Matisse Pharmaceuticals receives FDA Fast Track Designation for isupartob sodium in sepsis

Geleen, June 9, 2026

Matisse Pharmaceuticals B.V., a clinical stage company developing a medicinal product for the treatment of sepsis, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its lead compound isupartob sodium. The news follows Matisse’s announcement of IND clearance of isupartob on May 19th.  

“The FDA’s grant of Fast Track Designation recognizes the substantial unmet medical need in sepsis and provides an important external validation that our currently available data show the potential to target that need. Fast Track may facilitate a more efficient development pathway for isupartob sodium,” said Marcel Jacobs, Chief Executive Officer of Matisse Pharmaceuticals. “This designation reinforces our commitment to advancing isupartob for patients with limited therapeutic options and may enhance opportunities for more frequent FDA interaction during development.”

Fast Track Designation
Fast Track Designation is granted to therapies that address serious conditions and significant unmet medical needs and is intended to accelerate development and regulatory review. The purpose is to get important new drugs to the patient earlier. Benefits of Fast Track Designation include increased interaction with the FDA, eligibility for rolling submission of regulatory filings & potential eligibility for Priority Review and Accelerated Approval.

Unmet Medical Need
Sepsis remains one of the most significant unmet medical needs in critical care medicine. The condition affects approximately 49 million people worldwide each year and causes an estimated 11 million deaths annually. Despite decades of research, no targeted therapies have been successfully developed to address the dysregulated host response that drives organ failure and death in sepsis.

Mechanism of action
Isupartob is a novel therapeutic designed to neutralize extracellular histones, key mediators of endothelial injury, inflammation and organ failure in sepsis. By targeting this upstream mechanism in the inflammatory cascade, the therapy aims to reduce mortality and improve outcomes in critically ill patients.

About Matisse Pharmaceuticals
Matisse Pharmaceuticals B.V. was founded in 2014 in Geleen, the Netherlands. The company develops safe and innovative therapies for disease indications characterized by elevated levels of circulating cytotoxic histones, including sepsis.

Matisse’s lead compound isupartob is based on a specific discovery that in sepsis patients the innate immune system releases proteins knows as histones into the bloodstream. These histones are toxic to cell membranes leading to cell death and release of additional histones. The result is a self-enforcing cascade that drives organ failure. The highly negatively charged isupartob binds to these positively charged extracellular histones. It thereby inhibits the self-enforcing cascade, with the ultimate goal to prevent further organ damage and death.

About sepsis
According to the WHO, sepsis is one of the leading causes of death worldwide. Currently, there is no  treatment effective against sepsis approved by regulatory authorities. From the 49 million patients globally suffering from sepsis every year, more than 20% die. Approximately 40% of the sepsis cases are children under the age of 5, with close to 3 million children dying from sepsis each year. According to a study by Buchman et al. (2020), published in Critical Care Medicine, sepsis is the most common cause of in-hospital deaths, costing over $62 billion annually in the USA alone.  

For more information, please contact: 

Marcel Jacobs, CEO
(T) +31 6 575 27 541
(E) m.jacobs@matissepharmaceuticals.com
(W) www.matissepharmaceuticals.com

Attachments

• Product rendering
• 20260609 (NL) Matisse Pharmaceuticals ontvangt FT-status van de FDA