Macitentan - Actelion Pharmaceuticals
Alternative Names: ACT-064992; Actelion-1; JNJ-67896062-AAA; JNJ-67896062-AAA-G004; OPSUMIT; Opsumit; ZependoLatest Information Update: 03 Jun 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
- 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- 29 May 2024 Actelion terminates withdrawn prior to enrollment phase I trial in Pulmonary arterial hypertension in Germany and Poland (PO) due to sponsor decision (NCT05731492)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)