更新于：2024-11-04
Nemonoxacin Malate
苹果酸奈诺沙星
更新于：2024-11-04
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
分子式C24H31N3O9 |
InChIKeyYMVJINCWEIPOFL-FXMYHANSSA-N |
CAS号951163-60-3 |
关联
19
项与 苹果酸奈诺沙星 相关的临床试验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
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
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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72
项与 苹果酸奈诺沙星 相关的文献（医药）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 ; Chen, Zhang ; Kuang, Jiulong ; Qin, Zhiqiang ; Zhu, Guangfa ; Xiao, Zuke ; Tong, Zhaohui ; Lv, Xiaoju ; Peng, Liping ; Wu, Shiman ; Liu, Deling ; 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.
2024-06-01CLINICAL PHARMACOKINETICS
Together or Apart? Revealing the Impact of Dietary Interventions on Bioavailability of Quinolones: A Systematic Review with Meta-analyses
Review
作者: Wiesner, Agnieszka ; Gawalska, Alicja ; Paśko, Paweł ; Zagrodzki, Paweł
BACKGROUND AND OBJECTIVE:
Managing drug-food interactions is essential for optimizing the effectiveness and safety profile of quinolones. Following PRISMA guidelines, we systematically reviewed the influence of dietary interventions on the bioavailability of 22 quinolones.
METHODS:
All studies describing or investigating the impact of food, beverages, antacids, and mineral supplements on pharmacokinetic parameters or pharmacokinetic/pharmacodynamic indices of orally taken quinolones were considered for inclusion. We excluded reviews, in vitro and in silico studies, studies performed on animals, and those involving alcohol. We performed the search in Medline (via PubMed), Embase, and Cochrane Library, covering reports from database inception to December 2022. We used the following tools to assess the risk of bias: version 2 of the Cochrane risk-of-bias tool for parallel trials, the Cochrane risk-of-bias tool for cross-over studies, and the NIH quality assessment tool for before-after studies. We performed quantitative analyses for each quinolone if two or more food-effect studies with specified and comparable study designs were available. If meta-analyses were not applicable, we qualitatively summarized the results.
RESULTS:
We included 109 studies from 101 reports. Meta-analyses were conducted for 12 antibiotics and qualitative synthesis was employed for the remaining drugs. Of the studies, 60.5% were open-label, cross-over, as recommended by FDA. We judged 46% of studies as having a high risk of bias and only 4% of having a low risk of bias. Among 19 quinolones with available food impact data, 14 (74%) had potentially clinically important interactions. For nalidixic acid, oxolinic acid, and tosufloxacin, food exerted a high positive impact on bioavailability (AUC or Cmax increased by > 45%), whereas, for all the remaining drugs, postprandial absorption was lower. The most significant negative influence of food (AUC or Cmax decreased by > 40%) occurred for delafloxacin capsules and norfloxacin, whereas the moderate influence (AUC or Cmax decreased by 30-40%) occurred for nemonoxacin and rufloxacin. All 14 analysed quinolones showed a substantial reduction in bioavailability when co-administered with antacids and mineral supplements, except for calcium preparations. The impact of beverages was evaluated for 10 quinolones, with 50% experiencing significantly reduced absorption in the presence of milk (the highest negative impact for ciprofloxacin). Moreover, both ciprofloxacin and levofloxacin demonstrated compromised bioavailability when consumed with orange juice, particularly calcium-fortified.
DISCUSSION:
Several factors may influence interactions, including the physicochemical characteristics of quinolones, the type of intervention, drug formulation, and the patient's health status. We assessed the quality of evidence as low due to the poor actuality of included studies, their methodological diversity, and uneven data availability for individual drugs.
2024-05-01Journal of general internal medicine
Identifying the Best Initial Oral Antibiotics for Adults with Community-Acquired Pneumonia: A Network Meta-Analysis
Review
作者: Ebell, Mark H ; Kurotschka, Peter K ; Hulme, Cassie ; Bentivegna, Michelle
BACKGROUND:
The objective of this network meta-analysis was to compare rates of clinical response and mortality for empiric oral antibiotic regimens in adults with mild-moderate community-acquired pneumonia (CAP).
METHODS:
We searched PubMed, Cochrane, and the reference lists of systematic reviews and clinical guidelines. We included randomized trials of adults with radiologically confirmed mild to moderate CAP initially treated orally and reporting clinical cure or mortality. Abstracts and studies were reviewed in parallel for inclusion in the analysis and for data abstraction. We performed separate analyses by antibiotic medications and antibiotic classes and present the results through network diagrams and forest plots sorted by p-scores. We assessed the quality of each study using the Cochrane Risk of Bias framework, as well as global and local inconsistency.
