头孢洛扎/他唑巴坦(Ceftolozane Sulfate/Tazobactam Sodium) - 药物靶点：PBP1b x PBP3 x β-lactamase_在研适应症：医院获得性细菌性肺炎，呼吸机相关细菌性肺炎，肺炎_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Ceftolozane/tazobactam、CXA-101/tazobactam、TAZ/CTLZ

+ [7]

靶点

PBP1b x PBP3 x β-lactamase

作用机制

PBP1b抑制剂(细菌青霉素结合蛋白1b抑制剂)、PBP3抑制剂(细菌青霉素结合蛋白3抑制剂)、β-lactamase抑制剂(β-内酰胺酶抑制剂)

治疗领域

感染消化系统疾病呼吸系统疾病+ [4]

在研适应症

医院获得性细菌性肺炎呼吸机相关细菌性肺炎肺炎+ [17]

非在研适应症

危重病革兰氏阴性菌菌血症伤口感染

原研机构

Wakunaga Pharmaceutical Co., Ltd.

Astellas Pharma, Inc.

在研机构

Merck Sharp & Dohme BV

默沙东研发（中国）有限公司Merck Sharp & Dohme (Australia) Pty Ltd.

+ [3]

非在研机构

Steri-Pharma LLCOrganon Pharma (UK) Ltd.

最高研发阶段批准上市

首次获批日期

美国 (2014-12-19),

复杂腹腔感染复杂的尿路感染肾盂肾炎

最高研发阶段(中国)批准上市

特殊审评快速通道 (美国)

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结构/序列

分子式C33H42N16O13S3

InChIKeyGRHWKSLBMDQBQW-RRCBCHDBSA-N

CAS号1613740-46-7

关联

47

项与头孢洛扎/他唑巴坦相关的临床试验

NCT06342115

/ Not yet recruiting临床4期IIT

Ceftolozane/Tazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase (ESBL)-Producing Pathogens: a Randomized Double-blind Non-inferiority Trial.

The study proposes a planned, double-blind, non-inferiority clinical trial involving patients with febrile neutropenia and risk of extended-spectrum beta-lactamase (ESBL) infection. The goal is:
- Analyze the efficacy and tolerability of Ceftolozane/tazobactam (CEF/TAZ) compared to the current standard of care (meropenem) in patients with febrile neutropenia and risk of ESBL infection.
Patients will be randomly assigned to receive CEF/TAZ or meropenem, with assessment of clinical response, toxicity and microbiological evolution. Stool samples will be collected before, during and after treatment for intestinal microbiota analysis and intestinal microbiome analysis to evaluate possible effects on GVHD. Analysis of the results will include the taxonomic classification of the organisms present. Data will be analyzed to assess non-inferiority in clinical response, incidence of GVHD, antimicrobial resistance and other outcomes.

开始日期2024-10-01

申办/合作机构

Beneficência Portuguesa De São Paulo

[+1]

NCT06422533

/ RecruitingN/AIIT

Ceftolozane/Tazobactam vs. Piperacillin/Tazobactam for the Treatment of Bacteremia Due to Enterobacteriaceae and Pseudomonas Aeruginosa in Hemato-oncological Patients With Severe Neutropenia and Fever: Non-inferiority Study

Patients with hematological malignancies receive highly myelotoxic chemotherapy regimens that cause periods of severe myelosuppression, which places them at high risk of developing bacteremia.
At a global level, a very significant increase in multidrug-resistant (MDR) Gram-negative microorganisms, particularly Enterobacteriaceae producing extended-spectrum beta-lactamases (ESBL) and MDR P.aeruginosa, have been described during the last decade. Among the strategies to reduce bacterial resistance, ceftolozane/tazobactam (C/T) as a "carbapenem-sparing" antibiotic has been proposed.
C/T has broad-spectrum activity since it has action against ESBL-producing Enterobacteriaceae and MDR P. aeruginosa. Studies carried out in the real world using this antibiotic in patients with hematological malignancies have demonstrated clinical success in reports and case series, considered a therapeutic option in patients with Enterobacteriaceae and P. aeruginosa infections, particularly in MDR pathogens.
At the National Cancer Institute (in Spanish, Instituto Nacional de Cancerologia), Gram-negative bacilli have been identified for more than 20 years as the pathogens most frequently associated with bacteremia. Escherichia coli occupies the first place in 25% (41% ESBL), followed by Klebsiella spp. in 5.6% (11.2% ESBL) and P. aeruginosa in 5.6% (11.2% MDR). The protocol for approaching and treating hematological malignancy patients with severe neutropenia and fever is to initiate an antimicrobial regimen with piperacillin/tazobactam (P/T). In patients who persist with fever after 48 to 72 hours of starting antibiotics, who present with clinical deterioration, or in whom P/T-resistant bacteria are identified, this is escalated to carbapenem.
Therefore, it is proposed to compare the clinical and microbiological response in patients with hematological malignancies who present with severe neutropenia and fever and who present clinical data of bacteremia, with empirical treatment with C/T vs. P/T, trying to reduce the use of carbapenems in this group of patients.

