XARELTO (rivaroxaban)
Xarelto (rivaroxaban) is a Factor Xa inhibitor indicated for the prevention and treatment of various thromboembolic conditions in both adult and pediatric populations. In adults, it is used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, as well as to treat and prevent the recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE). The medication is also approved for prophylaxis against venous thromboembolism in surgical and acutely ill patients, and to reduce major cardiovascular or thrombotic events in patients with coronary or peripheral artery disease. Additionally, it is used in pediatric patients for the treatment of VTE and for thromboprophylaxis following the Fontan procedure.
How XARELTO Works
Rivaroxaban functions as a selective inhibitor of Factor Xa (FXa), an enzyme essential to the blood coagulation cascade. It acts directly on free FXa and prothrombinase activity without requiring a cofactor like anti-thrombin III. By blocking Factor Xa, the drug decreases the generation of thrombin, which in turn indirectly inhibits platelet aggregation. This process prevents the formation of blood clots associated with various cardiovascular and venous conditions.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2011-07-01
- Patent Cliff
- 2034
- Routes
- ORAL
- Dosage Forms
- FOR SUSPENSION, TABLET
XARELTO Approval History
What XARELTO Treats
10 indicationsXARELTO is approved for 10 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Stroke and systemic embolism risk reduction in nonvalvular atrial fibrillation
- Treatment of deep vein thrombosis (DVT)
- Treatment of pulmonary embolism (PE)
- Reduction in the risk of recurrence of DVT and PE
- Prophylaxis of DVT in patients undergoing knee or hip replacement surgery
- Prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients
- Reduction of major cardiovascular events in patients with coronary artery disease (CAD)
- Reduction of major thrombotic vascular events in patients with peripheral artery disease (PAD)
XARELTO Boxed Warning
(A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete boxed warning. (A) Premature discontinuation of XARELTO increases the risk of thrombotic events Premature discontinuation of any oral anticoagulant, including XARELTO, increases the risk of thrombotic events. To reduce this...
WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete boxed warning. (A) Premature discontinuation of XARELTO increases the risk of thrombotic events Premature discontinuation of any oral anticoagulant, including XARELTO, increases the risk of thrombotic events. To reduce this risk, consider coverage with another anticoagulant if XARELTO is discontinued for a reason other than pathological bleeding or completion of a course of therapy. ( 2.2 , 2.3 , 5.1 , 14.1 ) (B) Spinal/epidural hematoma Epidural or spinal hematomas have occurred in patients treated with XARELTO who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. ( 5.2 , 5.3 , 6.2 ) Monitor patients frequently for signs and symptoms of neurological impairment and if observed, treat urgently. Consider the benefits and risks before neuraxial intervention in patients who are or who need to be anticoagulated. ( 5.3 ) A. Premature discontinuation of XARELTO increases the risk of thrombotic events Premature discontinuation of any oral anticoagulant, including XARELTO, increases the risk of thrombotic events. If anticoagulation with XARELTO is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.3 , 2.4) , Warnings and Precautions (5.1) , and Clinical Studies (14.1) ] . B. Spinal/epidural hematoma Epidural or spinal hematomas have occurred in patients treated with XARELTO who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can inc
XARELTO Target & Pathway
ProTarget
The central enzyme in blood coagulation that converts fibrinogen to fibrin, forming blood clots. Direct thrombin inhibitors prevent clot formation and are used to prevent stroke and treat blood clots.
XARELTO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in XARELTO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications XARELTO treats. First-in-class if their pivotal trials read out positive.
