On 2 June, 2021, the US Food and Drug Administration approved ibrexafungerp (formerly MK-3118 and SCY-078) for the treatment of vulvovaginal candidiasis, also known as vaginal yeast infection. Ibrexafungerp is the first drug approved in a novel antifungal class in more than two decades, and the Food and Drug Administration’s decision was based on positive results from two pivotal phase III studies in which oral ibrexafungerp proved both safe and effective in patients with vulvovaginal candidiasis. The decision was also based on substantial preclinical and clinical work in both the pharmacokinetics and pharmacodynamics of ibrexafungerp. This paper reviews that research and looks ahead to explore how this novel antifungal agent may be used in the future to address the expanding problem of drug-resistant mycotic infections.

2021 年 6 月 2 日，美国食品药品监督管理局批准 ibrexafungerp（原名 MK-3118 和 SCY-078）用于治疗外阴阴道念珠菌病，也称为阴道酵母菌感染。Ibrexafungerp 是二十多年来第一个获批的新型抗真菌药物，美国食品药品监督管理局的决定是基于两项关键 III 期研究的积极结果，其中口服 ibrexafungerp 证明对外阴阴道念珠菌病患者既安全又有效。该决定还基于 ibrexafungerp 的药代动力学和药效学方面的大量临床前和临床工作。本文回顾了这项研究，并展望未来如何使用这种新型抗真菌剂来解决耐药性真菌感染这一不断扩大的问题。