开始日期2023-11-07

申办/合作机构

Instituto Nacional de Cancerología

ACTRN12623000976684

/ Not yet recruiting临床4期IIT

The feasibility of ceftolozane/tazobactam Continuous Infusion for Exacerbations of Cystic Fibrosis and Bronchiectasis Treated in an outpatient parenteral antibiotic therapy (OPAT) Setting

开始日期2023-10-02

申办/合作机构-

100 项与头孢洛扎/他唑巴坦相关的临床结果

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100 项与头孢洛扎/他唑巴坦相关的转化医学

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100 项与头孢洛扎/他唑巴坦相关的专利（医药）

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81

项与头孢洛扎/他唑巴坦相关的文献（医药）

2024-11-30·Cureus Journal of Medical Science

Impact of Antimicrobial Therapy on Mortality and Readmission in Multidrug-Resistant Pseudomonas Infections: A Retrospective Study at Dammam Medical Complex

Article

作者: Almomen, Abdulaziz ; Alsaeed, Ali ; AlSaghiri, Noura ; Jawad, Ali ; Alkhmis, Hassan ; AlNasser, Ahmed

Multidrug-resistant (MDR) Pseudomonas aeruginosa presents a significant treatment challenge, necessitating effective antimicrobial options. This retrospective, single-center cohort study was conducted at Dammam Medical Complex and aimed to evaluate the comparative effectiveness and safety of ceftazidime-avibactam (CAZ-AVI), ceftolozane-tazobactam (C-T), and meropenem and colistin in treating MDR P. aeruginosa infections. The study included 250 patients (n = 250, 100%) admitted between January 2022 and November 2024, who were treated with one of the three antimicrobials. The primary outcomes assessed were clinical cure, 30-day mortality, and all-cause in-hospital mortality. Secondary outcomes included readmission rates within 30 days and the rate of uncontrolled infection by day 14 (n = 40, 16%). The patient cohort consisted of a mix of ICU admissions (n = 138, 55.2%), mechanically ventilated patients (n = 140, 56%), and those requiring vasopressors (n = 100, 40%). Most patients were elderly with multiple pre-existing medical conditions, such as diabetes (n = 175, 70%), hypertension (n = 88, 35.2%), and chronic kidney disease (n = 63, 25.2%). Results demonstrated that ceftazidime-avibactam was associated with a statistically significant higher clinical cure rate (n = 180, 72%) compared to ceftolozane-tazobactam (n = 44, 59%) and meropenem and colistin (n = 24, 48%) (P < 0.05). Similarly, patients treated with CAZ-AVI had significantly lower readmission rates within 30 days compared to those on C-T or meropenem and colistin. The overall in-hospital mortality was highest among patients treated with meropenem and colistin (n = 19, 38%), followed by C-T (n = 24, 32%), and lowest with CAZ-AVI (n = 30, 24%) (P < 0.05). The findings suggest that ceftazidime-avibactam is more effective in achieving clinical cure and reducing readmission rates compared to ceftolozane-tazobactam and meropenem and colistin in patients with MDR P. aeruginosa infections. Meropenem and colistin were primarily used when supply constraints limited the availability of other agents, highlighting the need for improved access to preferred antimicrobials. These results underscore the importance of optimized antimicrobial stewardship in the management of MDR P. aeruginosa to improve patient outcomes.

2024-10-08·ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Molecular characterization of clinically isolated Pseudomonas aeruginosa with varying resistance to ceftazidime-avibactam and ceftolozane-tazobactam collected as a part of the ATLAS global surveillance program from 2020 to 2021

Article

作者: Shields, R. K. ; Stone, G. ; Kamat, S. ; Estabrook, M. ; Li, H. ; Oliver, A.

