CureGene Doses First Participant in U.S. Pivotal Trial of Evategrel, a Novel Dual-Formulation P2Y12 Inhibitor
Key Insights
CureGene has dosed the first participant in the U.S. pivotal clinical trial of Evategrel (search) (CG-0255), a next-generation antiplatelet agent, marking progress toward an NDA submission.
Evategrel (search) is the world's first P2Y12 receptor (search) inhibitor available in both intravenous and oral formulations, bypassing CYP450 metabolism to overcome clopidogrel resistance.
Previous clinical data show ultra-rapid onset (peak effect in under 15 minutes IV, under 30 minutes oral) and a clinical dose just 1% of clopidogrel's standard dose.
CureGene Pharmaceutical (search) announced on June 20, 2026 that the first participant has been dosed in the U.S. pivotal clinical trial of Evategrel (search) (CG-0255), the company's proprietary next-generation antiplatelet agent. The milestone represents a critical step toward a New Drug Application (NDA) submission in the United States and signals accelerating global commercialization efforts for a drug that could reshape antiplatelet therapy.
The U.S. registrational trial is designed to comprehensively evaluate the efficacy and safety of Evategrel (search) — available as both an injection and oral capsule — versus clopidogrel in subjects with targeted indications including acute coronary syndrome (search) (ACS), recent myocardial infarction (search), ischemic stroke (search), and peripheral arterial disease (search). Results from this trial will provide core clinical evidence for global regulatory submissions.
A Novel Mechanism Bypassing CYP450
Evategrel (search) is the leading asset developed from CureGene's proprietary A-proX™ Prodrug Platform and is described as the world's first P2Y12 receptor (search) inhibitor available in both intravenous and oral formulations. The drug employs an innovative thiol-hydrolyzing prodrug design: it is metabolized and activated by hydrolases — enzymes widely present in human tissues — completely bypassing the CYP450 enzyme pathway.
This mechanism directly addresses several long-standing clinical challenges associated with existing antiplatelet therapies. Clopidogrel resistance, which affects nearly 60% of East Asian patients, arises from CYP2C19 (search) metabolic enzyme deficiency. By circumventing CYP450 entirely, Evategrel (search) fundamentally overcomes this resistance. The design also mitigates slow onset of action, high inter-patient variability, and significant drug-drug interaction risks — representing what the company describes as a paradigm shift in antiplatelet therapy.
Three Key Clinical Advantages
Data from previous clinical studies have demonstrated three distinguishing features of Evategrel (search). First, the drug achieves ultra-rapid onset of action, with peak antiplatelet effect reached in under 15 minutes for the intravenous formulation and under 30 minutes for the oral formulation. This rapid inhibition of arterial thrombosis fills a critical gap in acute ischemic stroke (search) management where timely intervention is essential.
Second, Evategrel (search) demonstrates high potency at a remarkably low dose — the clinical dose is only 1% of clopidogrel's standard dose, which significantly reduces medication burden and potential safety risks.
Third, clinical data confirm a well-tolerated safety profile with low bleeding risk and minimal drug-drug interactions. The drug is considered highly suitable for elderly patients with multiple underlying comorbidities who are on combined medication regimens, offering what the company describes as outstanding clinical flexibility and convenience.
Executive Perspective
"The first participant dosing in our U.S. pivotal trial of Evategrel (search) is a major milestone in CureGene's journey of global innovative drug R&D," said Dr. Gongxin He, Founder and CEO of CureGene Pharmaceutical (search). "Cardiovascular and cerebrovascular diseases remain the leading cause of mortality and disability worldwide, and current treatment options have substantial unmet needs. With its novel mechanism of action and dual-formulation advantages, Evategrel is expected to reshape the global landscape of antiplatelet therapy."
Synchronized Global Development
Beyond the U.S. trial, Evategrel (search) is advancing in parallel in China. The company has received clinical trial approval from the Center for Drug Evaluation (CDE) of China, and a Phase II trial for ischemic stroke (search) is set to launch soon. This synchronized development strategy in both China and the U.S. is designed to support future simultaneous NDA filings and strengthen the company's position for global market access.
CureGene, founded in 2018, focuses on cardiovascular and cerebrovascular diseases as well as antiviral therapies. The company anticipates that Evategrel (search) could gain regulatory approval as early as 2027, positioning it as a potential best-in-class antiplatelet therapy covering full-spectrum clinical scenarios from emergency intervention to chronic management.