Durham – September 15, 2026 -- Seismic Pharmaceuticals has commenced a global Phase 3 trial of Istaroxime, aiming to deliver the first-ever approved drug for cardiogenic shock, a condition with no currently FDA-approved treatments.
Trial to enroll 600 patients across three continents
The study, named Rescue HF CS, will recruit approximately 600 patients at clinical sites in the United States, Europe and South America. It builds on four completed Phase 2 trials in which more than 340 patients received Istaroxime.
Drug targets a condition with high mortality and no approved therapies
Cardiogenic shock occurs when the heart fails to pump sufficient blood to meet the body's needs, cutting off oxygen delivery to vital organs. It can result from acute heart failure, severe heart attacks, or other serious cardiac events, and continues to carry high complication and mortality rates despite advances in critical care and mechanical circulatory support.
Istaroxime employs a dual mechanism absent from existing inotropic drugs
Unlike conventional inotropic therapies, Istaroxime is designed to improve both systolic contraction and diastolic relaxation simultaneously, targeting cardiac function and hemodynamic stability in cardiogenic shock patients.
CEO Gad Cotter frames trial launch as pivotal milestone
Gad Cotter, CEO and Chairman of the Board at Seismic Pharmaceuticals, said the trial launch marks an important milestone for the company and for Istaroxime's development, noting that cardiogenic shock remains a life-threatening condition lacking new treatment options.
Additional details on the trial's design, eligibility criteria and participating clinical sites will be posted on ClinicalTrials.gov and other clinical-trial registries.