Pharma Focus Asia

Jiangsu Vcare Submits Non-Disclosure Agreement (NDA) for Vicagrel Capsules to US FDA

Friday, January 05, 2024

Jiangsu Vcare PharmaTech Co., Ltd. has achieved a significant milestone by successfully submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its innovative drug, Vicagrel capsule. This marks the company's inaugural NDA submission and showcases its commitment to addressing unmet clinical needs through groundbreaking approaches.

The submission is based on extensive dialogues with the FDA, supported by robust nonclinical data and clinical studies conducted both in China and the United States. Vicagrel, identified as a novel oral P2Y12 receptor antagonist, is designed to treat various thrombotic cardiovascular and cerebrovascular diseases, including acute coronary syndrome, ischemic stroke, and peripheral arterial disease. Importantly, Vicagrel's mechanism of action addresses the concern of "clopidogrel resistance" by utilizing the same active metabolite as clopidogrel to effectively inhibit platelet activation and aggregation.

Jiangsu Vcare's NDA filing represents over a decade of persistent innovation and dedication. Upon approval, Vicagrel is poised to introduce a new treatment option for the estimated 27.6 million U.S. patients dealing with coronary heart disease and stroke.

Vicagrel, a collaborative effort between Jiangsu Vcare and China Pharmaceutical University, is exclusively owned by Jiangsu Vcare. Early breakthroughs in research and development were published in renowned journals, including the American Chemical Society's Journal of Medicinal Chemistry (2012) and Nature-affiliated SciBX (2012).

Setting itself apart in the realm of antithrombotic treatments, Vicagrel boasts key advantages in both pharmacogenomics and pharmacokinetics over clopidogrel, thanks to its unique structural design. Recent Pharmacokinetics/Pharmacodynamics data position Vicagrel as a superior alternative to clopidogrel, addressing concerns associated with clopidogrel use and reducing drug interaction risks, all achievable at a considerably lower daily dose.



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