甲硝唑(Metronidazole) - 在研适应症：贾第虫病，坏死性溃疡性龈炎，牙齿感染_专利_临床

概要

基本信息

简介甲硝唑是辉瑞公司于1960年批准的一种小分子药物，可抑制DNA合成，对厌氧菌和原生动物有高效作用。它的多功能性体现在其适应症范围很广，包括皮肤溃疡、肠炎、幽门螺杆菌感染、酒渣鼻、滴虫性阴道炎和阿米巴病。通过破坏 DNA 合成，甲硝唑抑制这些微生物的生长和繁殖。它还显示出作为某些抗生素耐药性细菌感染的替代疗法的潜力。然而，与所有药物一样，甲硝唑具有潜在的副作用，例如恶心、反流和口中的金属味。患者应仔细遵循规定的剂量和治疗持续时间，以避免抗生素耐药性和副作用的风险。

药物类型

小分子化药

别名

1-(2-hydroxy-1-ethyl)-2-methyl-5-nitroimidazole、1-(2-hydroxyethyl)-2-methyl-5-nitroimidazole、1-(β-ethylol)-2-methyl-5-nitro-3-azapyrrole

+ [94]

靶点-

作用机制

DNA合成抑制剂

治疗领域

感染神经系统疾病心血管疾病+ [6]

在研适应症

贾第虫病坏死性溃疡性龈炎牙齿感染+ [22]

非在研适应症

复杂腹腔感染克罗恩病痔疮+ [3]

原研机构

Pfizer Inc.

在研机构

Baxter Healthcare Corp.

Hospira, Inc.

Pfizer Inc.

+ [12]

非在研机构

S.L.A. Pharma AG

Braintree Laboratories, Inc.

Appili Therapeutics, Inc.

最高研发阶段批准上市

首次获批日期

法国 (1960-01-01),

细菌性阴道炎心内膜炎盆腔炎

最高研发阶段(中国)批准上市

特殊审评孤儿药 (欧盟)

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结构

分子式C6H9N3O3

InChIKeyVAOCPAMSLUNLGC-UHFFFAOYSA-N

CAS号443-48-1

关联

510

项与甲硝唑相关的临床试验

NCT06616597 / Not yet recruiting临床2期IIT

Phase II Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer

To determine if dexamethasone or dexamethasone plus metronidazole restore sensitivity to abiraterone for the treatment of metastatic prostate cancer.

开始日期2024-12-30

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

NCT06627270 / Not yet recruiting临床2期IIT

A Phase II Single-arm Cohort Study Establishing the Effect of Antibiotic Treatment on Intratumoral Bacteria in Surgical Patients With Oral Cancer

The goal of this phase II single arm clinical study is to evaluate the effect of antibiotics (metronidazole) and oral chlorhexidine (CHX) in reducing the bacteria load within tumors of patients undergoing surgery for oral cancer.

开始日期2024-12-01

申办/合作机构

The Case Comprehensive Cancer Center

NCT06650540 / Not yet recruitingN/AIIT

Levofloxacin Plus Metronidazole Suppositories Versus Levofloxacin Co-administered with Metronidazole Tablets for the Treatment of Chronic Endometritis: a Randomized Controlled Trial

This is a single randomised controlled trial. The investigators plan to randomise 800 participants to the levofloxacin plus metronidazole suppositories versus levofloxacin co-administered with metronidazole tablets for the treatment of chronic endometritis in a 1:1 rate. Primary outcome will be the live birth rate after the embryo transfer.

开始日期2024-10-22

申办/合作机构

北京大学第三医院

100 项与甲硝唑相关的临床结果

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100 项与甲硝唑相关的转化医学

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100 项与甲硝唑相关的专利（医药）

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18,575

项与甲硝唑相关的文献（医药）

2025-02-01·Parasitology International

Pulmonary infection by Lophomonas spp. and Aspergillus spp. in a B-cell acute lymphocytic leukemia patient from Chile

Article

作者: Cabrera, Johanna ; Hidalgo, Alejandro ; Fonseca-Salamanca, Flery ; Iturrieta-González, Isabel ; Chahin, Carolina ; Briones, Javier ; Moenen-Locoz, Enzo ; Concha, Carla ; Vega, Fernando

