Macitentan - Johnson & Johnson Innovative Medicine
Alternative Names: ACT-064992; Actelion-1; JNJ-67896062; JNJ-67896062-AAA; JNJ-67896062-AAA-G004; OPSUMIT; Opsumit; ZependoLatest Information Update: 01 Aug 2024
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
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- 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