NDAORALFOR SUSPENSIONPriority Review
Approved
Dec 2021
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
XARELTO (rivaroxaban) by Johnson & Johnson is factor xa inhibitors [moa]. Approved for factor xa inhibitor [epc]. First approved in 2021.
Drug data last refreshed Yesterday · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XARELTO (rivaroxaban) is an oral Factor Xa inhibitor used to prevent and treat blood clots in atrial fibrillation, venous thromboembolism, pulmonary embolism, and deep vein thrombosis. It works by selectively inhibiting free Factor Xa and prothrombinase activity, reducing thrombin generation without requiring a cofactor. The drug is formulated as an oral suspension for flexible dosing across patient populations.
Peak
At peak lifecycle with $6.3B in spending, XARELTO supports a mature commercial infrastructure but faces moderate competitive pressure requiring sustained promotional and managed care strategies.
Mechanism of Action
Factor Xa Inhibitors
Pharmacologic Class:
Factor Xa Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolism (VTE)
Started Sep 2026
850 enrolled
Venous ThromboembolismChildren Under 2 Years
Aspirin or Rivaroxaban Thromboprophylaxis for Patients With Multiple Myeloma
Started Sep 2025
530 enrolled
Multiple MyelomaVenous Thromboembolism
An Observational Study to Learn More About the Safety of Rivaroxaban in Participants With Peripheral Arterial Disease Who Had Surgery to Improve Blood Flow to Their Legs
Started Aug 2025
1,500 enrolled
Peripheral Arterial Disease (PAD)
Assessment of Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban, or Aspirin Plus REGN9933, or Aspirin Plus REGN7508 in Healthy Adult Participants
Started Sep 2024
224 enrolled
Healthy Volunteers
An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Heart Disease Who Had a Heart Surgery Called the Fontan Procedure
Started Jun 2024
61 enrolled
Prevention of Venous ThromboembolismCongenital Heart DiseaseFontan Procedure+1 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.