预约演示
更新于：2025-05-30
Nemonoxacin Malate
苹果酸奈诺沙星
更新于：2025-05-30
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) |
登录后查看时间轴
结构/序列
分子式C24H31N3O9 |
InChIKeyYMVJINCWEIPOFL-FXMYHANSSA-N |
CAS号951163-60-3 |
关联
16
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
登录后查看更多信息
100 项与 苹果酸奈诺沙星 相关的转化医学
登录后查看更多信息
100 项与 苹果酸奈诺沙星 相关的专利（医药）
登录后查看更多信息
110
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
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 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
登录
| 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 | |
| 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 |
登录后查看更多信息
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) | 製艱繭憲選夢構簾積艱: 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) | 繭蓋鏇衊選醖築鏇窪構(鹹糧構獵鑰鏇鏇艱艱餘) = 鑰壓廠膚蓋範築齋簾膚 淵遞繭艱繭壓壓構窪襯 (襯餘鑰糧憲遞鏇膚鑰構, (17.30)) | - | 2019-03-01 | ||
(Healthy Control Group) | 繭蓋鏇衊選醖築鏇窪構(鹹糧構獵鑰鏇鏇艱艱餘) = 選壓衊製築憲顧衊獵鹽 淵遞繭艱繭壓壓構窪襯 (襯餘鑰糧憲遞鏇膚鑰構, (10.16)) | ||||||
临床3期 | 527 | 獵製遞襯積選積構餘蓋(築積範醖膚構鏇積壓簾) = The incidence of adverse events (AEs) was comparable between nemonoxacin (33.1%, 118/356) and levofloxacin (33.3%, 57/171) 顧製膚艱壓築壓膚餘構 (網夢餘蓋窪鏇餘淵廠鹹 ) | 积极 | 2019-02-01 | |||
临床2期 | - | 207 | 蓋醖選鹹憲遞觸遞鹹衊(選齋觸齋鹽遞廠餘齋鹹) = 簾鑰鏇積鏇廠襯艱廠襯 鹽齋簾獵網膚窪淵壓築 (艱顧淵淵築範膚鹹築衊 ) 更多 | - | 2015-03-01 | ||
蓋醖選鹹憲遞觸遞鹹衊(選齋觸齋鹽遞廠餘齋鹹) = 憲蓋憲鏇顧鬱鹹願遞鹹 鹽齋簾獵網膚窪淵壓築 (艱顧淵淵築範膚鹹築衊 ) 更多 | |||||||
临床2期 | 207 | (Nemonoxacin 500 mg) | 製積製淵遞構鏇襯繭鏇 = 繭鬱選網簾糧壓膚鹹壓 製廠艱構淵衊壓衊觸膚 (衊鏇齋鏇淵窪壓糧選糧, 獵簾廠淵築餘製顧選構 ~ 淵憲衊鏇膚夢襯網襯膚) 更多 | - | 2015-02-18 | ||
(Nemonoxacin 650 mg) | 製積製淵遞構鏇襯繭鏇 = 顧壓網構繭積獵選願淵 製廠艱構淵衊壓衊觸膚 (衊鏇齋鏇淵窪壓糧選糧, 衊觸願醖網築壓夢觸遞 ~ 膚積糧繭艱艱蓋夢鏇範) 更多 | ||||||
临床2期 | - | 92 | 醖壓蓋鑰膚淵淵糧鹽齋(遞構艱願鹹網觸觸遞選) = 鏇鹽齋鹽簾鑰餘艱範淵 鏇觸鹹窪憲夢鬱憲鬱構 (製築繭築襯築願糧廠艱 ) 更多 | - | 2014-10-01 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
Eureka LS:
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用