The US Food and Drug Administration (US FDA) has accepted CeleCor Therapeutics’ New Drug Application (NDA) for zalunfiban (Disaggpro), an investigational treatment for ST-segment elevation myocardial infarction (STEMI) heart attacks.
The agency has also assigned a target action date of June 18, 2027, under the Prescription Drug User Fee Act (PDUFA).
Zalunfiban is a subcutaneously injected inhibitor of the platelet glycoprotein (GP) IIb/IIIa receptor being developed for rapid pre-hospital treatment of STEMI heart attacks.
CeleCor completed its NDA submission on June 24, following the presentation of positive Phase 3 results from the multinational CeleBrate study at the American Heart Association Scientific Sessions in November 2025. The results were also published in The New England Journal of Medicine Evidence.
According to the company, the CeleBrate study found that administering zalunfiban at the first point of medical contact reduced the risk of cardiovascular events over the 30 days following treatment in patients with STEMI.
“We look forward to working with the FDA as we seek approval for zalunfiban,” said Rob Hillman, president and CEO of CeleCor.
According to CeleCor, STEMI is the most severe form of heart attack and typically occurs when a blood clot blocks blood flow to part of the heart. The company estimates that STEMIs account for about 40 per cent of heart attacks.
The priority in treating STEMI is to open the coronary artery as quickly as possible to limit the risk of death and irreversible heart-muscle damage.
While advances in in-hospital care have improved outcomes for heart attack patients, CeleCor said there remains an unmet need for rapid treatment before patients reach the hospital. With zalunfiban, the company aims to address this time-to-treatment gap, potentially enabling rapid heart attack treatment across multiple pre-PCI settings.
CeleCor said zalunfiban begins acting within 15 minutes, while its antiplatelet effects diminish within less than two hours. According to the company, the relatively short duration of action could reduce the risk of bleeding and allow for rapid cardiac surgery if needed.
The company also said that, unlike commonly used platelet inhibitors that target specific platelet activation pathways, zalunfiban inhibits platelet aggregation induced by multiple platelet activators, including thrombin, thromboxane and adenosine diphosphate (ADP).
Zalunfiban has been designed for administration by medical first responders and emergency department staff through a subcutaneous injection.
The company added that the drug can also minimise the risk of thrombocytopenia, a rare but potentially serious adverse effect associated with some other GPIIb/IIIa inhibitors.
The FDA acceptance of the NDA means the application has been accepted for review; it does not indicate that the agency has approved zalunfiban. The final regulatory decision is expected by the June 18, 2027 PDUFA target date.
