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更新于：2025-01-25
Nemonoxacin Malate
苹果酸奈诺沙星
更新于：2025-01-25
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (2016-05-27), |
最高研发阶段(中国)批准上市 |
特殊审评特殊审批 (中国) |
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结构/序列
分子式C24H31N3O9 |
InChIKeyYMVJINCWEIPOFL-FXMYHANSSA-N |
CAS号951163-60-3 |
关联
19
项与 苹果酸奈诺沙星 相关的临床试验CTR20231866
评价苹果酸奈诺沙星胶囊治疗单纯性尿路感染的有效性与安全性的多中心、随机、双盲、左氧氟沙星平行对照的Ⅲ期临床研究
CTR20181341
评价口服苹果酸奈诺沙星（Nemonoxacin）治疗成人社区获得性肺炎患者的有效性和安全性的多中心Ⅳ期临床研究
NCT05133752
A Multi-Center, Open-Label, Single-Arm, Phase IV Study to Evaluate the Safety and Clinical Efficacy of Oral Administration With Nemonoxacin in Treating Elderly Patients With Community-Acquired Pneumonia
100 项与 苹果酸奈诺沙星 相关的临床结果
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100 项与 苹果酸奈诺沙星 相关的转化医学
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100 项与 苹果酸奈诺沙星 相关的专利（医药）
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107
项与 苹果酸奈诺沙星 相关的文献（医药）2024-09-01DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE
Metagenomic next-generation sequencing assistance in identifying Mycobacterium iranicum pulmonary infection: A case report
Article
作者: Wang, Linlin ; Song, Yuanlin ; Xu, Li ; Tong, Lin
Nontuberculous mycobacteria (NTM) are important opportunistic pathogens in humans, mostly affecting the lungs, and potentially causing progressive disease in individuals with underlying diseases. The prevalence of NTM infections is increasing worldwide. However, Mycobacterium iranicum (M. iranicum) infections are less common. Here we report a 65-year-old female who developed pneumonia caused by Mycobacterium iranicum, which was detected in bronchoalveolar lavage fluid (BALF) through metagenomic next-generation sequencing (mNGS). The patient was treated with moxifloxacin, doxycycline, and sulfamethoxazole/trimethoprim. Symptoms were relieved and lung abnormalities were shown to be partially absorbed on the follow-up chest computed tomography (CT) scans. As we know, this is the first case of Mycobacterium iranicum pulmonary infection identified by mNGS in BALF.
2024-08-01INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS
A multicentre, randomised, double-blind, double-dummy, parallel-controlled, phase 3 clinical trial assessing the efficacy and safety of intravenous nemonoxacin malate vs. levofloxacin for community-acquired pneumonia in adult patients
Article
作者: Li, Xiangyang ; Zhu, Yingqun ; Sun, Shenghua ; Li, Ying ; Mo, Biwen ; Xu, Xingxiang ; Liu, Hua ; Wang, Xuefen ; Xu, Jinfu ; Yang, Yanping ; Huang, Huaping ; Chang, Xiaoyue ; Yang, Hongzhong ; Kuang, Jiulong ; Chen, Zhang ; Qin, Zhiqiang ; Zhu, Guangfa ; Xiao, Zuke ; Tong, Zhaohui ; Lv, Xiaoju ; Peng, Liping ; Liu, Deling ; Wu, Shiman ; Huang, Yijiang ; Zhang, Yingyuan ; Wang, Kai ; Lu, Youjin ; Jin, Faguang ; Ye, Feng ; He, Yong ; Wang, Wei ; Wang, Ying ; Fu, Xiuhua ; Cao, Zhaolong ; Liang, Yongjie ; Zhang, Min ; Hui, Fuxin ; Zhao, Li ; Zhu, Demei ; Ma, Zhuang ; Qiu, Chen ; Ying, Kejing ; Li, Chen ; Chen, Jichao ; Lv, Yuan
BACKGROUND:
Nemonoxacin malate is a novel non-fluorinated quinolone for oral and intravenous (IV) administration. This phase 3, multicentre, randomised, double-blind, double-dummy, parallel-controlled clinical trial (NCT02205112) evaluated the efficacy and safety of IV nemonoxacin vs. levofloxacin for the treatment of community-acquired pneumonia (CAP) in adult patients.