The flagellated protozoan Lophomonas spp. is a commensal microorganism found in the intestinal tracts of cockroaches, termites, mites, and certain birds. It is the causative agent of a rare infection in humans called lophomoniasis, primarily affecting the lungs and mainly immunocompromised individuals. This parasitosis is transmitted to humans by air or through ingestion of the cystic forms of the parasite. We describe the case of a 50-year-old patient treated at a tertiary hospital in southern Chile with a history of B-cell acute lymphocytic leukemia. Radiological findings, along with increased levels of inflammatory parameters and galactomannan antigen in serum and Bronchoaveolar Lavage (BAL) raised the suspicion of a pulmonary infection. Microscopic study of BAL revealed oval to pyriform cells with mobile flagella at the anterior end, which were identified as Lophomonas spp. trophozoites, which based on EORTC/MSG criteria were associated with diagnosis of a probable pulmonary aspergillosis. Lophomoniasis was treated with metronidazole (500 mg IV every 8 h) for 14 days and pulmonary aspergillosis required a combination of fluconazole, voriconazole, anidulafungin, liposomal amphotericin B and isavuconazole. The patient responded favorably and was discharged after 95 days of hospitalization. This case highlights the importance of recognizing lophomoniasis as a parasitic infection in respiratory samples from immunocompromised patients who present pulmonary symptoms, especially those who do not respond satisfactorily to conventional antimicrobial treatments. Further research is needed to understand the various sources of Lophomonas spp. infection and develop infection prevention strategies particularly for high-risk patients.

2025-01-01·International Journal of Hygiene and Environmental Health

Prevalence of antibiotic-resistant enterobacteriaceae in domestic wastewater and associated health risks in reuse practices

Article

作者: Cangola, Jenita ; Abagale, Felix K ; Abagale, Felix K. ; Cobbina, Samuel J. ; Osei, Richard A. ; Cobbina, Samuel J ; Osei, Richard A

The use of wastewater for non-potable purposes is an important alternative for addressing water scarcity, especially in developing regions. However, minimizing the risks, particularly those associated with emerging contaminants that may induce resistance among pathogens in wastewater, is crucial. This study assessed the occurrence of antibiotic-resistant bacteria in untreated wastewater used for agricultural purposes and evaluated the quantifiable health risks associated with this practice in Tamale, Ghana. The resistance of some Enterobacteriaceae, such as E. coli, Klebsiella, and Salmonella-Shigella, to four commonly used antibiotics in Ghana was assessed using a conventional microbiological culture approach and the Kirby Bauer disk diffusion method. A Quantitative Microbial Risk Assessment (QMRA) was performed to estimate the health risks associated with two distinct scenarios of wastewater reuse: (1) accidental ingestion of contaminated wastewater and soil, and (2) consumption of vegetables irrigated with wastewater. This approach applied a Monte Carlo simulation based on 10,000 interactions and identified E. coli O157:H7 as the reference pathogen. Among Enterobacteriaceae, Klebsiella pneumoniae, Salmonella-Shigella and E. coli were isolated, in concentrations exceeding the limit recommended by the World Health Organization (10³ CFU/100 ml). All the isolated bacteria were resistant to metronidazole (5 μg). Thirty-three per cent of Klebsiella pneumoniae isolates were intermediate/moderately susceptible, and all other bacteria were resistant to amoxicillin (30 μg). All Klebsiella pneumoniae and the majority of Salmonella-Shigella (69.8 %) isolates were resistant to trimethoprim-sulfamethoxazole (25 μg) and tetracycline (30 μg). When assessing health risks, the mean annual probability of infection associated with consuming vegetables irrigated with wastewater varied between 5.14 × 10^-2 and 9.79 × 10^-1 per person per year. Conversely, for the accidental ingestion scenario, the probability was 1.00 per person per year. In these scenarios, the probability of illness ranged from 1.29 × 10^-2 to 2.4 × 10^-1 and 2.5 × 10^-1 per person per year. The health risks posed by these findings surpass the maximum threshold prescribed by the World Health Organization, thereby emphasizing the need for prompt mitigation strategies.

