智通财经APP获悉，10月13日，CDE官网显示，艾伯维(ABBV.US)注射用E型肉毒毒素(TrenibotE)上市申请获受理，注册分类为1类。根据公开资料和临床试验进展，Insight数据库推测适应症为中度至重度眉间纹。

截图来源：CDE官网

TrenibotE是同类首创的E型肉毒神经毒素，2025年4月，艾伯维向FDA提交了该产品的首个上市申请，此申请得到来自2100多名接受TrenibotE治疗患者的临床研究数据的支持，其中包括两项评估TrenibotE治疗中度至重度眉间纹的关键性III期临床研究(M21-500和M21-508)以及一项III期开放标签安全性研究(M21-509)。

III期研究的所有主要和次要终点均已达到，给药后8小时即可快速起效(最早评估时间)，且疗效持续时间为2-3周。此外，无论是作为单次治疗还是最多连续三次治疗，TrenibotE的治疗中出现的不良事件与安慰剂相似。

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