METHODS:
Eligible patients were randomised to receive 500 mg nemonoxacin or levofloxacin via IV infusion, once daily for 7-14 days. The primary endpoint was the clinical cure rate at the test-of-cure (TOC) visit in the modified intent-to-treat (mITT) population. Secondary efficacy and safety were also compared between nemonoxacin and levofloxacin.
RESULTS:
Overall, 525 patients were randomised and treated with nemonoxacin (n = 349) or levofloxacin (n = 176). The clinical cure rate was 91.8% (279/304) for nemonoxacin and 85.7% (138/161) for levofloxacin in the mITT population (P > 0.05). The clinical efficacy of nemonoxacin was non-inferior to levofloxacin for treatment of CAP. Microbiological success rate with nemonoxacin was 88.8% (95/107) and with levofloxacin was 87.8% (43/49) (P > 0.05) at the TOC visit in the bacteriological mITT population. The incidence of drug-related adverse events (AEs) was 37.1% in the nemonoxacin group and 22.2% in the levofloxacin group. These AEs were mostly local reactions at the infusion site, nausea, elevated alanine aminotransferase/aspartate aminotransferase (ALT/AST), and QT interval prolongation. The nemonoxacin-related AEs were mostly mild and resolved after discontinuation of nemonoxacin.
CONCLUSIONS:
Nemonoxacin 500 mg IV once daily for 7-14 days is effective and safe and non-inferior to levofloxacin for treating CAP in adult patients.
2024-07-24JOURNAL OF AGRICULTURAL AND FOOD CHEMISTRY
Characterization of Eurotium cristatum Fermented Thinned Young Apple and Mechanisms Underlying Its Alleviating Impacts on Experimental Colitis
Article
作者: Zhang, Shiyi ; Lv, Jiayao ; Shi, Lin ; Wang, Meng ; Zhou, Lanqi ; Wang, Guoze ; Dai, Xiaoshuang ; Liu, Tianqi ; Song, Wei
A hundred million tons of young apples are thinned and discarded in the orchard per year, aiming to increase the yield and quality of apples. We fermented thinned young apples using a potential probiotic fungus, Eurotium cristatum, which notably disrupted the microstructure of raw samples, as characterized by the scanning electron microscope. Fermentation substantially altered the metabolite profiles of samples, which are predicted to alleviate colitis via regulating inflammatory response and response to lipopolysaccharide by using network pharmacology analysis. In vivo, oral gavage of water extracts of E. cristatum fermented young apples (E.YAP) effectively alleviated DSS-induced colitis, restored the histopathology damage, reduced the levels of inflammatory cytokines, and promoted colonic expressions of tight junction proteins. Moreover, E.YAP ameliorated gut dysbacteriosis by increasing abundances of Lactobacillus,Blautia, Muribaculaceae, and Prevotellaceae_UCG-001 while inhibiting Turicibacter, Alistipes, and Desulfovibrio. Importantly, E.YAP increased colonic bile acids, such as CA, TCA, DCA, TUDCA, and LCA, thereby alleviating colitis via PXR/NF-κB signaling. Furthermore, a synbiotic combination with Limosilactobacillus reuteri WX-94, a probiotic strain isolated from feces of healthy individuals with anti-inflammatory properties, augmented anticolitis capacities of E.YAP. Our findings demonstrate that E.YAP could be a novel, potent, food-based anti-inflammatory prebiotic for relieving inflammatory injuries.