ABSTRACT:

Ceftazidime-avibactam (CZA) and ceftolozane-tazobactam (C/T) are important agents for treating multidrug-resistant P. aeruginosa infections. In this study, we evaluated the molecular characteristics of 300 globally collected clinical P. aeruginosa isolates non-susceptible (NS) to CZA, C/T, or both agents. Isolates were CZA-NS and C/T-NS ( n = 57), CZA-susceptible (S) and C/T-NS ( n = 145), or CZA-NS and C/T-S ( n = 98) selected from the Antimicrobial Testing Leadership and Surveillance (ATLAS) surveillance program from 2020 to 2021. Characterization was by whole-genome sequencing. Analysis was performed to identify β-lactamase genes and mutations that impact efflux regulation, AmpC regulation, and target binding (PBP3). Of the 57 CZA-NS+C/T-NS isolates, 64.9% carried a metallo-β-lactamase (MBL), and a cumulative 84.2% carried any non-intrinsic β-lactamase [i.e., not Pseudomonas- derived cephalosporinase (PDC) or OXA-50-like]. Of the 145 CZA-S+C/T-NS isolates, 26.2% carried an extended-spectrum β-lactamase (ESBL) and no carbapenemase, 17.9% carried a serine-carbapenemase, and 42.1% were negative for non-intrinsic β-lactamases. Of 98 CZA-NS+C/T-S isolates, 34.7% carried mutations previously described as causing an upregulation of the MexAB-OprM efflux pump, while only 9.2% carried a non-intrinsic β-lactamase, and no resistance mechanism was identified in 29.6% of these isolates. MBLs were present in most isolates NS to both agents. More than half of the CZA-S+C/T-NS isolates carried serine β-lactamases. The most frequently identified resistance mechanism identified in CZA-NS+C/T-S isolates was a marker indicating the upregulation of MexAB-OprM. No mechanism was identified that is thought to support resistance to these agents in numerous isolates. This may be due in part to the fact that whole genome sequencing (WGS) cannot directly measure gene expression of chromosomal resistance mechanisms.

2024-09-01·Journal of Global Antimicrobial Resistance

In vitro activity of cefiderocol against carbapenemase-producing and meropenem-non-susceptible Gram-negative bacteria collected in the Japan Antimicrobial Resistant Bacterial Surveillance

Article

作者: Kawakami, Sayoko ; Kayama, Shizuo ; Sugai, Motoyuki ; Hayashi, Wataru ; Sugawara, Yo ; Yu, Liansheng ; Yahara, Koji ; Kondo, Kohei ; Kitamura, Norikazu

OBJECTIVES:

The treatment options available for infections caused by multidrug-resistant Gram-negative pathogens are often limited. Cefiderocol (CFDC) is a novel siderophore cephalosporin that exhibits activity against these pathogens. Several studies have reported the in vitro activity of CFDC against isolates from Europe, the United States, and China, but the activity against carbapenem-resistant bacteria with IMP-type carbapenemase has not been extensively studied. We, therefore, studied the in vitro activities of CFDC against carbapenem-resistant bacteria with available genomic backgrounds based on whole-genome sequencing (WGS) in Japan, where the IMP-type is the predominant carbapenemase produced by Gram-negative rods.

METHODS:

We selected 603 isolates (528 Enterobacterales, 18 Pseudomonas aeruginosa, and 57 Acinetobacter spp.) from a collection of Gram-negative clinical isolates collected during a Japan Antimicrobial Resistance Bacterial Surveillance program and evaluated the antimicrobial activities of CFDC, ceftolozane/tazobactam (CTLZ/TAZ), imipenem-relebactam (IPM/REL), and ceftazidime/avibactam (CAZ/AVI) against carbapenemase-producing Enterobacterales, carbapenemase-non-producing meropenem-non-susceptible Enterobacterales, and carbapenemase-producing nonfermentative bacteria.

RESULTS:

Among these, 97.7% of carbapenemase-producing Enterobacterales (99.2% of IMP-type carbapenemase-producing Enterobacterales), 100% of carbapenemase-producing P. aeruginosa, and 91.2% of carbapenemase-producing Acinetobacter spp. were susceptible to CFDC, showing better antimicrobial activity than the other antimicrobial agents evaluated in this study. CFDC was highly effective against class A-, B-, and D β-lactamase-harbouring isolates when compared to the other antimicrobial agents. In addition, the relationship between CFDC resistance and three genetic factors involved in resistance was discussed.

CONCLUSIONS:

This is the first large-scale study to systematically demonstrate the efficacy of CFDC against IMP-type carbapenemase-producing strains with known genomic backgrounds.

