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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: 19 Nov 2025

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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

  • 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.
  • 30 Sep 2025 According to a Merck & Co media release, today announced positive results from the phase 3 HYPERION trial in recently diagnosed adults with pulmonary arterial hypertension (PAH, WHO* Group 1) functional class (FC) II or III at intermediate or high risk of disease progression.

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