A Multicentric Randomized Trial of Daily Nitrofurantoin Versus Bladder Fulguration Plus Daily Nitrofurantoin for the Long-term Management of Cystitis in Women With Recurrent Urinary Tract Infections

The goal of this clinical trial is to learn if the drug Nitrofurantoin (NF) taken as a daily antibiotic, works to treat cystitis compared to electrofulguration (EF) and Nitrofurantoin (NF) daily antibiotic.

开始日期2025-11-01

申办/合作机构

The University of Texas Southwestern Medical Center

[+3]

NCT07202832

/ Not yet recruitingN/AIIT

Efficacy and Safety of Urine Alkalinization in Treatment of Uncomplicated Urinary Tract Infection in Women: A Randomized Controlled Trial

The goal of this clinical trial is to evaluate whether urinary alkalinization using potassium citrate can relieve symptoms and improve urine culture results in women aged 18 to 50 years with uncomplicated urinary tract infections (UTIs). The main questions it aims to answer are:
Does urinary alkalinization reduce UTI symptom scores by Day 7?
Does it lead to better urine culture results compared to antibiotic?
Researchers will compare urinary alkalinization with potassium citrate to antibiotic to see if it provides more symptom relief and better microbiological outcomes.
Participants will:
Take either potassium citrate or antibiotic
Be assessed for symptoms and adverse events on Day 7
Provide a urine sample for culture before and after treatment
Report any return visits due to worsening symptoms or medication side effects

开始日期2025-10-15

申办/合作机构

Assiut University

NCT06723392

/ Not yet recruiting临床3期IIT

Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries: A Randomized Controlled Trial of the Global Network for Women's and Children's Health Research

This study, Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries (ABLE), is designed as a 2-arm randomized controlled trial (RCT) focused on pregnant individuals and newborn infants. A positive outcome of this study will contribute to global progress toward WHO Sustainable Development Goal Target 3.2 [End preventable deaths of newborns and children under 5 years of age] by examining the potential impact of this practice to reduce the incidence of SVN/SB and the lifelong health consequences associated with SVNs. In addition, the study will further explore the role and potential benefits of antibiotic treatment of AB in the pregnant individual. In total, 1,134 eligible participants, or approximately 162 per research site, will be randomized in the trial by the research teams in each of the seven international sites that, together with their United States of America (US) partners, participate in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's (NICHD's) Global Network for Women's and Children's Health Research (GN).

开始日期2025-09-01

申办/合作机构

National Institute of Child Health & Human Development

[+11]

100 项与呋喃妥因相关的临床结果

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100 项与呋喃妥因相关的转化医学

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100 项与呋喃妥因相关的专利（医药）

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8,317

项与呋喃妥因相关的文献（医药）

2026-01-01·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Rational design of AIE-ligand-based luminescent Zn(II) coordination polymers for visual recognition of Fe3+, nitro explosives and antibiotics

Article

作者: Li, Meiyin ; Zheng, Chunyang ; Wang, Dunjia ; Sun, Xuancheng ; Dong, Chuanzong

Luminescent coordination polymers (LCPs) represent an emerging class of materials for visual analyte detection. In this study, we propose a method to introduce the aggregation-induced emission (AIE) linker pyrazine-tetracarboxylic acid (H₄tcpp: 4,4',4″,4″'-(pyrazine-2,3,5,6-tetrayl) tetrabenzoic acid) into LCPs. By incorporating two N-containing ligands (Bpmh: 1,2-bis(pyridin-4-ylmethylene) hydrazine; Bpmh:1,4-bis((1H-imidazol-1-yl) methyl) benzene) with different flexibilities and adopting a mixed-ligand strategy, we successfully constructed two coordination polymers (CP1 and CP2) with distinct topological structures. Furthermore, it was revealed that both CPs present excellent sensitivity and selectivity to sense Fe³⁺, nitro explosives (4-nitrophenol, 4-NP; 2,4,6-trinitrophenol: TNP) and antibiotics (nitrofurazone: NFZ; nitrofurantoin: NFT) in aqueous solution through fluorescence quenching. The AIE linker and auxiliary ligands with different flexibilities simultaneously control the structure, regulate the porosity and enhance the emission intensity. This strategy significantly enhances the sensitivity, selectivity. In addition, the effective sensing mechanism was fully verified by spectral analysis and density functional theory (DFT), which revealed that collaborative effects of PET, FRET, CA and the weak intermolecular forces between CPs and the analytes are essential for the quenching of the CP's fluorescence signal. In addition, we demonstrate an instant, portable smartphone-assisted intelligent visual detection method for trinitrophenol (TNP) by integrating a smartphone as the signal output terminal.