21

项与头孢洛扎/他唑巴坦相关的新闻（医药）

2025-02-12

·摩熵医药

默沙东复方抗菌疗法在国内获批上市！

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 2月11日，据NMPA官网最新公示，默沙东提交的5.1类新药注射用头孢洛生他唑巴坦钠（Zerbaxa）上市申请已获得批准。该品种是一款复方抗菌药物，包含头孢类抗生素头孢洛生和β-内酰胺酶抑制剂他唑巴坦。截图来源：NMPA官网 Zerbaxa最早是由Cubist制药公司首创的抗生素复方制剂。2014年，默沙东公司通过支付约95亿美元的现金收购了Cubist，从而将Zerbaxa纳入其产品组合。同年，该产品获得了FDA的批准，用于治疗由特定革兰氏阴性菌引起的复杂性尿路感染，以及与甲硝唑联合应用于复杂性腹腔内感染的治疗。2019年6月，FDA进一步扩大了Zerbaxa的适应症范围，批准其用于治疗医院获得性肺炎/呼吸机相关性细菌性肺炎。截图来源：摩熵医药全球药物研发数据库默沙东此前已经在中国完成了一项3期临床研究，评估该产品治疗复杂性腹腔感染的疗效和安全性。作为抗生素领域的资深参与者，默沙东多年来在这一领域持续深耕，已成功推出超20款抗生素产品，其中不乏众多复方药物，展现了其在抗感染治疗领域的丰富经验和强大研发实力。截图来源：摩熵医药全球药物研发数据库 2022年8月，《国际感染病杂志》（Int J Infect Dis）发布了一项3期临床研究的结果，该研究聚焦于比较Zerbaxa联合甲硝唑与美罗培南在治疗中国复杂性腹腔内感染（cIAI）患者中的疗效与安全性，核心评估指标为治愈测试（TOC）的临床反应率。此次研究成果的发布，进一步巩固了默沙东在复杂感染治疗领域的领先地位，同时也为更多患者带来了潜在的治疗希望，我们期待默沙东这款抗菌复方疗法能够迅速获得批准，从而让更多患者受益。 END 近期热门资源获取后台回复关键词“深度报告”，获取价值18600元，报告大礼包后台回复关键词“2023首仿”，获取2023年首仿药物获批名单后台回复“GLP-1深度报告”，获取完整《GLP-1产业现状与未来发展》PDF版。后台回复“中国 I 类新药”，获取完整《中国 I 类新药靶点》PDF版。后台回复“NAFLD/NASH”，获取完整《NAFLD/NASH报告》PDF版。后台回复“AI+制药”，获取完整《中国AI制药企业白皮书》PDF版。后台回复“XXG”，获取完整《中国心血管系统药物分析报告》PDF版。后台回复“FZZJ”，获取完整《基于剂型改良的复杂注射剂分析》PDF版。后台回复“药品进出口”，获取完整《中国药品进出口白皮书》深度报告-PDF版。联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作 👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

