SHANGHAI – November 08, 2026 -- CureGene Pharmaceutical reported that its investigational P2Y12 antagonist Evategrel (CG-0255) produced comparable pharmacokinetics and platelet inhibition in Chinese and US healthy volunteers, clearing a key hurdle for running global trials in parallel. The data were presented as a poster at the American Heart Association (AHA) Scientific Sessions 2026 in Chicago, held November 6-9.
Two clinical pharmacology studies test ethnic and food effects on oral Evategrel
One study compared oral Evategrel pharmacokinetics (PK) and pharmacodynamics (PD) in Chinese and US participants. The second examined how food affects exposure to the oral formulation and its antiplatelet effect. Both used the same design, with one run in the United States and one in China.
Oral Evategrel was absorbed and cleared quickly. At matched doses, plasma concentrations and platelet inhibition followed the same course in both populations, and inhibition rose with dose rather than differing by ethnicity.
Food delays Evategrel's peak concentration but leaves total exposure unchanged
On an empty stomach, the drug was absorbed faster and peaked sooner. After a meal, the peak came later and lower. Total exposure and the degree of platelet inhibition were about the same in both conditions.
CureGene attributes this to the mechanism: the active metabolite H4 binds covalently and irreversibly to the P2Y12 receptor, so cumulative H4 matters more than momentary peak concentration. Maintenance patients therefore need not schedule doses around meals, while a fasting dose gives faster onset. Oral dosing produces clear platelet inhibition within about 30 minutes.
Thiol prodrug design bypasses CYP450 and CYP2C19 dependence
Clopidogrel is an inactive compound that the liver must oxidise through several CYP450 steps before H4 forms. Onset therefore usually takes hours, and patients carrying loss-of-function CYP2C19 variants respond poorly or not at all. Evategrel is a thiol prodrug: a single carboxylesterase-mediated hydrolysis step releases the same H4, with no CYP450 oxidation. CureGene says this makes response more consistent between patients.
Intravenous form targets stroke patients who cannot swallow
Roughly 40% of stroke patients arrive unable to swallow, and the source states no injectable P2Y12 option exists for them. CureGene is developing Evategrel in both oral and intravenous forms; the intravenous version is intended for the acute phase of ischaemic stroke. The company says that, to its knowledge, Evategrel is the first P2Y12 antagonist built on a thiol prodrug design and the only one in development in both forms. Intended indications match clopidogrel's: myocardial infarction and stroke.
US registration trial is running; China trials to start shortly
Evategrel comes from CureGene's proprietary A-proX prodrug platform. A registration trial is under way in the United States, and registration trials in China are due to begin shortly. The drug has not been approved by any regulatory authority, and its safety and efficacy are still being studied.