2025-12-01·MOLECULAR BIOLOGY REPORTS

Two case reports of biliary stent infections by extensively drug-resistant Escherichia coli carrying blaNDM-5 at a tertiary-care hospital in West Bengal, India

Article

作者: Das, Surojit ; Sarkar, Dipankar ; Mallick, Abhi ; Sarkar, Soma ; Saha, Puranjay

BACKGROUND:

Rising antimicrobial resistance (AMR) is an acute public health emergency impeding the clinical efficacy of surgical interventions. Biliary stent placement is one of the routine surgical procedures that rarely lead to infections that are empirically managed by broad-spectrum β-lactams and fluoroquinolones. Critical priority pathogens, such as carbapenem-resistant Escherichia coli challenge treatment outcomes and infection prevention.

METHODS AND RESULTS:

Two carbapenem-resistant Escherichia coli isolates recovered from biliary stent-infected patients were investigated for drug resistance and molecular typing from a tertiary-care hospital in eastern India. The isolates were extensively drug-resistant (XDR) and remained susceptible to aminoglycosides, tigecycline, fosfomycin, or colistin. Carbapenemase bla_NDM-5 was carried by both the isolates that either belonged to strain type ST361 or ST405.

CONCLUSIONS:

This is the first report of carbapenem-resistant Escherichia coli carrying bla_NDM-5 being recovered from biliary stent infections in India. Targeted antibiotic therapy is pivotal for the XDR infections, while molecular typing facilitates infection prevention measures by source tracking and control.

2025-12-01·Veterinary and Animal Science

Typing identification and biological characterization of Clostridium perfringens toxins associated with lamb dysentery in Xizang sheep

Review

作者: Ma, Zhuo ; Zhenjie, Yuan

The objectives of this study were to investigate the etiology of morbidity and mortality in Tibetan sheep from a township in Shannan, Tibet, and to characterize the biological characteristics of the causative pathogen, thereby providing a scientific basis for effective disease prevention and control. Pathological specimens were aseptically collected from deceased animals, and the pathogen was isolated and cultured based on clinical presentations. Identification of the isolate involved morphological observation, 16S rRNA PCR amplification and sequencing, biochemical assays, toxin gene typing, Kirby-Bauer disk diffusion antimicrobial susceptibility testing, and antibiotic resistance genes screening. On tryptose sulfite cycloserine (TSC) agar, the organism formed black, circular colonies. Gram staining revealed short, straight, Gram-positive bacilli arranged singly or in pairs, consistent with the Clostridium perfringens . 16S rRNA gene sequence alignment showed >99 % identity to reference C. perfringens sequences in the NCBI database. Confirming the strain asC. perfringens. Biochemical tests indicated positive reactions for glucose, Biochemical assays were positive for glucose, lactose, and maltose fermentation; gelatin hydrolysis; oxidase activity; nitrate reduction;hydrogen sulfide production; and ornithine decarboxylase, but negative results for indole production, mannitol and sorbitol fermentation, and urea hydrolysis, matching known traits of C. perfringens. . Toxin gene PCR detected cpa,cpb, and etx, but not iap, cpe, or netB, identifying the isolate as C. perfringens type B. Antimicrobial susceptibility testing revealed high sensitivity to sulfadiazine, norfloxacin, nitrofurantoin, and cefazolin, but resistance to amoxicillin, oxacillin, carbenicillin, and tetracycline.Among the resistance genes screened, only aac(6')-Ib-cr was detected.This study reports the first isolation of C. perfringens type B in Shannan, Tibet; elucidates its biological characteristics and toxin profile; identifies effective antibiotics for targeted intervention; and provides foundational data for controlling lamb dysentery caused by this pathogen and for understanding its pathogenicity in sheep.

