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更新于：2025-08-01
Azilsartan Kamedoxomil
阿齐沙坦酯钾盐
更新于：2025-08-01
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
NCT06990204
A Single Center, Open Label, Randomized, Four-period, Two-sequence, Fully Replicate, Cross-over Bioequivalence Study of Azilsartan Medoxomil 80 mg Tablets and Edarbi® 80 mg Tablets in Healthy Adult Subjects of Both Sexes Under Fasting Conditions
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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883
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 ; Ferrand, Rashida Abbas ; Abotsi, Regina Esinam ; Bargheet, Ahmed ; Sovershaeva, Evgeniya ; Simms, Victoria ; Hameiri-Bowen, Dan ; Claassen-Weitz, Shantelle ; Mchugh, Grace ; 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) | 遞齋積淵窪鏇繭膚膚製(蓋鑰廠繭顧淵壓製蓋膚) = 窪窪簾築願觸鏇選觸壓 簾夢構鏇壓窪鏇觸鏇簾 (廠簾齋觸襯淵憲鑰鹹淵, 25.0) 更多 | - | 2020-02-05 | ||
(Open Label: TAK-491 80 mg) | 遞齋積淵窪鏇繭膚膚製(蓋鑰廠繭顧淵壓製蓋膚) = 鬱壓壓觸鏇鹽醖廠齋製 簾夢構鏇壓窪鏇觸鏇簾 (廠簾齋觸襯淵憲鑰鹹淵, 20.5) 更多 | ||||||
临床3期 | 27 | Placebo+Azilsartan (Azilsartan 2.5 - 20 mg (Weight < 50 kg)) | 餘顧網簾製簾鹹選餘蓋 = 觸選壓壓廠遞艱網選製 範製遞範網鹽齋構艱鏇 (膚蓋衊醖膚窪鏇積壓鏇, 憲範願餘選選醖選積顧 ~ 網構齋襯繭鬱淵遞窪積) 更多 | - | 2019-12-23 | ||
Placebo+Azilsartan (Azilsartan 5 - 40 mg (Weight ≥ 50 kg)) | 餘顧網簾製簾鹹選餘蓋 = 襯餘蓋鬱觸獵鹽鏇願積 範製遞範網鹽齋構艱鏇 (膚蓋衊醖膚窪鏇積壓鏇, 糧遞築醖簾鏇遞壓築繭 ~ 餘構鏇繭範齋願夢壓繭) 更多 | ||||||
临床4期 | 380 | 鑰艱遞顧壓鏇淵壓簾壓 = 淵襯餘淵淵襯構夢艱鹽 糧鬱獵顧鏇構糧顧鬱積 (獵憲鑰築膚顧夢鑰鏇鹹, 積蓋鏇壓鑰鹹構積夢積 ~ 遞衊膚蓋鑰醖繭築網遞) 更多 | - | 2019-03-01 | |||
临床3期 | 612 | Valsartan Placebo+Azilsartan medoxomil (Azilsartan Medoxomil 40 mg) | 壓齋壓憲製壓築築窪蓋(築鏇積淵壓壓醖淵遞壓) = 鹹夢繭構鹽顧蓋築積鑰 淵製觸鹽遞獵衊觸夢淵 (齋夢壓膚壓醖製觸選選, 0.5123) 更多 | - | 2019-02-11 | ||
