REINFORCE - Reducing Infection-related Readmissions Following Cystectomy. a Multicentre Randomised Clinical Trial Testing Superiority of Individualised Targeted Antibiotic Prophylaxis Over Empiric Prophylaxis At Ureteral Stent Removal to Reduce Infection-related Readmissions Following Cystectomy.

The aim of this trial is to test whether postoperative antibiotics targeted towards bacteria in the urine can reduce the risk of infection after surgical removal of the bladder (cystectomy) compared to a standardised antibiotic prophylaxis.
Participants undergoing cystectomy will be randomly assigned to postoperatively receive (A) a standardised orally administered antibiotic prophylaxis currently given at Rigshospitalet, Copenhagen or (B) a conventional orally administered antibiotic prophylaxis targeting bacteria found in the urine postoperatively.
The investigators' hypothesis is that the targeted prophylactic antibiotic strategy will reduce the number of infection-related readmissions within 90 days of surgery compared to the standardised prophylaxis.

开始日期2025-01-07

申办/合作机构

Rigshospitalet

NCT05224401

/ Recruiting临床3期IIT

Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in Febrile UTIs Caused by ESBL-producing Enterobacterales (PACUTI)

To evaluate if the combination of pivmecillinam and clavulanic acid (PAC) is non-inferior to ciprofloxacin, trimethoprim-sulfamethoxazole or ertapenem as step down oral therapy in patients with febrile UTI caused by extended spectrum beta-lactamase (ESBL) producing Enterobacterales (EPE).

开始日期2023-05-29

申办/合作机构

University of Lund

NCT05545137

/ Completed临床3期

Pivmecillinam Hydrochloride Tablets Versus Fosfomycin Tromethamine Granules for Uncomplicated Urinary Tract Infection in Women -A Randomized, Double-blind, Double Simulation, Positive Drug Parallel-controlled, Multi Center Phase III Clinical Trial in China

the purpose of this study is to evaluate the efficacy and safety of pivmecillinam hydrochloride tablets in the treatment of uncomplicated urinary tract infection in China

开始日期2022-09-29

申办/合作机构

泊诺（天津）创新医药研究有限公司

100 项与盐酸匹美西林相关的临床结果

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100 项与盐酸匹美西林相关的转化医学

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100 项与盐酸匹美西林相关的专利（医药）

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503

项与盐酸匹美西林相关的文献（医药）

2025-08-01·ANNALS OF PHARMACOTHERAPY

Pivmecillinam for Uncomplicated Acute Cystitis: A Contemporary Review

Review

作者: White, Bryan P. ; Burchette, Jessica E. ; Covert, Kelly ; Chastain, Daniel B. ; Tu, Patrick ; Cluck, David B.

Objective::

To review the evidence and discuss use of pivmecillinam in uncomplicated acute cystitis.

Data sources::

A literature search was conducted utilizing PubMed (from 2000 through August 2024) and ClinicalTrials.gov. Medical Subject Headings (MeSH) terms, such as mecillinam or pivmecillinam and urinary tract infections, were utilized. Additional references were identified by reviewing literature citations.

Study selection and data extraction::

Articles were limited to English language publications evaluating the efficacy or safety of pivmecillinam for urinary tract infections (UTIs) in adult populations.

Data synthesis::

Data from 6 randomized controlled trials support pivmecillinam for acute uncomplicated cystitis at doses of 200 to 400 mg 3 times daily for 3 to 7 days, with more consistent clinical and bacteriologic cure observed with 400 mg doses and longer therapy durations. Clinical evaluation of 400 mg 2 to 3 times daily is available with use more common in non–US Food and Drug Administration (FDA)-approved populations, such as men, pregnancy, and multidrug resistant infections. There are limited data supporting pivmecillinam for pyelonephritis; routine use is cautioned until further clinical data are available.

Relevance to patient care and clinical practice in comparison with existing drugs::

As resistance to first-line antimicrobials rises, the need for safe and effective treatment options remains high. Pivmecillinam represents a new therapeutic option available in the United States for outpatient management of uncomplicated acute cystitis.

Conclusion::

Pivmecillinam could be a key agent for uncomplicated acute cystitis. Utilization will likely be cost driven, but the promise of low resistance encourages the place in therapy when other agents are not susceptible to infecting uropathogens.

2025-05-14·JOURNAL OF CLINICAL MICROBIOLOGY

Performance of disc diffusion and four commercially available MIC tests to determine mecillinam susceptibility on carbapenemase-producing Enterobacterales

Article

作者: Rouabah, Lamia ; Dortet, Laurent ; Milleville, Sacha ; Rezzoug, Inès ; Emeraud, Cécile ; De Swardt, Hippolyte ; Bernabeu, Sandrine ; Santerre Henriksen, Anne

ABSTRACT:

