CureGene administers first patient in pivotal US trial of antiplatelet Evategrel

USA—CureGene Pharmaceutical has announced that the first participant has been dosed in the company’s pivotal U.S. clinical trial evaluating Evategrel (CG-0255), a next-generation antiplatelet therapy designed to prevent blood clot formation in patients with cardiovascular and cerebrovascular diseases.

The milestone marks an important step in CureGene’s efforts to secure U.S. regulatory approval for the drug and expands the company’s global development program for a treatment that could address several limitations associated with currently available antiplatelet medicines.

Novel approach to antiplatelet treatment

Evategrel is the lead candidate developed through CureGene’s proprietary A-proX™ Prodrug Platform.

The therapy is the first P2Y12 receptor inhibitor available in both intravenous and oral formulations, giving physicians flexibility across emergency and long-term treatment settings.

Unlike conventional therapies that rely on the CYP450 enzyme system for activation, Evategrel uses a thiol-hydrolyzing prodrug design and is activated by hydrolases that are widely distributed throughout the body.

By bypassing the CYP450 pathway, the drug aims to overcome several well-known challenges associated with existing antiplatelet therapies, including delayed onset of action, variable patient responses, drug-drug interactions, and resistance to treatment.

According to the company, clopidogrel resistance affects a significant proportion of patients, particularly among East Asian populations, creating a need for more reliable treatment options.

Previous studies have shown that Evategrel produces rapid and consistent platelet inhibition while maintaining a favorable safety profile.

U.S. registrational study underway

The ongoing U.S. registrational trial will compare Evategrel, administered as both an injection and an oral capsule, with clopidogrel.

Researchers will assess the drug’s efficacy and safety in patients with acute coronary syndrome (ACS), recent myocardial infarction, ischemic stroke, and peripheral arterial disease.

Data generated from the study are expected to support future regulatory submissions in the United States and other international markets.

Clinical findings from earlier studies suggest that Evategrel offers a rapid onset of action, with peak antiplatelet activity occurring in less than 15 minutes following intravenous administration and within 30 minutes after oral dosing.

Such speed could prove particularly valuable in emergency situations, including acute ischemic stroke and heart attack management.

The company also reported that Evategrel achieves strong antiplatelet effects at doses substantially lower than those required for clopidogrel, potentially reducing medication burden while maintaining efficacy.

In addition, clinical studies have indicated low bleeding risk, limited drug-drug interactions, and broad suitability for elderly patients and individuals managing multiple chronic conditions.

Expanding development in China and abroad

Commenting on the development, Dr. Gongxin He, Founder and Chief Executive Officer of CureGene Pharmaceutical, described the first patient dosing as a major milestone in the company’s global drug development strategy.

He noted that cardiovascular and cerebrovascular diseases remain the leading causes of death and disability worldwide, while current treatment options continue to leave important unmet medical needs.

He added that Evategrel’s novel mechanism and dual-formulation design could significantly improve antiplatelet treatment across a wide range of clinical settings.

Alongside its U.S. program, CureGene continues to advance Evategrel in China.

The company recently received regulatory clearance from China’s National Medical Products Administration to initiate a clinical study of the drug in patients with ischemic stroke, further expanding its development program.

The broader pipeline expansion follows a strong period of corporate growth for CureGene.

Earlier this year, the company completed a Series C financing round worth more than RMB 300 million (US$41.8 million), with proceeds earmarked for accelerating the global clinical development of its cardiovascular, metabolic, and antiviral drug candidates.

CureGene said the synchronized development of Evategrel in both China and the United States is expected to support future regulatory submissions in multiple markets and strengthen the company’s position in the global cardiovascular therapeutics sector.