Clinical Trial Registry
98 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06517563 | VMX-C001-02 2022-003675-41 | Ph 1 | completed | Effects of VMX-C001 on the Anticoagulant Effect of Different Forms of Heparin |
| NCT03331484 CAPITAL PCI AF | MRL-PCI AF | Ph 3 | completed | The Safety and Efficacy Of Rivaroxaban and Ticagrelor for Patients With Atrial Fibrillation After Percutaneous Coronary Intervention |
| NCT05735639 THRIVE | 22CX7510 ISRCTN18501431 | Ph 4 | recruiting | THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE) |
| NCT07312851 | D9609C00001 2025-522513-30-00 | Ph 1 | recruiting | A Study to Investigate Andexanet Dosing and the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Participants |
| NCT04642430 COBRRA-AF | COBRRA-AF | Ph 4 | recruiting | COmparison of Bleeding Risk Between Rivaroxaban and Apixaban in Patients With Atrial Fibrillation |
| NCT02810704 PEPPER | FED19132 | Ph 4 | completed | Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement |
| NCT06953726 VALIANT-AF-T | 2037T 2037 | Ph 4 | not yet recruiting | Comparing the Safety and Efficacy of Apixaban and Rivaroxaban |
| NCT06650501 DABI-SNAP | 2025-10900 500464 | Ph 4 | recruiting | Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia |
| NCT07468448 CATIS-ICAS | CATIS-ICAS | Ph 3 | not yet recruiting | Combination Antithrombotic Treatment for Prevention of Recurrent Ischemic Stroke in IntraCranial Atherosclerotic diseaSe (CATIS- ICAS) |
| NCT06370273 TiLLI | 1009305 | Ph 3 | recruiting | Thromboprophylaxis in Lower Limb Immobilisation |
| NCT07318610 ROXI-PALISADE | R9933-PAD-2394 2025-522954-37-00 | Ph 3 | not yet recruiting | Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease |
| NCT03463317 CLOSURE-AF | CLOSURE-AF-DZHK16 | Ph 4 | completed | Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation Compared to Medical Therapy |
| NCT03266783 COBRRA | COBRRA | Ph 4 | completed | Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism |
| NCT02559856 COBRRA Pilot | COBRRA Pilot 20150574-01H | Ph 4 | completed | Comparison of Bleeding Risk Between Rivaroxaban and Apixaban: The Pilot Study |
| NCT04755283 AZALEA-TIMI 71 results posted | ANT-006 2020-004507-13, CMAA868A2204 | Ph 2 | active not recruiting | Safety and Tolerability of Abelacimab (MAA868) vs. Rivaroxaban in Patients With Atrial Fibrillation |
| NCT02168829 OCEAN | 327494 | Ph 4 | completed | Optimal Anticoagulation for Higher Risk Patients Post-Catheter Ablation for Atrial Fibrillation Trial |
| NCT07195812 | 20251206 | Ph 4 | not yet recruiting | Rivaroxaban for Slow Coronary Flow After PCI in STEMI |
| NCT05180773 REBIRTH | STUDY21090058 UG3HL153847 | Ph 4 | recruiting | Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy |
| NCT03172910 results posted | PER977-02-012 | Ph 2 | completed | Phase 2 Study of Rivaroxaban Reversal by Ciraparantag as Measured by WBCT |
| NCT03749057 ERSAF | k （2018）39 | Ph 4 | completed | Early Rivaroxaban for Acute Ischemic Stroke or TIA Patients With Atrial Fibrillation |
| NCT07077954 | adeel 8 | Ph 1 | completed | COMPARISON OF WARFARIN AND RIVAROXABAN IN THE TREATMENT OF LOWER LIMB DEEP VENOUS THROMBOSIS |
| NCT06444178 | R9933-HV-2424 | Ph 1 | completed | Assessment of Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban, or Aspirin Plus REGN9933, or Aspirin Plus REGN7508 in Healthy Adult Participants |
| NCT02387229 BRAIN-AF | BRAIN-001 | Ph 3 | terminated | Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in AF |
| NCT04263038 SAFE-SSPE | 2019-02297 | Ph 4 | recruiting | Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism |
| NCT05794399 WaRMIN | SGNHC-RCT | Ph 4 | recruiting | Anticoagulation in Post MI LV Thrombus Trial in Nepal |
| NCT02846532 UNIVERSE results posted | CR108075 39039039CHD3001, 2015-002610-76 | Ph 3 | completed | Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure |
| NCT06812455 RIVA-RAO | 107/2025 | Ph 4 | recruiting | Effect of RIVAroxaban in Radial Artery Occlusion Treatment After Cardiac Catheterization |
| NCT02561923 | CR107832 39039039NAP1004 | Ph 1 | completed | A Study to Assess the Independent Effects of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding/Pharmacodynamics in Healthy Participants |
| NCT03996772 PRESTIGE-AF | 17HH4268 2018-002176-41, 754517 | Ph 3 | completed | PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation |
