HY-074

HY-074 is a small molecule drug being developed by Hyloris Pharmaceuticals as an intravenous (IV) formulation of a current standard-of-care oral antiplatelet treatment for the management of acute coronary syndrome (ACS). Developed via the 505(b)(2) regulatory pathway, HY-074 is designed to provide a faster onset of action, which is critical for reducing the risk of morbidity and mortality during emergency cardiac events such as myocardial infarction. The IV administration offers significant advantages for patients who are nauseated, unconscious, or otherwise unable to swallow oral medications, while also providing clinicians with better dosage control. Hyloris completed formulation development and all non-clinical studies in 2023, and the FDA has confirmed the development path for the proposed formulation. A pivotal pharmacokinetic (PK) bridging trial is planned to commence in late 2025. The product is protected by patent applications filed through the Patent Cooperation Treaty (PCT), with potential protection extending into 2043 and 2044.