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Macitentan - Johnson & Johnson Innovative Medicine

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Drug Profile

Macitentan - Johnson & Johnson Innovative Medicine

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

Latest Information Update: 01 Aug 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
  • Phase III Eisenmenger complex; Pulmonary hypertension
  • Phase II Heart failure
  • Discontinued Congenital heart defects; Glioblastoma; Idiopathic pulmonary fibrosis; Portal hypertension; Skin ulcer

Most Recent Events

  • 25 Jul 2024 Discontinued - Clinical-Phase-Unknown for Portal hypertension in France, Czech Republic, Brazil, Germany, Spain, United Kingdom, USA (PO) prior to July 2024 (Johnson & Johnson pipeline, July 2024)
  • 25 Jul 2024 Discontinued - Phase-III for Congenital heart defects (In adolescents, In children, In the elderly, In adults) in Taiwan, Poland, Czech Republic, Canada, United Kingdom, New Zealand, France, China, Australia, Denmark, Denmark, Germany, USA (PO) prior to July 2024 (Johnson & Johnson pipeline, July 2024)
  • 25 Jul 2024 CHMP recommends approval of macitentan for Pulmonary arterial hypertension (In adolescents, In Children) in the European Union

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