2024-12-31·Gut Microbes

The effects of antibiotic exposures on the gut resistome during hematopoietic cell transplantation in children

Article

作者: Bhattarai, Shakti K ; Bucci, Vanni ; Seed, Patrick C ; Martin, Paul L ; Arshad, Mehreen ; Jenkins, Kirsten ; Kelly, Matthew S ; Heston, Sarah M. ; Ward, Doyle V ; Heston, Sarah M ; Chao, Nelson J ; Stokhuyzen, Andre ; Young, Rebecca R

Antibiotic resistance is a global threat driven primarily by antibiotic use. We evaluated the effects of antibiotic exposures on the gut microbiomes and resistomes of children at high risk of colonization by antibiotic-resistant bacteria. We performed shotgun metagenomic sequencing of 691 serially collected fecal samples from 80 children (<18 years) undergoing hematopoietic cell transplantation. We evaluated the effects of aerobic (cefepime, vancomycin, fluoroquinolones, aminoglycosides, macrolides, and trimethoprim-sulfamethoxazole) and anaerobic (piperacillin-tazobactam, carbapenems, metronidazole, and clindamycin) antibiotic exposures on the diversity and composition of the gut microbiome and resistome. We identified 372 unique antibiotic resistance genes (ARGs); the most frequent ARGs identified encode resistance to tetracyclines (n = 88), beta-lactams (n = 84), and fluoroquinolones (n = 79). Both aerobic and anaerobic antibiotic exposures were associated with a decrease in the number of bacterial species (aerobic, β = 0.71, 95% CI: 0.64, 0.79; anaerobic, β = 0.66, 95% CI: 0.53, 0.82) and the number of unique ARGs (aerobic, β = 0.81, 95% CI: 0.74, 0.90; anaerobic, β = 0.73, 95% CI: 0.61, 0.88) within the gut metagenome. However, only antibiotic regimens that included anaerobic activity were associated with an increase in acquisition of new ARGs (anaerobic, β = 1.50; 95% CI: 1.12, 2.01) and an increase in the relative abundance of ARGs in the gut resistome (anaerobic, β = 1.62; 95% CI: 1.15, 2.27). Specific antibiotic exposures were associated with distinct changes in the number and abundance of ARGs for individual antibiotic classes. Our findings detail the impact of antibiotics on the gut microbiome and resistome and demonstrate that anaerobic antibiotics are particularly likely to promote acquisition and expansion of antibiotic-resistant bacteria.