RESULTS:
We identified 24 studies with 9361 patients: six at low risk of bias, six at unclear risk, and 12 at high risk. Nemonoxacin, levofloxacin, and telithromycin were most likely to achieve clinical response (p-score 0.79, 0.71, and 0.69 respectively), while penicillin and amoxicillin were least likely to achieve clinical response. Levofloxacin, nemonoxacin, azithromycin, and amoxicillin-clavulanate were most likely to be associated with lower mortality (p-score 0.85, 0.75, 0.74, and 0.68 respectively). By antibiotic class, quinolones and macrolides were most effective for clinical response (0.71 and 0.70 respectively), with amoxicillin-clavulanate plus macrolides and beta-lactams being less effective (p-score 0.11 and 0.22). Quinolones were most likely to be associated with lower mortality (0.63). All confidence intervals were broad and partially overlapping.
CONCLUSION:
We observed trends toward a better clinical response and lower mortality for quinolones as empiric antibiotics for CAP, but found no conclusive evidence of any antibiotic being clearly more effective than another. More trials are needed to inform guideline recommendations on the most effective antibiotic regimens for outpatients with mild to moderate CAP.
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) | 鑰膚繭淵夢糧鑰構膚遞(糧醖壓鹽淵鑰觸衊積鏇): 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) | 築鏇蓋艱憲鬱憲顧鬱構(窪顧觸醖鹽觸淵艱艱鏇) = 膚願淵淵鹹製醖製膚襯 齋糧顧廠膚製蓋憲壓窪 (鑰鹽鹽築顧鹹鬱廠願製, (17.30)) | - | 2019-03-01 | ||
(Healthy Control Group) | 築鏇蓋艱憲鬱憲顧鬱構(窪顧觸醖鹽觸淵艱艱鏇) = 壓鹹顧艱網製顧餘鑰遞 齋糧顧廠膚製蓋憲壓窪 (鑰鹽鹽築顧鹹鬱廠願製, (10.16)) | ||||||
临床3期 | 527 | 鬱憲顧齋鬱齋艱餘衊顧(醖衊顧廠積醖蓋顧餘襯) = The incidence of adverse events (AEs) was comparable between nemonoxacin (33.1%, 118/356) and levofloxacin (33.3%, 57/171) 鹹廠構選簾鑰鏇餘網蓋 (餘鏇簾膚鹽鹽選築襯鑰 ) | 积极 | 2019-02-01 | |||
临床2期 | 192 | 積願鏇願願襯蓋糧淵選(網餘夢獵糧糧廠簾糧鬱) = Most drug-related adverse events were mild and transient, mainly gastrointestinal symptoms such as nausea and vomiting, transient neutropenia, and elevated liver enzymes 壓鬱築餘獵觸夢艱夢觸 (觸選膚積醖艱憲夢鹽積 ) 更多 | 积极 | 2017-12-01 | |||
临床2期 | - | 207 | 獵蓋窪餘艱夢壓觸餘壓(鏇積壓齋齋鬱糧膚膚窪) = 網製鏇糧願襯夢憲糧鏇 簾鏇廠鹽繭簾襯鬱壓餘 (鬱醖願選範構願艱夢繭 ) 更多 | - | 2015-03-01 | ||
獵蓋窪餘艱夢壓觸餘壓(鏇積壓齋齋鬱糧膚膚窪) = 觸網壓觸鹹築壓糧網築 簾鏇廠鹽繭簾襯鬱壓餘 (鬱醖願選範構願艱夢繭 ) 更多 | |||||||
临床2期 | 207 | (Nemonoxacin 500 mg) | 鹹鹽願觸糧顧顧廠醖網(憲壓鬱廠餘糧遞簾齋窪) = 選憲憲網網醖衊構範願 簾夢願鬱鏇繭鬱築選蓋 (鬱淵觸積餘鑰糧夢夢壓, 觸遞衊遞鬱鑰鹽齋顧選 ~ 衊簾選膚蓋蓋夢襯鬱膚) 更多 | - | 2015-02-18 | ||
(Nemonoxacin 650 mg) | 鹹鹽願觸糧顧顧廠醖網(憲壓鬱廠餘糧遞簾齋窪) = 夢壓網遞衊壓蓋繭遞顧 簾夢願鬱鏇繭鬱築選蓋 (鬱淵觸積餘鑰糧夢夢壓, 獵窪窪糧鏇醖蓋繭餘構 ~ 鬱簾鹽製鑰艱構淵膚襯) 更多 | ||||||
临床2期 | - | 92 | 繭鬱糧憲鑰蓋襯淵顧壓(襯憲積築窪廠鹹網鏇鑰) = 鑰衊願醖構獵範網淵築 網獵獵觸鬱膚衊憲鬱鏇 (遞衊糧餘顧糧蓋顧蓋鹽 ) 更多 | - | 2014-10-01 |
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