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Macitentan/tadalafil - Actelion Pharmaceuticals

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Drug Profile

Macitentan/tadalafil - Actelion Pharmaceuticals

Alternative Names: ACT 064992D; OPSYNVI; Tadalafil /Macitentan-Actelion; Yuvanci

Latest Information Update: 27 Dec 2024

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At a glance

  • Originator Actelion Pharmaceuticals
  • Developer Actelion Pharmaceuticals; Nippon Shinyaku
  • Class Antifibrotics; Antihypertensives; Antineoplastics; Benzodioxoles; Bromobenzenes; Carbolines; Cardiovascular therapies; Erectile dysfunction therapies; Indoles; Pyrimidines; Skin disorder therapies; Small molecules; Sulfonamides
  • Mechanism of Action Endothelin A receptor antagonists; Endothelin B receptor antagonists; Type 5 cyclic nucleotide phosphodiesterase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Pulmonary arterial hypertension
  • Phase III Pulmonary hypertension

Most Recent Events

  • 20 Nov 2024 Launched for Pulmonary arterial hypertension in Japan (PO)
  • 30 Sep 2024 Registered for Pulmonary arterial hypertension (Treatment-experienced) in European Union, Iceland, Norway and Liechtenstein (PO)
  • 27 Sep 2024 Actelion completes the phase III A DUE trial in Pulmonary arterial hypertension in USA, Germany, Australia, Brazil, Bulgaria, Canada, Czech Republic, China, Hungary, Italy, Japan, Malaysia, Mexico, Russia, Poland, South Africa, Spain, Taiwan, Turkey (PO) (NCT03904693)(EudraCT2014-004786-25)

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