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ACCEL Lite: ZENITH Phase 3 Trial: Sotatercept in Pulmonary Arterial Hypertension With High Mortality Risk

May 20, 2025   |  Allen J. Taylor, MD, FACC; Marc Humbert, MD, PhD

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The ZENITH trial evaluated sotatercept, an activin signaling inhibitor, in patients with advanced pulmonary arterial hypertension (PAH) at high risk of death. Sotatercept met its primary endpoint—time to first morbidity or mortality event—prompting an independent data monitoring committee to recommend early trial termination and offer the drug to all participants.

In this interview, Drs. Allen J. Taylor and Marc Humbert discuss how ZENITH highlights sotatercept’s clinical benefit even in the sickest PAH patients, offering renewed hope for a disease long seen as unrelenting.

Related References:

  1. Humbert M, McLaughlin VV, Badesch DB, et al., for the ZENITH Trial Investigators. Sotatercept in Patients With Pulmonary Arterial Hypertension at High Risk for Death. N Engl J Med 2025;Mar 31:[Epub ahead of print].
  2. Hoeper MM, Badesch DB, Ghofrani HA, et al.; STELLAR Trial Investigators. Phase 3 trial of sotatercept for treatment of pulmonary arterial hypertension. N Engl J Med 2023;388:1478-90.
  3. Humbert M, McLaughlin V, Gibbs JSR, et al.; PULSAR Trial Investigators. Sotatercept for the treatment of pulmonary arterial hypertension. N Engl J Med 2021;384:1204-15.
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Clinical Topics: Heart Failure and Cardiomyopathies, Pulmonary Hypertension and Venous Thromboembolism, Pulmonary Hypertension, Vascular Medicine

Keywords: ACCELLite, Pulmonary Arterial Hypertension, ACC25, ACC25