en.Wedoany.com Reported - CureGene Pharmaceutical announced that its self-developed antiplatelet drug Evategrel (CG-0255) has completed first patient dosing in a pivotal clinical trial in the United States, marking a significant milestone in advancing the drug toward a New Drug Application in the U.S.
Evategrel (CG-0255) is a P2Y12 receptor inhibitor developed based on CureGene's proprietary A-proX prodrug platform, and is the world's first drug of its class available in both intravenous and oral formulations. Its innovation lies in the thiol hydrolysis prodrug design, which is metabolically activated by widely distributed hydrolases in human tissues, completely bypassing the CYP450 enzyme pathway. This mechanism addresses clinical issues such as clopidogrel resistance (affecting nearly 60% of East Asian patients), slow onset of action, high inter-individual variability, and risks of drug-drug interactions.
The ongoing U.S. registration trial aims to evaluate the efficacy and safety of Evategrel (injectable and oral capsule forms) compared with clopidogrel in subjects with indications including acute coronary syndrome (ACS), recent myocardial infarction, ischemic stroke, and peripheral artery disease. Previous clinical data show that the time to peak antiplatelet effect is less than 15 minutes after intravenous administration and less than 30 minutes after oral administration; the clinical dose of Evategrel is only 1% of the standard dose of clopidogrel; clinical data confirm good tolerability, low bleeding risk, and few drug-drug interactions.
Dr. Gongxin He, founder and CEO of CureGene Pharmaceutical, stated that cardiovascular and cerebrovascular diseases remain the leading cause of death and disability worldwide, with unmet needs in existing treatments. Evategrel is expected to change the landscape of antiplatelet therapy through its novel mechanism of action and dual-formulation advantages.
In addition to the U.S., Evategrel has received clinical trial approval from the Center for Drug Evaluation (CDE) in China, and a Phase II trial for ischemic stroke is about to be initiated. Concurrent development in China and the U.S. lays the foundation for future New Drug Applications. The drug is currently in late-stage clinical development and is expected to be approved for marketing as early as 2027.
Evategrel (CG-0255) is a next-generation antiplatelet drug independently developed by CureGene, designed using thiol hydrolysis prodrug technology, with a molecular structure that directly releases the active metabolite through a single hydrolysis step. Its intravenous formulation aims to fill a clinical gap in emergency treatments for conditions such as stroke and myocardial infarction. Founded in 2018, CureGene Pharmaceutical focuses on cardiovascular and cerebrovascular diseases and antiviral therapies, with proprietary core platform technologies and a pipeline of multiple innovative drugs.
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