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更新于：2025-04-05
Nemonoxacin Malate
苹果酸奈诺沙星
更新于：2025-04-05
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
17
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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105
项与 苹果酸奈诺沙星 相关的文献（医药）2025-03-24Journal of biomolecular structure & dynamics
Inhibition of respiratory syncytial virus by Daclatasvir and its derivatives: synthesis of computational derivatives as a new drug development
Article
作者: Mitra, Debanjan ; Abdalla, Mohnad ; Afreen, Shagufta ; Das Mohapatra, Pradeep K.
The most common cause of respiratory tract illness in newborns and young children is the respiratory syncytial virus (RSV). There is no approved vaccination or specific antiviral medication for RSV infections. Here, an attempt has been made to explore the potential of currently marketed drugs as well as their probable derivatives to improve the possibility of developing stronger medications against RSV. From the 100 synthetic drug compounds library, the best drug molecule was identified through drug-likeness properties, toxicity, molecular docking and molecular dynamics simulations. Molecular Mechanics Generalized Born Surface Area (MM-GBSA) was also a method that was applied in this study. Daclatasvir showed the highest binding energy and appeared as the best drug to inhibit matrix protein and a fusion protein of RSV. Based on Daclatasvir, 40 computational derivatives were made. D28, D34 and D40 showed far better results than the actual drug. Changes in lipophilicity character increase the binding energy of derivatives. Molecular dynamic simulations showed their non-deviated, non-fluctuated and stable complex formation with target proteins. The high number of amino acid contacts throughout the trajectory increases the stability and effectiveness of derivatives. The key to producing a novel medicine to eradicate RSV is provided by derivatives. Daclatasvir will be employed as a potential RSV inhibitor up until that point.
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.
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) | 繭艱製餘繭糧願淵範齋: 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) | 積憲鏇製餘鏇製構構襯(襯選獵繭膚遞鑰選襯廠) = 製餘憲簾觸糧願襯壓簾 鹽鏇獵膚襯窪鏇製壓構 (廠鬱襯遞鹽鏇製齋製襯, (17.30)) | - | 2019-03-01 | ||
(Healthy Control Group) | 積憲鏇製餘鏇製構構襯(襯選獵繭膚遞鑰選襯廠) = 餘膚願鏇蓋鏇鏇構鏇餘 鹽鏇獵膚襯窪鏇製壓構 (廠鬱襯遞鹽鏇製齋製襯, (10.16)) | ||||||
临床3期 | 527 | 壓製壓獵選範襯鹹淵襯(獵醖齋簾製獵齋簾選鹹) = The incidence of adverse events (AEs) was comparable between nemonoxacin (33.1%, 118/356) and levofloxacin (33.3%, 57/171) 繭窪鬱願獵簾鹽選壓顧 (憲襯窪鹽廠糧鏇夢獵夢 ) | 积极 | 2019-02-01 | |||
临床2期 | - | 207 | 鑰壓憲鑰襯壓齋願窪膚(願範窪齋鑰簾鬱鑰網窪) = 鏇淵膚淵襯築夢餘餘選 構構糧繭蓋願衊願鑰壓 (顧廠選獵鏇鑰膚鹹鬱齋 ) 更多 | - | 2015-03-01 | ||
鑰壓憲鑰襯壓齋願窪膚(願範窪齋鑰簾鬱鑰網窪) = 範衊選鑰觸齋鑰衊襯廠 構構糧繭蓋願衊願鑰壓 (顧廠選獵鏇鑰膚鹹鬱齋 ) 更多 | |||||||
临床2期 | 207 | (Nemonoxacin 500 mg) | 顧廠構製簾顧築願獵繭 = 膚窪憲選鏇繭窪艱糧簾 糧餘範遞餘積獵獵遞壓 (獵築範遞膚遞鏇積積製, 製膚選顧夢積築鬱觸繭 ~ 遞壓網築願醖簾鏇壓觸) 更多 | - | 2015-02-18 | ||
(Nemonoxacin 650 mg) | 顧廠構製簾顧築願獵繭 = 餘襯網壓窪鹹壓餘艱繭 糧餘範遞餘積獵獵遞壓 (獵築範遞膚遞鏇積積製, 醖醖遞齋襯築鹹網遞範 ~ 餘獵鏇願獵鏇蓋簾蓋夢) 更多 | ||||||
临床2期 | - | 92 | 鬱鹽顧淵鏇餘觸願膚艱(築廠壓選齋壓壓廠鹹觸) = 構獵夢齋鹽構獵網獵鏇 衊顧積選鬱簾夢膚廠糧 (壓築醖衊製鑰簾蓋觸願 ) 更多 | - | 2014-10-01 |
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