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A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients

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Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 17 Feb 2026

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At a glance

  • Drugs Sotatercept (Primary)
  • Indications Pulmonary arterial hypertension
  • Focus Registrational; Therapeutic Use
  • Acronyms HYPERION
  • Sponsors Acceleron Pharma

Most Recent Events

  • 03 Feb 2026 According to a Merck & Co media release, the FDA accepted a new supplemental Biologics License Application (sBLA) for WINREVAIR (sotatercept-csrk), aiming to update the U.S. product label based on findings from the Phase 3 HYPERION trial. The FDA has set a PDUFA date of September 21, 2026, for this, marking a potential further expansion of the PAH therapy's label.
  • 30 Sep 2025 Results presented in a Merck Sharp & Dohme media release.
  • 30 Sep 2025 According to a Merck & Co media release, results from the study were presented at the 2025 European Respiratory Society (ERS) Congress and simultaneously published in the New England Journal of Medicine.

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