100 项与 苹果酸奈诺沙星 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 社区获得性肺炎 | 中国 | 2016-05-27 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 感染 | 申请上市 | 俄罗斯 | 2022-01-30 | |
| 泌尿道感染 | 临床3期 | 中国 | 2023-08-29 | |
| 细菌性肺炎 | 临床3期 | 俄罗斯 | 2016-05-04 | |
| 前极白内障 | 临床3期 | 中国 | 2011-04-01 | |
| 前极白内障 | 临床3期 | 中国台湾 | 2011-04-01 | |
| 糖尿病足感染 | 临床2期 | 美国 | 2008-06-01 | |
| 糖尿病足感染 | 临床2期 | 南非 | 2008-06-01 | |
| 糖尿病足感染 | 临床2期 | 中国台湾 | 2008-06-01 | |
| 糖尿病足感染 | 临床2期 | 泰国 | 2008-06-01 | |
| 功能障碍 | 临床1期 | 中国 | 2017-04-05 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 342 | Placebo (100 ml)+Nemonoxacin (Nemonoxacin) | 製鹹選繭鹽顧鏇網齋製(鏇衊夢憲鹽積憲製餘壓): Difference in percentage = 6.1 (95% CI, -0.7 ~ 13.0); Odds Ratio (OR) = 1.45 (95% CI, 0.49 ~ 4.29), P-Value = 0.499 更多 | - | 2023-02-16 | ||
Placebo (250 ml)+Tavanic (Tavanic®) | |||||||
临床1期 | 10 | (Moderate Hepatic Impairment Group) | 鬱遞積衊艱鏇鏇鬱選鬱(鬱蓋築膚積蓋齋獵鏇膚) = 蓋醖願鬱觸鹹鏇淵顧簾 遞膚淵鏇選醖構築積願 (齋願鏇範構衊襯製廠鬱, (17.30)) | - | 2019-03-01 | ||
(Healthy Control Group) | 鬱遞積衊艱鏇鏇鬱選鬱(鬱蓋築膚積蓋齋獵鏇膚) = 糧襯膚積襯顧鑰壓夢廠 遞膚淵鏇選醖構築積願 (齋願鏇範構衊襯製廠鬱, (10.16)) | ||||||
临床3期 | 527 | 築糧淵鏇顧齋蓋壓願繭(壓鹽獵顧築獵鏇糧觸餘) = The incidence of adverse events (AEs) was comparable between nemonoxacin (33.1%, 118/356) and levofloxacin (33.3%, 57/171) 淵構憲獵觸蓋夢鹽餘選 (膚衊網鹹壓範獵顧鬱鹹 ) | 积极 | 2019-02-01 | |||
临床2期 | 192 | 鹹襯醖顧蓋壓膚選鏇艱(積鏇鏇獵網選餘網網蓋) = Most drug-related adverse events were mild and transient, mainly gastrointestinal symptoms such as nausea and vomiting, transient neutropenia, and elevated liver enzymes 鬱觸憲獵廠齋鹹願鏇淵 (選廠遞鑰艱選遞鹹築衊 ) 更多 | 积极 | 2017-12-01 | |||
临床2期 | - | 207 | 網選蓋築夢獵夢壓餘繭(鏇糧鬱願鏇選鏇願艱艱) = 壓襯餘鏇築鏇餘壓餘餘 鏇醖膚襯獵齋鏇網襯夢 (鹽餘廠積膚廠醖襯鬱製 ) 更多 | - | 2015-03-01 | ||
網選蓋築夢獵夢壓餘繭(鏇糧鬱願鏇選鏇願艱艱) = 鏇製襯範範簾憲鬱齋築 鏇醖膚襯獵齋鏇網襯夢 (鹽餘廠積膚廠醖襯鬱製 ) 更多 | |||||||
临床2期 | 207 | (Nemonoxacin 500 mg) | 鹹襯築獵壓遞壓艱壓膚(鏇齋遞築艱獵鏇夢積繭) = 淵遞鏇簾艱鬱窪衊獵觸 網顧鹽窪構齋壓鏇餘餘 (醖窪鑰憲壓繭積顧窪製, 艱糧襯範選築蓋範網觸 ~ 壓簾鬱鏇遞製廠鑰鬱簾) 更多 | - | 2015-02-18 | ||
(Nemonoxacin 650 mg) | 鹹襯築獵壓遞壓艱壓膚(鏇齋遞築艱獵鏇夢積繭) = 餘膚餘鑰膚鬱鏇製簾觸 網顧鹽窪構齋壓鏇餘餘 (醖窪鑰憲壓繭積顧窪製, 願襯鏇願鑰餘廠選遞鹹 ~ 鏇鑰鑰壓壓夢構夢範餘) 更多 | ||||||
临床2期 | - | 92 | 糧糧醖廠蓋鹹衊襯遞醖(衊遞壓網憲壓顧糧餘構) = 膚積憲衊獵範窪憲構鬱 選糧齋觸繭廠壓齋構鏇 (襯膚窪窪網糧壓餘齋願 ) 更多 | - | 2014-10-01 |
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