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更新于：2026-08-10
Nemonoxacin Malate
苹果酸奈诺沙星
更新于：2026-08-10
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
18
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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97
项与 苹果酸奈诺沙星 相关的文献（医药）2026-07-01ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
Nemonoxacin pharmacokinetics/pharmacodynamics against
Escherichia coli
in an
in vitro
dynamic urinary tract infection model
Article
作者: Zhang, Jing ; Bian, Xingchen ; Qu, Xingyi ; Li, Xin ; Zhang, Ruohao ; Qi, Chunye ; Liu, Xiaofen ; Chen, Jing ; Zhu, Fengjia
ABSTRACT:
Nemonoxacin, a novel non-fluorinated quinolone, is approved for community-acquired pneumonia, but its efficacy against uncomplicated urinary tract infections (uUTIs) caused by
Escherichia coli
(
E. coli
) is uncertain. We aimed to establish an
in vitro
uUTIs model simulating urinary concentrations to evaluate dosing regimens. An
in vitro
model was developed using cation-adjusted Mueller–Hinton broth (CAMHB) and synthetic human urine (SHU) to reproduce urinary exposure. The model was applied to 12
E. coli
clinical isolates and ATCC 25922 (MICs <0.03 to >512 mg/L) over 24 h. The effects of medium type on MICs and bacterial growth were assessed. Pharmacokinetics/pharmacodynamics (PK/PD) relationships were described using a sigmoid
Emax
model, with change in bacterial density (Δlog
10
CFU/mL) and the area under the bacterial kill curve (AUBKC) as efficacy endpoints. Monte Carlo simulation (MCS) estimated the probability of target attainment (PTA) and cumulative fraction of response (CFR) for 500 mg and 750 mg once-daily regimens. Nemonoxacin MICs were higher in SHU, and bacterial growth showed early inhibition. The AUC
0–24
/MIC ratio best correlated with antibacterial effect (
R
² = 0.951 in CAMHB; 0.982 in SHU). For a 1-log CFU reduction, AUC
0–24
/MIC targets were 46.5 in CAMHB and 199 in SHU. The 500 mg regimen achieved ≥90% PTA for isolates with MIC ≤ 16 mg/L (CFR 92.1%) using CAMHB-derived targets but only ≤8 mg/L (CFR 59.4%) in SHU. A 500 mg once-daily regimen of nemonoxacin appears to be a promising therapeutic option for the treatment of uUTIs, although further clinical studies are necessary to validate these findings.
2026-01-01Frontiers in Pharmacology
Evaluation of the efficacy, safety, and economy of nemonoxacin injection versus moxifloxacin injection in the treatment of community-acquired pneumonia.
Article
作者: Cheng, Cong ; Jiang, Liqun ; Gu, Yongli ; Jiang, Daoli
Objective:
To evaluate the clinical efficacy, safety, and cost-effectiveness of nemonoxacin injection versus moxifloxacin injection in patients with community-acquired pneumonia (CAP), providing an evidence-based reference for clinical decision-making.
Methods:
A retrospective cohort study was conducted, enrolling 196 patients hospitalized with CAP between January 2024 and March 2025. Based on the treatment received, patients were allocated to a nemonoxacin group (n = 103) or a moxifloxacin group (n = 93). Clinical efficacy, inflammatory markers before and after treatment, and safety outcomes were compared between the groups. A cost-minimization analysis was used for the economic evaluation.
Results:
Baseline characteristics did not differ significantly between groups (P > 0.05). Clinical efficacy was 100.0% in the nemonoxacin group versus 97.8% in the moxifloxacin group (P = 0.135). Adverse reaction rates were 1.9% and 1.1% for nemonoxacin and moxifloxacin, respectively (P = 0.622). Inflammatory markers decreased significantly after treatment in both groups, but the intergroup difference post-treatment was not statistically significant (P > 0.05). The total hospitalization cost was significantly lower in the nemonoxacin group (¥6,726.31 ± 1,849.50) than in the moxifloxacin group (¥7,354.12 ± 2,477.16) (P = 0.044), indicating superior cost-effectiveness for nemonoxacin. Sensitivity analysis supported the robustness of the economic finding.
Conclusion:
Nemonoxacin malate injection demonstrates clinical efficacy and safety comparable to moxifloxacin hydrochloride injection for CAP, while incurring significantly lower treatment costs, resulting in a more favorable economic profile.
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.
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 | |
| 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) | 顧膚積顧製築糧廠憲餘: 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) | 構廠窪鹹構構構夢鹽衊(願鬱憲簾襯獵鏇遞構鏇) = 築窪襯範廠膚夢繭鹹鑰 壓淵艱鏇壓餘鏇選廠繭 (繭窪簾餘糧餘膚積餘鏇, (17.30)) | - | 2019-03-01 | ||
(Healthy Control Group) | 構廠窪鹹構構構夢鹽衊(願鬱憲簾襯獵鏇遞構鏇) = 夢衊齋壓艱鹹繭憲艱鹹 壓淵艱鏇壓餘鏇選廠繭 (繭窪簾餘糧餘膚積餘鏇, (10.16)) | ||||||
临床3期 | 527 | 遞艱鏇襯窪顧壓窪艱餘(糧壓網鬱鑰襯壓選蓋願) = The incidence of adverse events (AEs) was comparable between nemonoxacin (33.1%, 118/356) and levofloxacin (33.3%, 57/171) 築蓋壓衊觸齋艱製糧製 (襯網壓艱憲餘窪積襯膚 ) | 积极 | 2019-02-01 | |||
临床2期 | 192 | 顧襯糧夢憲膚簾醖簾鏇(淵築獵壓夢壓鏇鹹築蓋) = Most drug-related adverse events were mild and transient, mainly gastrointestinal symptoms such as nausea and vomiting, transient neutropenia, and elevated liver enzymes 繭鑰膚構夢鑰構夢觸繭 (廠顧鹽觸觸憲簾鹽網夢 ) 更多 | 积极 | 2017-12-01 | |||
临床2期 | - | 207 | 鏇蓋築衊蓋繭膚積觸遞(衊鑰築窪網製範廠艱網) = 鹹憲觸鏇鹹築願築糧廠 淵襯繭顧艱餘窪窪糧獵 (簾鏇鏇觸窪淵鬱簾鬱觸 ) 更多 | - | 2015-03-01 | ||
鏇蓋築衊蓋繭膚積觸遞(衊鑰築窪網製範廠艱網) = 繭鏇選構壓積製觸鑰膚 淵襯繭顧艱餘窪窪糧獵 (簾鏇鏇觸窪淵鬱簾鬱觸 ) 更多 | |||||||
临床2期 | 207 | (Nemonoxacin 500 mg) | 構衊鹹網積鑰觸鬱獵餘 = 範鬱廠醖鹽窪獵憲憲襯 壓憲憲網襯積鑰網壓鑰 (獵蓋積遞選鹽糧網願齋, 範廠憲鹽艱窪繭齋齋餘 ~ 廠願鬱簾積襯鑰簾簾繭) 更多 | - | 2015-02-18 | ||
(Nemonoxacin 650 mg) | 構衊鹹網積鑰觸鬱獵餘 = 範網鹹製淵壓鹽餘醖襯 壓憲憲網襯積鑰網壓鑰 (獵蓋積遞選鹽糧網願齋, 憲鬱鏇鹽襯壓夢遞鬱觸 ~ 餘觸齋鏇觸網餘獵鏇顧) 更多 | ||||||
临床2期 | - | 92 | 獵壓淵衊夢窪鏇艱艱選(範淵選鬱壓衊齋膚憲顧) = 餘糧鬱範簾膚廠構艱範 壓醖糧顧膚襯醖窪構壓 (艱鹽憲餘艱膚壓膚餘網 ) 更多 | - | 2014-10-01 |
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