项与呋喃妥因相关的新闻（医药）

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

2025-07-20

·信狐药迅

浙江百代2.2类改良新苯磺酸氨氯地平颗粒提交上市申请|新受理（7.14-7.20）

本周药品注册受理数据，分门别类呈现，一目了然。(7.14-7.20）新药上市申请药品名称企业注册分类受理号苯磺酸氨氯地平颗粒浙江百代医药科技有限公司2.2CXHS2500083苯磺酸氨氯地平颗粒浙江百代医药科技有限公司2.2CXHS2500082苯磺酸氨氯地平颗粒浙江百代医药科技有限公司2.2CXHS2500081苯磺酸氨氯地平颗粒浙江百代医药科技有限公司2.2CXHS2500080新药临床申请药品名称企业注册分类受理号CKBA乳膏江苏博创园生物医药科技有限公司1CXHL2500725CKBA乳膏江苏博创园生物医药科技有限公司1CXHL2500724CKBA乳膏江苏博创园生物医药科技有限公司1CXHL2500723CKBA乳膏江苏博创园生物医药科技有限公司1CXHL2500722CKBA乳膏江苏博创园生物医药科技有限公司1CXHL2500721YUQ-A1007片元启(苏州)生物制药有限公司1CXHL2500720YUQ-A1007片元启(苏州)生物制药有限公司1CXHL2500719JYP0061片广州嘉越医药科技有限公司1CXHL2500718JYP0061片广州嘉越医药科技有限公司1CXHL2500717JYP0061片广州嘉越医药科技有限公司1CXHL2500716GTA182片上海湃隆生物科技有限公司1CXHL2500707GTA182片上海湃隆生物科技有限公司1CXHL2500706D-2570片益方生物科技(上海)股份有限公司1CXHL2500705SYH2070注射液石药集团中诺药业(石家庄)有限公司1CXHL2500709PH027-1片苏州浦合医药科技有限公司1CXHL2500704PH027-1片苏州浦合医药科技有限公司1CXHL2500703IBI3032信达生物科技有限公司1CXHL2500702IBI3032信达生物科技有限公司1CXHL2500701IBI3032信达生物科技有限公司1CXHL2500700IBI3032信达生物科技有限公司1CXHL2500699盐酸左沙丁胺醇异丙托溴铵吸入溶液济南景笙科技有限公司2.1CXHL2500710AKZ001直服颗粒海南爱科制药有限公司2.2CXHL2500726LPD-003原位凝胶浙江紫藤药业科技有限公司2.2CXHL2500708SQ-129玻璃体缓释注射液沈阳兴齐眼药股份有限公司2.2CXHL2500712SQ-129玻璃体缓释注射液沈阳兴齐眼药股份有限公司2.2CXHL2500711BTP4507江苏诺和必拓新药研发有限公司2.3CXHL2500698APG-2575片苏州亚盛药业有限公司2.4CXHL2500715APG-2575片苏州亚盛药业有限公司2.4CXHL2500714APG-2575片苏州亚盛药业有限公司2.4CXHL2500713ACYW135群脑膜炎球菌结合疫苗上海瑞宙生物科技有限公司2.2CXSL2500594SHR-7787注射液上海恒瑞医药有限公司1CXSL2500605SHR-7787 注射液上海恒瑞医药有限公司1CXSL2500604SHR-1905注射液广东恒瑞医药有限公司1CXSL2500602SHR-4849注射液苏州盛迪亚生物医药有限公司1CXSL2500601HiCM388注射液艾尔普再生医学科技(深圳)有限公司1CXSL2500607注射用YLSH003成都苑东生物制药股份有限公司1CXSL2500600EMB-07注射液上海岸迈生物科技有限公司1CXSL2500599HS_SW01细胞注射液深圳惠善生物科技有限公司1CXSL2500598HS_SW01细胞注射液深圳惠善生物科技有限公司1CXSL2500597TJ101注射液天境生物科技(杭州)有限公司1CXSL2500596HX044注射液翰思艾泰生物医药科技(武汉)股份有限公司1CXSL2500595注射用AK138D1中山康方生物医药有限公司1CXSL2500593OVV-01注射液上海荣瑞医药科技有限公司1CXSL2500592OVV-01注射液上海荣瑞医药科技有限公司1CXSL2500591重组人源化抗HER2双特异性抗体注射液上海津曼特生物科技有限公司1CXSL2500590注射用MR001双特异性抗体深圳市迈加瑞生物技术有限公司1CXSL2500589注射用QLC5508齐鲁制药有限公司1CXSL2500585KDTV001注射液武汉凯德基诺生物技术有限公司1CXSL2500586EVM14注射液云顶新耀(北京)医药科技有限公司1CXSL2500584贝伐珠单抗注射液苏州盛迪亚生物医药有限公司2.2CXSL2500606阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500603恩朗苏拜单抗注射液石药集团巨石生物制药有限公司2.2CXSL2500588QL2107注射液齐鲁制药有限公司2.2CXSL2500587仿制药申请药品名称企业注册分类受理号生理氯化钠溶液山东华茂药业有限公司3CYHS2502610盐酸克林霉素棕榈酸酯颗粒安徽省先锋制药有限公司3CYHS2502578头孢羟氨苄干混悬剂苏州第三制药厂有限责任公司3CYHS2502582异烟肼口服溶液江苏润恒制药有限公司3CYHS2502577碳酸氢钠血滤置换液(无钾、无钙、0.6 