GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has accepted for priority review a supplemental New Drug Application for gepotidacin as an oral option for the treatment of uncomplicated urogenital gonorrhoea in patients 12 years of age and older (weighing ≥45 kg).

GSK plc（LSE/NYSE：GSK）今天宣布，美国食品和药物管理局（FDA）已接受对gepotidacin的补充新药申请进行优先审查，该药物作为口服治疗12岁及以上（体重≥45公斤）患者的非复杂性泌尿生殖道淋病的选择。

The US FDA has assigned a Prescription Drug User Fee Act action date of 11 December 2025. In March 2025, gepotidacin was approved by the US FDA under the licensing name .

美国食品药品监督管理局（FDA）已设定《处方药使用者费用法案》行动日期为2025年12月11日。2025年3月，gepotidacin获得美国FDA批准，其许可名称为 。

Blujepa

布鲁杰帕

as oral treatment for female adult and paediatric patients 12 years of age and older (weighing ≥40 kg) with uncomplicated urinary tract infection (uUTI).

用于治疗12岁及以上（体重≥40公斤）的女性成人和儿科患者无并发症的尿路感染（uUTI）的口服药物。

Gonorrhoea is a common, sexually transmitted infection caused by

淋病是一种常见的性传播感染，由

Neisseria gonorrhoeae

淋病奈瑟菌

, which has been recognised by the World Health Organization as a priority pathogen

，它已被世界卫生组织确认为优先病原体

and an urgent public health threat by the US Centers for Disease Control and Prevention (CDC).

美国疾病控制与预防中心（CDC）认为是紧迫的公共卫生威胁。

It affects both men and women and if left untreated or inadequately treated, it can lead to infertility and other sexual and reproductive health complications. There were more than 600,000 cases of gonorrhoea reported in the United States in 2023 according to the CDC, making it the second most commonly reported sexually transmitted infection in the country..

它影响男性和女性，如果未治疗或治疗不当，可能导致不育和其他性与生殖健康并发症。根据美国疾病控制与预防中心的数据，2023年美国报告了超过60万例淋病病例，使其成为该国第二大最常报告的性传播感染疾病。

There is currently no vaccine licensed in the US for the prevention of gonorrhoea infection and the standard of care is injectable treatment which may not be suitable or available for all patients.

目前美国尚无获准用于预防淋病感染的疫苗，标准治疗方法是注射治疗，但这种治疗可能不适合或无法为所有患者提供。

The US application is based on results from the EAGLE-1 phase III trial recently published in

美国的申请是基于最近在 EAGLE-1 三期试验中发表的结果，

The Lancet

柳叶刀

, showing that gepotidacin (oral, two doses of 3,000mg) was non-inferior, with 92.6% (187/202, [95% CI 88·0 to 95·8]) success rates at urogenital site when compared to 91.2% (186/204, [95% CI 86.4-94.7]) success rates for intramuscular ceftriaxone (500mg) plus oral azithromycin (1,000mg) combined therapy, a leading combination treatment regimen for gonorrhoea.

，显示出吉贝沙星（口服，两剂各3000毫克）在尿道生殖部位的成功率为92.6%（187/202，[95%置信区间88.0至95.8]），与肌肉注射头孢曲松（500毫克）加口服阿奇霉素（1000毫克）联合疗法的成功率91.2%（186/204，[95%置信区间86.4至94.7]）相比，效果不逊色。后者是治疗淋病的主流组合疗法。

Additionally, there were no failures at the urogenital site due to bacterial persistence of .

此外，由于细菌持续存在，泌尿生殖部位没有出现感染失败的情况。

N. gonorrhoeae

淋病奈瑟菌

in either treatment arm. The safety and tolerability profile of gepotidacin in the EAGLE-1 trial was consistent with results seen in previous clinical trials, with no serious drug related adverse events observed in either the gepotidacin or the comparator arm. The most common reported adverse reactions were mild to moderate gastrointestinal events..

在两个治疗组中，gepotidacin 在 EAGLE-1 试验中的安全性和耐受性特征与之前临床试验中观察到的结果一致，无论是 gepotidacin 组还是对照组均未观察到严重的药物相关不良事件。最常见的报告不良反应为轻至中度的胃肠道事件。

This is the second major indication filed in the US for gepotidacin, and review of regulatory submissions for the uUTI indication is also ongoing in the UK and Australia.