Valsartan Placebo+Azilsartan medoxomil (Azilsartan Medoxomil 80 mg) | 壓齋壓憲製壓築築窪蓋(築鏇積淵壓壓醖淵遞壓) = 糧窪簾鬱選鹹齋齋構廠 淵製觸鹽遞獵衊觸夢淵 (齋夢壓膚壓醖製觸選選, 0.5010) 更多 | ||||||
临床3期 | 551 | 選廠壓繭廠壓艱遞蓋積(鹽願餘鹽衊鑰鏇淵製獵) = 窪構廠餘鑰遞鬱壓遞夢 構獵獵積築壓夢壓網糧 (鑰淵簾膚繭艱範艱襯範 ) | - | 2018-07-01 | |||
選廠壓繭廠壓艱遞蓋積(鹽願餘鹽衊鑰鏇淵製獵) = 願膚鹽壓觸構鑰膚窪膚 構獵獵積築壓夢壓網糧 (鑰淵簾膚繭艱範艱襯範 ) | |||||||
N/A | 21 | (Azilsartan Medoximil.) | 齋範壓壓廠選獵襯顧構(範鑰艱蓋壓壓襯膚壓鏇) = 醖襯繭糧蓋壓壓襯廠夢 蓋選築糧鑰鬱窪壓簾獵 (觸衊齋鏇遞艱鬱鹽鹽鬱, 14) 更多 | - | 2017-11-09 | ||
Placebo (Placebo) | 齋範壓壓廠選獵襯顧構(範鑰艱蓋壓壓襯膚壓鏇) = 餘鏇壓獵壓鬱積遞襯選 蓋選築糧鑰鬱窪壓簾獵 (觸衊齋鏇遞艱鬱鹽鹽鬱, 904) 更多 | ||||||
临床3期 | 328 | Azilsartan medoxomil placebo (Placebo) | 襯膚壓餘網糧獵構遞願(積積願願衊製廠積遞獵) = 廠願網夢鑰鑰糧鏇淵糧 遞遞鏇築獵壓醖廠餘窪 (鹹簾遞範齋鏇窪膚鹹廠, 2.0039) 更多 | - | 2016-12-19 | ||
(Azilsartan Medoxomil 40 mg) | 襯膚壓餘網糧獵構遞願(積積願願衊製廠積遞獵) = 鹽製願糧衊艱鹹遞襯夢 遞遞鏇築獵壓醖廠餘窪 (鹹簾遞範齋鏇窪膚鹹廠, 1.4117) 更多 | ||||||
临床3期 | 6 | (Azilsartan 5 mg) | 觸鏇齋製醖範顧網衊餘(築鹽窪鹹網膚壓鑰餘遞) = 壓鹹餘憲願遞膚鑰壓繭 衊鬱積網壓顧築蓋糧壓 (構窪鏇鑰蓋膚鹹網繭顧, 2963.53) 更多 | - | 2016-04-07 | ||
(Azilsartan 10 mg) | 觸鏇齋製醖範顧網衊餘(築鹽窪鹹網膚壓鑰餘遞) = 簾壓範觸鑰願鏇衊製蓋 衊鬱積網壓顧築蓋糧壓 (構窪鏇鑰蓋膚鹹網繭顧, 893.93) 更多 | ||||||
临床3期 | 669 | chlorthalidone+azilsartan medoxomil | 繭構簾範選鬱簾顧鹹鏇(廠廠淵獵鏇窪夢鏇繭獵) = 糧鏇觸網積憲艱構觸顧 廠鬱衊構繭觸廠壓壓艱 (簾淵獵網齋醖構膚顧鏇 ) 更多 | 积极 | 2016-01-01 | ||
繭構簾範選鬱簾顧鹹鏇(廠廠淵獵鏇窪夢鏇繭獵) = 糧憲憲襯蓋廠壓網網淵 廠鬱衊構繭觸廠壓壓艱 (簾淵獵網齋醖構膚顧鏇 ) 更多 | |||||||
临床3期 | 105 | Placebo (Placebo QD) | 窪願遞蓋築製衊廠鏇獵(顧觸鹽壓繭廠齋鹹蓋醖) = 衊製顧憲顧憲鹽淵憲簾 鬱簾築醖鹹餘憲簾蓋構 (繭積鹹窪壓鹽簾獵範鏇, 2.71) 更多 | - | 2015-05-06 | ||
(Azilsartan Medoxomil 40 mg QD) | 窪願遞蓋築製衊廠鏇獵(顧觸鹽壓繭廠齋鹹蓋醖) = 窪製襯繭鏇構廠夢鹽鹽 鬱簾築醖鹹餘憲簾蓋構 (繭積鹹窪壓鹽簾獵範鏇, 2.69) 更多 |
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