Urinary tract infections (UTIs) are predominantly caused by Enterobacterales, and escalating resistance poses significant challenges due to carbapenemase production, which can compromise the efficacy of last-resort antibiotics. Pivmecillinam, as the prodrug of mecillinam, may serve as a treatment option for UTIs caused by carbapenemase-producing Enterobacterales (CPE). However, accurate methods are required to accurately assess susceptibility to this antibiotic. This study aimed to evaluate the in vitro susceptibility of mecillinam on a collection of 161 well-characterized CPE isolates collected from July to November 2023 in France and assess the performances of disc diffusion, Liofilchem MTS gradient strip, bioMérieux E-test, Sensititre broth microdilution, and VITEK 2 compared to agar dilution (reference method) in this specific population of CPE. None of the commercially available tests met the International Organization for Standardization standards with this entire collection. Using Clinical and Laboratory Standards Institute (CLSI) or European Committee on Antimicrobial Susceptibility Testing (EUCAST) guidelines on the complete collection of CPE, disc diffusion possessed the best categorical agreement [77.0 (124/161) or 84.5% (131/161), respectively]. Sensititre broth microdilution and VITEK 2 overestimated MICs (by 1.8 and one doubling-dilution, respectively) but had low very major error (VME) rates (0% (0/53) for Sensititre and 4.2% (6/53) for VITEK 2 with CLSI and 0% (0/53) for Sensititre and 11.3% (6/53) for VITEK 2 with EUCAST). Notably, when focusing solely on E. coli isolates ( n = 45), performance improved considerably. Both disc diffusion and VITEK 2 demonstrated high categorical agreements [95.6 (43/45) and 93.3% (42/45), respectively] with no VME observed for either method using CLSI breakpoints. In conclusion, while agar dilution remains the reference method for mecillinam MIC determination, disc diffusion and VITEK2 are accurate alternatives to determine mecillinam susceptibility in CPE isolates, especially for Escherichia coli .

IMPORTANCE:

The rising prevalence of carbapenemase-producing Enterobacterales (CPE) poses significant challenges to effective antibiotic therapy, particularly for urinary tract infections. Pivmecillinam, the prodrug of mecillinam, offers a promising treatment option due to its activity against certain carbapenemase-producing strains. However, selecting accurate susceptibility testing methods is crucial for ensuring appropriate clinical use. This study rigorously evaluates the performances of various susceptibility testing methods against a challenging collection of CPE isolates, identifying the strengths and limitations of each. By providing critical insights into their reliability, particularly for routine clinical settings, this research supports improved diagnostic accuracy and optimal use of mecillinam in combating multidrug-resistant infections. These findings are especially relevant as pivmecillinam gains international approval, underscoring its potential as a valuable alternative in the fight against antibiotic resistance.

2025-03-04·Microbiology Spectrum

Mecillinam activity against multidrug-resistant Shigella sonnei and Shigella flexneri

Article

作者: Payne, Michael ; Stefanovic, Aleksandra ; Lee, Colin ; Romney, Marc G. ; Leung, Victor ; Lowe, Christopher F. ; Gowland, Leah ; Chorlton, Sam ; Matic, Nancy ; Ritchie, Gordon

ABSTRACT:

We performed phenotypic susceptibility testing and whole-genome sequencing to investigate in vitro mecillinam activity against multidrug-resistant (MDR) Shigella . Ninety-five isolates (53 [56%] Shigella sonnei and 42 [44%] Shigella flexneri ) were included. The MIC 50 and MIC 90 were 1 and 2 µg/mL, respectively, by agar dilution, and all zone diameters were ≥15 mm by disc diffusion testing. No known clinically relevant mecillinam resistance mutations (including cys B) were detected. The favorable MIC profile and absence of resistance markers make pivmecillinam an agent worth considering for the treatment of infections caused by MDR Shigella . Clinically feasible susceptibility testing methods and standardized interpretations for mecillinam and Shigella spp. are needed to guide therapy.

IMPORTANCE:

Rapidly emerging resistance in Shigella species leaves few antibiotic treatment options. The World Health Organization recommends pivmecillinam, a prodrug of mecillinam, for the treatment of Shigella infections. However, little is known about the susceptibility of Shigella spp. to mecillinam in North America. We performed mecillinam susceptibility testing on our collection of resistant Shigella isolates and investigated genetic mechanisms of resistance using whole-genome sequencing. We observed a favorable mecillinam susceptibility profile and a lack of known genetic mechanisms of resistance. However, in the absence of standardized laboratory guidelines for mecillinam susceptibility testing, interpreting susceptibility test results is challenging. We propose that further studies are needed to correlate susceptibility testing data with clinical outcomes, with the aim of establishing standardized clinical breakpoints for Shigella spp. and mecillinam.