这是gepotidacin在美国提交的第二个主要适应症，其用于uUTI适应症的监管提交也正在英国和澳大利亚接受审查。

The development of gepotidacin has been funded in part with federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Agreement number HHSO100201300011C and with federal funds awarded by the US Department of Defense’s Threat Reduction Agency under agreement number HDTRA1-07-9-0002..

Gepotidacin 的开发部分得到了美国卫生与公众服务部、战略准备与响应管理局、生物医学高级研究与发展局 (BARDA) 的联邦资金支持，合作协定编号为 HHSO100201300011C，并且还获得了美国国防部威胁减少局根据协议编号 HDTRA1-07-9-0002 授予的联邦资金支持。

About gepotidacin

关于gepotidacin

Gepotidacin, discovered by GSK scientists, is a bactericidal, first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by a distinct binding site, a novel mechanism of action, and for most pathogens, provides well-balanced inhibition of two different Type II topoisomerase enzymes.

Gepotidacin由GSK科学家发现，是一种杀菌性的、首创的三唑并苊烯类抗生素，它通过独特的结合位点抑制细菌DNA复制，具有新颖的作用机制，并且对大多数病原体能够均衡地抑制两种不同的II型拓扑异构酶。

This provides activity against .

这提供了针对 的活性。

Neisseria gonorrhoeae

淋病奈瑟菌

and most target uropathogens (such as

并且大多数目标尿路病原体（例如

Escherichia coli

大肠杆菌

and

和

Staphylococcus saprophyticus

腐生葡萄球菌

), including isolates resistant to current antibiotics. Due to this well-balanced inhibition for most pathogens, a single target-specific mutation may not significantly impact gepotidacin activity.

），包括对当前抗生素有耐药性的分离株。由于对大多数病原体的抑制作用非常均衡，单一的靶标特异性突变可能不会显著影响吉波替acin的活性。

About the EAGLE clinical programme

关于EAGLE临床项目

The EAGLE-1 trial (NCT04010539) is part of a comprehensive global phase III clinical programme for gepotidacin in adults and adolescents including:

EAGLE-1 试验（NCT04010539）是针对成人和青少年进行的 gepotidacin 全球综合 III 期临床计划的一部分，包括：

EAGLE-1 (non-inferiority urogenital gonorrhoea trial) compared the efficacy and safety of gepotidacin (oral, two doses of 3,000mg) to intramuscular ceftriaxone (500mg) plus oral azithromycin (1,000mg) in approximately 600 patients with uncomplicated urogenital gonorrhoea. The data were presented at ESCMID in April 2024.

EAGLE-1（非劣效性泌尿生殖系统淋病试验）比较了口服吉泊坦辛（两次剂量，每次3,000mg）与肌肉注射头孢曲松（500mg）加口服阿奇霉素（1,000mg）在约600名无并发症泌尿生殖系统淋病患者中的疗效和安全性。该数据于2024年4月在ESCMID上公布。

EAGLE-2 and EAGLE-3 (non-inferiority uUTI trials) compared the efficacy and safety of gepotidacin (1,500mg administered orally twice daily for five days) to nitrofurantoin (100mg administered orally twice daily for five days). The data were first presented at European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in 2023..

EAGLE-2 和 EAGLE-3（非劣效性 uUTI 试验）比较了吉波地辛（1500 毫克，每日两次口服，连续五天）与硝基呋喃妥因（100 毫克，每日两次口服，连续五天）的疗效和安全性。这些数据首次在 2023 年欧洲临床微生物学和感染病大会（ECCMID）上公布。

GSK in infectious diseases

葛兰素史克在传染病领域

GSK has pioneered innovation in infectious diseases for over 70 years, and the Company’s pipeline of medicines and vaccines is one of the largest and most diverse in the industry, with a goal of developing preventive and therapeutic treatments for multiple disease areas or diseases with high unmet needs globally.

GSK在传染病领域的创新已超过70年，公司拥有业内规模最大、最多样化的产品管线之一，目标是为多个疾病领域或全球范围内存在高度未满足需求的疾病开发预防和治疗方案。

Our expertise and capabilities in infectious disease strongly position us to help prevent disease and mitigate the challenge of antimicrobial resistance (AMR)..

我们在传染病方面的专业知识和能力使我们能够帮助预防疾病并减轻抗菌药物耐药性 (AMR) 的挑战。

About GSK

关于GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

GSK是一家全球生物制药公司，致力于联合科学、技术和人才，共同战胜疾病。欲了解更多信息，请访问gsk.com。