| NCT04970576 | ERC-70/2021 | Ph 4 | completed | Rivaroxaban in Left Ventricular Thrombus |
| NCT02376010 results posted | 21429 | Ph 4 | completed | Rivaroxaban Versus Warfarin in the Evaluation of Progression of Coronary Calcium |
| NCT06476301 | IIT-2023-0325 | Ph 4 | not yet recruiting | Efficacy and Safety of Rivaroxaban in the Early Postoperative Period for Patients With Bioprosthetic Valves |
| NCT04794569 TILE | 3315 | Ph 4 | terminated | Tinzaparin Lead-In to Prevent the Post-Thrombotic Syndrome |
| NCT04324463 ACTCOVID19 | PHRI.ACT.COVID19 | Ph 3 | completed | Anti-Coronavirus Therapies to Prevent Progression of Coronavirus Disease 2019 (COVID-19) Trial |
| NCT03864406 results posted | 190063 19-CC-0063 | Ph 1 | completed | Impact of Steady State Cobicistat and Darunavir/Cobicistat on the Pharmacokinetics and Pharmacodynamics of Oral Anticoagulants (Rivaroxaban, Apixaban) in Health Volunteers |
| NCT02829957 (RAMBLE) results posted | RAMBLE | Ph 2, Ph 3 | completed | RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding |
| NCT02164578 MicroVasc-DIVA results posted | MicroVasc-DIVA | Ph 3 | completed | Microvascular and Antiinflammatory Effects of Rivaroxaban Compared to Aspirin in Type-2 Diabetic Patients With Subclinical Inflammation and High Cardiovascular Risk |
| NCT03702582 NEW-AF results posted | 2018P002307 | Ph 3 | completed | Rivaroxaban vs. Warfarin for Post Cardiac Surgery Atrial Fibrillation |
| NCT04508023 PREVENT-HD results posted | CR108849 39039039DVT3004 | Ph 3 | terminated | A Study of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events, Hospitalization and Death in Medically Ill Outpatients With Acute, Symptomatic Coronavirus Disease 2019 (COVID-19) Infection |
| NCT05152420 | VMX-C001-01 | Ph 1 | completed | Study of Intravenous VMX-C001 in Healthy Subjects and in Combination With Selected Direct Oral Anticoagulants in Healthy Older Subjects |
| NCT01499953 results posted | SURPRISE-2011 | Ph 3 | completed | Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux |
| NCT04006288 SWAP-AC results posted | IIS-RIVA02 | Ph 4 | completed | Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease |
| NCT04002011 DOAC/VKA | 21755 | Ph 2 | withdrawn | DOAC Versus VKA After Cardiac Surgery |
| NCT03310021 results posted | 16-508 | Ph 2 | completed | A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects |
| NCT04569279 RWCVT | 3934 | Ph 3 | completed | Rivaroxaban vs. Warfarin in CVT Treatment |
| NCT03178864 SECRET | H17-00440 | Ph 2 | completed | Study of Rivaroxaban for CeREbral Venous Thrombosis |
| NCT04767776 RICHAR2 | 18CH050 2019-004425-25 | Ph 1 | completed | Non Inferiority Study of a Reduced Dose of Activated Charcoal on Rivaroxaban Pharmacokinetics. |
| NCT05035277 ACASA-TAVI | 247400 2021-001554-61 | Ph 3 | recruiting | AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation |
| NCT02664155 VERDICT | 1508189 2016-000858-35 | Ph 3 | terminated | Venous Thromboembolism in Renally Impaired Patients and Direct Oral Anticoagulants |
| NCT02555111 RIPORT | AOM 11077 - P 110150 2015-001190-40 | Ph 3 | completed | Xarelto Versus no Treatment for the Prevention of Recurrent Thrombosis in Patients With Chronic Portal Vein Thrombosis. |
Showing 50 of 98 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
XARELTO FDA Label Details
Indications & Usage
FDA Label (PDF)XARELTO is indicated for the treatment of Stroke and systemic embolism risk reduction in nonvalvular atrial fibrillation; Treatment of deep vein thrombosis (DVT); Treatment of pulmonary embolism (PE); Reduction in the risk of recurrence of DVT and PE; Prophylaxis of DVT in patients undergoing knee or hip replacement surgery; Prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients; Reduction of major cardiovascular events in patients with coronary artery disease (CAD); Reduction of major thrombotic vascular events in patients with peripheral artery disease (PAD); Treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients; Thromboprophylaxis in pediatric patients with congenital heart disease after the Fontan procedure.
WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete boxed warning....
XARELTO Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for XARELTO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 52 active patents
Trial Analysis
- • 99 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment