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更新于：2026-10-23
Nemonoxacin Malate
苹果酸奈诺沙星
更新于：2026-10-23
概要
基本信息
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
16
项与 苹果酸奈诺沙星 相关的临床试验CTR20254173
苹果酸奈诺沙星胶囊人体生物等效性研究
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
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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86
项与 苹果酸奈诺沙星 相关的文献（医药）2026-10-01INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS
Concentration and penetration of nemonoxacin in bronchopulmonary tissues of patients undergoing pulmonary surgery: an observational PK study
Article
作者: Zhu, Fengjia ; Fan, Yaxin ; Guo, Beining ; Zhu, Yongjun ; Yang, Haijing ; Chen, Yuancheng ; Li, Yi ; Xu, Xiaoyong ; Zhang, Jing ; Chen, Zhiming ; Li, Xin ; Wu, Jufang ; Zhao, Jinjin ; Chen, Jing
BACKGROUND:
Nemonoxacin is a novel nonfluorinated quinolone with broad-spectrum antibacterial activity. It is indicated for the treatment of community-acquired pneumonia (CAP). This study was designed to characterize the pharmacokinetics (PK) and penetration of nemonoxacin in human bronchopulmonary tissues.
METHODS:
Forty patients undergoing pulmonary surgery were enrolled and randomly assigned to one of the five groups according to the predefined timepoints of sampling. All patients received oral 500 mg nemonoxacin once daily for 3-5 consecutive days before surgery. Blood, lung tissue, bronchial mucosa, bronchial secretion, and bronchial cartilage samples were collected during surgery at 3 ± 1, 5 ± 1, 9 ± 1, 12 ± 2, or 24 ± 4 h following the last nemonoxacin dose. Nemonoxacin concentrations were determined and steady state PK profiles were calculated.
RESULTS:
Nemonoxacin reached higher concentrations in lung tissues, bronchial mucosa, and bronchial secretions than in plasma. The tissue-to-plasma 24-h exposure ratio in lung tissue, bronchial mucosa, bronchial secretion, and bronchial cartilage was 4.15, 3.61, 2.13, and 0.62, respectively. The fAUC0-24/MIC in plasma, lung tissue, and bronchial mucosa against Streptococcus pneumoniae was 154.22, 640.45, and 556.82, respectively, which were much higher than the PK/PD targets. These results indicate that nemonoxacin has sufficient bronchopulmonary penetration for an antibacterial effect following multiple oral 500 mg doses in patients undergoing pulmonary surgery. Oral nemonoxacin 500 mg once daily is expected to achieve sufficient microbiological efficacy for CAP caused by S. pneumoniae.
CONCLUSION:
The findings in this study further justify the recommended dosing regimen of nemonoxacin for CAP.
TRIAL REGISTRATION:
This study was registered at www.chictr.org.cn (identifier ChiCTR1900022591).
2026-01-01Respiratory Medicine Case Reports
A case of severe Legionella pneumonia treated with omadacycline and nemonoxacin
Article
作者: Zhao, Tingrui ; Chen, Yukai ; Sun, He
Severe Legionella pneumophila pneumonia carries high mortality, and treatment is challenged by emerging resistance to conventional fluoroquinolones/macrolides and diagnostic delays. Novel agents such as omadacycline and nemonoxacin show theoretical promise, yet robust clinical evidence in legionellosis is lacking. We report a 59-year-old man with severe community-acquired pneumonia(sCAP) who initially received empiric ceftazidime-avibactam plus nemonoxacin. Respiratory failure did not improve, and the inflammatory markers did not decline. Subsequent bronchoalveolar lavage fluid metagenomic next-generation sequencing(BALF-mNGS) and urinary Legionella antigen confirmed Legionella pneumonia. We then switched to dual therapy with omadacycline and nemonoxacin. The combination led to rapid improvements in inflammatory markers, hypoxemia, and creatine kinase levels. This case provides a clinical rationale for using omadacycline plus nemonoxacin as salvage therapy in severe Legionella pneumonia when conventional regimens fail.
2025-10-03JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY
Phenotypic and genotypic profiles of clinical isolates of various Nocardia species to carbapenems and fluoroquinolones
Article
作者: Xue, Jiaoyu ; Jiang, Tingfei ; Zhang, Mingrui ; Shi, Dongyan ; Yang, Jing
Abstract:
Objectives:
To establish patterns of the antimicrobial susceptibility of Nocardia species to carbapenems and fluoroquinolones and analysis of phenotypic–genotypic correlations.
Methods:
Isolates were identified to the species using 16S rRNA, secA1, or rpoB gene sequencing analysis. The antimicrobial susceptibility testing was performed using the broth microdilution method, and WGS was employed to analyse the presence of resistance genes and/or mutations of Nocardia species against carbapenems and fluoroquinolones.
