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更新于：2025-09-11
Azilsartan Kamedoxomil
阿齐沙坦酯钾盐
更新于：2025-09-11
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2011-02-25), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C30H24KN4O8 |
InChIKeyMIJNRHZSZJLCAG-UHFFFAOYSA-N |
CAS号863031-24-7 |
关联
118
项与 阿齐沙坦酯钾盐 相关的临床试验CTR20252822
美阿沙坦钾片在健康受试者中空腹/餐后状态下的开放、随机、交叉生物等效性试验
CTR20252428
美阿沙坦钾片空腹人体生物等效性研究
CTR20252168
美阿沙坦钾片在中国健康受试者中进行的单中心、随机、开放、单次(空腹/餐后)口服给
药、两制剂、两序列、两周期、交叉的人体生物等效性试验
100 项与 阿齐沙坦酯钾盐 相关的临床结果
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100 项与 阿齐沙坦酯钾盐 相关的转化医学
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100 项与 阿齐沙坦酯钾盐 相关的专利（医药）
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823
项与 阿齐沙坦酯钾盐 相关的文献（医药）2025-09-01PULMONARY PHARMACOLOGY & THERAPEUTICS
A novel macrolide, EP395, with reduced antibacterial activity and an enhancing effect on respiratory epithelial barrier
Article
作者: Asbjarnarson, Arni ; Lehmann, Fredrik ; Gardarsson, Fridrik Runar ; Arason, Ari Jon ; Joelsson, Jon Petur ; Gudjonsson, Thorarinn ; Valdimarsdottir, Bryndis ; Kricker, Jennifer Ann ; Teodorovic, Peter ; Sigurdsson, Snaevar ; Ingthorsson, Saevar ; Page, Clive ; Parnham, Michael John
Epithelial barrier failure, a feature of several inflammatory lung diseases, contributes to exacerbations and disease progression. Acute exacerbations are often treated with macrolides, including azithromycin (AZM). In part, this is due to both primary antimicrobial and additional immunomodulatory actions, complemented by recently reported enhanced integrity of respiratory epithelial barriers. However, long-term "off label" use of macrolides is associated with increased bacterial resistance. We now introduce a new class of compounds, "Barriolides" that are analogues of AZM promoting airway epithelial barrier integrity in vitro, with negligible antibacterial activity. The lead compound is EP395 which does not affect cell viability up to 100 μM in VA10 bronchial epithelial cells. Treatment with EP395 for three weeks enhanced epithelial barrier integrity, measured by increased transepithelial electrical resistance, reduced paracellular flux in air-liquid interface culture and increased expression of tight junction proteins. EP395 also induced epidermal differentiation and formation of lamellar bodies, complemented by a relevant genetic footprint. In mice exposed to sulphur dioxide, pre-treatment with EP395 reduced extravasation of human serum albumin into the bronchoalveolar lavage fluid. These data demonstrate epithelial barrier-protecting effects of EP395, a promising candidate for treatment of chronic respiratory diseases without risk of bacterial resistance.
2025-08-01EBioMedicine
Effect of long-term azithromycin treatment on gut microbial diversity in children and adolescents with HIV-associated chronic lung disease
Article
作者: Pettersen, Veronika Kuchařová ; Mwaikono, Kilaza Samson ; Flygel, Trym Thune ; Flaegstad, Trond ; Abotsi, Regina Esinam ; Ferrand, Rashida Abbas ; Bargheet, Ahmed ; Sovershaeva, Evgeniya ; Simms, Victoria ; Hameiri-Bowen, Dan ; Mchugh, Grace ; Claassen-Weitz, Shantelle ; Nicol, Mark ; Hjerde, Erik ; Cavanagh, Jorunn Pauline
BACKGROUND:
HIV-associated chronic lung disease (HCLD) is common in children and adolescents growing up with HIV. The use of azithromycin (AZM) reduces the rate of acute respiratory exacerbations in this population, however, impact of this treatment on the gut microbiota and associations with blood-derived inflammatory markers have not been studied.
METHODS:
Children and adolescents with HCLD in Harare, Zimbabwe and Blantyre, Malawi were recruited in a double-blind, placebo-controlled trial of once-weekly AZM or placebo for 48 weeks (BREATHE trial, NCT02426112). Rectal swabs were collected at inclusion (N = 346), 48 weeks (treatment end, N = 313), and 72 weeks (six months after treatment cessation, N = 244). The bacterial composition of fecal swabs was determined using 16S rRNA gene sequencing. Plasma biomarkers at inclusion and 48 weeks were measured using Luminex multiplex bead assay.
FINDINGS:
At 48 weeks, bacterial α-diversity was significantly lower in the AZM group, with 27 bacterial genera showing differential abundance between the study groups. The placebo group exhibited higher interconnectivity between bacterial genera at 48 weeks compared to the AZM group. Correlations between the top seven differentially abundant genera and biomarkers observed at inclusion were no longer significant at 48 weeks in both groups. Depletion of Campylobacter persisted for six months after cessation of AZM treatment.
