A Phase 3b, Open-label, Single-arm Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and the Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (Acute Cystitis)

The study will be conducted to evaluate the clinical symptom improvement and safety of oral gepotidacin for treatment of uncomplicated UTI (acute cystitis) in adolescent and adult female participants.

开始日期2024-10-02

申办/合作机构

GSK Plc

NCT05630833

/ Completed临床3期

A Phase III, Multicenter, Randomized, Active Reference, Double Blind, Double-dummy Study in Japanese Female Participants to Evaluate the Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)

The purpose of this study is to evaluate the consistency of therapeutic response of gepotidacin in female participants with acute uncomplicated cystitis with qualifying bacterial uropathogen(s) at baseline that all are susceptible to nitrofurantoin in Japan, with that from global studies (Studies 204989 [NCT04020341] and 212390 [NCT04187144]).

开始日期2023-01-11

申办/合作机构

GSK Plc

JPRN-jRCT2031220467

/ Not yet recruiting临床3期IIT

A Phase III, Multicenter, Randomized, Active Reference, Double-blind, Double-dummy Study in Japanese Female Participants to Evaluate the Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis) - A study to investigate the efficacy and safety with gepotidacin in Japanese female participants with uncomplicated urinary tract infection (acute cystitis); Efficacy of Antibacterial Gepotidacin Evaluated in Japan (EAGLE-J)

开始日期2023-01-11

申办/合作机构-

100 项与 Gepotidacin 相关的临床结果

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100 项与 Gepotidacin 相关的转化医学

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100 项与 Gepotidacin 相关的专利（医药）

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102

项与 Gepotidacin 相关的文献（医药）

2025-10-01·ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Efficacy and in vitro activity of gepotidacin against bacterial uropathogens, including subsets with molecularly characterized resistance mechanisms and genotypes/epidemiological clones, in females with uncomplicated urinary tract infections: results from two global, pivotal, phase 3 trials (EAGLE-2 and EAGLE-3)

Article

作者: Scangarella-Oman, Nicole E. ; Breton, John ; Butler, Deborah L. ; Kasapidis, Cara ; Brown, Derrek ; Sheets, Amanda J.

ABSTRACT:

Gepotidacin, a novel, bactericidal, first-in-class triazaacenaphthylene antibacterial, was noninferior to nitrofurantoin in two pivotal trials (EAGLE-2 and EAGLE-3) in females with uncomplicated urinary tract infections (uUTIs). Using pooled data, gepotidacin in vitro activity and clinical efficacy were evaluated for subsets of molecularly characterized isolates in the microbiological Intent-to-Treat population. The subsets of isolates were characterized based on phenotypic/MIC criteria; all microbiological failure isolates were also characterized. Of 1,159 Escherichia coli isolates , 30% harbored quinolone resistance-determining region (QRDR) mutations; most prevalent was gyrA S83L, D87N (27%). Extended-spectrum β-lactamases (ESBLs) were detected in 13% of E. coli isolates. For 114 Klebsiella pneumoniae isolates, 22% were plasmid-mediated quinolone resistance (PMQR) gene-positive, 11% had QRDR mutations, and 12% had ESBLs. Among 67 Proteus mirabilis isolates, 21% harbored QRDR mutations. Gepotidacin MIC 90 values ranged from 1 to 32 µg/mL against qualifying Enterobacterales uropathogens and genotypic subcategories, with no isolates considered resistant to gepotidacin. For all genotypic subcategories, gepotidacin MIC 90 values were similar (i.e., lower, equal to, or 1-dilution higher) compared with the overall species (4 µg/mL), with the exception of E. coli isolates with the PMQR qnrS1 gene (16 µg/mL); all were gepotidacin-susceptible. For the majority of uropathogens, including those with genotypes likely to cause resistance to standard uUTI therapies, success rates for gepotidacin were similar across genotypic subcategories for each species. These data show gepotidacin’s efficacy and in vitro activity against a wide range of uropathogen genotypes. Additionally, these pooled results provide a robust, contemporary data set and insight into current genotypic mechanisms of resistance.

CLINICAL TRIALS:

This study is registered with ClinicalTrials.gov as NCT04020341 and NCT04187144 .

2025-10-01·JOURNAL OF INFECTION AND CHEMOTHERAPY

Oral gepotidacin for the treatment of uncomplicated urinary tract infection in Japanese female patients: a randomized, active reference, double-blind, double-dummy, Phase 3 trial (EAGLE-J)

