XARELTO
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.
Details
- Status
- Prescription
- First Approved
- 2011-07-01
- Routes
- ORAL
- Dosage Forms
- TABLET, FOR SUSPENSION
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 Competitors
Pro6 other drugs also target THROMBIN. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (THROMBIN). Earlier expiry dates signal biosimilar/generic opportunities.
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
ProIndications & Usage
FDA Label (PDF)XARELTO is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation for treatment of deep vein thrombosis (DVT) for treatment of pulmonary embolism (PE) for reduction in the risk of recurrence of DVT or PE for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) to reduce the risk of major thrombotic vascular events ...
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....
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.