Research Institute·Phase 4·NCT04853719·88 enrolled

Calcification2 trials

Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients

Completed·OOnze Lieve Vrouw Hospital·Phase 4·NCT02610933·117 enrolled

Vascular CalcIfiCation and sTiffness Induced by ORal antIcoAgulation

Completed·UUniversity Hospital, Angers·Phase 4·NCT02161965·51 enrolled

Cohort Study2 trials

Non-interventional, Retrospective Cohort Study to Explore OAC Treatment in Korea

Completed· Pfizer logo

Pfizer··NCT03572972·64,684 enrolled

Treatment of Splanchnic Vein Thrombosis With Rivaroxaban. A Pilot, Prospective Cohort Study

Unknown status·UUniversità degli Studi dell'Insubria·Phase 3·NCT02627053·100 enrolled

Left Ventricular Thrombus2 trials

Rivaroxaban in Left Ventricular Thrombus

Completed·NNational Institute of Cardiovascular Diseases, Pakistan·Phase 4·NCT04970576·261 enrolled

Rivaroxaban vErsus Warfarin for Antithrombotic TheRapy in Patients With LeFt Ventricular Thrombus After Acute STEMI

Completed·RRajaie Cardiovascular Medical and Research Center·Phase 3·NCT05705089·50 enrolled

Total Knee Arthroplasty2 trials

The Blood Saving Effect of Tranexamic Acid in Total Knee Arthroplasty With Rivaroxaban as Thromboprophylaxis

Completed·—·Phase 4·NCT02458729·294 enrolled

Xarelto for Thromboprophylaxis After Total Hip and Total Knee Arthroplasty

Unknown status·—·N/A·NCT05449327·178 enrolled

Total Hip Replacement2 trials

Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE, a Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement

Completed· Bayer logo

Bayer·Phase 3·NCT00332020·2,457 enrolled

Rivaroxaban (10mg) Given Once Daily in Patients Undergoing Total Hip Replacement Compared to Enoxaparin

Completed· Bayer logo

Bayer·Phase 3·NCT00329628·4,541 enrolled

Effectiveness2 trials

Real-world Comparative Effectiveness of Rivaroxaban Versus VKA

Completed· Bayer logo

Bayer··NCT02690155·38,831 enrolled

Study to Learn More About the Safety and Effectiveness of Rivaroxaban (Xarelto) When Given Together With Acetylsalicylic Acid to Indian People With Narrowing of the Arteries of the Heart (CAD) and/or With Reduced Blood Flow in the Arteries of the Legs and Arms With Symptoms (Symptomatic PAD)

Completed· Bayer logo

Bayer··NCT04298567·300 enrolled

Oral Anticoagulation2 trials

Comparative Study of Oral Anticoagulation in Left Ventricular Thrombi

Completed·TThe Young Investigator Group of Cardiovascular Research·Phase 3·NCT03926780·79 enrolled

Oral Anticoagulation in Hemodialysis

Completed·OOnze Lieve Vrouw Hospital·Phase 4·NCT03799822·132 enrolled

Renal Impairment1 trial

Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment

Unknown status·SSamsung Medical Center··NCT04096547·1,200 enrolled

Cognitive impairment1 trial

Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in AF

Terminated·MMontreal Heart Institute·Phase 3·NCT02387229·1,238 enrolled

Prospective1 trial

A Prospective Pharmacodynamic Study of Rivaroxaban

Completed·UUniversity of North Carolina, Chapel Hill··NCT01743898·65 enrolled

Post-thrombotic Syndrome1 trial

Tinzaparin Lead-In to Prevent the Post-Thrombotic Syndrome

Terminated·SSunnybrook Health Sciences Centre·Phase 4·NCT04794569·9 enrolled

Trial1 trial

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

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

Portal Hypertension1 trial

Multicenter Prospective Randomized Trial of the Effect of Rivaroxaban on Survival and Development of Complications of Portal Hypertension in Patients With Cirrhosis

Unknown status·DDavid Garcia Cinca·Phase 3·NCT02643212·160 enrolled

After Cardiac Surgery1 trial

DOAC Versus VKA After Cardiac Surgery

Withdrawn·LLaval University·Phase 2·NCT04002011

Peripheral Artery Disease1 trial

Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease

Completed· Bayer logo

Bayer·Phase 3·NCT01776424·27,395 enrolled

Aortic Valve Replacement1 trial

Comparison of Antithrombotic Treatments After Aortic Valve Replacement. Rivaroxaban: A New Antithrombotic Treatment for Patients With Mechanical Prosthetic Aortic Heart Valve.

