Drug Profile


Alternative Names: ACT-064992; Actelion-1; Opsumit; Zependo

Latest Information Update: 07 Dec 2017

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At a glance

  • Originator Actelion Pharmaceuticals
  • Developer Actelion Pharmaceuticals; Nippon Shinyaku
  • Class Antifibrotics; Antihypertensives; Antineoplastics; Bromobenzenes; Cardiovascular 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 Congenital heart defects; Eisenmenger complex
  • Phase II Heart failure
  • Clinical Phase Unknown Portal hypertension
  • Discontinued Glioblastoma; Idiopathic pulmonary fibrosis; Skin ulcer

Most Recent Events

  • 03 Nov 2017 Actelion initiates enrolment in a phase I trial for Healthy volunteers in Germany (NCT03359291)
  • 02 Oct 2017 Phase-III clinical trials in Congenital heart disorders (In children, In adolescents, In adults, In the elderly) in Denmark, Germany, USA (PO) (EudraCT2016-003320-23) (NCT03153137)
  • 21 Aug 2017 Phase-II clinical trials in Heart failure in Sweden, Russia, Romania, Poland, Israel, Germany, France, Denmark, Czech Republic, Bulgaria, USA, United Kingdom (PO), before August 2017 (NCT03153111)
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