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A Multicenter, Open-label, Single-sequence Cross-over Study to Assess Safety, Tolerability, and Pharmacokinetics of Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension Switching From an Oral Stable Dose of Selexipag

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Trial Profile

A Multicenter, Open-label, Single-sequence Cross-over Study to Assess Safety, Tolerability, and Pharmacokinetics of Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension Switching From an Oral Stable Dose of Selexipag

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Feb 2024

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At a glance

  • Drugs Selexipag (Primary) ; Selexipag (Primary)
  • Indications Pulmonary arterial hypertension
  • Focus Adverse reactions
  • Acronyms UPTRAVI IV
  • Sponsors Actelion Pharmaceuticals

Most Recent Events

  • 30 Jul 2021 According to a Janssen Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has approved UPTRAVI (selexipag) injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients with WHO functional class (FC) II-III, who are temporarily unable to take oral therapy, based on data from this trial.
  • 30 Sep 2020 Results presented in a Johnson & Johnson Media Release.
  • 30 Sep 2020 According to a Johnson & Johnson media release, the company announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for UPTRAVI (selexipag) as an injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults with WHO functional class 2 to 3, who are currently prescribed oral UPTRAVI but are temporarily unable to take oral therapy. Based on data from this study.

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