Terminated·IInsel Gruppe AG, University Hospital Bern·Phase 2·NCT02128841·12 enrolled

Coronary Artery Disease1 trial

Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease

Completed·UUniversity of Florida·Phase 4·NCT04006288·90 enrolled

Thrombocytopenia1 trial

Rivaroxaban for Treatment of Patients With Suspected or Confirmed Heparin-Induced Thrombocytopenia

Terminated·MMcMaster University·Phase 3·NCT01598168·22 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Rivaroxaban in the Early Postoperative Period for Patients With Bioprosthetic Valves

Not yet recruiting·RRenJi Hospital·Phase 4·NCT06476301·250 enrolled

End-Stage Renal Disease1 trial

Chronic Anticoagulation With a Reduced Dose Regimen of Rivaroxaban in End-stage Renal Disease Patients

Unknown status·UUniversity Hospital, Tours·Phase 3·NCT05410275·10 enrolled

Membranous Nephropathy1 trial

Rivaroxaban in Idiopathic Membranous Nephropathy

Recruiting·—·Phase 4·NCT07404436·134 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

Hematologic Malignancies1 trial

Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies

Recruiting·MMedical University of Gdansk·N/A·NCT07270263·100 enrolled

Antiphospholipid Syndrome1 trial

Rivaroxaban for Patients With Antiphospholipid Syndrome

Completed·HHospital Universitari Vall d'Hebron Research Institute·Phase 3·NCT02926170·190 enrolled

Elderly Participants1 trial

A Study to Investigate Biomarkers After Single Doses of Anticoagulants in Healthy Young Male and Healthy Elderly Participants (MK-0000-216 AM1)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01379300·42 enrolled

Antiplatelet1 trial

Comparison of a Rivaroxaban-based Strategy With an Antiplatelet-based Strategy Following Successful TAVR for the Prevention of Leaflet Thickening and Reduced Leaflet Motion as Evaluated by Four-dimensional, Volume-rendered Computed Tomography (4DCT)

Completed·EECRI bv·Phase 3·NCT02833948·231 enrolled

Cerebrovascular Event1 trial

Treatment of Rivaroxaban Versus Aspirin for Non-disabling Cerebrovascular Events

Unknown status·XXijing Hospital·Phase 2/3·NCT01923818·3,700 enrolled

Cardiovascular1 trial

Post-Operative Biomarker-Guided Precision Medicine For Cardiovascular Risk Reduction

Recruiting·NNYU Langone Health·Phase 1·NCT06961630·50 enrolled

Sickle Cell Disease1 trial

The Effect of Rivaroxaban in Sickle Cell Disease

Completed·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT02072668·14 enrolled

Tranexamic Acid1 trial

A Study to Assess the Independent Effects of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding/Pharmacodynamics in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02561923·158 enrolled

Atrial Appendage1 trial

Efficacy of Different Anti-Thrombotic Strategies on the Incidence of Silent Cerebral Embolism After Percutaneous Left Atrial Appendage Occlusion

Unknown status·TThe First Affiliated Hospital with Nanjing Medical University·Phase 4·NCT05671276·150 enrolled

Hypothermia1 trial

The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM

Completed·TThomas Kander··NCT05669313·15 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Rivaroxaban and Apixaban in Comparison to Warfarin in Left Ventricular Clot- Clinical Trial

Unknown status·PPeshawar Institute of Cardiology·Phase 4·NCT05973188·141 enrolled

Total Hip Arthroplasty1 trial

Comparison of Blood Loss Following Total Hip Arthroplasty With the Use of Three Thromboprophylactic Regimes: Dabigatran, Enoxaparin and Rivaroxaban.

