FDA Reviews CeleCor Heart Attack Drug Zalunfiban

The regulatory milestone follows the completion of the multinational CeleBrate study, which concluded that early administration of the drug at the first point of medical contact effectively lowers the risk of cardiovascular events. Results from the trial were presented at the American Heart Association Scientific Sessions in late 2025 and subsequently appeared in The New England Journal of Medicine Evidence.

Zalunfiban targets the platelet GPIIb/IIIa receptor to rapidly clear blocked coronary arteries, a procedure critical for preventing irreversible cardiac damage. While CeleCor Therapeutics aims to bring this treatment to market, the agent is not yet approved for any use, and its final safety profile remains subject to the FDA’s ongoing review process.