并购临床3期上市批准临床结果微生物疗法

2025-02-12

·SYNAPSE

2025年2月12日全球新药进展早知道

1. 强生两款first in class双抗国内获批上市 2月11日，强生宣布锐珂（埃万妥单抗）和拓立珂（塔奎妥单抗）的上市申请均已获得国家药监局批准。前者是全球首款获批上市的EGFR/c-MET双抗，后者是首个获批的靶向GPRC5D的双特异性抗体药物。本次埃万妥单抗获批的适应症是：与卡铂和培美曲塞联合给药，用于经检测确认携带表皮生长因子受体（EGFR）20号外显子插入突变的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗。而塔奎妥单抗获批的适应症是：单药适用于既往接受过至少三线治疗（包括一种蛋白酶体抑制剂、一种免疫调节剂和一种抗CD38抗体）的复发或难治性多发性骨髓瘤（RRMM）成人患者。 2. 默沙东抗生素复方国内获批上市 2月11日，NMPA官网显示，默沙东抗生素复方「注射用头孢洛生他唑巴坦钠」获批上市。该复方（研发代号：MK-7625A）于2014年12月首次在美国获批上市，商品名为Zerbaxa，用于联合甲硝唑治疗指定易感微生物引起的复杂性腹腔感染和复杂性尿路感染（包括肾盂肾炎）。后来，其适应症又扩大至医院获得性细菌性肺炎（HABP）和呼吸机相关性细菌性肺炎（VABP）。 3. 每月一次PCSK9抑制剂在美国申报上市 2月10日，LIB Therapeutics公司宣布，美国FDA已受理潜在“best-in-class”在研疗法lerodalcibep的生物制品许可申请（BLA），lerodalcibep旨在降低低密度脂蛋白胆固醇（LDL-C），用于治疗动脉粥样硬化性心血管疾病（ASCVD）患者，以及具有极高或高ASCVD风险或原发性高脂血症（包括杂合子和纯合子家族性高胆固醇血症，HeFH/HoFH）患者。FDA预计在今年12月12日之前完成审评。Lerodalcibep是一种与PCSK9结合的创新第三代抑制剂，具有长期常温稳定性，开发目的是为患者提供一种更便捷、每月一次、可自行皮下注射的治疗方案。Lerodalcibep是一种小结合蛋白（SBP），其PCSK9靶向结合域为一种经过工程化设计的多肽，能够以亚纳摩尔级别的高亲和力与人类PCSK9蛋白结合。 4. 美泊利珠单抗在国内申报第4项新适应症 2 月 11 日，CDE 官网显示，GSK 美泊利珠单抗（Mepolizumab，Nucala）新适应症上市申请获受理。根据临床试验进展，该适应症可能为慢性阻塞性肺疾病（COPD）。这是美泊利珠单抗第 4 项在中国申报上市的适应症。美泊利珠单抗是一种特异性靶向白细胞介素 5（IL-5）的单克隆抗体，2015 年 11 月率先获 FDA 批准上市，成为全球首款获批的 IL-5 靶向单抗。而在中国，美泊利珠单抗已有 3 项适应症获批上市，分别为变应性肉芽肿血管炎、嗜酸性粒细胞哮喘和慢性鼻窦炎伴鼻息肉病。 5. 勃林格殷格翰PDE4B抑制剂第2项III期临床成功，拟申报上市 2月10日，勃林格殷格翰宣布其研发的口服、选择性磷酸二酯酶 4B（PDE4B）抑制剂Nerandomilast治疗特发性肺纤维化的第二项三期临床FIBRONEER-ILD试验中，成功达到主要终点。基于这些结果，该公司计划向美国FDA和全球其它监管机构提交nerandomilast治疗渐进性肺纤维化（PPF）的新药申请。Nerandomilast的临床开发计划包括两项3期研究——针对特发性肺纤维化（IPF）患者的FIBRONEER-IPF试验以及针对渐进性肺纤维化患者的FIBRONEER-ILD试验。去年9月，勃林格殷格翰宣布nerandomilast已经在治疗IPF的3期临床试验FIBRONEER-IPF中达到主要终点，显著改善IPF患者的肺功能。 6. 科伦博泰TROP2 ADC尿路上皮癌获得优异疗效 2月13-15日，2025年ASCO GU将在旧金山召开，科伦博泰芦康沙妥珠单抗（研发代码SKB264、MK-2870）单药治疗晚期尿路上皮癌1/2期临床数据将于2025年2月11日06:00在“Poster Session B：Urothelial Carcinoma”上以海报形式报告。此次科伦博泰公布的TROP2 ADC芦康沙妥珠单抗单药治疗使用过含铂化疗及PD-(L)1免疫治疗的后线转移性尿路上皮癌患者的疗效数据媲美Padcev用于同线次患者的疗效，并显著优于化疗的治疗效果。有望为晚期尿路上皮癌患者带来全新的治疗选择。默沙东正在开展PD-1+芦康沙妥珠单抗联合治疗转移性尿路上皮癌的二期临床试验。此外，默沙东还在开展PD-1+Padcev+芦康沙妥珠单联合治疗尿路上皮癌的1/2期临床试验。两款ADC靶点不同，payload杀伤机制也不同，分别为微管抑制剂MMAE和TOPO1抑制剂，两者联用有望发挥更好的协同抗肿瘤效应。 1. 礼来一天达成两项重磅交易，押注核药、RNAi 2月10日，礼来宣布了两项重要合作，分别与Advancell（核药公司）、OliX Pharmaceuticals（RNAi疗法公司）合作，进一步加大在这两大领域的投资。礼来与Advancell的合作中，双方将利用AdvanCell专有的Pb-212生产技术和放射性核素开发基础设施、礼来公司的候选药物计划以及药物开发方面的广泛专业知识，促进靶向α疗法扩大组合的开发和加速临床进展。礼来与OliX Pharmaceuticals的合作重点是OLX75016的开发和商业化，OLX75016是一种主要针对MASH和其他心脏代谢适应症的I期RNAi药物。OliX Pharmaceuticals将收到礼来的首期付款，以完成目前正在澳大利亚进行的I期临床试验。 2. 超30亿美元！诺华收购一款心血管重磅新药 2月11日，跨国药企巨头诺华宣布收购波士顿临床阶段生物制药公司Anthos Therapeutics，该公司拥有一款正在开发的，用于预防心房颤动患者中风和全身栓塞的晚期药物abelacimab（阿贝拉昔单抗）。该交易预计将于2025年上半年完成，诺华将交易完成后支付9.25亿美元的预付款，并在达到规定的监管和销售里程碑后可能额外支付高达21.5亿美元。内容来源于网络，如有侵权，请联系删除。

