Dabigatran etexilate

Drug Profile

Dabigatran etexilate

Alternative Names: BIBR 953; BIBR 953 ZW; BIBR-1048; BIBR-1048MS; Dabigatran; Dabigatran etexilate mesilate; Dabigatran etexilate mesylate; Pradax; Pradaxa; Pradaxar; Prazaxa

Latest Information Update: 28 Mar 2017

Price : $50

At a glance

  • Originator Boehringer Ingelheim
  • Class Anticoagulants; Antithrombotics; Benzimidazoles; Pyridines; Small molecules
  • Mechanism of Action Thrombin 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Deep vein thrombosis; Embolism; Pulmonary embolism; Stroke; Venous thromboembolism
  • Discontinued Acute coronary syndromes

Most Recent Events

  • 06 Mar 2017 Boehringer Ingelheim plans a phase I trial in Healthy volunteers in Japan (NCT03070171)
  • 06 Feb 2017 Boehringer Ingelheim completes a phase III trial in Stroke (Combination therapy, Prevention) in USA, Argentina, Australia, Austria, Brazil, Belgium, Bulgaria, Chile, Colombia, Croatia, Czech Republic, El Salvador, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Russia, Slovakia, Singapore, Slovenia, Taiwan, Thailand, Turkey, United Kingdom, Canada, Sweden, Spain, Denmark, Portugal, Finland, South Korea and Hong Kong (CTRI2015-05-005794)
  • 06 Dec 2016 Pharmacokinetics and adverse event data from a phase II trial in Venous thromboembolism presented at the 58th Annual Meeting and Exposition of the American Society of Haematology (ASH-2016)
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