202

项与甲硝唑相关的新闻（医药）

2024-11-19

·戊戌数据

【品种报告】甲硝唑凝胶

品种概述 1、基本情况甲硝唑对大多数厌氧菌（如多种革兰氏阴性和革兰氏阳性厌氧菌）有强大的抗菌活性，对阴道滴虫、阿米巴原虫和蓝氏贾第鞭毛虫也有良好的抗原虫作用，但对需氧菌无效。甲硝唑目前常见的剂型有：片剂、注射剂、栓剂、乳膏剂以及凝胶剂等。甲硝唑凝胶已被收录于国家医保目录乙类（2023版），其说明书适应症为：用于炎症性丘疹、脓疱疮、酒渣鼻红斑的局部治疗。国内：（1）甲硝唑凝胶：目前共有5家企业持有其上市批文，其规格均为0.75%，而原研Galderma的甲硝唑凝胶未在国内上市。（2）甲硝唑乳膏：目前共有1家企业持有其上市批文。国外：Galderma的甲硝唑凝胶以Type 3 - New Dosage Form（新剂型） NDA申请类型获批在美国上市，其商品名为Metrogel，规格有两个：1%和0.75%。Galderma在日本上市的甲硝唑凝胶规格只有0.75%，商品名为Rozex，上市时间为2015年5月。 2、作用机制和优势作用机制：甲硝唑通过抑制细菌DNA合成，干扰细菌的生长和繁殖，从而起到杀菌作用。优势：（1）广谱抗菌作用，抗菌活性强：对大多数厌氧菌（如多种革兰氏阴性和革兰氏阳性厌氧菌）有强大的抗菌活性，但对需氧菌无效。（2）抗寄生虫作用：包括滴虫、阿米巴原虫、蠕形螨/毛囊虫、蛔虫等。（3）抗炎作用：甲硝唑通过减少活性氧产物的生成和清除活性氧而达到抗炎作用，从而够减轻炎症反应。（4）安全性较高：甲硝唑已在国内外上市多年，安全性数据充分。此外，甲硝唑引起变应性接触性皮炎（外用皮肤制剂最常见的不良反应）的报道较为罕见。（5）剂型优势：凝胶剂具有良好的渗透性，尤其是在治疗深部感染性皮肤病时，能够迅速达到治疗浓度。 3、国内上市药品专利情况暂无相关信息。且根据橙皮书的相关信息，Galderma 的Metrogel主要涉及商品外观专利，但已到期，因此开发本品并无相关专利障碍。 4、国内上市情况现共有5家企业获得了甲硝唑凝胶的上市批文，分别为海南海神同洲制药、江苏知原药业、天津市天骄制药、山东方明药业、湖北康正药业，这5家企业均未通过一致性评价。图：国内甲硝唑凝胶的上市信息 5、国内注册情况截至目前，共11家企业进行了甲硝唑凝胶的注册申请（化药4类），均暂未获批。图：甲硝唑凝胶的部分注册申请信息 6、国内临床试验情况无相关信息。二、市场可行性分析 1、适应症及流行病学玫瑰痤疮：玫瑰痤疮是一种好发于面中部，主要累及面部血管、神经及毛囊皮脂腺单位的慢性复发性炎症性疾病。早年间，国内教科书及很多皮肤病专著大多用“酒渣鼻”来称呼“玫瑰痤疮”，之后就改为“玫瑰痤疮” ，一直沿用至今。玫瑰痤疮主要临床表现为面部皮肤阵发性潮红、持续性红斑或丘疹、脓疱、毛细血管扩张等，少数患者可出现增生肥大及眼部改变。关于“玫瑰痤疮”和“痤疮”：玫瑰痤疮≠痤疮。二者相同点是都出现丘疹和脓包，不同点是痤疮常有粉刺，而玫瑰痤疮有阵发性潮红及毛细血管扩张。据最新的国际各人群流行病学数据荟萃分析，玫瑰痤疮国际患病率平均为5.46%。国内2019年一项10095例长沙市社区居民调查结果显示，该地区玫瑰痤疮患病率为3.48%，并发现玫瑰痤疮更容易合并黄褐斑、高血压、甲状腺功能亢进及乳腺癌；2020年两所大学共9227名大学生人群流行病学调查显示，玫瑰痤疮患病率为3.4%，并发现玫瑰痤疮与雄激素性秃发、中重度痤疮及皮肤划痕症有显著的正相关，手部湿疹与玫瑰痤疮的发生呈负相关。该病好发于20～50岁女性，但儿童和老年人同样可以发病。 2、临床指南/共识玫瑰痤疮的治疗方式包括局部治疗、系统治疗、光电等物理治疗以及手术治疗等。其中以局部治疗较为常用，局部治疗又包括：修复和维持皮肤屏障功能、外用药物治疗以及眼部局部用药。而在治疗玫瑰痤疮的外用药物中，皮肤用的甲硝唑为指南推荐等级最高的药物。表：玫瑰痤疮相关指南/共识推荐 3、同类型产品比较表：治疗玫瑰痤疮的常用局部外用药物数据来源：《中国玫瑰痤疮诊疗指南（2021版）》及网络公开信息整理 4、中国皮肤病局部用药物市场情况皮肤病临床治疗中，药物可以分为局部用药物和系统性药物，其中局部用药适用疾病更多、使用率更高。2017年到2022年，中国皮肤病局部用药物市场从59亿元增长至87亿元，复合年增长率为8.0%，构成皮肤病药物市场的重要组成部分。预计，2026年市场规模达125亿元人民币，2022年至2026年期间的复合年增长率为9.5%。数据来源：华经产业研究院 5、中国甲硝唑单方制剂的市场情况疫情后的2021年，甲硝唑单方制剂的市场规模迅速增长，到了2022年增长趋势就不是很明显，2022年的市场规模达到了14.46亿元。预计未来几年甲硝唑单方制剂的市场规模会处于平稳增长的状态，增幅会较小。数据来源：米内网 2022年甲硝唑凝胶销售额在甲硝唑单方制剂中位列第五名，销售额占比为7.47%。数据来源：米内网 6、中国甲硝唑凝胶市场情况甲硝唑凝胶的市场规模从2019年开始，市场规模均处于增长状态，且增幅明显，销售终端以零售端为主导地位。到了2022年开始，其市场规模达到了8117万元，增长率为35.35%，5年CAGR为20.82%。预计未来几年甲硝唑凝胶的市场规模会处于快速增长的状态，2025年的市场规模预计会超过1.6亿元。数据来源：米内网从厂家的市场占有率来看，天津天骄的市场占有率今年在逐渐减少， 2022年为24.26% ；山东方明（3.41%）和江苏知原（31.43%）近年的市场占有率变化不明显；湖北康正（24.18%）和海南海神通州（16.72%）近年的市场占有率在逐渐增大。数据来源：米内网 END ★ 点击下方卡片，发现更多精彩