上市批准临床结果Best in Class抗体药物偶联物核酸药物

2025-02-11

·医药魔方Info

默沙东抗生素复方在华获批上市

2月11日，NMPA官网显示，默沙东抗生素复方「注射用头孢洛生他唑巴坦钠」获批上市。该复方（研发代号：MK-7625A）于2014年12月首次在美国获批上市，商品名为Zerbaxa，用于联合甲硝唑治疗指定易感微生物引起的复杂性腹腔感染和复杂性尿路感染（包括肾盂肾炎）。后来，其适应症又扩大至医院获得性细菌性肺炎（HABP）和呼吸机相关性细菌性肺炎（VABP）。 2022年8月，默沙东在《International Journal of Infectious Diseases》期刊上发表了注射用头孢洛生他唑巴坦钠治疗复杂性腹腔感染的中国III期MK-7625A-015研究结果。该研究共纳入268例患者，评估了该复方（1500mg，每日3次）联合甲硝唑（500mg，每日3次）对比美罗培南（1000mg，每日3次）的疗效和安全性。研究的主要终点为在临床可评价（CE）人群中，治愈评价（TOC）访视时的临床疗效（临床治愈或临床失败）。结果显示，复方组和美罗培南组患者的临床治愈率分别为95.2%和93.1%，达到非劣效性标准。此外，在次要终点的微生物学应答指标方面，该复方也显示出了治疗优势（应答率94.4% vs. 93.2%）。默沙东在抗生素赛道深耕多年，已推出20多款抗生素产品，不少为复方药物。三联复方「二丙酸倍他米松+克霉唑+庆大霉素」、三联复方「亚胺西瑞」和二联复方「亚胺培南+西司他丁」已在中国上市。细菌感染患者有望迎来更多的治疗选择。推荐阅读全球首个治疗“慢性排异”ROCK2抑制剂正式纳入医保报销 Copyright © 2025 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

上市批准临床3期一致性评价

100 项与头孢洛扎/他唑巴坦相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J01	-

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
医院获得性细菌性肺炎	中国	默沙东研发（中国）有限公司	2025-02-08
呼吸机相关细菌性肺炎	中国	默沙东研发（中国）有限公司	2025-02-08
肺炎	日本	Merck Sharp & Dohme Corp.	2019-12-20
脓毒症	日本	Merck Sharp & Dohme Corp.	2019-12-20
腹腔脓肿	日本	Merck Sharp & Dohme Corp.	2019-01-08
胆囊炎	日本	Merck Sharp & Dohme Corp.	2019-01-08
膀胱炎	日本	Merck Sharp & Dohme Corp.	2019-01-08
肝脓肿	日本	Merck Sharp & Dohme Corp.	2019-01-08
腹膜炎	日本	Merck Sharp & Dohme Corp.	2019-01-08
腹腔感染	加拿大	Merck Sharp & Dohme Corp.	2016-01-12
泌尿道感染	加拿大	Merck Sharp & Dohme Corp.	2016-01-12
急性肾盂肾炎	欧盟	Merck Sharp & Dohme BV	2015-09-18
急性肾盂肾炎	冰岛	Merck Sharp & Dohme BV	2015-09-18
急性肾盂肾炎	列支敦士登	Merck Sharp & Dohme BV	2015-09-18
急性肾盂肾炎	挪威	Merck Sharp & Dohme BV	2015-09-18
医院获得性肺炎	欧盟	Merck Sharp & Dohme BV	2015-09-18
医院获得性肺炎	冰岛	Merck Sharp & Dohme BV	2015-09-18
医院获得性肺炎	列支敦士登	Merck Sharp & Dohme BV	2015-09-18
医院获得性肺炎	挪威	Merck Sharp & Dohme BV	2015-09-18
呼吸机相关性肺炎	欧盟	Merck Sharp & Dohme BV	2015-09-18

