Wednesday, July 8, 2026

Drug profile · INN

rivaroxaban

rivaroxaban (APO-RIVAROXABAN) is a coagulation factor x inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved NMPA: clinical trials Blood and blood forming organs (B01) B01AF01
US status approved
Patents linked 0
Pipeline programs 24
News articles 0
Drug details — rivaroxaban
US status
approved
Class
Blood and blood forming organs (B01)
Route
ORAL
Patents
0
Programs
24
Data quality
0.89

Quick answer

rivaroxaban (APO-RIVAROXABAN) is a coagulation factor x inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN rivaroxaban
Brand APO-RIVAROXABAN
Mechanism Coagulation factor X inhibitor
Target Coagulation factor X
Therapeutic class Blood and blood forming organs (B01)
Route ORAL
Formulation FOR SUSPENSION
ATC code B01AF01

Mechanism of action

Coagulation factor X inhibitor

Primary target: Coagulation factor X

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved
NMPA clinical trials

Pipeline programs

  1. D9604C00001 Phase 3 · AstraZeneca · Reversal of anticoagulation effect in patients on a FXa inhi
  2. DSC/08/2357/32 Phase 3 · ITALFARMACO S.P.A · JAK2V617F-positive high-risk Polycythemia Vera
  3. Rivaroxaban Phase 3 · Janssen Research & · Atrial Fibrillation
  4. Rivaroxaban (Xarelto, BAY59-7939) Phase 3 · Bayer HealthCare Animal · Prevention & Control
  5. Rivaroxaban (Xarelto, BAY59-7939) Phase 3 · Bayer HealthCare Animal · Venous Thromboembolism
  6. Rivaroxaban (Xarelto, BAY59-7939) Phase 3 · Bayer HealthCare Animal · Pulmonary Embolism
  7. Rivaroxaban 2.5 Mg Oral Tablet Phase 3 · George Institute for · Chronic Kidney Diseases
  8. Rivaroxaban 2.5 mg Phase 3 · Janssen Research & · Acute Coronary Syndrome

Related & competitor drugs

  1. apixaban Blood and blood forming organs (B01)
  2. berotralstat Blood and blood forming organs (B06)
  3. bivalirudin Blood and blood forming organs (B01)
  4. c1 inhibitor (human) Blood and blood forming organs (B06)
  5. clopidogrel Blood and blood forming organs (B01)
  6. dabigatran etexilate Blood and blood forming organs (B01)

Frequently asked questions

What is rivaroxaban?

rivaroxaban (APO-RIVAROXABAN) is a coagulation factor x inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for rivaroxaban?

APO-RIVAROXABAN is a marketed brand name for rivaroxaban. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of rivaroxaban?

rivaroxaban has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.