上市批准一致性评价专利到期

2024-11-18

·PRNewswire

TenNor Announces Positive Topline Results from Rifasutenizol Phase III Trial for H. pylori Infection

SUZHOU, China, Nov 18, 2024 /PRNewswire/ -- TenNor Therapeutics, a clinical-stage company dedicated to developing novel therapies to address unmet needs in infectious diseases, announced today the successful completion of a phase III clinical trial of rifasutenizol (TNP-2198) for the treatment of Helicobacter pylori (H. pylori) infection. The study met its primary endpoints, showing multiple advantages of rifasutenizol regimen compared with bismuth-containing quadruple therapy (BQT), the current standard of care. The completed study is a multicenter, randomized, double-blind, controlled phase III clinical trial to evaluate the efficacy and safety of TNP-2198 in combination with amoxicillin and rabeprazole for the treatment of H. pylori infection in treatment-naive patients. The study was conducted in 40 hospitals in China. A total of 700 treatment-naive patients with H. pylori infection confirmed by a positive carbon-13 urea breath test (C-13 UBT) and histological examination were randomly assigned in a 1:1 ratio to receive rifasutenizol triple therapy (rifasutenizol 400 mg, amoxicillin 1 g and rabeprazole 20 mg) or BQT (bismuth potassium citrate 240 mg, clarithromycin 500 mg, amoxicillin 1 g and rabeprazole 20 mg) treatment, twice a day for 14 days. The efficacy endpoint was the C-13 UBT test result 4 to 6 weeks after the end of treatment. Patient compliance was high in the study with a low dropout rate of 3%. H. pylori was successfully cultured in 87% patients. There were no significant differences in demographics or baseline antibiotic resistance characteristics between the two treatment groups that could affect the study outcomes. Resistance rates to clarithromycin, metronidazole, levofloxacin and amoxicillin among H. pylori clinical isolates from this study were 41%, 68%, 35% and 8% respectively, which are consistent with data reported recently by other studies, indicating antibiotic resistance to H. pylori is a serious problem in China. All clinical isolates from the study were susceptible to rifasutenizol. Rifasutenizol triple therapy achieved >90% eradication rate in the modified intention-to-treat (mITT) population, higher than BQT control (92.0% vs. 87.9%, difference 4.1%, non-inferiority test p<0.0001, superiority test p= 0.0338). The rifasutenizol regimen also achieved a higher eradication rate than BQT in the per protocol (PP) population (93.7% vs. 90.3%, difference 3.4%, non-inferiority test p<0.0001, superiority test p=0.0563). In patients infected with H. pylori resistant to any of the current antibiotics, rifasutenizol triple therapy also achieved a higher eradication rate than BQT (90.9% vs. 87.2%, difference 3.7%, non-inferiority test p<0.0001), indicating rifasutenizol regimen is highly effective in patients with antibiotic-resistant H. pylori infections. Rifasutenizol regimen showed better safety and tolerability profile than BQT. The treatment-emergent adverse events (TEAEs), investigational drug related TEAEs, TEAEs with grade 3 or above are all lower in the rifasutenizol arm. Most TEAEs were Grade 1 and no investigational drug related serious adverse events (SAEs) reported. Rifasutenizol is a novel multi-targeting drug candidate with a synergistic mechanism of action against anaerobic and microaerophile bacteria. It has potential to become the first new drug developed specifically for H. pylori infection in more than 30 years. Rifasutenizol could play an important role in supporting the large-scale test-and-treatment strategy to prevent gastric cancers in populations with high gastric cancer risk, as the rifasutenizol regimen does not require drug sensitivity test and can be seamlessly integrated with the UBT testing. TenNor completed 7 phase I-III clinical trials in China and has received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the U.S. Food and Drug Administration (FDA). About TenNor Therapeutics TenNor Therapeutics is a clinical-stage company specialized in the discovery and development of differentiated new drug products for diseases associated with bacterial infection and metabolism. TenNor possesses a unique multi-targeting drug conjugate technology and a strong new drug development portfolio with global IP protection. Several products are currently in late-stage of clinical development targeting H. pylori infection, medical device infections, hepatic encephalopathy and irritable bowel syndrome with diarrhea. The company is committed to address unmet needs in the disease area and provide safe and effective therapies for patients in China and around the world. For more information please visit: . SOURCE TenNor Therapeutics (Suzhou) Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期快速通道临床结果合格传染病产品

