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: 28 May 2025

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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

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

28 May 2025 No recent reports of development identified for phase-I development in Pulmonary-hypertension(In adolescents, In children, In infants) in Japan (PO, Tablet)
05 Mar 2025 Janssen Pharmaceutical completes a phase I trial in Pulmonary hypertension (In infants, In children, In adolescents) in Japan (PO) (NCT05167825)
26 Nov 2024 Launched for Pulmonary arterial hypertension (Combination therapy, In adolescents, In children) in Sweden, Spain, Portugal, Netherlands, Luxembourg, Italy, Ireland, Hungary, Germany, France, Finland, Denmark, Belgium, Austria, Iceland, Norway (PO)

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