Rivaroxaban

Drug Profile

Rivaroxaban

Alternative Names: BAY-59-7939; JNJ-39039039; Xarelto

Latest Information Update: 22 Sep 2017

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At a glance

  • Originator Bayer; Johnson & Johnson Pharmaceutical Research & Development
  • Developer Bayer; Janssen Research & Development; Johnson & Johnson; McMaster University; Population Health Research Institute
  • Class Amides; Anticoagulants; Antithrombotics; Morpholines; Oxazolidinones; Small molecules; Thiophenes
  • Mechanism of Action Factor IXa inhibitors; Factor Xa inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Embolism; Stroke; Venous thromboembolism
  • Registered Acute coronary syndromes; Deep vein thrombosis; Pulmonary embolism
  • Phase III Atrial fibrillation; Cardiovascular disorders; Peripheral arterial disorders; Thromboembolism; Thrombosis
  • Phase II Coronary thrombosis

Most Recent Events

  • 17 Sep 2017 Bayer and Janssen Research & Development plans a observational XaMINA trial for Stroke (Prevention) in atrial fibrillation in South Korea and Taiwan in September 2017 (NCT03284762)
  • 15 Sep 2017 Committee for Medicinal Products for Human Use recommends approval of label update of rivaroxaban 10 mg for Venous thromboembolism (Prevention) in European Union
  • 15 Sep 2017 EMA's European Commission final decision for label update of oral rivaroxaban 10 mg once daily dose for the extended prevention of recurrent venous thromboembolism anticipated by November 2017
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