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The New Antithrombotic Drug Vicagrel Jointly Developed by China Pharmaceutical University and Enterprises has Obtained the Clinical License from the FDA

Time:2021-03-31   Browse times:10

Recently, the new antithrombotic drug Vicagrel jointly developed by Professor Sun Hongbin and his team from China Pharmaceutical University and Jiangsu Vcare Pharmatech Co., Ltd has been allowed with clinical trials by the U.S. Food and Drug Administration (FDA). In the previous Pre-IND meeting, FDA gave high praise and constructive guidance to Vicagrel.


Vicagrel is a new drug designed to overcome "Clopidogrel resistance". Some preliminary research results were published in Journal of Medical Chemistry (2012) and were reported by SciBX, a publication of Nature. Clopidogrel (Plavix) is a basic drug for the prevention and treatment of thrombotic cardiovascular and cerebrovascular diseases. It needs to be metabolized by liver enzyme CYP2C19 to produce active metabolites. However, due to the gene polymorphism of CYP2C19, about 13% ~ 15% of East Asian patients cannot effectively metabolize Clopidogrel to produce active metabolites (i.e. "Clopidogrel resistance"), which increases the risk of serious cardiovascular events such as stent thrombosis. Therefore, the drug was given a black box warning by FDA.


Vicagrel has completed Phase II clinical research in China, and some clinical results have been published in British Journal of Clinical Pharmacology (2020) and European Journal of Pharmaceutical Sciences (2019). The results of existing clinical trials show that Vicagrel has the advantages of fast onset, low dose, low risk of bleeding, no obvious side effects of respiratory inhibition, and is expected to overcome the "Clopidogrel resistance" caused by CYP2C19 gene polymorphism. In addition to the prevention and treatment of acute coronary syndrome, it is also expected to further expand its clinical application in stroke patients who are more sensitive to bleeding risk.


Han Yaling, chairman of Chinese Society of Cardiology, honorary president of the Cardiovascular Physician Branch of the Chinese Medical Doctor Association, and academician of General Hospital of Northern Military Area (the former The General Shenyang Military Hospital), as the project PI, guided the clinical team to complete a number of key clinical studies such as Vicagrel Phase II and spoke high of it. The Phase III clinical trial of Vicagrel will be launched in China in the near future. With the clinical license from the FDA, a number of international multicenter clinical research will also be started.


The research is supported by funds from “Significant New Drug Development”, national major scientific and technological project in the 12th Five-Year Plan and the 13th Five-Year plan.


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