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对molnupiravir的综合性基因毒性和致癌性评估

Patricia A Escobar¹, Zhanna Sobol¹, Randy R Miller¹

¹Nonclinical Drug Safety and Pharmacokinetics Dynamics Metabolism and Bioanalysis, Preclinical Development, Merck & Co. Inc., Rahway, NJ 07065, United States.

Toxicological sciences : an official journal of the Society of Toxicology

|September 20, 2024

概括

口服COVID-19治疗的Molnupiravir被评估为基因毒性和致癌性. 在体内研究表明,患者的突变或癌症风险没有增加,这证实了其安全性.

科学领域:

药理学药理学是指药理学的学科.
遗传学是一个遗传学.
毒理学毒理学毒理学

背景情况:

莫尔努皮拉维尔是治疗COVID-19的口服抗病毒药物.
它充当前药物,转化为活性NHC-TP,从而引入SARS-CoV-2基因组中的错误,抑制复制.

研究的目的:

综合评估molnupiravir.vir的基因毒性和致癌性潜力.
为了确定molnupiravir是否对患者构成基因组突变或DNA损伤的风险.

主要方法:

在体外和体外基因毒性测试,包括细菌和哺乳动物细胞突变测试.
在体和生殖细胞中的体内突变性研究 (Pig-a,Big Blue® TGR测试).
在转基因rasH2-Tg小鼠中进行了一项致癌性研究,暴露时间和剂量延长.

主要成果:

莫尔努皮拉维尔及其活性形式在体外诱导了突变,但没有染色体损伤.
在体内研究表明,体内或生殖细胞突变的增加没有.
莫尔努皮拉维尔在致癌性研究中呈阴性结果.

结论:

在体外的基因毒性发现被强大的体内数据所取代.
在全面的动物研究中,莫尔努皮拉维尔没有显示出变种或致癌潜力.
临床使用molnupiravir与基因毒性或致癌性风险无关.

关键词:

这是一种抗病毒药物.致癌性致癌性致癌性遗传毒性遗传毒性遗传毒性遗传毒性莫尔努皮拉维尔 (Molnupiravir) 是一种突变性突变性突变性 β-D-N4-基胺 (NHC) 是一种基胺.

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