Article

作者: Konishi, Takatoshi ; Banerjee, Rudrani ; Kameoka, Hiroshi ; Nakamura, Kiyoshi ; Igarashi, Hiroshi ; Maenaka, Takao ; Manabe, Fumio ; Mori, Masaru ; Huang, Tingwen ; Kayama, Yoko ; Suyama, Kenichi ; Yamamoto, Shingo ; Takashima, Hideo ; Scangarella-Oman, Nicole E. ; Hayami, Yutaro ; Ramirez, Marcela ; Sekiguchi, Yuki ; Ura, Shintaro ; Ogishima, Tatsuya ; Nimura, Akinori ; Kawahara, Motoshi ; Mozzicato, Susan ; Kamei, Maiko ; Iwata, Shinji ; Sagiyama, Kazuyuki ; Fujii, Kenji ; Hayashi, Mototaka ; Umeyama, Tomokazu ; Kamijo, Toshiyuki ; Kusuyama, Hiroyuki ; Kayama, Shigenori ; Hashimoto, Jiro ; Tanahashi, Yoshikatsu ; Nanri, Masaharu ; Muromiya, Yasuto ; Sugimoto, Kenji

BACKGROUND:

Two global Phase 3 trials, EAGLE-2 and EAGLE-3, found gepotidacin non-inferior (and superior in EAGLE-3) to nitrofurantoin for the treatment of uUTI in female participants, with an acceptable safety profile; however, these studies did not include Japanese centers.

METHODS:

EAGLE-J (NCT05630833; jRCT2031220467) was a Phase 3, randomized, double-blind, active reference study evaluating the efficacy and safety of gepotidacin for the treatment of uUTI in Japan. Eligible participants were females aged ≥12 years with ≥2 uUTI symptoms and urinary nitrite or pyuria. Participants were randomly assigned (3:1) oral gepotidacin (1500 mg) or nitrofurantoin (100 mg) twice daily for 5 days. To bridge data, consistency of therapeutic response at test-of-cure (day 10-13) in the gepotidacin arm of EAGLE-J with EAGLE-2/EAGLE-3 was assessed in participants with qualifying nitrofurantoin-susceptible uropathogens (≥10⁵ colony-forming units/mL). Therapeutic success comprised clinical (symptom resolution) and microbiological success (eradication). Consistency was claimed if the therapeutic success rate in EAGLE-J was greater than the consistency threshold predicted from EAGLE-2/EAGLE-3.

FINDINGS:

Overall, the primary analysis included 108 participants (83 gepotidacin, 25 nitrofurantoin). At test-of-cure, gepotidacin therapeutic success was 83.1 % (69/83), exceeding the consistency threshold (48.2 %). Adverse events were mostly mild-to-moderate; common adverse events were diarrhea (gepotidacin: 60 %, 168/281; nitrofurantoin: 8 %, 7/93) and nausea (gepotidacin: 12 %, 35/281; nitrofurantoin: 2 %, 2/93). No fatalities occurred.

INTERPRETATION:

Gepotidacin therapeutic success at test-of-cure was consistent between EAGLE-J and EAGLE-2/-3. Gepotidacin has potential as a valuable oral treatment option for uUTI in Japan. No new safety signals were identified.

2025-08-01·ANNALS OF INTERNAL MEDICINE

In urogenital gonorrhea, gepotidacin was noninferior to ceftriaxone + azithromycin for microbiological success

Article

作者: Glatt, Aaron E. ; Brennan, Keith ; Anaekwe, Adaeze

CLINICAL IMPACT RATINGS:

GIM/FP/GP: [Formula: see text] Infectious Disease: [Formula: see text].

105

项与 Gepotidacin 相关的新闻（医药）

2025-10-21

·EndPoints

GSK, Spero reveal full Phase 3 data for oral antibiotic, set for end-of-year filing

GSK and Spero Therapeutics are taking their oral antibiotic to the FDA after reporting the full Phase 3 non-inferiority data. The companies said Monday that tebipenem HBr performed no worse than an approved IV antibiotic regimen for complicated urinary tract infections (cUTIs), and all side effects were mild or moderate. Looking at overall responses, patients taking tebipenem HBr saw a 58.5% success rate compared to 60.2% for the IV regimen, which is known as imipenem-cilastatin. Additionally, 93.5% of patients treated with tebipenem HBr did not have any symptoms after treatment, compared to 95.2% in the control group. With the data in hand, Spero said GSK is ready to submit the data package to the FDA by the end of the year — as previously announced. Its share price $SPRO was up about 4% on Tuesday morning. GSK and Spero stopped the trial in May due to efficacy, giving Spero a lifeline and lifting it out of penny-stock status. Spero developed the antibiotic and tried getting it approved by itself, but the agency rejected the drug in 2022. At the time, FDA officials felt the data package was not sufficient to support approval, according to feedback they provided to Spero . A few months later, GSK signed a licensing deal with Spero that’s worth $66 million upfront plus milestones totaling $525 million. The “delivery” of the Phase 3 data entitles Spero to a $150 million milestone. GSK is handling the FDA application. Despite the emergence of drug-resistant “superbug” bacteria, antibiotics are not traditionally a popular investment. But GSK has found some recent success. In March, the FDA approved another GSK antibiotic program for uncomplicated UTIs, and the company is also testing that drug — branded as Blujepa — as a treatment for gonorrhea . It’s also preparing to pitch tebipenem HBr as a tool to keep patients from being admitted to the hospital.