2024-11-18

·药智网

30年首个！幽门螺杆菌「首创新药」更新进展

今日（11月18日），丹诺医药宣布其用于治疗幽门螺杆菌感染的全球首创新药TNP-2198成功完成III期临床试验并达到研究预设的主要终点指标，同铋剂四联相比体现多方面优势。丹诺医药创始人马振坤博士表示：“TNP-2198是30年以来全球第一个专门针对幽门螺杆菌感染开发的抗菌新药，具有独特的多靶点协同作用机制。” 丹诺医药官微显示，这是一项多中心、随机、双盲、铋剂四联对照的III期临床试验，旨在评价TNP-2198联合阿莫西林和雷贝拉唑三联方案在初治患者中根除幽门螺杆菌的有效性和安全性。这项研究由北京大学第三医院周丽雅教授牵头，在全国40家医院开展。研究共纳入700例既往未接受过根除治疗、碳-13尿素呼气试验（UBT）阳性并经组织学确认的幽门螺杆菌感染者，患者按1:1随机分配至TNP-2198三联方案（试验组）或铋剂四联方案（对照组），接受每天2次，连续14天治疗，有效性终点为治疗结束后4~6周的UBT检测结果。这项III期临床试验的整体执行情况良好，脱落率仅为3%，服药依从性高达96%，基线幽门螺杆菌培养成功率高达87%。试验组和对照组在人口学及基线药敏特征方面没有影响研究结果的显著差异。本研究中感染者克拉霉素、甲硝唑、左氧氟沙星和阿莫西林的耐药率分别达到41%、68%、35%和8%，与近期文献报道结果一致，表明中国幽门螺杆菌感染者中耐药问题严重。研究中未分离到对TNP-2198的耐药菌株。有效性的主要分析人群为改良意向治疗分析集（mITT），即在随机分组后接受至少一次试验用药品治疗的感染者。TNP-2198三联方案在mITT人群中对幽门螺杆菌的根除率超过90%，高于铋剂四联对照（92.0%vs.87.9%，差值4.1%，非劣检验P<0.0001，优效检验P=0.0338）。在符合方案集（PP），即未发生影响疗效分析的重大方案违背的感染者中，TNP-2198三联方案的根除率同样高于铋剂四联（93.7%vs.90.3%，差值3.4%，非劣检验P<0.0001，优效检验P=0.0563）。在微生物学意向治疗分析集（Micro-ITT），即基线幽门螺杆菌培养阳性且有药敏试验结果的感染者中，基于药敏试验结果的任何抗生素耐药亚组（即对目前用于幽门螺杆菌根除的5种抗生素中的任何一个耐药）分析表明，TNP-2198三联方案对幽门螺杆菌的根除率仍超过90%，同样高于铋剂四联方案，与主要分析人群结果一致，表明TNP-2198三联方案对耐药感染具有良好的根除效果。 TNP-2198三联方案组在治疗期间发生的不良事件（TEAE）、试验用药品相关TEAE、3级及以上TEAE的发生率，均低于铋剂四联方案组，且大部分为1级，未出现与试验用药品相关的严重不良事件（SAE），表明TNP-2198三联方案具有良好的安全耐受性。丹诺医药官微显示，TNP-2198是一个具有独特多靶点协同作用机制的抗菌新药候选物，拥有克服抗生素耐药、降低耐药频率和对慢代谢球形菌有效的优势，曾获得国家十三五“重大新药创制”科技重大专项的支持。丹诺医药已经完成TNP-2198的7项I-III期临床试验，并取得积极结果。丹诺医药拥有TNP-2198在美国的新药临床试验（IND）许可、美国FDA合格抗感染产品（QIDP）和快速通道（Fast Track）资格认定。声明：本内容仅用作医药行业信息传播，不代表药智网立场。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 史蒂文阅读原文，是受欢迎的文章哦

临床3期临床结果

100 项与甲硝唑相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00409	甲硝唑	G01AF01 D06BX01 J01XD01 A01AB17 P01AB01	DB00916