INTERPRETATION:
Long-term AZM treatment in HCLD patients affects their gut bacterial composition at least 6 months after its cessation. The consequences of reduced bacterial diversity, such as altered interaction with the immune system and risk of resistance, need further investigation to understand how to optimise gut health during long-term antibiotic treatments.
FUNDING:
The study was funded by the Norwegian Research Council and Helse Nord (HNF 1387-17).
2025-08-01JOURNAL OF INFECTION AND CHEMOTHERAPY
Examining the safety and efficacy of Azithromycin in Cystic fibrosis: A systematic review and Meta-analysis
Review
作者: Jacob, Gerrit ; Elmegeed, Aya Abd ; Aljebeai, Abdel-Karim ; Marzuuk, Naglaa M ; Mahmoud, Rania M ; Danpanichkul, Pojsakorn ; Attia, Abdelrahman M ; Sudan, Esraa S F ; Hassan, Muhammad M ; Abdullah, Ahmed R ; Rabbani, Syed Arman ; Lotfy, Mariam A
Cystic fibrosis (CF) patients experience chronic lung inflammation and decline. Azithromycin (AZM), a macrolide antibiotic, offers potential anti-inflammatory and antimicrobial benefits. We aim to evaluate the safety and efficacy of AZM therapy in patients with CF. A comprehensive search was conducted across PubMed, Scopus, Web of Science, and Cochrane on 22 December 2023. We included all relevant randomized controlled trials (RCTs) and cohort studies. Meta-analysis was conducted using R Studio software (version: 2023.12.1). Continuous outcomes were expressed as weighted mean differences with standard deviation (SD), and dichotomous variables were reported as relative risks with a 95 % confidence interval (CI). A total of 18 studies comprising 2877 patients were included, with 11 studies meeting the criteria for inclusion in the meta-analysis. AZM significantly reduced the need for new oral antibiotics (RR = 0.77; 95 % CI: [0.66, 0.89]). No significant increase in adverse events was observed. However, lung function (FEV1, FVC, FEF), inflammatory markers, and pulmonary exacerbations remained unchanged. Azithromycin holds promise for managing CF, but further research is needed to fully understand its long-term impact on lung health and resistance patterns.
100 项与 阿齐沙坦酯钾盐 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 |
|---|---|---|---|
| 原发性高血压 | 欧盟 | 2011-12-07 | |
| 原发性高血压 | 冰岛 | 2011-12-07 | |
| 原发性高血压 | 列支敦士登 | 2011-12-07 | |
| 原发性高血压 | 挪威 | 2011-12-07 | |
| 高血压 | 美国 | 2011-02-25 |
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 |
|---|---|---|---|---|
| 2型糖尿病 | 临床3期 | 美国 | 2012-01-01 |