临床3期引进/卖出临床结果

2025-10-14

·医学新视点

致敬时代 | 近60%患者肿瘤缩小或几乎“全消失”！多款抗癌“新救星”为这类患者点亮生命之光

编者按：2025年，药明康德迎来创立25周年的重要里程碑。值此契机，我们向所有与我们共同书写产业变革篇章的科学家、医药人和投资者致以衷心感谢与诚挚敬意，也特别推出“致敬时代”系列，回顾全球同仁如何借助科学与合作的力量，不断拓展治疗边界、改善患者命运。四分之一个世纪的坚守，只为加速每一款新药的诞生。下一个25年，我们将继续心怀感恩与敬畏，依托独特的CRDMO模式，与全球伙伴携手同行，共赴健康未来。如今随着防晒的普及，越来越多人知道了一类与紫外线暴露有关的癌症——皮肤癌。在各种皮肤癌中，黑色素瘤约占1%，却是皮肤癌患者死亡的主要原因，被称为“皮肤癌之王”。黑色素瘤是由黑色素细胞基因突变与环境因素交互作用引起的一种恶性肿瘤，紫外线是主要风险因素，其他影响因素包括创伤和慢性炎症等。它可以发生于人的皮肤、眼睛、内耳、头颈和足底等多个部位。国际癌症研究机构（IARC）统计显示，每一天约有909人会被诊断为皮肤黑色素瘤，并有约161人会死于这种恶疾。这相当于，每2分钟就约有1人会被诊断为皮肤黑色素瘤，每10分钟约有1人会死于这种癌症。图片来源：123RF 从1787年有文献记载开始，到20世纪60年代，手术一直承担着早期黑色素瘤治疗的重任，但对于转移性黑色素瘤疗效有限。直到1975年，转移性黑色素瘤患者才迎来首款有效的化疗药物——达卡巴嗪（dacarbazine），它能让13.4%的患者获得缓解（偶有完全缓解案例），27%的人能活过1年、中位生存期5-11个月。此后，人们也探索过联合化疗或白细胞介素疗法的可能性，但结果都不尽理想。因此在长达三十多年的时间里，达卡巴嗪一直担任着转移性黑色素瘤治疗金标准的角色。为了让患者获得更好的生活质量，科学家们一直在努力寻找新的治疗方案。进入21世纪，黑色素瘤的治疗有了非常大的突破，从传统化疗走向了靶向治疗和免疫治疗交相辉映的新时代。作为全球医药及生命科学行业值得信赖的合作伙伴和重要贡献者，药明康德在25年发展历程中，很荣幸见证了多款黑色素瘤新疗法从实验室到临床的突破历程，更通过提供一体化、端到端的新药研发和生产服务，助力全球合作伙伴加速多款黑色素瘤创新疗法的研发进程、造福病患。今天这篇文章将回望近25年来黑色素瘤新疗法的发展历程，向那些为广大患者点亮生命之光的人们致敬。靶向疗法：半数患者的希望说到近十几年黑色素瘤靶向疗法的发展，就不得不提BRAF抑制剂。其中维莫非尼（vemurafenib）的问世更是一大里程碑，成为首个针对黑色素瘤特异性突变的靶向治疗药物。 20世纪80年代末，科学家在人类尤文氏肉瘤中发现并克隆了一个名为BRAF的基因。21世纪初，随着分子生物学和遗传学研究的深入，研究人员发现在大多数黑色素瘤中存在激活的BRAF基因突变，而且超过85%的突变是由BRAF V600E突变导致的。这一重大发现引发了科学家们开发黑色素瘤靶向药物的浪潮。起初，科学家们尝试用低效抑制剂来对付这种突变蛋白，但收效甚微。后来，在高通量筛选技术的帮助下，维莫非尼被挑选出来，它是一种对黑色素瘤中BRAF V600突变具有高度选择性和特异性的激酶抑制剂。图片来源：123RF 后续的研究中，维莫非尼也没让大家失望。在针对携带BRAF V600E基因突变的黑色素瘤患者的早期临床试验中，维莫非尼展现出惊人的缓解率，患者的肿瘤很快缩小。随后一项包含675名患者的3期临床试验再次取得令人瞩目的结果：维莫非尼的总体有效率高达48%，远远超过标准化疗的5%，并相比化疗将患者死亡风险降低了63%。基于振奋人心的疗效结果，维莫非尼在2011年8月获美国FDA批准用于携带BRAF V600E基因突变的晚期（转移性）或不可手术切除的黑色素瘤患者（商品名：Zelboraf），至此黑色素瘤终于迎来了首款靶向疗法，改变了过去三十多年来依赖化疗的局面。现在人们已经知道，BRAF基因编码一种丝氨酸/苏氨酸蛋白激酶，这个激酶就像一个“生长开关”，可调控细胞生长。正常的BRAF蛋白激酶只有在细胞需要生长的时候才激活，而突变的BRAF蛋白激酶一直处于激活状态，进而导致细胞野蛮生长。BRAF抑制剂就是通过关闭这个“开关”，从而遏制肿瘤生长。维莫非尼之后，科学家还开发出了针对MAPK信号通路中BRAF下游MEK的抑制剂，以及BRAF抑制剂和MEK抑制剂构成的组合疗法。2014-2015年，两组联合疗法先后获FDA批准用于BRAF突变的晚期黑色素瘤患者，它们分别是达拉非尼（dabrafenib，商品名：Tafinlar，BRAF抑制剂）/曲美替尼（trametinib，商品名：Mekinist，MEK抑制剂）联合疗法，以及考比替尼（cobimetinib，商品名：Cotellic，MEK抑制剂）/维莫非尼联合疗法。研究证明，“双剑合璧”的确达到了更好的疗效。于2018年获FDA批准的恩考芬尼（encorafenib，商品名：Braftovi，BRAF抑制剂）/比美替尼（binimetinib，商品名：Mektovi，MEK抑制剂）联合疗法，将携带BRAF V600突变的晚期黑色素瘤患者的中位无进展生存期和中位总生存期分别提高到了14.9个月和33.6个月。以维莫非尼为代表的这些靶向药的问世，在晚期黑色素瘤的治疗史上是个巨大进步。携带BRAF V600突变的患者在黑色素瘤中约占50%，这意味着，它们为半数患者带来了新的治疗选择，无需再依赖化疗。免疫疗法：诺奖级成果，改变更多患者命运对于另一半没有BRAF突变的患者，也有新的疗法正在加速到来。21世纪初，以免疫检查点抑制剂为代表的免疫疗法已经开始萌芽。与靶向药直接作用于癌细胞不同，免疫检查点抑制剂是通过人体自身的免疫系统来杀死癌细胞。在人体免疫系统中，有一种扮演着“警卫”角色的T细胞，当它们在巡逻中发现异常细胞时，就会复制出很多同胞兄弟来一起“干掉”这些“坏人”。