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
感染性肠炎	日本	Shionogi Pharma Co., Ltd.	2012-08-10
神经系统血吸虫病	日本	Shionogi Pharma Co., Ltd.	2012-08-10
幽门螺杆菌感染	日本	Shionogi Pharma Co., Ltd.	2007-08-23
玫瑰痤疮	美国	Bausch Health US LLC	1997-09-26
滴虫性阴道炎	美国	Pfizer Inc.	1995-05-03
感染	中国	天津力生制药股份有限公司	1981-01-01
阿米巴病	美国	Pfizer Inc.	1963-07-18
厌氧菌感染	美国	Pfizer Inc.	1963-07-18
骨和关节感染	美国	Pfizer Inc.	1963-07-18
中枢神经系统感染	美国	Pfizer Inc.	1963-07-18
妇科感染	美国	Pfizer Inc.	1963-07-18
腹腔感染	美国	Pfizer Inc.	1963-07-18
下呼吸道感染	美国	Pfizer Inc.	1963-07-18
脓毒症	美国	Pfizer Inc.	1963-07-18
皮肤和皮肤结构感染	美国	Pfizer Inc.	1963-07-18
阿米巴痢疾	日本	Shionogi Pharma Co., Ltd.	1961-08-22
滴虫感染	日本	Shionogi Pharma Co., Ltd.	1961-08-22
细菌性阴道炎	法国	Pfizer Inc.	1960-01-01
心内膜炎	法国	Pfizer Inc.	1960-01-01
盆腔炎	法国	Pfizer Inc.	1960-01-01

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
复杂腹腔感染	临床1期	乌克兰	Pfizer Inc.	2012-03-01
复杂腹腔感染	临床1期	南非	Pfizer Inc.	2012-03-01
复杂腹腔感染	药物发现	俄罗斯	Pfizer Inc.	2012-03-01
复杂腹腔感染	药物发现	马来西亚	Pfizer Inc.	2012-03-01
复杂腹腔感染	药物发现	保加利亚	Pfizer Inc.	2012-03-01
痔疮	药物发现	英国	S.L.A. Pharma AG	2006-09-01
疼痛	药物发现	英国	S.L.A. Pharma AG	2006-09-01
克罗恩病引起的肛周瘘	药物发现	美国	S.L.A. Pharma AG	2005-05-01
克罗恩病引起的肛周瘘	药物发现	英国	S.L.A. Pharma AG	2005-05-01

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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


