{"title":"Gepotidacin:首次批准。","authors":"Susan J Keam","doi":"10.1007/s40265-025-02214-9","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":14.4000,"publicationDate":"2025-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Gepotidacin: First Approval.\",\"authors\":\"Susan J Keam\",\"doi\":\"10.1007/s40265-025-02214-9\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":11482,\"journal\":{\"name\":\"Drugs\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":14.4000,\"publicationDate\":\"2025-08-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Drugs\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s40265-025-02214-9\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drugs","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40265-025-02214-9","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
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.
期刊介绍:
Drugs is a journal that aims to enhance pharmacotherapy by publishing review and original research articles on key aspects of clinical pharmacology and therapeutics. The journal includes:
Leading/current opinion articles providing an overview of contentious or emerging issues.
Definitive reviews of drugs and drug classes, and their place in disease management.
Therapy in Practice articles including recommendations for specific clinical situations.
High-quality, well designed, original clinical research.
Adis Drug Evaluations reviewing the properties and place in therapy of both newer and established drugs.
AdisInsight Reports summarising development at first global approval.
Moreover, the journal offers additional digital features such as animated abstracts, video abstracts, instructional videos, and podcasts to increase visibility and educational value. Plain language summaries accompany articles to assist readers with some knowledge of the field in understanding important medical advances.