Jiangsu Vcare Completes Enrollment in Phase III Clinical Trial of Antiplatelet Drug Vicagrel in China

　　Recently, Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) announced the completion of patient enrollment for its self-developed Class 1 innovative antiplatelet drug, Vicagrel Capsules, in a Phase III clinical trial conducted in China. This study evaluates the efficacy and safety of Vicagrel compared to Clopidogrel in patients with acute coronary syndrome (ACS). The milestone marks a critical step toward Vicagrel’s potential market approval.

　　This study is a multicenter, randomized, double-blind, double-dummy, parallel-controlled Phase III clinical trial conducted in patients with acute coronary syndrome (ACS) scheduled to undergo percutaneous coronary intervention (PCI). The primary efficacy endpoints include the incidence of MACE at 1, 6, and 12 months post-treatment. Interim blinded data analysis indicates favorable efficacy and safety profiles at this stage.

　　Vicagrel, a novel oral P2Y12 receptor antagonist, belongs to the antiplatelet drug class. It is designed to treat and prevent atherosclerotic thrombotic events, such as ACS, ischemic stroke, and peripheral arterial disease while addressing clinical challenges like "Clopidogrel resistance." Developed through an industry-academia collaboration between Jiangsu Vcare and China Pharmaceutical University, Vicagrel Capsules is a Class 1 innovative chemical drug, with full intellectual property rights held by Jiangsu Vcare.

　　About Vicagrel

　　Vicagrel is Jiangsu Vcare’s most representative achievement under its philosophy of "addressing unmet clinical needs through differentiation." The drug’s design aims to resolve Clopidogrel’s black box warning related to resistance while retaining its active metabolites, thereby achieving a more balanced approach to managing the dual challenges of efficacy and safety in antiplatelet therapy. Having undergone a comprehensive series of clinical studies—including Phase I, Phase II, PK/PD bridging studies, and Phase III trials—from healthy volunteers to patient populations, Vicagrel demonstrates the following four core advantages over existing therapies:

　　1. Enhanced Stability by Addressing CYP2C19 Polymorphism Effects

　　Vicagrel achieves more stable therapeutic efficacy by mitigating the impact of CYP2C19 genetic polymorphism that affects Clopidogrel. Its key activation step occurs via intestinal esterases, bypassing Clopidogrel’s strong dependence on hepatic CYP2C19 metabolism. Critical clinical studies demonstrate that Vicagrel overcomes "clopidogrel resistance" caused by loss-of-function (LOF) alleles(CYP2C19*2 and *3, prevalent in >55% of East Asians), offering stable antiplatelet effects for resistant populations. Concurrently, Vicagrel reduces the risk of excessive platelet inhibition associated with gain-of-function alleles (CYP2C19*17, 24–32% in Caucasians), and is thus expected to alleviate the high bleeding risk problem brought about by the excessive efficacy of Clopidogrel.

　　2. Equivalent Efficacy with Controlled Bleeding Risk in Normal Metabolizers

　　In CYP2C19*1 wild-type (normal metabolizer) populations, Clopidogrel exhibits moderate antiplatelet activity and superior bleeding risk control compared to other drugs. Vicagrel matches Clopidogrel’s antiplatelet efficacy in these populations while retaining its safety profile. Due to its metabolic stability across CYP2C19 phenotypes, Vicagrel is particularly suitable for high-bleeding-risk patients, especially elderly individuals (≥65 years, estimated 30–40% prevalence) with dual ischemic/bleeding risks.

　　3. Optimized Metabolism: Lower Dose, Faster Onset, and Reduced Drug-Drug Interactions (DDIs)

　　Vicagrel’s first-pass intestinal esterase activation avoids Clopidogrel’s 85% hepatic metabolic inefficiency, resulting in: ①Dose efficiency: Achieves equivalent efficacy at <1/12th of Clopidogrel’s dose. ②Rapid onset: Esterase-driven hydrolysis enables faster action, ideal for emergency care. ③DDI mitigation: Eliminates Clopidogrel’s CYP2C8 inhibition (e.g., contraindication with repaglinide), addressing polypharmacy needs in comorbid patients.

　　4. Reliable Metabolic Profile with No Novel Metabolites

　　Vicagrel is fully hydrolyzed to intermediate M1via intestinal esterases, ultimately generating the same active metabolite (M15-2) as Clopidogrel. Its metabolic profile fully overlaps with Clopidogrel’s while reducing inactive metabolites. Crucially, no parent drug or exogenous metabolites are detected in systemic circulation, ensuring safety continuity with Clopidogrel’s established profile while retaining clinical advantages as a next-generation drug.

　　By optimizing Clopidogrel’s metabolic pathway without altering its active metabolite, Vicagrel delivers stable efficacy, controllable bleeding risks, and Best-in-Class potential. It is poised to address personalized antiplatelet therapy demands and emerge as a blockbuster in the market.