Approximately 600 patients expected to be enrolled at clinical sites across the United States, Europe and South America

Global Phase 3 program, Rescue HF CS, builds upon four completed Phase 2 trials in which more than 340 patients received istaroxime

DURHAM, N.C., Sept. 9, 2026 /PRNewswire/ — Seismic Pharmaceuticals, a biotechnology company dedicated to advancing novel treatments for heart failure, today announced the commencement of its global Phase 3 clinical trial evaluating Istaroxime in patients with cardiogenic shock. The trial, entitled Rescue HF CS, will recruit patients from around the globe and is designed to become the first ever drug approved to treat the life threatening condition of Cardiogenic Shock. 

The approximately 600-patient study will be conducted at clinical sites across the United States, Europe and South America. The trial is designed to build upon the successful clinical results generated through four previously completed Phase 2 trials in which more than 340 patients received Istaroxime.  

Cardiogenic shock is a life-threatening condition that occurs when the heart is unable to pump enough blood to meet the body’s needs, resulting in inadequate blood flow and oxygen delivery to vital organs. It may occur as a complication of acute heart failure, a severe heart attack or other serious cardiac conditions. Despite advances in critical care and mechanical circulatory support, cardiogenic shock continues to be associated with high rates of complications and mortality, underscoring the urgent need for new therapeutic options. Furthermore, there are no currently FDA approved treatments for the condition. 

Istaroxime is a novel, first-in-class therapy being developed to improve cardiac function and hemodynamic stability in patients with cardiogenic shock. Unlike conventional inotropic therapies, Istaroxime has a unique dual mechanism of action designed to improve both systolic contraction and diastolic relaxation.

“The commencement of this global Phase 3 trial represents an important milestone for Seismic Pharmaceuticals and for the development of Istaroxime,” said Gad Cotter, CEO and Chairman of the Board. “Cardiogenic shock remains a life-threatening condition with a significant need for new treatment options. This study builds upon the clinical experience generated in more than 340 patients across four Phase 2 trials, and we look forward to working with investigators and clinical sites throughout the United States, Europe and South America to advance this program.”

The Phase 3 trial, Rescue HF CS, is expected to enroll approximately 600 patients with cardiogenic shock. Additional information regarding the trial’s design, eligibility criteria and participating clinical sites will be available at ClinicalTrials.gov and other applicable clinical-trial registries.

About Istaroxime

Istaroxime is a novel, first-in-class investigational therapy being developed for the treatment of cardiogenic shock and acute heart failure. Istaroxime is designed to improve cardiac function through a dual mechanism of action that increases myocardial contractility while supporting myocardial relaxation. More than 340 patients have received Istaroxime across four previously completed Phase 2 clinical trials.

About Seismic Pharmaceuticals

Seismic Pharmaceuticals is a biotechnology company dedicated to advancing novel treatments for heart failure. The company combines deep therapeutic expertise with a proven track record in acute heart failure drug development. Seismic Pharma’s founding portfolio of drug candidates was acquired from Windtree Therapeutics and is being advanced through clinical development with the support of a board of directors with extensive experience in successful heart-failure programs. The company is headquartered in Durham, North Carolina.

Media Contact

Gad Cotter
Seismic Pharmaceuticals
gadcotter@seismicrx.com 

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SOURCE Seismic Pharmaceuticals