Results:
Among 143 Nocardia isolates, N. farcinica (27.27%, 39/143) and N. cyriacigeorgica (25.17%, 36/143) were the most common species, followed by N. abscessus Complex (18.88%, 27/143). The MIC90s of the seven carbapenems were 8 mg/L for doripenem, 8 mg/L for meropenem, 16 mg/L for ertapenem, 16 mg/L for biapenem, 64 mg/L for imipenem, 64 mg/L for faropenem and 128 mg/L for tebipenem, respectively. The susceptibility rates to imipenem were 76.9% and 88.9% for N. farcinica and N. cyriacigeorgica, respectively, but only 14.3% and 0% for N. otitidiscavarium and N. brasiliensis, respectively. Further, 90% of N. brasiliensis and 50% of N. otitidiscaviarum isolates were susceptible and intermediate to meropenem. WGS identified blaFAR-1 gene in N. farcinica and blaAST-1 gene in N. cyriacigeorgica, respectively. The MIC90s of the four fluoroquinolones were 1 mg/L for sitafloxacin, 4 mg/L for nemonoxacin, 4 mg/L for moxifloxacin and 16 mg/L for ciprofloxacin, respectively. The susceptibility rate of Nocardia species to ciprofloxacin was low except for N. farcinica. The resistance to fluoroquinolones arise from mutations in the gyrA gene.
Conclusions:
Nocardia spp. exhibited varying patterns of susceptibility to carbapenems and fluoroquinolones respectively. Importantly, different Nocardia spp. exhibited different patterns of susceptibility to carbapenems and fluoroquinolones, respectively.
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 | |
| 医院获得性肺炎 | 临床3期 | 中国 | 2014-06-17 | |
| 医院获得性肺炎 | 临床3期 | 中国 | 2014-06-17 | |
| 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) | 簾簾製構醖醖夢構齋壓: 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) | 鬱鹹鬱獵艱廠繭齋鬱夢(簾齋鬱製淵範繭窪淵築) = 遞選製壓糧淵蓋壓蓋顧 網簾築糧壓艱選夢網範 (簾繭觸壓鏇淵選窪遞壓, (17.30)) | - | 2019-03-01 | ||
(Healthy Control Group) | 鬱鹹鬱獵艱廠繭齋鬱夢(簾齋鬱製淵範繭窪淵築) = 蓋觸製淵觸廠構艱遞餘 網簾築糧壓艱選夢網範 (簾繭觸壓鏇淵選窪遞壓, (10.16)) | ||||||
临床3期 | 527 | 築鹽餘簾艱齋壓構簾範(鏇壓鏇齋艱鹽鑰淵選壓) = The incidence of adverse events (AEs) was comparable between nemonoxacin (33.1%, 118/356) and levofloxacin (33.3%, 57/171) 網範鬱鏇鏇蓋醖窪繭獵 (積蓋獵選願蓋顧鏇廠醖 ) | 积极 | 2019-02-01 | |||
临床2期 | 192 | 憲憲鏇簾淵廠鑰淵糧襯(積夢膚衊憲遞鏇夢艱範) = Most drug-related adverse events were mild and transient, mainly gastrointestinal symptoms such as nausea and vomiting, transient neutropenia, and elevated liver enzymes 遞鑰廠鹽鹹襯顧襯壓膚 (獵顧窪廠簾築構憲憲壓 ) 更多 | 积极 | 2017-12-01 | |||
临床2期 | - | 207 | 繭廠糧齋窪襯憲顧蓋繭(遞襯顧築觸築鑰醖淵糧) = 餘範齋憲築憲憲觸鹽鹹 壓願願獵窪鑰鬱鹽壓遞 (構餘鑰淵襯構夢夢鏇積 ) 更多 | - | 2015-03-01 | ||
繭廠糧齋窪襯憲顧蓋繭(遞襯顧築觸築鑰醖淵糧) = 廠範淵顧襯糧齋鹹壓願 壓願願獵窪鑰鬱鹽壓遞 (構餘鑰淵襯構夢夢鏇積 ) 更多 | |||||||
临床2期 | 207 | (Nemonoxacin 500 mg) | 壓獵艱齋鏇餘簾窪廠鏇 = 簾製鹹醖餘遞衊獵憲築 鬱廠廠鑰壓遞製夢鹹糧 (糧蓋齋範鏇廠鏇繭顧壓, 鹽網製顧齋鹹壓糧糧網 ~ 鑰壓窪願網艱廠餘窪簾) 更多 | - | 2015-02-18 | ||
(Nemonoxacin 650 mg) | 壓獵艱齋鏇餘簾窪廠鏇 = 網選廠網製鏇網餘鹹夢 鬱廠廠鑰壓遞製夢鹹糧 (糧蓋齋範鏇廠鏇繭顧壓, 膚構鬱範醖鏇膚襯糧製 ~ 網願鏇襯廠壓獵窪獵糧) 更多 | ||||||
临床2期 | - | 92 | 醖蓋齋觸衊積簾獵構觸(壓衊蓋淵觸蓋窪餘憲選) = 糧鑰窪餘廠獵顧膚鏇鑰 積範糧鑰鏇鹽築繭鹽餘 (遞憲築艱鬱憲積艱憲構 ) 更多 | - | 2014-10-01 |
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