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
革兰氏阴性菌菌血症	临床3期	澳大利亚	Merck Sharp & Dohme Corp.	2022-01-01
革兰氏阴性菌菌血症	临床3期	意大利	Merck Sharp & Dohme Corp.	2022-01-01
革兰氏阴性菌菌血症	临床3期	沙特阿拉伯	Merck Sharp & Dohme Corp.	2022-01-01
革兰氏阴性菌菌血症	临床3期	新加坡	Merck Sharp & Dohme Corp.	2022-01-01
革兰氏阴性菌菌血症	临床3期	西班牙	Merck Sharp & Dohme Corp.	2022-01-01
血液肿瘤	临床2期	美国	Merck Sharp & Dohme Corp.	2022-07-20
铜绿假单胞菌感染	临床2期	美国	Merck Sharp & Dohme Corp.	2022-07-20
医疗保健相关性肺炎	临床1期	美国	Merck Sharp & Dohme Corp.	2020-04-17
医疗保健相关性肺炎	临床1期	智利	Merck Sharp & Dohme Corp.	2020-04-17
医疗保健相关性肺炎	临床1期	哥伦比亚	Merck Sharp & Dohme Corp.	2020-04-17

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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


NCT03217136 (7625A-035 \| MK-7625A-035, Pubmed)	临床2期	复杂腹腔感染	91	Ceftolozane/tazobactam+metronidazole	鏇艱鹹繭壓蓋襯遞鏇廠(壓選鬱夢築繭廠鹽餘積) = 製選鹹遞鏇襯淵艱衊醖廠製衊鏇鏇繭願鹽夢積 (襯簾範衊餘廠鹽壓窪廠 )	积极	2023-03-29
				Meropenem	鏇艱鹹繭壓蓋襯遞鏇廠(壓選鬱夢築繭廠鹽餘積) = 鹹蓋願範鬱淵遞憲顧齋廠製衊鏇鏇繭願鹽夢積 (襯簾範衊餘廠鹽壓窪廠 )
NCT02070757 (MK-7625A-008 \| ASPECT-NP \| 7625A-008, Pubmed)	临床3期	医疗保健相关性肺炎	726	Ceftolozane/tazobactam	願淵範獵膚衊淵窪廠膚(鏇製範遞鹹鑰繭糧顧鹽) = 膚鑰獵餘壓膚積鹽憲壓襯壓遞鬱繭衊網淵顧糧 (鹽艱選網夢鹽鏇積繭淵 ) 更多	-	2023-02-11
				Meropenem	願淵範獵膚衊淵窪廠膚(鏇製範遞鹹鑰繭糧顧鹽) = 夢願夢鏇膚繭廠積鹽鬱襯壓遞鬱繭衊網淵顧糧 (鹽艱選網夢鹽鏇積繭淵 ) 更多
NCT03230838 (7625A-034, Pubmed)	临床2期	复杂的尿路感染	95	Ceftolozane/tazobactam	網鹹膚鹹鬱衊鑰範醖繭(齋鬱網廠艱鏇顧壓簾蓋) = 築選願網範壓製憲願鏇襯構膚鏇醖積積築繭膚 (積淵觸淵廠積廠廠鏇網 ) 更多	积极	2023-01-23
				Meropenem	網鹹膚鹹鬱衊鑰範醖繭(齋鬱網廠艱鏇顧壓簾蓋) = 網構願遞構繭鑰網襯廠襯構膚鏇醖積積築繭膚 (積淵觸淵廠積廠廠鏇網 ) 更多
NCT02070757 (MK-7625A-008 \| ASPECT-NP \| 7625A-008, Pubmed)	临床3期	-	726	Ceftolozane/tazobactam	鹹鏇窪壓蓋遞膚簾範選(鹹窪艱淵襯餘繭獵鹽餘) = 選蓋壓製構齋窪鏇憲鹽餘積夢衊繭網淵壓淵範 (膚廠餘衊顧鹹蓋製鬱艱 ) 更多	积极	2022-12-01
				Meropenem	鹹鏇窪壓蓋遞膚簾範選(鹹窪艱淵襯餘繭獵鹽餘) = 簾獵膚願繭積膚淵糧鏇餘積夢衊繭網淵壓淵範 (膚廠餘衊顧鹹蓋製鬱艱 ) 更多