不过“警卫”并非越多越好，T细胞过度活跃也可能“误伤”正常细胞、导致自身免疫疾病，所以正常情况下，人体会通过一个类似“刹车”系统的机制让T细胞及时收手，CTLA-4、PD-1就是这个“刹车”系统中的成员。但是狡猾的癌细胞也进化出了超强的“踩刹车”能力，以逃脱免疫细胞的攻击。CTLA-4抑制剂和PD-1抑制剂就是为了解除原本会被癌细胞“踩下的刹车”，从而让免疫细胞去消灭它们。其中，CTLA-4抑制剂的临床研究开展更早。2011年3月，首个CTLA-4抑制剂伊匹木单抗（ipilimumab，商品名：Yervoy）获FDA批准上市，为没有BRAF基因突变的晚期黑色素瘤患者带来了新的治疗选择。相比单纯化疗，伊匹木单抗与化疗药物的联合疗法让疗效获得了改善，1年和3年生存率分别为47.3%和20.8%（单纯化疗组为36.3%和12.2%），缓解率为15.2%（单纯化疗组为10.3%）。此后，PD-1/PD-L1抑制剂、LAG-3抑制剂等多款免疫疗法凭借亮眼的疗效接连问世。自2014年以来，帕博利珠单抗（pembrolizumab，商品名：Keytruda）、纳武利尤单抗（nivolumab，商品名：Opdivo）等免疫检查点疗法都已获批用于黑色素瘤，无论患者是否携带BRAF突变，都可以从中受益。同样地，免疫疗法的“双剑合璧”，如伊匹木单抗/纳武利尤单抗组合疗法、纳武利尤单抗/瑞拉利单抗（relatlimab，LAG-3抑制剂）组合疗法等，也相比单药获得了更惊艳的疗效。比如，在代号为CheckMate-067的3期临床试验中，科学家对945名不可切除晚期黑色素瘤初治患者经过长达5年随访的结果显示，纳武利尤单抗/伊匹木单抗联合治疗组的中位总生存期已超过60个月、5年总生存率为52%，近六成（58%）患者获得缓解（即肿瘤明显缩小或消失）、超两成（22%）患者达到完全缓解（即肿瘤几乎“全消失”），明显高于这两款药单药治疗的相应数据。值得一提的是，在联合治疗组中，携带BRAF突变患者的生存情况比无突变的患者更好，5年生存率已达60%（后者为48%）。另外科学家发现，免疫疗法还可以成为靶向药的“助攻”，多管齐下治疗BRAF V600突变阳性的黑色素瘤。比如此前已斩获其他多个癌种适应症的PD-L1抑制剂阿替利珠单抗（atezolizumab，商品名：Tecentriq），其与考比替尼/维莫非尼的联合疗法已于2020年获FDA批准上市，用于治疗BRAF V600突变阳性晚期黑色素瘤患者。目前，免疫疗法已成为晚期黑色素瘤的标准一线治疗。除了黑色素瘤，肺癌、头颈癌、淋巴瘤等至少二十种恶性肿瘤患者也已从这些疗法中获益，人类抗击癌症的历史已因它们的到来而改变。免疫检查点的两个经典靶点的发现者也因其突破性贡献斩获了诺贝尔奖——2018年，诺贝尔生理学或医学奖颁给了CTLA-4的发现者詹姆斯·艾利森（James P. Allison）教授和PD-1的发现者本庶佑（Tasuku Honjo）教授，以表彰他们在癌症治疗方面所做的贡献。这些新疗法接连的问世，让晚期黑色素瘤患者的生存率发生了翻天覆地的变化。就在十多年前，单纯化疗患者的3年生存率还只有10%左右；而当年勇敢参加纳武利尤单抗1期临床试验的患者，5年生存率就达到了34.2%，更有超过30%的患者在随访96个月（8年）时依然存活；纳武利尤单抗/伊匹木单抗联合疗法更是将晚期黑色素瘤患者的5年生存率提高到了52%。 ▲纳武利尤单抗在1期临床试验中单药治疗3种癌症的十年随访数据，MEL代表晚期黑色素瘤患者（图片来源：参考资料[9]）然而，免疫检查点抑制剂并非“万能神药”。针对免疫疗法难治性患者，产业界也在不断探索新药研发。2024年，肿瘤浸润淋巴细胞（TIL）疗法lifileucel（商品名：Amtagvi）获FDA加速批准，用于先前接受过PD-1抑制剂治疗的不可切除或转移性黑色素瘤成年患者，如果患者呈BRAF V600突变阳性，还可使用BRAF抑制剂，并且选择联合或不联合MEK抑制剂。针对这类问题的新药还有妥拉美替尼，这是一款MEK抑制剂，于2024年在中国获批上市（商品名：科露平），适合于接受抗PD-1/PD-L1治疗失败，携带NRAS突变的晚期黑色素瘤患者。向治愈出发，更多新疗法蓄势待发过去25年间，美国FDA共批准了至少14款治疗黑色素瘤的新疗法，除上述药物之外，还有2015年获批的溶瘤病毒局部疗法talimogene laherparepvec（商品名：Imlygic），以及2022年获批用于晚期葡萄膜黑色素瘤的T细胞受体（TCR）疗法tebentafusp（商品名：Kimmtrak）。此外，近25年在中国获批用于黑色素瘤适应症的还有化疗药物表柔比星、重组人白细胞介素2，以及PD-1抑制剂普特利单抗（商品名：普佑恒）和特瑞普利单抗（商品名：拓益）。药明康德很高兴能为其中多款疗法提供赋能、助力合作伙伴的这些创新疗法来到全球患者身边。为帮助患者达到更高的生存目标，产业圈仍在探索之路上继续前行。当下还有500多款针对黑色素瘤的新疗法正处于积极的临床研究中，有望在未来造福更多患者。其中近百款药物已进入3期临床阶段，涵盖小分子靶向药、T细胞受体工程T细胞（TCR-T）疗法和癌症疫苗（包括多肽疫苗、mRNA疫苗）等多种类型。比如在研癌症疫苗Cylembio（imsapepimut与etimupepimut），近期公布的关键临床3期试验主要结果显示，在不可切除或转移性黑色素瘤患者中，与帕博利珠单抗单药相比，这款癌症疫苗与帕博利珠单抗的联合疗法能产生更好的疗效，中位无进展生存期达到了19.4个月（前者为11个月）。在未接受过新辅助/辅助PD-1抑制剂治疗的患者亚组中，中位无进展生存期更是延长到了24.8个月（即超过2年）。联合疗法的总生存期也呈现出改善趋势，但数据尚未成熟。目前，该创新疫苗已有向美国FDA申请上市的计划。图片来源：123RF 在攻克黑色素瘤的征程中，这些创新疗法的问世离不开科学家们的潜心钻研，也离不开学术界和产业界的携手努力。最后，让我们再次向那些向“皮肤癌之王”发起挑战、越过重重难关的英雄们致以崇高的敬意。