Del Mar, California-based CeleCor Therapeutics has completed submission of a New Drug Application (NDA) to the US FDA for Disaggpro (zalunfiban), an investigational subcutaneous antiplatelet agent designed for use at the first point of medical contact in patients with ST-segment elevation myocardial infarction (STEMI). The filing marks the first regulatory submission for zalunfiban anywhere in the world and positions the drug as a potential first approved antiplatelet therapy specifically engineered for pre-hospital or emergency department administration in the most severe form of heart attack.
The NDA was submitted on a rolling basis after the FDA granted zalunfiban Rolling Review in January 2026, allowing completed sections to be filed incrementally rather than as a single package, the company said. Zalunfiban also holds FDA Fast Track status, reflecting the agency's assessment that the drug addresses an unmet need in a serious condition. CeleCor did not disclose whether priority review has been requested or announce a Prescription Drug User Fee Act target action date, as that milestone follows formal FDA acceptance of the application. The filing seeks approval for a single subcutaneous injection of zalunfiban administered to STEMI patients before they reach a cardiac catheterization laboratory.
The NDA is supported by data from the CeleBrate study, a pivotal Phase III prospective, double-blinded, randomized, placebo-controlled multinational trial. The study enrolled 2,467 patients at 45 sites across the United States, Canada, Mexico, and Europe. Eligible STEMI patients were enrolled at home, in the ambulance, or in a hospital emergency department — reflecting the drug's intended use profile across multiple pre-hospital settings. The trial's primary efficacy endpoint was based on a seven-point clinical scale, and the primary safety endpoint assessed bleeding. CeleCor reported that the CeleBrate study met both its primary efficacy and primary safety outcomes, with topline data first disclosed in September 2025 and full results presented in November 2025 at the American Heart Association Scientific Sessions in New Orleans. The complete dataset was subsequently published in The New England Journal of Medicine Evidence. According to the company, rapid zalunfiban treatment for STEMI at first point of medical contact lowered the risk of more severe heart damage in combination with other serious heart attack complications.
Zalunfiban is a small-molecule inhibitor of the platelet glycoprotein IIb/IIIa (GPIIb/IIIa) receptor, a critical mediator of platelet aggregation and clot formation. It was specifically engineered for subcutaneous delivery using an auto-injector, allowing a full therapeutic dose to be contained in a volume of less than one milliliter. The drug reaches maximal antiplatelet effect within approximately 15 minutes and has a pharmacokinetic half-life of roughly one hour, with antiplatelet activity returning to baseline within approximately two hours. This pharmacokinetic profile was designed to allow frontline medical personnel — including paramedics and emergency department staff — to administer the drug rapidly upon STEMI diagnosis, while minimizing interference with subsequent in-hospital interventional procedures such as percutaneous coronary intervention or cardiac surgery.