Keam Susan J
Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
Drugs. 2025 Aug 5. doi: 10.1007/s40265-025-02214-9.
Gepotidacin (BLUJEPA), a small molecule triazaacenaphthylene bacterial type II topoisomerase inhibitor (BTI) antibacterial, has been developed by GSK for the treatment of uncomplicated urinary tract infections (uUTIs) and uncomplicated urogenital gonorrhoea (uUGC). In March 2025, gepotidacin was approved for the treatment of uUTIs caused by susceptible isolates of Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis in female adult and paediatric patients aged ≥ 12 years and weighing ≥ 40 kg in the USA. This article summarizes the milestones in the development of gepotidacin leading to this first approval for the treatment of bacterial uUTIs.
格派沙星（BLUJEPA）是一种小分子三氮杂蒽类细菌II型拓扑异构酶抑制剂（BTI）抗菌药物，由葛兰素史克公司研发，用于治疗单纯性尿路感染（uUTIs）和单纯性泌尿生殖系统淋病（uUGC）。2025年3月，格派沙星在美国被批准用于治疗由大肠埃希菌、肺炎克雷伯菌、弗氏柠檬酸杆菌复合体、腐生葡萄球菌和粪肠球菌的敏感菌株引起的uUTIs，适用于成年女性及年龄≥12岁、体重≥40kg的儿科患者。本文概述了格派沙星研发过程中的重要节点，这些节点促成了其首次获批用于治疗细菌性uUTIs。
