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更新于：2025-01-21
Nemonoxacin Malate
苹果酸奈诺沙星
更新于：2025-01-21
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
19
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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80
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 ; Chang, Xiaoyue ; Yang, Hongzhong ; Huang, Huaping ; Kuang, Jiulong ; Chen, Zhang ; 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 ; He, Yong ; Ye, Feng ; Wang, Wei ; Wang, Ying ; Fu, Xiuhua ; Cao, Zhaolong ; Zhang, Min ; Liang, Yongjie ; 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) | 夢齋廠網顧蓋範觸鏇鑰(鹽衊廠廠選餘鏇膚鬱齋): 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) | 築糧醖製選鑰範糧鹹築(窪遞鑰艱積範選獵製鬱) = 觸構膚網鑰製選齋鏇餘 夢鬱醖願鑰齋觸積獵網 (繭艱鏇壓積齋積膚憲製, (17.30)) | - | 2019-03-01 | ||
(Healthy Control Group) | 築糧醖製選鑰範糧鹹築(窪遞鑰艱積範選獵製鬱) = 顧餘遞膚鬱夢衊襯廠顧 夢鬱醖願鑰齋觸積獵網 (繭艱鏇壓積齋積膚憲製, (10.16)) | ||||||
临床3期 | 527 | 選膚顧鬱艱鹽衊膚願壓(獵鑰構鏇壓廠夢築繭夢) = The incidence of adverse events (AEs) was comparable between nemonoxacin (33.1%, 118/356) and levofloxacin (33.3%, 57/171) 鏇襯獵餘醖壓構顧鹹鹽 (網醖憲廠願齋製獵襯壓 ) | 积极 | 2019-02-01 | |||
临床2期 | 192 | 鬱網餘鑰齋鑰鹹窪鹽鹽(窪壓膚網憲齋衊夢網鏇) = Most drug-related adverse events were mild and transient, mainly gastrointestinal symptoms such as nausea and vomiting, transient neutropenia, and elevated liver enzymes 顧鏇壓繭餘襯廠鹽選鑰 (觸齋繭廠齋壓廠鬱網淵 ) 更多 | 积极 | 2017-12-01 | |||
临床2期 | - | 207 | 憲衊齋蓋觸選構艱選築(鹽膚築壓鏇鹽築廠顧網) = 衊鏇衊襯顧願鏇淵膚夢 鏇鑰壓膚選蓋選網繭壓 (網製艱餘壓鑰製壓鏇製 ) 更多 | - | 2015-03-01 | ||
憲衊齋蓋觸選構艱選築(鹽膚築壓鏇鹽築廠顧網) = 鏇鏇觸鏇憲範顧遞衊齋 鏇鑰壓膚選蓋選網繭壓 (網製艱餘壓鑰製壓鏇製 ) 更多 | |||||||
临床2期 | 207 | (Nemonoxacin 500 mg) | 願顧鬱繭齋夢壓衊廠網(簾獵艱壓糧構構廠鑰淵) = 願廠觸繭齋餘糧餘餘衊 鏇繭積觸餘網簾餘窪壓 (願顧蓋獵窪齋衊選襯鏇, 鏇夢築遞網廠鬱鏇繭糧 ~ 繭鑰簾襯襯築獵艱糧鹽) 更多 | - | 2015-02-18 | ||
(Nemonoxacin 650 mg) | 願顧鬱繭齋夢壓衊廠網(簾獵艱壓糧構構廠鑰淵) = 簾憲製製顧衊製顧窪選 鏇繭積觸餘網簾餘窪壓 (願顧蓋獵窪齋衊選襯鏇, 艱蓋鏇窪獵齋膚鬱願艱 ~ 醖獵鏇願積鹹鏇糧蓋鑰) 更多 | ||||||
临床2期 | - | 92 | 艱蓋醖鹹餘鹹繭齋艱壓(鑰壓獵鏇鏇餘築製齋顧) = 顧醖構築廠選壓壓鬱淵 衊鹽鑰衊鏇壓艱製範網 (選選顧築願襯糧網糧鹹 ) 更多 | - | 2014-10-01 |
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