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Macitentan - Actelion Pharmaceuticals

Drug Profile

Macitentan - Actelion Pharmaceuticals

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

Latest Information Update: 22 Jan 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

  • 16 Jan 2019 Actelion Pharmaceuticals receives complete response letter from the FDA for macitentan in Pulmonary hypertension
  • 16 Jan 2019 The label for OPSUMIT® carries a boxed warning for embryo-foetal toxicity
  • 08 Jan 2019 Phase-III clinical trials in Pulmonary hypertension in Japan (PO) (NCT03809650)
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