Macitentan - Actelion Pharmaceuticals

Drug Profile

Macitentan - Actelion Pharmaceuticals

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

Latest Information Update: 12 Oct 2018

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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 arterial hypertension; Idiopathic pulmonary fibrosis; Pulmonary 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
  • Clinical Phase Unknown Portal hypertension
  • Discontinued Glioblastoma; Idiopathic pulmonary fibrosis; Skin ulcer

Most Recent Events

  • 19 Sep 2018 Actelion completes a phase III extension trial in Pulmonary hypertension in France, Italy, Spain (NCT02112487)
  • 20 Aug 2018 Actelion terminates the phase III MAESTRO-OL trial in Eisenmenger complex in the US, Austria, Belgium, Bulgaria, Canada, Chile, China, Czech Republic, France, Germany, Greece, Hungary, India, Israel, Italy, Malaysia, Mexico, Netherlands, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, South Africa, Spain, Taiwan, Turkey, United Kingdom and Vietnam (PO) (NCT01739400)
  • 24 Jun 2018 Biomarkers information updated
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