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Macitentan - Actelion Pharmaceuticals

Drug Profile

Macitentan - Actelion Pharmaceuticals

Alternative Names: ACT-064992; Actelion-1; OPSUMIT; Opsumit; Zependo

Latest Information Update: 24 Sep 2019

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At a glance

  • Originator Actelion Pharmaceuticals
  • Developer Actelion Pharmaceuticals; Nippon Shinyaku
  • Class Antifibrotics; Antihypertensives; Antineoplastics; Bromobenzenes; Cardiovascular therapies; Pyrimidines; Skin disorder therapies; Small molecules; Sulfonamides
  • Mechanism of Action Endothelin A receptor antagonists; Endothelin B receptor antagonists
  • Orphan Drug Status

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

    Yes - Pulmonary hypertension; Idiopathic pulmonary fibrosis; Pulmonary arterial hypertension
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Pulmonary arterial hypertension
  • Preregistration Pulmonary hypertension
  • Phase III Congenital heart defects; Eisenmenger complex
  • Phase II Heart failure
  • No development reported Portal hypertension
  • Discontinued Glioblastoma; Idiopathic pulmonary fibrosis; Skin ulcer

Most Recent Events

  • 17 May 2019 Efficacy and adverse events data from the phase III MERIT-2 trial in Pulmonary hypertension presented at the 115th International Conference of the American Thoracic Society (ATS-2019)
  • 17 May 2019 Pharmacokinetics and adverse events data from a phase I trial in Pulmonary arterial hypertension (In volunteers) presented at the 115th International Conference of the American Thoracic Society (ATS-2019)
  • 10 Apr 2019 Actelion initiates enrolment in the RUBATO OL phase III trial for Congenital heart defects (In adolescents, In adults, In children, In the elderly) in France and Denmark (NCT03775421) (EudraCT2018-002821-45)
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