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Macitentan - Actelion Pharmaceuticals

Drug Profile

Macitentan - Actelion Pharmaceuticals

Alternative Names: ACT-064992; Actelion-1; JNJ-67896062-AAA; JNJ-67896062-AAA-G004; OPSUMIT; Opsumit; Zependo

Latest Information Update: 03 Jun 2024

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At a glance

  • Originator Actelion Pharmaceuticals
  • Developer Actelion Pharmaceuticals; Johnson & Johnson Innovative Medicine; Nippon Shinyaku
  • Class Antifibrotics; Antihypertensives; Antineoplastics; Bromobenzenes; Cardiovascular therapies; Heart failure 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

  • 29 May 2024 Actelion terminates withdrawn prior to enrollment phase I trial in Pulmonary arterial hypertension in Germany and Poland (PO) due to sponsor decision (NCT05731492)
  • 27 Dec 2023 Actelion completes the phase III UMBRELLA trial in Pulmonary arterial hypertension (Treatment experienced, In adults, In the elderly) in Belarus, Belgium, France, Poland, Russia, Turkey, Ukraine (PO,Tablet) (NCT03422328) (EudraCT2017-003934-10)
  • 17 Oct 2023 Preregistration for Pulmonary arterial hypertension (In children) in European Union (PO)
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