mmol/L镁)宁波天益药业科技有限公司3CYHS2502596碳酸氢钠血滤置换液宁波天益药业科技有限公司3CYHS2502595碳酸氢钠血滤置换液宁波天益药业科技有限公司3CYHS2502592布美他尼注射液海南普利制药股份有限公司3CYHS2502591维生素B6注射液海南普利制药股份有限公司3CYHS2502590碳酸氢钠血滤置换液宁波天益药业科技有限公司3CYHS2502589碳酸氢钠血滤置换液(钾2mmol/L无钙)宁波天益药业科技有限公司3CYHS2502587盐酸溴己新口服溶液石家庄四药有限公司3CYHS2502586头孢羟氨苄干混悬剂苏州第三制药厂有限责任公司3CYHS2502583硫糖铝口服混悬液青岛双鲸药业股份有限公司3CYHS2502571维生素B12注射液南京恩泰医药科技有限公司3CYHS2502568联苯苄唑溶液江苏和晨药业有限公司3CYHS2502567磷酸奥司他韦颗粒江西施美药业股份有限公司3CYHS2502573多种微量元素注射液(4-Ⅱ)北京柏雅联合药物研究所有限公司3CYHS2502551维生素K1滴剂葵花药业集团(襄阳)隆中有限公司3CYHS2502534西咪替丁注射液山东华鲁制药有限公司3CYHS2502539恩格列净二甲双胍缓释片石药集团欧意药业有限公司3CYHS2502556恩格列净二甲双胍缓释片石药集团欧意药业有限公司3CYHS2502555恩格列净二甲双胍缓释片石药集团欧意药业有限公司3CYHS2502554呋喃妥因胶囊石家庄荣雾迪医药科技有限公司3CYHS2502553维生素K1滴剂浙江维康药业股份有限公司3CYHS2502535呋喃妥因胶囊石家庄荣雾迪医药科技有限公司3CYHS2502552中性腹膜透析液(碳酸氢盐-G2.5%)青岛瑞奈医疗科技有限公司3CYHS2502550中性腹膜透析液(碳酸氢盐-G1.5%)青岛瑞奈医疗科技有限公司3CYHS2502549呋塞米口服溶液郑州达若医药科技有限公司3CYHS2502546地塞米松磷酸钠注射液华夏生生药业(北京)有限公司3CYHS2502529硫代硫酸钠注射液知和(山东)大药厂有限公司3CYHS2502527辅酶Q10片杭州和泽坤元药业有限公司3CYHS2502526腺苷钴胺胶囊湖南先施制药有限公司3CYHS2502531盐酸普萘洛尔注射液德全药品(江苏)股份有限公司3CYHS2502518苯磺酸美洛加巴林片海南合瑞制药股份有限公司4CYHS2502614苯磺酸美洛加巴林片海南合瑞制药股份有限公司4CYHS2502613布南色林片石家庄科仁医药科技有限公司4CYHS2502612复方氨基酸注射液(18AA-VII)山东豪瑞恩制药有限公司4CYHS2502611枸橼酸钠血滤置换液山东华茂药业有限公司4CYHS2502609精氨酸布洛芬颗粒海南海神同洲制药有限公司4CYHS2502608精氨酸布洛芬颗粒海南海神同洲制药有限公司4CYHS2502607枸橼酸莫沙必利片浙江东亚药业股份有限公司4CYHS2502606枸橼酸莫沙必利片浙江东亚药业股份有限公司4CYHS2502605乌帕替尼缓释片江苏亚邦爱普森药业有限公司4CYHS2502604ω-3脂肪酸乙酯90软胶囊丽珠集团丽珠制药厂4CYHS2502581替普瑞酮胶囊珠海同源药业有限公司4CYHS2502580乌帕替尼缓释片广州誉东健康制药有限公司4CYHS2502579硫酸艾沙康唑胶囊北京博康健基因科技有限公司4CYHS2502599甘油磷酸钠注射液深圳大佛药业股份有限公司4CYHS2502598甘油磷酸钠注射液山东化药医药科技有限公司4CYHS2502597艾普拉唑肠溶片辰欣药业股份有限公司4CYHS2502594佩玛贝特片海南赛立克药业有限公司4CYHS2502593注射用哌拉西林钠他唑巴坦钠/氯化钠注射液山东二叶制药有限公司4CYHS2502588环孢素软胶囊人福普克药业(武汉)有限公司4CYHS2502585环孢素软胶囊人福普克药业(武汉)有限公司4CYHS2502584苯磺酸左氨氯地平片安徽省先锋制药有限公司4CYHS2502603苯磺酸左氨氯地平片安徽省先锋制药有限公司4CYHS2502602枸橼酸西地那非口腔崩解片津华医药科技(湖州)有限公司4CYHS2502601卡泊三醇软膏重庆胜凯制药有限公司4CYHS2502572阿帕他胺片华东医药(西安)博华制药有限公司4CYHS2502570吗啉硝唑氯化钠注射液湖北华仁同济药业有限责任公司4CYHS2502569蔗糖羟基氧化铁咀嚼片丽彩