药明康德也期待与业界同仁继续同行，见证更多创新疗法从萌芽到开花结果、为翘首以盼的患者带去更多希望。参考资料（可上下滑动查看） [1] Metastatic melanoma survivor finds hope in clinical trials. Retrieved Sep 4, 2025 from https://www.mdanderson.org/publications/cancerwise/metastatic-melanoma-survivor-finds-hope-in-immunotherapy-targeted-therapy-clinical-trials.h00-159305412.html [2] Vito W. Rebecca，et al. (2012) .A Brief History of Melanoma: From Mummies to Mutations. Melanoma Res. doi: 10.1097/CMR.0b013e328351fa4d [3] Carrie Lee MD, MPH，et al. (2013). Historical review of melanoma treatment and outcomes. Clinics in Dermatology. https://doi.org/10.1016/j.clindermatol.2012.08.015. [4] Paul B. Chapman et al. (2011). Improved survival with vemurafenib in melanoma with BRAF V600E mutation, N Engl J Med. doi: 10.1056/NEJMoa1103782 [5] Kim, A., & Cohen, M. S. (2016). The discovery of vemurafenib for the treatment of BRAF-mutated metastatic melanoma. Expert Opinion on Drug Discovery, 11(9), 907–916. doi:10.1080/17460441.2016.1201057 [6] Mary Elizabeth's story. Retrieved Sep 4, 2025 from https://www.cancerresearch.org/patients/what-is-immunotherapy/featured-stories/mary-elizabeth-w [7] Nikhil Wagle et al, (2011). Dissecting therapeutic resistance to RAF inhibition in melanoma by tumor genomic profiling, J Clin Oncol. doi:10.1200/jco.2010.33.2312 [8] FDA Approves Braftovi + Mektovi Combination . Retrieved Sep 4, 2025 from https://www.drugs.com/newdrugs/array-biopharma-announces-fda-approval-braftovi-encorafenib-combination-mektovi-binimetinib-4771.html [9] SuzanneL, Topalian, et al. (2019) . Five-Year Survival and Correlates Among Patients With Advanced Melanoma, Renal Cell Carcinoma, or Non–Small Cell Lung Cancer Treated With Nivolumab. JAMA Oncology. doi:10.1001/jamaoncol.2019.2187 [10] James Larkin, F.R.C.P., et al. (2019). Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. The New England Journal of Medicine. DOI: 10.1056/NEJMoa1910836 [11] Mary Elizabeth Williams，（2016）. A Series of Catastrophes and Miracles: A True Story of Love, Science, and Cancer. [12] My“rapidly fatal”diagnosis: My worst nightmare was also a miraculous stroke of luck. Retrieved Sep 4, 2025 from https://www.salon.com/2016/04/24/my_rapidly_fatal_diagnosis_my_worst_nightmare_was_also_a_miraculous_stroke_of_luck/?sf25084491=1 [13] Plexxikon Inc. To Join Daiichi Sankyo Group - Press Releases - Media - Daiichi Sankyo . Retrieved Sep 4, 2025 from https://www.daiichisankyo.com/media/press_release/detail/index_3788.html [14] Yang A, Chapman P,(2009). The History and Future of