FDA Accepts New Drug Application for CeleCor's Investigational Heart Attack Drug

The U.S. Food and Drug Administration (FDA) has accepted CeleCor Therapeutics' New Drug Application (NDA) for zalunfiban, an investigational drug for heart attack treatment. The agency has assigned a target action date of June 18, 2027, under the Prescription Drug User Fee Act (PDUFA).

Zalunfiban is designed as a subcutaneously injected inhibitor of the platelet GPIIb/IIIa receptor. It aims to treat patients experiencing ST-segment elevation myocardial infarction (STEMI), the most severe type of heart attack, where rapid restoration of blood flow is critical to prevent mortality and irreversible damage.

CeleCor announced the completion of its NDA submission on June 24, 2026. This follows the presentation of positive Phase 3 results from its CeleBrate study in November 2025 at the American Heart Association Scientific Sessions, with simultaneous publication in The New England Journal of Medicine Evidence.

The multinational CeleBrate study found that rapid treatment with zalunfiban at the first point of medical contact for STEMI patients reduced the risk of cardiovascular events within 30 days post-treatment. Zalunfiban is currently an investigational agent, and its safety and efficacy have not yet been established.

Zalunfiban is a novel small-molecule inhibitor of the platelet GPIIb/IIIa receptor, specifically developed for subcutaneous administration in STEMI patients. CeleCor Therapeutics was founded with the goal of improving heart attack treatment at the initial medical contact.