甘肃西峰制药有限公司4CYHS2502566乙酰半胱氨酸泡腾片珠海联邦制药股份有限公司中山分公司4CYHS2502565双氯芬酸钠盐酸利多卡因注射液广州合和医药有限公司4CYHS2502563西甲硅油乳剂湖南千金协力药业有限公司4CYHS2502562伏立康唑片植恩生物技术股份有限公司4CYHS2502561伏立康唑片植恩生物技术股份有限公司4CYHS2502560碳酸司维拉姆片江苏中天药业有限公司4CYHS2502575噻托溴铵吸入喷雾剂齐鲁安替制药有限公司4CYHS2502600普拉洛芬滴眼液湖北泰林医药有限公司4CYHS2502564阿昔莫司胶囊乐声药业石家庄有限公司4CYHS2502576富马酸福莫特罗吸入溶液成都普什制药有限公司4CYHS2502574口服用苯丁酸甘油酯宿州亿帆药业有限公司4CYHS2502559巴瑞替尼片山东鲁抗医药集团赛特有限责任公司4CYHS2502558盐酸尼卡地平注射液南京正科医药股份有限公司4CYHS2502557盐酸奥洛他定片海南赛立克药业有限公司4CYHS2502544富马酸贝达喹啉片浙江海正药业股份有限公司4CYHS2502543乙酰半胱氨酸注射液四川天杏汇医药科技有限公司4CYHS2502542乙酰半胱氨酸注射液济南康桥医药科技有限公司4CYHS2502541瑞维那新吸入溶液长风药业股份有限公司4CYHS2502540硫酸氨基葡萄糖胶囊河南羚锐制药股份有限公司4CYHS2502538克立硼罗软膏江苏正大清江制药有限公司4CYHS2502537屈螺酮炔雌醇片(II)浙江爱生药业有限公司4CYHS2502536达格列净二甲双胍缓释片(III)湖南千金湘江药业股份有限公司4CYHS2502548达格列净二甲双胍缓释片(I)湖南千金湘江药业股份有限公司4CYHS2502547盐酸奥洛他定片海南赛立克药业有限公司4CYHS2502545注射用帕瑞昔布钠湖北长联杜勒制药有限公司4CYHS2502530泊沙康唑口服混悬液成都倍特得诺药业有限公司4CYHS2502528蔗糖铁注射液成都欣捷高新技术开发股份有限公司4CYHS2502525低钙腹膜透析液(乳酸盐-G4.25%)四川青山利康药业有限公司4CYHS2502524低钙腹膜透析液(乳酸盐-G4.25%)四川青山利康药业有限公司4CYHS2502523低钙腹膜透析液(乳酸盐-G2.5%)四川青山利康药业有限公司4CYHS2502522低钙腹膜透析液(乳酸盐-G2.5%)四川青山利康药业有限公司4CYHS2502521低钙腹膜透析液(乳酸盐-G1.5%)成都青山利康药业股份有限公司4CYHS2502520低钙腹膜透析液(乳酸盐-G1.5%)四川青山利康药业有限公司4CYHS2502519羟乙基淀粉130/0.4氯化钠注射液华夏生生药业(北京)有限公司4CYHS2502533羟乙基淀粉130/0.4氯化钠注射液华夏生生药业(北京)有限公司4CYHS2502532甲钴胺片四川依科制药有限公司4CYHS2502517流感病毒裂解疫苗江苏金迪克生物技术股份有限公司3.3CXSS2500075人血管性血友病因子/凝血因子Ⅷ复合物山东泰邦生物制品有限公司3.2CXSS2500076吲哚美辛凝胶贴膏海南回元堂药业有限公司3CYHL2500130卡左双多巴肠凝胶湖南派格兰药业有限公司3CYHL2500128注射用多黏菌素E甲磺酸钠湖南科伦制药有限公司3CYHL2500129进口申请药品名称企业注册分类受理号罗培干扰素α-2b注射液PharmaEssentia Corporation2.2JXSS2500099注射用德曲妥珠单抗Daiichi Sankyo Europe GmbH3.1JXSS2500101加达西单抗注射液CSL Behring AG3.1JXSS2500100注射用塔拉妥单抗Amgen Inc.3.1JXSS2500103注射用塔拉妥单抗Amgen Inc.3.1JXSS2500102BMS-986504片Bristol-Myers Squibb Company1JXHL2500189BMS-986504片Bristol-Myers Squibb Company1JXHL2500188BMS-986504片Bristol-Myers Squibb Company1JXHL2500187Leflutrozole胶囊ReproNovo SA1JXHL2500186Leflutrozole胶囊ReproNovo SA1JXHL2500185Leflutrozole胶囊ReproNovo SA1JXHL2500184盐酸依匹斯汀乳膏Santen Pharmaceutical Co., Ltd.5.1JXHL2500190IcoSema 注射液Novo Nordisk A/S1JXSL2500122中药相关申请药品名称企业注册分类受理号宣郁通经汤颗粒合肥华润神鹿药业有限公司3.1CXZS2500030注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市临床申请