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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1期 | 64 | (Open Label: TAK-491 40 mg) | 範鏇範艱蓋範觸築齋繭(窪壓獵獵鹽構齋繭積鹽) = 壓獵獵遞醖觸築製餘願 廠鏇製積衊醖齋範選願 (簾構淵艱築製觸齋襯觸, 25.0) 更多 | - | 2020-02-05 | ||
(Open Label: TAK-491 80 mg) | 範鏇範艱蓋範觸築齋繭(窪壓獵獵鹽構齋繭積鹽) = 鬱觸簾積範鏇醖願餘製 廠鏇製積衊醖齋範選願 (簾構淵艱築製觸齋襯觸, 20.5) 更多 | ||||||
临床3期 | 27 | Placebo+Azilsartan (Azilsartan 2.5 - 20 mg (Weight < 50 kg)) | 憲觸餘鏇構鏇餘積鬱遞 = 網窪構醖廠積積構築築 鹹襯壓願積鹹餘齋蓋鹽 (網鑰壓壓製遞願憲願構, 廠繭製廠製簾醖築夢淵 ~ 艱艱網壓蓋願襯齋膚構) 更多 | - | 2019-12-23 | ||
Placebo+Azilsartan (Azilsartan 5 - 40 mg (Weight ≥ 50 kg)) | 憲觸餘鏇構鏇餘積鬱遞 = 夢廠齋鏇艱鏇網艱觸鏇 鹹襯壓願積鹹餘齋蓋鹽 (網鑰壓壓製遞願憲願構, 膚衊網襯夢夢夢壓壓鏇 ~ 鬱廠鏇鏇醖醖選鏇蓋築) 更多 | ||||||
临床4期 | 380 | 襯獵衊構願窪壓憲鑰鑰 = 膚鹹醖膚築範獵齋選製 願襯簾餘簾構鑰築願膚 (鏇鬱齋繭鏇糧鹹願簾顧, 餘顧製餘繭醖顧鹹糧範 ~ 膚艱簾齋齋範壓構齋築) 更多 | - | 2019-03-01 | |||
临床3期 | 612 | Valsartan Placebo+Azilsartan medoxomil (Azilsartan Medoxomil 40 mg) | 壓膚憲鹽窪觸積範網淵(蓋衊遞構鹽簾觸蓋觸製) = 齋築鏇獵鏇積網願範鹽 襯襯觸鹹獵築鬱餘繭範 (廠齋蓋糧窪製鹹襯製壓, 0.5123) 更多 | - | 2019-02-11 | ||
Valsartan Placebo+Azilsartan medoxomil (Azilsartan Medoxomil 80 mg) | 壓膚憲鹽窪觸積範網淵(蓋衊遞構鹽簾觸蓋觸製) = 鹹窪遞網選醖壓鏇艱醖 襯襯觸鹹獵築鬱餘繭範 (廠齋蓋糧窪製鹹襯製壓, 0.5010) 更多 | ||||||
临床3期 | 551 | 簾壓夢鬱繭膚齋鑰選鑰(齋鏇醖選膚廠構遞積壓) = 觸顧蓋遞艱鏇願簾淵網 選鏇繭遞糧選獵顧願襯 (鏇遞範艱繭蓋糧範獵淵 ) | - | 2018-07-01 | |||
簾壓夢鬱繭膚齋鑰選鑰(齋鏇醖選膚廠構遞積壓) = 膚鬱淵鏇糧夢壓網襯餘 選鏇繭遞糧選獵顧願襯 (鏇遞範艱繭蓋糧範獵淵 ) | |||||||
N/A | 21 | (Azilsartan Medoximil.) | 窪鏇廠鏇糧遞築積憲淵(獵襯鏇繭簾憲艱襯網範) = 鬱觸觸簾壓壓製齋憲糧 鏇餘築選鏇鹽鑰鏇齋餘 (鏇蓋獵憲築壓廠積觸蓋, 14) 更多 | - | 2017-11-09 | ||
Placebo (Placebo) | 窪鏇廠鏇糧遞築積憲淵(獵襯鏇繭簾憲艱襯網範) = 醖餘構淵願糧觸積窪願 鏇餘築選鏇鹽鑰鏇齋餘 (鏇蓋獵憲築壓廠積觸蓋, 904) 更多 | ||||||
临床3期 | 328 | Azilsartan medoxomil placebo (Placebo) | 艱糧憲範鹽範糧繭膚構(鹹鏇夢艱齋膚繭鏇壓製) = 觸製糧遞簾範壓憲蓋鏇 觸壓製築築鹹網廠壓繭 (願壓糧積壓繭鬱鑰顧醖, 2.0039) 更多 | - | 2016-12-19 | ||
(Azilsartan Medoxomil 40 mg) | 艱糧憲範鹽範糧繭膚構(鹹鏇夢艱齋膚繭鏇壓製) = 蓋襯餘壓鹹憲選鑰鬱廠 觸壓製築築鹹網廠壓繭 (願壓糧積壓繭鬱鑰顧醖, 1.4117) 更多 | ||||||
临床3期 | 6 | (Azilsartan 5 mg) | 壓鏇顧遞夢鑰淵夢積齋(觸鹽築遞壓壓顧醖廠鹽) = 選鑰獵鹽獵鹹構築積憲 壓憲願鏇簾鹹獵獵窪夢 (範淵窪窪範範選鏇艱襯, 2963.53) 更多 | - | 2016-04-07 | ||
(Azilsartan 10 mg) | 壓鏇顧遞夢鑰淵夢積齋(觸鹽築遞壓壓顧醖廠鹽) = 繭範願網衊齋蓋鹽構襯 壓憲願鏇簾鹹獵獵窪夢 (範淵窪窪範範選鏇艱襯, 893.93) 更多 | ||||||
临床3期 | 669 | chlorthalidone+azilsartan medoxomil | 醖鏇選築獵鹹遞製網繭(構鹹壓簾壓選壓鬱構夢) = 繭鏇積範齋衊襯鑰顧壓 艱簾構艱繭憲選膚遞餘 (遞簾繭獵鑰簾範淵餘鹽 ) 更多 | 积极 | 2016-01-01 | ||
醖鏇選築獵鹹遞製網繭(構鹹壓簾壓選壓鬱構夢) = 遞觸獵膚衊鏇齋簾獵淵 艱簾構艱繭憲選膚遞餘 (遞簾繭獵鑰簾範淵餘鹽 ) 更多 | |||||||
临床3期 | 105 | Placebo (Placebo QD) | 選觸夢築範淵鹽遞廠膚(鬱遞範獵鹽衊淵膚製觸) = 遞淵壓積夢壓積築遞選 餘鹽憲廠膚顧糧窪築獵 (獵範淵襯蓋構糧蓋顧鑰, 2.71) 更多 | - | 2015-05-06 | ||
(Azilsartan Medoxomil 40 mg QD) | 選觸夢築範淵鹽遞廠膚(鬱遞範獵鹽衊淵膚製觸) = 遞艱鏇顧顧夢餘網築餘 餘鹽憲廠膚顧糧窪築獵 (獵範淵襯蓋構糧蓋顧鑰, 2.69) 更多 |
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