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A Phase 3 Open-label Extension (OLE) Study to Evaluate the Long-term Safety and Efficacy of Ralinepag in Subjects With World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH)

Trial Profile

A Phase 3 Open-label Extension (OLE) Study to Evaluate the Long-term Safety and Efficacy of Ralinepag in Subjects With World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 24 Apr 2025

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At a glance

  • Drugs Ralinepag (Primary)
  • Indications Pulmonary arterial hypertension
  • Focus Adverse reactions
  • Acronyms ADVANCE EXTENSION
  • Sponsors Arena Pharmaceuticals; Pfizer; United Therapeutics Corporation

Most Recent Events

  • 21 Apr 2025 According to United Therapeutics media release, Interim long-term data from the ongoing ralinepag phase 3 ADVANCE EXTENSION open-label study to be presented at American Thoracic Society (ATS) International Conference in San Francisco on May 16-21, 2025.
  • 03 Apr 2025 Planned End Date changed from 1 Sep 2024 to 1 Dec 2026.
  • 03 Apr 2025 Planned primary completion date changed from 1 Sep 2024 to 1 Dec 2026.

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