Chemotherapy for Melanoma. Hamatology/Oncology Clinics of N America.23:583–597. doi: 10.1016/j.hoc.2009.03.006. [15] Japan Tobacco Inc : Trametinib, the first MEK inhibitor, received U.S. regulatory approval, JT's licence partner GlaxoSmithKline announced PDF | MarketScreener. Retrieved Sep 4, 2025 from https://www.marketscreener.com/quote/stock/JAPAN-TOBACCO-INC-6491271/news/Japan-Tobacco-Inc-Trametinib-the-first-MEK-inhibitor-received-U-S-regulatory-approval-JT-s-lic-16915802/ [16] Wolchok, J. D., Thomas, L., Bondarenko, I. N., O'Day, S., Weber, J. S., Garbe, C., ... & Robert, C. (2011). Phase III randomized study of ipilimumab (IPI) plus dacarbazine (DTIC) versus DTIC alone as first-line treatment in patients with unresectable stage III or IV melanoma. Journal of Clinical Oncology, 29(18_suppl), LBA5-LBA5.https://doi.org/10.1200/jco.2011.29.18_suppl.lba5 [17] Wang, X., Si, L., & Guo, J. (2014). Treatment algorithm of metastatic mucosal melanoma. Chinese clinical oncology, 3(3), 38-38. doi: 10.3978/j.issn.2304-3865.2014.08.04 [18] Novartis announces both ianalumab Phase III clinical trials met primary endpoint in patients with Sjögren’s disease. Retrieved Sep 4,2025 from https://www.novartis.com/news/media-releases/novartis-announces-both-ianalumab-phase-iii-clinical-trials-met-primary-endpoint-patients-sjogrens-disease [19] Gepotidacin accepted for priority review by the US FDA for the oral treatment of uncomplicated urogenital gonorrhoea. Retrieved Sep 4,2025 from https://www.gsk.com/media/flmllaky/gepo-gc-us-filing-acceptance_sea_final.pdf [20] IO Biotech Announces Clinical Improvement in Progression Free Survival Demonstrated in Pivotal Phase 3 Trial of Cylembio® plus KEYTRUDA® (Pembrolizumab) for the Treatment of First-line Advanced Melanoma, but Statistical Significance Narrowly Missed. Retrieved Sep 4, 2025 from https://iobiotech.com/press-releases/?workflow=6562e614-30a0-4300-9a37-ab75253933a2 [21] Bray, F., Laversanne, M., Sung, H., Ferlay, J., Siegel, R. L., Soerjomataram, I., & Jemal, A. (2024). Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: a cancer journal for clinicians, 74(3), 229-263.https://doi.org/10.3322/caac.21834Citations: 1016 [22] How the Approval of Lifileucel Impacts the Treatment Landscape for IO-Refractory Advanced Nonuveal Melanoma (ascopubs.org) . Retrieved Sep 4,2025 from https://dailynews.ascopubs.org/do/approval-lifileucel-impacts-treatment-landscape-io-refractory-advanced-nonuveal 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，传递医学新知