项与盐酸匹美西林相关的新闻（医药）

2025-07-07

·Pharmaceutical Technology

Alembic Pharmaceuticals acquires UTILITY therapeutics

Pivya has been proven safe in three studies. Credit: Summit Art Creations/Shutterstock. Alembic Pharmaceuticals has acquired UTILITY therapeutics, expanding its portfolio with the addition of Pivya (pivmecillinam 185 mg tablets), a penicillin class antibacterial for treating uncomplicated urinary tract infections (uUTIs). In April 2024, Pivya received approval from the US Food and Drug Administration (FDA) for uUTIs. uUTI is caused by strains of Proteus mirabilis, Escherichia coli and Staphylococcus saprophyticus. The drug’s unique mechanism targets gram-negative bacteria cell walls effectively. Alembic Pharmaceuticals president Craig Salmon stated: “The acquisition of UTILITY and the commercialisation of Pivya are important steps in Alembic’s strategic goal to provide branded pharmaceutical products to the US healthcare market. “Pivya will further enhance Alembic’s ability to build long-term value by combining global research, regulatory and manufacturing strengths with a sharpened focus on speciality segments. Alembic plans to make Pivya available in the US in the fourth quarter of 2025.” Pivya has been proven safe in three studies. The most common adverse reactions are diarrhoea, nausea, vulvovaginal candidiasis, genital pruritus and headache. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence UTILITY Therapeutics co-founder and board member Dr Morten Sommer stated: “I am excited to see Alembic drive the commercialisation of Pivya, which is uniquely positioned to help millions of American women with urinary tract infections. “With a novel mechanism of action, not previously deployed in the US, Pivya can become a cornerstone of the treatment of urinary tract infections based on its first-line positioning in the Infectious Disease Society of America treatment guidelines. On behalf of the co-founders, investors and board of directors, we are excited that Pivya will help address the societal impact of the uUTI disease burden in women.” Pharmaceutical Technology Excellence Awards - Have you nominated? Nominations are now open for the prestigious Pharmaceutical Technology Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact . This is your chance to showcase your achievements, highlight industry advancements , and gain global recognition . Don't miss the opportunity to be honoured among the best - submit your nomination today! Nominate Now

上市批准并购

2025-07-03

·ETPharma

Alembic Pharmaceuticals Acquires Utility Therapeutics to Enter U.S. Branded Drug Market

Mumbai: Alembic Pharmaceuticals , Inc., the U.S. subsidiary of Alembic Pharmaceuticals Ltd., has acquired UK-based Utility Therapeutics Ltd. in a $12 million deal. The acquisition is indicated to mark the company's entry into the speciality and branded pharmaceuticals segment in the United States. The acquisition includes Pivya ( pivmecillinam ), a recently FDA-approved treatment for uncomplicated urinary tract infections . Approved in April 2024, Pivya will now be commercialized in the U.S. by Alembic. According to the company, the aim of the acquisition is to strengthen its U.S. presence and expand into branded prescription products. The company states that the acquisition will enhance its ability to deliver long-term value by combining global research, regulatory, and manufacturing capabilities with a focused approach to the U.S. specialty pharmaceutical market. “This acquisition gives us a strategic entry into the specialty and branded prescription products. It will give us exposure to the branded pharmaceutical market with a near-term commercial launch,” said Pranav Amin, Managing Director, Alembic Pharmaceuticals Ltd. By Online Bureau ,

上市批准并购

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 项与盐酸匹美西林相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01499	盐酸匹美西林	J01CA08	DB01605

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	UTILITY therapeutics Ltd.	2024-04-24
膀胱炎	比利时	Karo Healthcare AB	2014-09-10
膀胱炎	丹麦	Karo Healthcare AB	2014-09-10
膀胱炎	德国	Karo Healthcare AB	2014-09-10
膀胱炎	爱尔兰	Karo Healthcare AB	2014-09-10
膀胱炎	意大利	Karo Healthcare AB	2014-09-10
膀胱炎	卢森堡	Karo Healthcare AB	2014-09-10
膀胱炎	荷兰	Karo Healthcare AB	2014-09-10
膀胱炎	波兰	Karo Healthcare AB	2014-09-10
膀胱炎	西班牙	Karo Healthcare AB	2014-09-10

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
沙门氏菌感染	申请上市	中国	Recipharm Strängnäs AB	2021-03-20

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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


CTR20211748 (FDA_CDER) 人工标引	N/A	泌尿道感染	282	PIVYA	願鹽淵選獵範鬱夢築憲(製構衊醖網遞獵糧膚窪) = 鏇衊鏇築遞淵艱積築壓壓襯艱選壓選壓衊憲簾 (遞衊衊顧網襯繭齋獵淵 ) 更多	积极	2024-04-24
CTR20211748 (FDA_CDER) 人工标引	N/A	泌尿道感染	84	PIVYA	襯獵鹹膚鏇齋壓鑰淵觸(衊獵憲憲鏇膚範鏇願獵) = 鑰觸壓窪網鹹衊憲遞憲選觸壓艱構繭繭艱壓顧 (醖製膚餘醖積網夢鬱膚 )	积极	2024-04-24
NCT01849926 (FDA_CDER) 人工标引	临床3期	泌尿道感染	224	PIVYA	鹹餘窪淵壓壓築簾範願(鑰鏇築襯願繭遞築積壓) = 願顧範鬱淵廠襯鹹廠網憲襯願鏇鹹夢膚鑰窪繭 (鑰觸憲窪鹹淵獵選淵膚 ) 更多	积极	2024-04-24
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