Jiangsu Vcare's Novel Drug Vicagrel Receives FDA Approval for Clinical Trials
Published Time:
2021-03-22 17:35
Source:
Recently, Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) announced encouraging news regarding its novel antiplatelet drug Vicagrel: The US FDA has provided feedback on the company's submitted IND application for Vicagrel, permitting the company to initiate clinical trials.
Vicagrel has already completed Phase II clinical studies in China. Existing clinical trial results have demonstrated multiple advantages, including rapid onset of action, low dosage, no significant respiratory depression, low bleeding risk, and the design to overcome "clopidogrel resistance." Beyond its application in ACS, it has the potential to further expand its indications to include stroke patients, who are more sensitive to bleeding risks. Following FDA approval, we will initiate multiple international multi-center clinical studies.
Dr. Gong Yanchun, Co-founder and CEO of Jiangsu Vcare, stated: "The IND approval for Vicagrel in the US marks a significant milestone in its clinical development program and the first step towards international expansion. We extend our gratitude to the Vcare team for their decade-long dedication and hard work. The previous Pre-IND meeting proceeded smoothly, with the FDA providing highly positive feedback and commendation for Vicagrel. Moving forward, we will collaborate closely with clinical trial sites and regulatory agencies to accelerate Vicagrel's development, striving to bring this more effective treatment option to cardiovascular disease patients as soon as possible."
About Vicagrel
Vicagrel is a collaborative industry-academia-research project between Jiangsu Vcare and China Pharmaceutical University. The company holds full rights and intellectual property for the project. Research findings have been successively published in several core domestic and international journals. The project was highlighted by SciBX (published by Nature), which rated Vicagrel as "one of the most commercially promising projects in this field of novel drugs."
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