Unknown status·CCentre of Postgraduate Medical Education·N/A·NCT02085824·60 enrolled

Stroke1 trial

Plasma Modifications Associated With Rivaroxaban® Treatment for Stroke Prevention

Completed·—··NCT02273700·5 enrolled

Peripheral Arterial Disease1 trial

Effectiveness of Combined Anticoagulation and Antithrombotic Therapy vs Antithrombotic Therapy Alone After Lower Extremity Revascularization for Peripheral Arterial Disease

Unknown status·AArmed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi·Phase 1·NCT04994223·60 enrolled

High Risk1 trial

Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events

Completed·OOttawa Heart Institute Research Corporation·Phase 3·NCT01675076·663 enrolled

Multiple Myeloma1 trial

Aspirin or Rivaroxaban Thromboprophylaxis for Patients With Multiple Myeloma

Not yet recruiting·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 3·NCT06580223·530 enrolled

Treatment1 trial

A Study to Collect Data on the Treatment Pattern of Xarelto + Acetylsalicylic Acid in the Routine Clinical Practice in Patients Who Are Suffering From a Condition That Narrows the Blood Vessels Supplying the Heart and / or a Condition That Most Commonly Narrows the Blood Vessel in the Legs

Completed· Bayer logo

Bayer··NCT04401761·3,189 enrolled

Observational Study1 trial

Observational Study to Assess Sociodemographic and Clinical Features of Patients Treated With Rivaroxaban in Routine Clinical Practice of Hematologists, Cardiologists and Internists of Spain

Completed· Bayer logo

Bayer··NCT02262676·2,251 enrolled

Thromboembolism1 trial

Characterizing Recurrent Thromboembolism, Major Bleeding and All-Cause Death in Patients With Cancer-Associated Thromboembolism Treated With Rivaroxaban

Completed· Bayer logo

Bayer··NCT03214172·1,000 enrolled

MPA1 trial

A Study to Compare Pharmacokinetic Parameters and Safety Profiles Between AD-109 and AD-1091

Completed·AAddpharma Inc.·Phase 1·NCT05128591·38 enrolled

Myocardial Infarction1 trial

Anti-CoagulaTion on Left Ventricular Thrombus After ST Segment Elevation Myocardial Infarction

Unknown status·JJilin University·N/A·NCT05892042·320 enrolled

Transcatheter Aortic Valve Replacement1 trial

Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes

Terminated· Bayer logo

Bayer·Phase 3·NCT02556203·1,653 enrolled

Interaction1 trial

Rivaroxaban Sotorasib Interaction Study

Completed·RRadboud University Medical Center·Phase 4·NCT06314763·21 enrolled

Percutaneous Coronary Intervention1 trial

Exploring the Efficacy and Safety of Rivaroxaban to Support Elective Percutaneous Coronary Intervention

Completed· Bayer logo

Bayer·Phase 2·NCT01442792·108 enrolled

Ischemic stroke1 trial

Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke

Not yet recruiting·—·Phase 4·NCT06396858·4,500 enrolled

Vascular Disease1 trial

Effects of Rivaroxaban on Vascular FMD in Patients With Stable Atherosclerotic Vascular Diseases

Completed·TThe University of Hong Kong·Phase 4·NCT06986369·140 enrolled

Spinal Cord Injury1 trial

Absorption of Rivaroxaban in Patients With Cervical Spinal Cord Injury

Withdrawn·SSwiss Paraplegic Research, Nottwil·Phase 4·NCT02970773

Fasting Conditions1 trial

Bioequivalence Study of Two Formulations of Rivaroxaban Tablets 10 mg in Healthy Male Volunteers in Fasting Conditions

Unknown status·PPharmtechnology LLC·Phase 1·NCT04753489·34 enrolled

Bariatric Surgery1 trial

Rivaroxaban in Bariatric Surgery

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 1·NCT02438098·13 enrolled

Cognition1 trial

AntiCoagulants and COGnition

Unknown status·UUniversity Hospital, Angers·Phase 4·NCT04073316·48 enrolled

Patent foramen ovale1 trial

Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale

Unknown status·—·Phase 4·NCT05546320·1,000 enrolled

Dual Antiplatelet Therapy1 trial

Can Very Low Dose Rivaroxaban in Addition to Dual Antiplatelet Therapy (DAPT) Improve Thrombotic Status in Acute Coronray Syndrome (ACS) ACS

Unknown status·EEast and North Hertfordshire NHS Trust·Phase 4·NCT03775746·150 enrolled

