Rivaroxaban

Drug Profile

Rivaroxaban

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

Latest Information Update: 22 Mar 2017

Price : $50

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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    Acute coronary syndromes; Cardiovascular disorders
  • 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

  • 18 Mar 2017 Efficacy and adverse events data from the phase III EINSTEIN CHOICE trial in Venous thromboembolism released by Bayer and Janssen
  • 08 Feb 2017 Bayer terminates the COMPASS phase III trial in Major adverse cardiac events (Prevention) in USA, Canada, Argentina, Brazil, Chile, Colombia, Ecuador, Australia, South Africa, United kingdom, Ireland, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Slovakia, Sweden, Switzerland, Ukraine, Israel, Japan, China, South Korea, Malaysia, Philippines and Russia due to early positive results
  • 04 Jan 2017 Phase-I/II clinical trials in Thrombosis (In infants, In neonates) in Israel, France (PO) (NCT02564718)
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