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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: 29 Nov 2019

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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

  • 19 Nov 2019 Boehringer Ingelheim completes a phase-III development in Venous thromboembolism (In adolescents, In children, In infants, Prevention) is ongoing in USA, Austria, Finland, Slovakia, Argentina, Brazil, Bulgaria, Czech Republic, Denmark, Germany, Greece, Hungary, Mexico, Russia, Sweden, Taiwan, Turkey, France, Lithuania, Spian, Switzerland, Ukraine, Thailand, Canada, Norway, Italy and Belgium (PO; Capsule, Liquid, Pellets) (NCT02197416) (EudraCT2014-000583-18)
  • 14 Nov 2019 Boehringer Ingelheim completes a phase IIb/III DIVERSITY trial in Venous Thromboembolism in US, Argentina, Austria, Belgium, Bulgaria, Brazil, Canada, Czech Republic, Denmark, Finland, France, Greece, Germany, Hungary, Israel, Italy, Lithuania, Norway, Mexico, Russia, Sweden, Slovakia, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine (NCT01895777) (EudraCT2013-002114-12)
  • 04 Sep 2019 Safety and efficacy data from the phase III RE-SPECT CVT® trial in Venous thromboembolism released by Boehringer Ingelheim
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