Knee Arthroplasty1 trial

Xarelto for VTE Prophylaxis After Hip or Knee Arthroplasty

Completed· Bayer logo

Bayer··NCT00831714·19,076 enrolled

Central Nervous System1 trial

Study to Gain Information on the Drug Xarelto for the Prevention of Brain Attack and Blockage of an Artery in the Non-central Nervous System Due to Irregular Heartbeat in Taiwanese Patients Suffering From Decreased Renal Function

Completed· Bayer logo

Bayer··NCT04356989·493 enrolled

Hemodialysis1 trial

Dose-finding of Rivaroxaban in Hemodialysis

Completed·AAZ Sint-Jan AV·Phase 4·NCT02047006·18 enrolled

Aneurysm1 trial

Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease

Recruiting·—·Phase 4·NCT06978439·10 enrolled

Prophylaxis1 trial

Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients

Completed· Bayer logo

Bayer·Phase 3·NCT00571649·8,101 enrolled

Unspecified4 trials

NOAC Portuguese Real World Study

Withdrawn· Pfizer logo

Pfizer··NCT04808934

Xarelto Regulatory Post-Marketing Surveillance

Completed· Bayer logo

Bayer··NCT01029743·3,388 enrolled

Low-dose NOAC Versus GDMT After LAAO

Recruiting·XXijing Hospital·N/A·NCT05960721·4,220 enrolled

Show 1 more trial

Xarelto [SPAF] Post-marketing Surveillance in Japan

Completed· Bayer logo

Bayer··NCT01582737·11,310 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 1, 2011

XARELTO

NDA NDA022406

Nov 2, 2012

XARELTO

NDA NDA022406

Nov 2, 2012

XARELTO

NDA NDA022406

Jan 31, 2013

XARELTO

NDA NDA022406

Mar 1, 2013

XARELTO

NDA NDA022406

Jan 7, 2014

XARELTO

NDA NDA022406

Feb 13, 2014

XARELTO

NDA NDA022406

Mar 6, 2014

XARELTO

NDA NDA022406

Sep 15, 2014

XARELTO

NDA NDA022406

Dec 19, 2014

XARELTO

NDA NDA022406

Jan 15, 2015

XARELTO

NDA NDA022406

Feb 16, 2015

XARELTO

NDA NDA022406

May 5, 2015

XARELTO

NDA NDA022406

Oct 26, 2015

XARELTO

NDA NDA022406

Aug 17, 2016

XARELTO

NDA NDA022406

Aug 25, 2016

XARELTO

NDA NDA022406

Aug 25, 2016

XARELTO

NDA NDA022406

Feb 10, 2017

XARELTO

NDA NDA022406

Jun 28, 2017

XARELTO

NDA NDA022406

Oct 27, 2017

XARELTO

NDA NDA022406

Jul 30, 2018

XARELTO

NDA NDA022406

Oct 11, 2018

XARELTO

NDA NDA022406

Nov 7, 2018

XARELTO

NDA NDA022406

Jan 15, 2019

XARELTO

NDA NDA022406

Jan 15, 2019

XARELTO

NDA NDA022406

Aug 23, 2019

XARELTO

NDA NDA022406

Oct 11, 2019

XARELTO

NDA NDA022406

Nov 15, 2019

XARELTO

NDA NDA022406

Mar 10, 2020

XARELTO

NDA NDA022406

Jan 28, 2021

XARELTO

NDA NDA022406

Aug 23, 2021

XARELTO

NDA NDA022406

Dec 20, 2021

XARELTO

NDA NDA215859

Dec 20, 2021

XARELTO

NDA NDA215859

Mar 1, 2022

XARELTO

NDA NDA022406

Feb 8, 2023

XARELTO

NDA NDA215859

Feb 8, 2023

XARELTO

NDA NDA022406

Jun 17, 2025

XARELTO

NDA NDA215859

Jun 17, 2025

XARELTO

NDA NDA022406

Mar 24, 2026

XARELTO

NDA NDA022406

Mar 24, 2026

XARELTO

NDA NDA215859

Sources

References

[1]
ClinicalTrials.gov — 415 trial records for Rivaroxaban. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Xarelto drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Rivaroxaban compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Rivaroxaban. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022406). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Xarelto. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Wim Janssens 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: WWim Janssens

Patent Landscape[6]

Patent Cliff

Feb 17, 2034

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9539218Feb 17, 2034

9539218*PEDAug 17, 2034