NCT03830333 (7625A-015 \| MK-7625A-015, Pubmed)	临床3期	复杂腹腔感染	268	Ceftolozane/tazobactam plus metronidazole	鑰鹽襯齋構製觸壓蓋顧(夢膚艱遞壓鬱壓鏇觸鑰) = 衊遞鹽壓鏇艱範願構夢艱築鑰膚廠鬱願醖獵衊 (壓窪膚鹽範鬱構蓋憲壓 )	积极	2022-08-17
				Meropenem plus placebo	鑰鹽襯齋構製觸壓蓋顧(夢膚艱遞壓鬱壓鏇觸鑰) = 夢鹽膚獵積築淵觸鏇廠艱築鑰膚廠鬱願醖獵衊 (壓窪膚鹽範鬱構蓋憲壓 )
NCT02070757 (MK-7625A-008 \| ASPECT-NP \| 7625A-008, Pubmed \| J Antimicrob Chemother)	临床3期	医院获得性细菌性肺炎	726	Ceftolozane/tazobactam	壓鏇襯廠鑰醖壓餘簾蓋(齋餘蓋鹽範窪範鑰壓衊) = 廠範醖窪簾簾鹽鏇襯鬱窪廠積鏇廠憲選餘製築 (鏇醖構襯顧餘齋範築醖 ) 更多	积极	2022-07-04
				Meropenem	壓鏇襯廠鑰醖壓餘簾蓋(齋餘蓋鹽範窪範鑰壓衊) = 觸鹹糧築顧積選憲艱衊窪廠積鏇廠憲選餘製築 (鏇醖構襯顧餘齋範築醖 ) 更多
NCT03217136 (7625A-035 \| MK-7625A-035, CTgov)	临床2期	复杂腹腔感染	94	Metronidazole+Ceftolozane/Tazobactam	獵餘鬱築顧艱憲鏇衊齋(獵淵鹹廠壓蓋範衊簾遞) = 積築蓋廠積顧醖鹹獵襯壓鹽構廠襯糧鏇鑰簾鹽 (餘範製憲製憲鏇窪簾鬱, 鏇衊積廠廠膚網餘艱選 ~ 觸淵鏇淵鹽壓餘餘獵鑰) 更多	-	2021-12-21
NCT02070757 (ASPECT-NP, Pubmed \| Crit Care)	临床3期	医院获得性细菌性肺炎	207	Ceftolozane/tazobactam	鹽夢齋窪糧繭糧壓醖鏇(窪憲鑰獵醖餘網醖網觸) = 糧膚憲製築壓壓鹹遞範醖鏇築願夢膚鏇憲夢醖 (艱築遞構顧顧鏇簾衊糧 ) 更多	积极	2021-12-01
				Meropenem	鹽夢齋窪糧繭糧壓醖鏇(窪憲鑰獵醖餘網醖網觸) = 獵繭構選獵願觸製願糧醖鏇築願夢膚鏇憲夢醖 (艱築遞構顧顧鏇簾衊糧 ) 更多
NCT03230838 (7625A-034, CTgov)	临床2期	肾盂肾炎 \| 复杂的尿路感染	134	Ceftolozane/Tazobactam (Ceftolozane/Tazobactam)	衊鏇鏇積夢製艱鬱築鏇(觸鏇網鑰顧鹽願淵觸襯) = 觸艱鹽積獵選蓋壓壓齋遞鹹鹹鬱齋顧繭繭蓋觸 (艱壓醖醖顧積顧簾觸鑰, 簾顧範糧鏇網遞願蓋築 ~ 廠蓋觸夢醖積齋糧糧製) 更多	-	2021-12-01
				Meropenem (Meropenem)	衊鏇鏇積夢製艱鬱築鏇(觸鏇網鑰顧鹽願淵觸襯) = 鑰願遞膚襯襯鏇鑰簾遞遞鹹鹹鬱齋顧繭繭蓋觸 (艱壓醖醖顧積顧簾觸鑰, 網艱鹽願簾遞觸淵選鹽 ~ 鹽糧廠憲觸積鏇獵廠顧) 更多
NCT03830333 (7625A-015 \| MK-7625A-015 \| 7625ACNPhase3, CTgov)	临床3期	复杂腹腔感染	268	Metronidazole+Ceftolozane/Tazobactam (Ceftolozane/Tazobactam + Metronidazole)	襯壓廠鏇襯製衊觸衊觸(鹹廠淵積觸鹽顧餘糧膚) = 鹽觸膚願鹹鹽顧顧遞醖構鑰齋簾積網鬱襯艱鏇 (願鹹壓鹹壓膚積構積壓, 壓繭夢艱鬱製艱餘選構 ~ 鏇繭廠艱網簾廠衊顧夢) 更多	-	2021-10-22
				Placebo+Meropenem (Meropenem + Placebo)	襯壓廠鏇襯製衊觸衊觸(鹹廠淵積觸鹽顧餘糧膚) = 觸艱積齋淵廠艱鹽構鹽構鑰齋簾積網鬱襯艱鏇 (願鹹壓鹹壓膚積構積壓, 範網膚簾網構遞觸製鹽 ~ 憲蓋鹽繭襯壓鏇觸壓構) 更多