Dabigatran etexilate - Boehringer Ingelheim

Drug Profile

Dabigatran etexilate - Boehringer Ingelheim

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

Latest Information Update: 21 Sep 2018

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At a glance

  • Originator Boehringer Ingelheim
  • Developer Boehringer Ingelheim; Population Health Research Institute
  • 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.

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Deep vein thrombosis; Embolism; Pulmonary embolism; Stroke; Venous thromboembolism
  • Phase III Cardiomyopathies; Cardiovascular disorders; Gastrointestinal haemorrhage; Vascular disorders
  • Discontinued Acute coronary syndromes

Most Recent Events

  • 21 Sep 2018 3346435 - Updated KDM and TT section; clinical HE
  • 25 Aug 2018 Subgroup analysis efficacy data from the phase III RE-DUAL PCI trial in Stroke presented at the Annual Congress of the European Society of Cardiology 2018 (ESC-CARD 2018)
  • 14 Aug 2018 Boehringer Ingelheim completes the RE-SPECT ESUS phase III trial for Stroke (Prevention) in USA, Chile, Australia, Austria, Belgium, Canada, Croatia, Germany, Hong Kong, Hungary, Italy, New Zealand, Portugal, Singapore, Spain, South Korea, Sweden, Slovenia, Argentina, Brazil, China, Colombia, Czech Republic, Estonia, France, Greece, India, Israel, Japan, Malaysia, Mexico, New Zealand, Peru, Poland, Russia, Serbia, Slovakia, South Africa, Switzerland, Taiwan, Turkey, Thailand, and Ukraine (NCT02239120)
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