2025-04-16

·ChenFJMU

新药速递｜2025年3月FDA批准上市2款新药【解读：从剂型，到临床药理，到合理用药】

ChenFJMU团队编辑（原创）思语湖畔QuoteThe only way to do great work is to love what you do. If you haven’t found it yet, keep looking. Don’t settle. — Steve JobsFDA新药速递【25年3月】看点FDA于2025年3月批准2款新药，分别为用于治疗体重至少为40 kg的12岁及以上女性由微生物引起的无并发症尿路感染（uUTI）患者的三氮杂苊类抗生素Blujepa；用于常规预防或减少12 岁及以上患有血友病 A/B 儿童和成人患者出血发作频率的抗凝血酶（AT）降低疗法Fitusiran。01 近三十年首款——GSK的“First-in-class”药物Blujepa开创uUTI抗菌新疗法。02 重磅预防——全球第七款siRNA药物Fitusiran获批，用于血友病A/B出血发作，每两月皮下注射一次！细说FDA新药【25年3月】（ChenFJMU）Blujepa，01Blujepa（Gepotidacin，吉泊达星），由英国制药公司葛兰素史克研发，于2025年3月25日获得FDA的批准。Gepotidacin用于治疗由特定敏感微生物引起的儿科患者和成年女性的单纯性尿路感染（uUTIs），这些微生物包括大肠杆菌、肺炎克雷伯菌、弗氏柠檬酸杆菌复合菌、腐生葡萄球菌和粪肠球菌。uUTIs是女性最常见的感染之一，患者对新型口服抗生素（尤其是对产生耐药的尿路感染病原体）的治疗需求仍未得到满足。作为近三十年来首个具有新型作用机制的口服抗生素， Blujepa的获批为反复感染和对现有治疗耐药上升的患者提供了新选择。此外，全球获FDA批准用于治疗uUTI的药物还有多款，包括两款传统抗菌药物（Nitrofurantoin，呋喃妥因和Ciprofloxacin，环丙沙星）以及2024年获批的Pivya（Pivmecillinam，吡美西林）和Orlynvah（Sulopenem etzadroxil/Probenecid，舒洛培南和丙磺舒）。FDA批准用于治疗uUTI的药物（ChenFJMU原创）注：ChenFJMU原创，转载需要标注出处！【结构与剂型处方】Blujepa片剂含有活性成分Gepotidacin，这是一种抑制细菌DNA回旋酶和拓扑异构酶IV的三氮杂苊抗菌剂，化学名称为（R）-2-((4-(((3，4-二氢-2H-吡喃并[2，3-c]吡啶-6-基)甲基)氨基)哌啶-1-基)甲基)-1，2-二氢-3H，8H-2a，5，8a-三氮杂苊-3，8-二酮甲磺酸盐二水合物，分子式为C24H28N6O3●CH4O3S●2H2O，分子量为580.66。化学结构如下：每片Blujepa口服片剂含有750 mg Gepotidacin（相当于910.7 mg无水Gepotidacin甲磺酸盐）。非活性成分包括：二氧化硅胶体、交联羧甲基纤维素钠、硬脂酸镁、微晶纤维素、聚乙二醇、聚乙烯醇、滑石、二氧化钛和黄铁氧化物。【作用机制】Gepotidacin是一种新型三氮杂苊烯类口服抗生素，通过抑制细菌的II型拓扑异构酶（包括细菌DNA拓扑异构酶II（促旋酶）和拓扑异构酶IV），来抑制细菌DNA复制而发挥良好的杀菌作用。这种独特的结合位点和作用机制使其对大多数目标病原体（如大肠杆菌和腐生葡萄球菌）具有活性，包括对现有抗生素耐药的菌株。经时间杀伤研究证实，Gepotidacin对病原体具有杀菌活性。体外研究表明，在最低抑菌浓度（MIC）为5倍的情况下，Gepotidacin对大肠杆菌的抗生素后作用为1.8~2.2 h，对肺炎克雷伯菌的作用为1~6.6 h，对奇异杆菌的作用为1.4~3 h，对弗氏梭菌的作用为1.5~2.6 h，对腐生链球菌的作用为2.7~4.3 h，对粪肠球菌的作用为1.2~2.7 h。Gepotidacin的作用机制（Tiffany C, et al. Clin Transl Sci. 2022; 15: 2251-2264.）【药效学及药代动力学】药效学：动物感染和体外药代动力学-药效学（PK-PD）模型显示，24 h游离药物AUC与MIC之比是预测Gepotidacin抗菌疗效的PK-PD指数。药代动力学：除非另有说明，否则下表中以平均值（标准偏差[SD]）总结Gepotidacin的药代动力学特性。特殊人群用药：1、孕妇：尚无关于孕妇使用Gepotidacin评估重大出生缺陷、流产或其他不良母体或胎儿结果的药物相关风险的可用数据。2、哺乳期：尚无关于人乳中存在Gepotidacin、其对母乳喂养儿童或产奶量的影响的数据。根据对哺乳期小鼠的研究，其可能会转移到乳汁中。3、儿童患者：尚未确定Gepotidacin对12岁以下或体重低于40 kg的儿童患者的安全性和有效性。4、老年患者：未观察到65岁以上老年患者与年轻成人患者之间在Gepotidacin的安全性或有效性方面存在总体差异，但不能排除一些老年人的更大敏感性。5、肝功能损伤患者：轻度或中度肝功能损害（Child-Pugh分级A/B）的患者无需调整剂量，严重肝功能损害患者避免使用。6、肾功能损伤患者：轻度或中度肾功能损害（轻度：eGFR 60至89 mL/min；中度：eGFR 30至59 mL/min）的患者无需调整剂量，严重肾功能损害患者避免使用。【非临床毒理学】Gepotidacin尚未进行长期致癌性研究，在动物研究中未发现该药影响生育能力。但在人类外周血淋巴细胞的体外微核试验和L5178Y小鼠淋巴瘤试验中呈阳性，在大鼠体内微核试验或彗星试验中呈阴性。基于证据的总体权重，其不太可能具有基因毒性。【临床研究】在2项多中心、双盲、双模拟、随机非劣效性（NI）试验中（试验1 EAGLE-2[NCT04020341]，N=1531和试验2 EAGLE-3[NCT04187144]，N=1605）对Gepotidacin的安全性进行了评估，受试者为12岁及以上患有uUTI的儿童患者和成年女性。试验共招募3136名患者，比较了Gepotidacin（1500 mg，每日两次）与呋喃妥因（100 mg，每日两次）在治疗uUTI上的有效性和安全性。研究的主要终点是在第10至13天的治愈检验期（TOC）访视中，达到临床和微生物学应答的患者比例。这两项试验中，Gepotidacin在治疗患uUTI的成年女性（≥40 kg）及大于12岁青少年患者（≥40 kg）时，与当前标准治疗之一呋喃妥因相比具有非劣效性。在EAGLE‑2研究中，Gepotidacin的治疗成功率为50.6%（162/320），活性对照组为47.0%（135/287），提高了4.3%（95%CI：-3.6～12.1）；其中临床成功率相近（65.6% vs 65.2%），微生物学成功率提高5.2%（72.5% vs 67.6%）。在EAGLE‑3研究中，Gepotidacin与活性对照组相比， Gepotidacin组治疗成功率为58.5%（162/277），活性对照组为43.6%（115/264），提高了14.6%（95%CI：6.4～22.8），表现出优效性；其中临床成功率提高4.4%（67.9% vs 63.3%），微生物学成功率提高15.0%（72.2% vs 57.2%）。【用药指南】往期回顾编辑：廖源榕排版：周纯情补充和审核：陈昌买推送：ChenFJMU（欢迎个人转发分享，企业及其他公众号需授权后转载，并注明出处！）