IBIS (UEGW)	N/A	感染一线	489	Vancomycin	(糧壓簾蓋廠築積遞鹹範) = 廠壓觸衊醖壓憲廠觸蓋鹽築觸膚齋獵鑰衊觸觸 (餘壓築艱簾簾夢鏇窪積 )	积极	2024-10-13
				Metronidazole	(糧壓簾蓋廠築積遞鹹範) = 繭衊齋壓獵鑰襯蓋觸鏇鹽築觸膚齋獵鑰衊觸觸 (餘壓築艱簾簾夢鏇窪積 )
NCT03329092 (REVISIT, CTgov)	临床3期	革兰氏阴性菌感染 \| 复杂腹腔感染 \| 呼吸机相关性肺炎 \| 医院获得性肺炎	422	MTZ+ATM-AVI	夢網鹽膚壓窪鑰襯鬱鏇(淵膚憲遞願鏇齋衊範構) = 積淵鏇築築繭繭觸餘艱膚繭遞觸積壓積觸淵衊 (鹹鏇膚衊網壓鹽網夢膚, 鹽觸鹽鏇繭夢襯廠餘壓 ~ 廠壓醖艱夢顧遞簾壓壓) 更多	-	2024-05-07
EudraCT: 2020-002489-15 (phase 4, Pubmed \| JAMA Netw Open)	N/A	细菌性阴道炎一线 premenopausal women	147	Dequalinium chloride	鑰遞鑰襯製襯淵簾網觸(製鹽衊觸齋鏇艱憲齋顧) = Three patients in the metronidazole group suspended treatment due to an adverse event 餘淵鏇襯齋鹽壓淵願膚 (淵艱齋廠憲蓋壓糧繭築 )	积极	2024-05-02
				Metronidazole
Pubmed 人工标引	N/A	牙髓坏死	38	modified 3Mix-Simvastatin combinationSimvastatin+cefixime+ciprofloxacin+metronidazole	壓蓋顧繭夢壓築鏇鬱蓋(壓鏇壓鹹廠觸醖獵積廠) = 淵淵製觸膚齋繭醖鑰獵鑰艱壓糧繭憲製築築簾 (範蓋衊憲窪積築餘鑰淵 )	积极	2024-04-01
				underwent conventional root canal treatment	壓蓋顧繭夢壓築鏇鬱蓋(壓鏇壓鹹廠觸醖獵積廠) = 鏇遞糧顧窪膚壓衊窪鏇鑰艱壓糧繭憲製築築簾 (範蓋衊憲窪積築餘鑰淵 )
NCT04927312 (CTgov)	临床3期	复杂腹腔感染	60	PF-06947386+metronidazole	窪醖襯襯窪糧艱糧願膚(顧壓繭衊網網鹽顧遞憲) = 觸齋齋構獵繭積鏇鬱鹹遞積鬱遞鏇餘艱網選夢 (襯窪築糧願繭繭鬱積憲, 淵襯膚願觸築壓繭築繭 ~ 範選窪築壓壓糧鬱蓋遞) 更多	-	2024-03-08
CTR20210714 (BusinessWire) 人工标引	临床3期	细菌性阴道炎	320	Vaginal live lactobacillus+metronidazole	(鏇夢鏇築簾構餘範淵鏇) = Significantly Reduced 蓋選鑰獵鑰艱齋夢鑰鹽 (繭選鏇蓋選齋鑰齋壓獵 )	积极	2023-12-12
				Placebo+metronidazole
NCT01442363 (CTgov)	临床2期	克罗恩病引起的肛周瘘	4	BLI-1300 high dose (BLI-1300 (High Dose))	廠蓋製齋選鹹鏇廠遞鏇(膚憲膚衊鹽鹹範憲餘壓) = 糧製醖齋顧蓋壓鏇糧衊艱觸醖衊艱廠壓積顧選 (壓糧糧壓獵齋獵顧壓艱, 廠鹽製鏇憲鏇衊膚窪繭 ~ 艱艱簾簾選衊鏇製夢淵) 更多	-	2023-11-13
				BLI-1300 low dose (BLI-1300 (Low Dose))	廠蓋製齋選鹹鏇廠遞鏇(膚憲膚衊鹽鹹範憲餘壓) = 範築製餘遞鹹鏇鬱壓餘艱觸醖衊艱廠壓積顧選 (壓糧糧壓獵齋獵顧壓艱, 夢憲構築範壓築鏇艱範 ~ 鑰襯構鏇衊鬱衊廠糧網) 更多
ISRCTN14161293 (VITA, Pubmed \| Int J STD AIDS)	临床3期	-	155	Oral Metronidazole 400mg	蓋鹹獵夢蓋鏇製鬱築獵(顧選鏇遞艱窪遞膚簾膚) = 99/155 reported at least one metronidazole AE, including 72/155 who reported gastrointestinal symptoms mostly within 3 days of starting treatment and resolving within 5 days of onset. Treatment discontinuation occurred in 8% (12/148) overall and AEs were given as the reason for discontinuing in only 3% (4/148) 壓遞範廠積積鏇鹹鹽繭 (觸網選鹽願製餘窪鑰鑰 )	积极	2023-10-01
SGO	N/A	女性生殖器官肿瘤	-	First or second-generation cephalosporins	鹽繭網網觸繭顧蓋觸窪(襯膚襯廠網築齋鹹選鹹) = 夢網觸構繭觸鬱築齋獵製範窪願繭鏇憲範糧鑰 (壓夢鹽積壓壓獵選壓廠 )	-	2023-09-01
				Metronidazole	鹽繭網網觸繭顧蓋觸窪(襯膚襯廠網築齋鹹選鹹) = 遞顧艱顧積淵構製窪簾製範窪願繭鏇憲範糧鑰 (壓夢鹽積壓壓獵選壓廠 )
NCT04578015 (CTgov)	临床4期	细菌性阴道炎	16	Metronidazole (Metronidazole 500 mg)	觸鹽願鑰範製鬱衊繭夢(廠繭夢餘餘襯夢製齋壓) = 簾製繭齋壓鏇糧襯憲鏇廠築遞範襯夢願鏇夢衊 (膚糧積膚糧願積淵鑰鬱, 網醖築衊鹽築憲淵餘構 ~ 廠鏇蓋窪廠遞觸糧獵顧) 更多	-	2023-06-15
				Placebo (Placebo)	觸鹽願鑰範製鬱衊繭夢(廠繭夢餘餘襯夢製齋壓) = 齋鹽窪觸襯蓋淵鹽鏇願廠築遞範襯夢願鏇夢衊 (膚糧積膚糧願積淵鑰鬱, 餘顧遞願簾憲鏇範簾餘 ~ 積襯選顧築鹽鏇襯選遞) 更多