临床研究放射疗法

2025-09-03

·PMLiVE

UK’s first new type of antibiotic for UTIs in nearly 30 years approved by MHRA

Gepotidacin (Blujepa) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for use by women and girls from 12 years of age, with a weight of at least 40kg. The new antibiotic is an oral pill that can be used to treat uncomplicated urinary tract infections (UTIs). It is effective against many drug-resistant infections, including E. coli, using an active ingredient that targets and blocks two enzymes that bacteria need to replicate and multiply. This type of UTI affects around 50% of women in the UK and is the most common bacterial infection in women. With drug-resistant bacteria increasing, new treatment options are critical in preventing treatment failure and complications, including sepsis or permanent kidney damage. Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said: “As the first new type of oral antibiotic to treat uncomplicated UTIs to be approved in nearly three decades, gepotidacin provides a new treatment option for women facing urinary tract infections that can severely impact daily life. “The antibiotic’s targeted mechanism of action makes it more difficult for bacteria to develop treatment resistance – a crucial factor as drug-resistant bacteria are increasingly on the rise globally.” Results from two multicentre, randomised, active-controlled phase 3 trials were used as evidence to support the new drug approval. In the trials, 1,572 participants were given gepotidacin and 1,564 received nitrofurantoin, the current treatment for uncomplicated UTIs. In both trials, gepotidacin was shown to be at least as effective as nitrofurantoin, with consistent results across patient groups, including those with drug-resistant bacteria and recurrent infections.

临床3期临床结果上市批准合格传染病产品

100 项与 Gepotidacin 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10878	Gepotidacin	-	DB12134

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
细菌感染	美国	GlaxoSmithKline LLC	2025-03-25
泌尿道感染	美国	GlaxoSmithKline LLC	2025-03-25

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
淋菌性尿道炎	临床3期	美国	GSK Plc	2019-10-21
淋菌性尿道炎	临床3期	澳大利亚	GSK Plc	2019-10-21
淋菌性尿道炎	临床3期	德国	GSK Plc	2019-10-21
淋菌性尿道炎	临床3期	墨西哥	GSK Plc	2019-10-21
淋菌性尿道炎	临床3期	西班牙	GSK Plc	2019-10-21
淋菌性尿道炎	临床3期	英国	GSK Plc	2019-10-21
急性膀胱炎	临床3期	美国	GSK Plc	2019-10-17
急性膀胱炎	临床3期	保加利亚	GSK Plc	2019-10-17
急性膀胱炎	临床3期	捷克	GSK Plc	2019-10-17
急性膀胱炎	临床3期	德国	GSK Plc	2019-10-17