上市批准siRNA快速通道

100 项与呋喃妥因相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00439	呋喃妥因	J01XE01	DB00698

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
泌尿道感染	美国	Procter & Gamble Pharmaceuticals, Inc.	1953-02-06

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
急性膀胱炎	临床2期	美国	Procter & Gamble, Inc.	2002-01-01

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临床结果

适应症

分期

评价

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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


NCT03287089 (Pubmed \| Female Pelvic Med Reconstr Surg)	临床4期	-	164	Nitrofurantoin	繭衊繭繭獵廠繭衊遞壓(遞鑰憲憲淵築齋淵簾構) = 鬱繭觸膚築積繭窪鹽繭顧夢鏇廠夢繭範醖製鏇 (夢糧願願衊齋選淵壓遞 )	不佳	2021-03-01
				Placebo	繭衊繭繭獵廠繭衊遞壓(遞鑰憲憲淵築齋淵簾構) = 範簾鏇淵範鹽獵簾齋遞顧夢鏇廠夢繭範醖製鏇 (夢糧願願衊齋選淵壓遞 )
NCT03287089 (NAUTICA, CTgov)	临床4期	导管相关感染	164	Nitrofurantoin 100 MG (Nitrofurantoin)	簾繭製鏇繭衊蓋醖艱鑰 = 廠壓繭鹽夢醖鹹選餘淵餘膚繭積顧顧築獵齋構 (範蓋衊鏇鏇蓋願築築築, 衊鏇構選襯憲蓋鏇鬱齋 ~ 簾膚鬱願醖餘蓋繭憲願) 更多	-	2020-06-09
				Placebo Oral Tablet (Placebo)	簾繭製鏇繭衊蓋醖艱鑰 = 齋鑰壓廠簾醖鬱鏇衊衊餘膚繭積顧顧築獵齋構 (範蓋衊鏇鏇蓋願築築築, 糧壓簾鏇網構鹽鹽膚襯 ~ 觸構齋壓選衊選鬱獵網) 更多
NCT02384200 (CTgov)	临床4期	肾结石 \| 泌尿道感染	86	nitrofurantoin monohydrate+gentamicin+ceftriaxone+ampicillin+Vancomycin (Antibiotic)	夢選網積簾鹹鑰簾繭鬱 = 獵夢願齋膚餘齋製齋鹽顧鏇獵壓膚鬱壓獵鏇衊 (蓋鹽糧網鑰鑰顧壓簾鏇, 鹽範鏇衊夢獵鏇鏇齋構 ~ 鹹簾選艱觸簾憲願簾製) 更多	-	2019-08-22
				gentamicin+ceftriaxone+ampicillin+Vancomycin (No Preoperative Oral Antibiotics)	夢選網積簾鹹鑰簾繭鬱 = 艱繭餘鑰鏇蓋繭衊窪獵顧鏇獵壓膚鬱壓獵鏇衊 (蓋鹽糧網鑰鑰顧壓簾鏇, 簾艱鹹獵襯膚壓醖鹹鏇 ~ 憲糧糧獵夢願網簾廠襯) 更多
NCT02727322 (CTgov)	临床4期	盆腔脏器脱垂 \| 急性尿潴留	154	Nitrofurantoin (Nitrofurantoin)	窪壓糧淵觸鬱糧顧齋餘 = 願廠遞糧繭願遞構鑰積遞遞餘憲網糧蓋觸膚鹹 (衊淵醖醖繭衊憲膚艱範, 遞醖製窪蓋蓋壓鑰積衊 ~ 鬱鑰鬱構鹽鹹繭遞憲顧) 更多	-	2019-05-20
