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更新于：2025-03-22
Nemonoxacin Malate
苹果酸奈诺沙星
更新于：2025-03-22
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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109
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) | 繭鑰壓憲願膚衊鹽觸繭: 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) | 壓鑰糧蓋鏇選襯醖艱壓(糧窪齋顧獵壓齋齋糧願) = 壓蓋觸積願齋鬱壓醖網 膚膚遞鹽繭齋築襯蓋構 (鹽繭構衊餘範鑰選憲艱, (17.30)) | - | 2019-03-01 | ||
(Healthy Control Group) | 壓鑰糧蓋鏇選襯醖艱壓(糧窪齋顧獵壓齋齋糧願) = 積簾壓鑰鑰鏇範窪鹽積 膚膚遞鹽繭齋築襯蓋構 (鹽繭構衊餘範鑰選憲艱, (10.16)) | ||||||
临床3期 | 527 | 範窪齋顧襯觸襯顧襯憲(蓋壓壓襯夢糧夢積淵選) = The incidence of adverse events (AEs) was comparable between nemonoxacin (33.1%, 118/356) and levofloxacin (33.3%, 57/171) 簾蓋鏇鑰鹽蓋願窪製壓 (觸夢選衊艱膚憲鑰淵願 ) | 积极 | 2019-02-01 | |||
临床2期 | - | 207 | 繭繭範餘繭顧鹽襯淵夢(繭夢壓窪簾範顧膚製壓) = 憲淵積鏇繭憲襯鬱鑰簾 製膚醖蓋遞簾艱選鏇艱 (糧膚襯選繭觸夢鹹製遞 ) 更多 | - | 2015-03-01 | ||
繭繭範餘繭顧鹽襯淵夢(繭夢壓窪簾範顧膚製壓) = 鹹窪遞蓋鬱範鹽獵築糧 製膚醖蓋遞簾艱選鏇艱 (糧膚襯選繭觸夢鹹製遞 ) 更多 | |||||||
临床2期 | 207 | (Nemonoxacin 500 mg) | 鹽齋憲願築糧簾顧淵鹹 = 淵鏇襯願憲齋簾鬱憲製 願範願製築鹽繭獵築淵 (簾鏇鹹顧蓋醖鏇觸膚淵, 簾鏇襯獵憲窪醖繭範觸 ~ 鏇構蓋鹽襯鏇製築淵廠) 更多 | - | 2015-02-18 | ||
(Nemonoxacin 650 mg) | 鹽齋憲願築糧簾顧淵鹹 = 選糧壓夢鏇顧窪窪襯膚 願範願製築鹽繭獵築淵 (簾鏇鹹顧蓋醖鏇觸膚淵, 範構鏇觸鬱獵選鏇膚廠 ~ 遞醖鏇齋餘簾齋簾夢襯) 更多 | ||||||
临床2期 | - | 92 | 願艱鹹壓繭製顧衊製糧(醖鏇範憲艱鬱鑰願簾夢) = 餘襯選壓製願憲廠鹹選 淵鑰鑰窪襯遞觸積製鏇 (製糧膚蓋壓選糧鏇範積 ) 更多 | - | 2014-10-01 |
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