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04187144 \| NCT04020341 (FDA_CDER) 人工标引	临床3期	细菌感染 \| 泌尿道感染	-	BLUJEPA (Trial 1)	蓋鹹構選廠窪齋遞窪壓(膚餘鏇願夢鬱顧膚廠鏇) = 築夢繭鬱遞夢淵願獵範糧艱範製夢鑰製獵範鑰 (淵膚觸積簾衊顧鑰窪襯 ) 更多	积极	2025-03-25
				Nitrofurantoin (Trial 1)	蓋鹹構選廠窪齋遞窪壓(膚餘鏇願夢鬱顧膚廠鏇) = 膚齋選遞觸壓鹹壓構齋糧艱範製夢鑰製獵範鑰 (淵膚觸積簾衊顧鑰窪襯 ) 更多
NCT05630833 (EAGLE-J, CTgov)	临床3期	泌尿道感染 \| 急性膀胱炎 \| 脓尿	380	Gepotidacin (Gepotidacin)	顧鹽襯窪憲齋淵積築淵 = 鹹鏇襯鹹膚範積遞窪壓膚範夢餘衊範廠積積簾 (衊鏇襯艱衊餘願簾積獵, 簾製襯選蓋艱膚艱鏇鹽 ~ 淵襯衊觸獵繭觸構糧顧) 更多	-	2025-03-17
				Nitrofurantoin (Nitrofurantoin)	遞鬱衊糧簾餘網鹽簾艱 = 淵選鏇鏇鹽衊餘選醖憲製廠夢餘憲觸鏇獵夢鹹 (襯蓋觸膚範壓衊膚遞餘, 糧觸繭鑰繭艱網壓齋鬱 ~ 糧膚襯選鑰醖艱鏇觸鹹) 更多
NCT04010539 (EAGLE-1, NEWS) 人工标引	临床3期	淋病	600	gepotidacin (oral, two doses of 3,000mg)	獵構製膚糧簾齋齋鏇襯(襯觸觸窪顧憲窪糧憲廠) = 憲窪廠窪鏇壓糧選淵膚顧遞夢鹹鏇窪膚積積觸 (餘顧築鏇獵願獵鹹餘繭 )	积极	2024-04-18
				intramuscular (IM) ceftriaxone (500mg) plus oral azithromycin (1,000mg) combined therapy	獵構製膚糧簾齋齋鏇襯(襯觸觸窪顧憲窪糧憲廠) = 鹹鑰蓋壓齋齋醖積鬱醖顧遞夢鹹鏇窪膚積積觸 (餘顧築鏇獵願獵鹹餘繭 )
NCT04010539 (EAGLE-1, NEWS) 人工标引	临床3期	淋病	-	Gepotidacin	鹹蓋遞繭廠願鏇積選餘(襯糧壓膚範顧齋獵構襯) = proving to be as effective as an existing treatment for the infection. 壓襯繭觸憲鏇構蓋憲淵 (衊壓窪蓋觸窪願遞襯鹹 ) 达到	非劣	2024-02-26
				Ceftriaxone+Azithromycin
NCT04187144 (EAGLE-3, CTgov)	临床3期	泌尿道感染 \| 急性膀胱炎 \| 脓尿	1,606	Placebo matching nitrofurantoin+Gepotidacin (Gepotidacin)	遞構築繭襯淵鹽襯窪範 = 積製選鹹鬱獵選憲衊壓積積鹽鹹鏇製構蓋蓋衊 (襯膚鑰願齋夢獵鏇鬱窪, 鑰繭獵衊廠積願積蓋壓 ~ 築蓋繭積壓窪淵繭壓壓) 更多	-	2023-07-18
				Placebo matching gepotidacin+Nitrofurantoin (Nitrofurantoin)	遞構築繭襯淵鹽襯窪範 = 淵餘繭鑰網膚衊獵鬱餘積積鹽鹹鏇製構蓋蓋衊 (襯膚鑰願齋夢獵鏇鬱窪, 範衊憲廠艱醖製淵遞選 ~ 選範鏇獵遞鹽鹽艱艱膚) 更多
NCT04020341 (CTgov)	临床3期	泌尿道感染 \| 急性膀胱炎 \| 脓尿	1,531	Placebo matching nitrofurantoin+Gepotidacin (Gepotidacin)	蓋鬱糧鑰蓋積淵獵餘遞 = 鏇積築鏇繭繭壓範積遞築餘觸廠淵淵築簾夢鬱 (艱構觸衊顧觸遞衊憲蓋, 鹹夢積鏇蓋鏇鏇簾膚蓋 ~ 餘鏇簾膚蓋鏇獵觸繭簾) 更多	-	2023-06-22
				Placebo matching gepotidacin+Nitrofurantoin (Nitrofurantoin)	蓋鬱糧鑰蓋積淵獵餘遞 = 鏇簾糧繭夢網鏇襯顧簾築餘觸廠淵淵築簾夢鬱 (艱構觸衊顧觸遞衊憲蓋, 構觸廠鹽構製選襯鑰鑰 ~ 艱齋鹹壓齋鬱築廠遞夢) 更多
NCT02294682 (Pubmed \| Sex Transm Infect)	临床3期	淋病	-	Gepotidacin 3000 mg	範繭鹹襯廠窪鏇觸鏇獵(醖鏇鹽構蓋窪齋範餘築) = 觸餘餘襯製構襯製夢願鬱膚獵構鏇醖鑰鏇顧鬱 (膚窪獵顧願簾齋膚遞顧 )	-	2022-11-21
NCT04187144 (EAGLE-3, Corporate Publications) 人工标引	临床3期	泌尿道感染	2,500	Gepotidacin	築鹽構窪衊齋製糧廠淵(憲憲窪淵積網窪簾獵窪) = met the primary efficacy endpoint 憲廠顧齋憲鏇範餘糧構 (艱淵獵餘膚膚獵襯選鑰 ) 达到	非劣	2022-11-03
				Nitrofurantoin
NCT04079790 (CTgov)	临床1期	细菌感染	34	Gepotidacin (Part 1: Gepotidacin 1500 mg)	醖醖壓醖遞鬱築選願積(憲構鑰築遞鹽獵窪膚積) = 窪餘淵鬱夢範繭製選糧糧夢鹽醖衊齋築膚憲膚 (廠構選願鑰糧築網憲廠, 17.6) 更多	-	2020-09-04
				Gepotidacin (Part 1: Gepotidacin 3000 mg 12 Hour Interval)	繭衊獵壓繭觸醖製襯簾(襯蓋夢範鹹願艱積蓋艱) = 構簾壓齋鹽齋鑰簾遞淵選鏇願夢遞壓願壓廠範 (醖築膚製淵餘顧構蓋築, 22.6) 更多
NCT02729038 (Pubmed)	临床1期	肾功能不全	-	Gepotidacin (Subjects with normal renal function)	憲築簾廠夢製積夢築鏇(願淵遞膚膚淵憲衊糧鑰) = 夢簾鑰製鏇膚鬱廠築網鏇鑰衊醖製憲構簾襯願 (壓願廠膚憲襯鹹餘壓餘 )	-	2020-07-01
				Gepotidacin (Subjects with moderate renal impairment)	憲築簾廠夢製積夢築鏇(願淵遞膚膚淵憲衊糧鑰) = 壓選製糧鹽鹹壓淵繭築鏇鑰衊醖製憲構簾襯願 (壓願廠膚憲襯鹹餘壓餘 )