				Placebo (Placebo)	窪壓糧淵觸鬱糧顧齋餘 = 鏇觸繭窪淵醖鬱夢獵淵遞遞餘憲網糧蓋觸膚鹹 (衊淵醖醖繭衊憲膚艱範, 蓋簾艱選鑰憲醖憲壓壓 ~ 膚簾鹹淵積壓糧鏇遞觸) 更多
NCT01749605 (CTgov)	临床4期	膀胱炎	35	Nitrofurantoin monohydrate (Nitrofurantoin 100 mg)	糧蓋構壓醖遞顧襯糧鏇 = 衊簾蓋網製觸構蓋築窪廠艱範齋醖齋夢壓餘製 (積廠積淵襯遞憲繭鏇膚, 齋艱鹹壓糧衊構廠襯糧 ~ 鬱齋顧選築鬱膚鹽淵遞) 更多	-	2017-04-27
				ciprofloxacin (Ciprofloxacin 250 mg)	糧蓋構壓醖遞顧襯糧鏇 = 衊顧遞衊選選窪構觸選廠艱範齋醖齋夢壓餘製 (積廠積淵襯遞憲繭鏇膚, 顧夢範顧醖醖構選鑰夢 ~ 鬱鏇鹹鏇遞製顧鏇鹹糧) 更多
NCT00734968 (CTgov)	临床4期	泌尿道感染 \| 压力性尿失禁	161	Nitrofurantoin (Treatment)	醖選積廠鹹簾壓憲鑰繭 = 憲製選鹹鑰糧選糧選襯齋餘顧鏇襯醖壓願齋鹽 (範遞顧鑰襯鑰製選壓積, 餘鏇觸廠憲網簾醖廠繭 ~ 夢願鑰壓夢齋積遞壓獵) 更多	-	2016-10-11
				Placebo (Placebo)	醖選積廠鹹簾壓憲鑰繭 = 鏇襯襯鏇艱糧膚艱範觸齋餘顧鏇襯醖壓願齋鹽 (範遞顧鑰襯鑰製選壓積, 餘鏇壓獵簾鹽願製觸獵 ~ 壓鹽醖繭獵獵衊衊網積) 更多
NCT02829060 (Pubmed)	N/A	尿脓毒症	205	Nitrofurantoin 100 mg bid for 7 days	齋鹹糧願蓋醖鬱襯齋選(積願夢醖鹽蓋積鏇蓋鏇) = 網構齋築鏇顧餘艱餘窪網鏇衊網願繭築網鏇遞 (衊製艱獵夢製蓋鏇獵願 ) 更多	-	2012-02-01
NCT02789579 \| NCT02829060 (Pubmed \| Urology)	早期临床1期	呼吸道感染 \| 尿脓毒症	101	Nitrofurantoin prophylaxis	顧選觸憲艱顧製夢觸淵(衊齋憲膚積襯選築齋齋) = 鬱願壓鹽鹽齋簾鬱衊鏇餘壓構廠齋獵鏇願獵蓋 (夢蓋廠觸鑰壓構製蓋淵 ) 更多	积极	2011-01-01
ISRCTN11966080 (Pubmed \| Obstet Gynecol)	临床3期	妊娠期无症状菌尿	778	1-day nitrofurantoin regimen	憲淵襯衊願廠築壓鹹範(夢醖淵鬱鏇壓夢鬱淵選) = 醖鑰構選鑰觸壓範範夢積繭範窪餘夢艱窪選遞 (鹽壓壓齋築願築淵構衊 )	不佳	2009-02-01
				7-day nitrofurantoin regimen	憲淵襯衊願廠築壓鹹範(夢醖淵鬱鏇壓夢鬱淵選) = 醖壓艱蓋憲選膚獵襯簾積繭範窪餘夢艱窪選遞 (鹽壓壓齋築願築淵構衊 )
NCT00391651 (Pubmed)	临床2期	急性膀胱炎	338	Trimethoprim-sulfamethoxazole	淵繭艱願簾鏇淵製鹹齋(窪繭鏇願壓簾願廠範鏇) = 窪簾獵獵積淵繭夢糧糧鹹糧淵鬱構鬱壓構壓獵 (簾繭鬱鑰築廠糧窪範夢 )	积极	2007-11-12
				Nitrofurantoin	淵繭艱願簾鏇淵製鹹齋(窪繭鏇願壓簾願廠範鏇) = 廠糧餘廠鑰觸製築壓願鹹糧淵鬱構鬱壓構壓獵 (簾繭鬱鑰築廠糧窪範夢 )