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Bosentan - Actelion

Drug Profile

Bosentan - Actelion

Alternative Names: Bosentan monohydrate; RO-470203; RO-470203-029; Tracleer

Latest Information Update: 14 Jan 2023

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At a glance

  • Originator Roche
  • Developer Actelion Pharmaceuticals; Erasmus MC
  • Class Anti-inflammatories; Anti-ischaemics; Antiasthmatics; Antihypertensives; Benzene derivatives; Foot disorder therapies; Heart failure therapies; Pyrimidines; Skin disorder therapies; Small molecules; Sulfonamides; Urologics
  • 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 - Systemic scleroderma; Skin ulcer; Idiopathic pulmonary fibrosis; Pulmonary arterial hypertension; Pulmonary hypertension
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Pulmonary arterial hypertension; Skin ulcer
  • Phase II Behcet's syndrome
  • No development reported Diabetic foot ulcer
  • Discontinued Asthma; Heart failure; Inflammatory bowel diseases; Ischaemic heart disorders; Kidney disorders; Malignant melanoma; Myocardial infarction; Pulmonary fibrosis; Reperfusion injury; Transplant rejection

Most Recent Events

  • 06 Sep 2017 Actelion expects to make the 32mg dosage option of bosentan (Tracleer®) available in USA by the fourth quarter of 2017
  • 06 Sep 2017 Registered for Pulmonary arterial hypertension (In children, In adolescents) (32mg) in USA (PO)
  • 16 Jun 2017 Actelion Pharmaceuticals has been acquired by Janssen Pharmaceuticals
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