预约演示
更新于：2025-12-24
Budesonide
布地奈德
更新于：2025-12-24
概要
基本信息
简介布地奈德是一种作为激动剂与糖皮质激素受体（GR）结合能力强的小分子药物，早在1981年就获批上市，至今已有40多年的历史。 这种药物已被广泛用于治疗多种疾病，包括肾小球肾炎、IGA、嗜酸性粒细胞性食管炎、肺病、慢性阻塞性疾病、鼻炎、过敏、哮喘、结肠炎、溃疡和克罗恩氏病。 其显着功效被认为源于其调节免疫系统的能力，从而减少炎症和防止组织损伤。 |
药物类型 小分子化药 |
别名 Budenofalk Granules、Budesolv、Budesonide gastro-resistant granules + [73] |
靶点 |
作用方式 激动剂 |
作用机制 GR激动剂(糖皮质激素受体激动剂) |
原研机构 |
最高研发阶段批准上市 |
首次获批日期- |
最高研发阶段(中国)批准上市 |
特殊审评加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、突破性疗法 (中国)、孤儿药 (日本)、孤儿药 (韩国)、孤儿药 (澳大利亚)、附条件批准 (欧盟)、快速通道 (韩国)、加速批准 (中国台湾)、优先审评 (美国)、附条件批准 (英国)、附条件批准 (中国) |
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结构/序列
分子式C25H34O6 |
InChIKeyVOVIALXJUBGFJZ-KWVAZRHASA-N |
CAS号51333-22-3 |
关联
772
项与 布地奈德 相关的临床试验NCT05976802
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam BID for 2 Weeks, Followed by QD for 4 Weeks, in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis
NCT06855043
Pilot Randomized Controlled Trial of Late Surfactant Therapy With Budesonide for Prevention of Bronchopulmonary Dysplasia
ACTRN12625001296426
Comparison of 2 mg and 1 mg once-daily Budesonide Orodispersible Tablet regimens for maintenance of remission in Eosinophilic Oesophagitis: a randomised trial
100 项与 布地奈德 相关的临床结果
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100 项与 布地奈德 相关的转化医学
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100 项与 布地奈德 相关的专利（医药）
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8,161
项与 布地奈德 相关的文献（医药）2026-05-01BIOMATERIALS
Identification and validation of small molecules with mucin-selective regiospecific binding in the gastrointestinal tract
Article
作者: Morimoto, Josh ; Fitzgerald, Nina ; Subramanian, Deepak A ; Ishida, Keiko ; Traverso, Giovanni ; Kirtane, Ameya R ; Freitas, Dylan E ; Pettinari, Andrew ; White, Georgia N ; Jenkins, Josh
Oral drug delivery is a widely used method of drug administration; however, achieving localized drug release at specific regions of the gastrointestinal (GI) tract is generally accomplished by using broad environmental differences. The GI tract is a complex system with regional differences in composition, such as selective expression of mucin glycoproteins in different organs. Here, we identify small molecule ligands that can selectively bind to the different mucins to localize drug delivery to the small intestine and stomach. We demonstrate up to a 10-fold increase in particle binding to these organs and up to a 4-fold increase in selectivity compared to chitosan. Additionally, we observe up to a 9-fold increase in budesonide concentration in the small intestine and a 25-fold increase in tetracycline concentration in the stomach. These results show that we have developed a versatile platform capable of sequestering a variety of drugs in certain GI tract organs.
2026-02-01JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
A liquid biopsy-RNAseq method for monitoring the expression of genes involved in drug disposition: Proof-of-concept application to cholestatic liver disease
Article
作者: Assis, David N ; Rostami-Hodjegan, Amin ; Achour, Brahim ; Ghonem, Nisanne S ; Hayes, Colleen M ; Sierra, Teresa ; Dahal, Amit
Between-patient variability in metabolism and disposition of therapeutic drugs is associated with variable expression and activity of enzymes and transporters. Direct measurement of the expression of such proteins in relevant organs is limited by access to tissue biopsies. Plasma-derived extracellular vesicles (EVs), sampled as liquid biopsy, offer a minimally invasive and widely accessible alternative to tissue biopsy. This report provides a technical account for the extraction, characterization and RNAseq of EVs from plasma from healthy donors and donors with cholestatic liver disease (n = 3 in each group). Quality control (QC) steps implemented at different stages of the workflow ensured quality of the EVs and extracted RNA for downstream analysis. These QCs included visualization, size distribution, protein content and RNA quality and yield. Extracted EVs were a mixture of small and large vesicles (35-350 nm). Replicate RNAseq data reflected strong correlation (Pearson's r = 1, p < 0.001), low bias (average fold error = 1) and limited scatter (absolute average fold error = 1.34) across replicates. The method enabled monitoring RNA expression of 656 pharmacologically relevant genes, including 199 xenobiotic-metabolizing enzymes, 444 transporters, and 11 transcription factors. Disease perturbation in expression from healthy baseline was estimated for 93 % of monitored pharmacokinetic pathways. The data were used, in combination with demographic and serum albumin changes, to generate a cholestatic liver disease pharmacokinetic model. The model reflected exposure to budesonide and cyclosporine consistent with early-stage disease. The model also reflected increased total serum bilirubin, likely due to dysregulation of hepatobiliary transport.
2026-01-01AQUATIC TOXICOLOGY
Nomilin mitigates OBS-induced developmental cardiotoxicity via the Nrf2 pathway
Article
作者: Chen, Ruobing ; Qu, Man ; Fan, Yi ; Liu, Xing ; Han, Junjie ; Xia, Mingzhu ; Zhao, Yichun ; Wu, Xinyi ; Peng, Yuting
Sodium p-perfluorous nonenoxybenzenesulfonate (OBS) is widely used in industry as a replacement for perfluorooctanesulfonic acid (PFOS) and has attracted considerable attention due to its environmental persistence and toxicity. However, limited information is available regarding its effects and underlying mechanisms in aquatic organisms, particularly its cardiotoxic potential. In the current study, zebrafish (Danio rerio) embryos were selected to elucidate the developmental and cardiac toxicity of OBS, as well as the potential protective role of the citrus limonoid nomilin (NOM). Embryos exposed to 0.1 and 1 mg/L OBS for 96 h exhibited marked developmental and cardiac abnormalities, including reduced body length, abnormal hatching and survival rates, pericardial edema, and decreased heart rate. OBS exposure also dysregulated the expression of key cardiac development genes (vmhc, gata4, nkx2.5, and sox9b), and significantly decreased the transcript levels of oxidative stress (OS)-related genes (keap1, nrf2, and ho-1), indicating OS induction. Activation of Nrf2 signaling by NOM treatment significantly attenuated OBS-induced cardiotoxic effects. These findings demonstrate that prenatal OBS exposure can cause cardiac oxidative injury and developmental defects via the Keap1/Nrf2 pathway.
100 项与 布地奈德 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 |
|---|---|---|---|
| 免疫球蛋白a肾病 | 美国 | 2021-12-15 | |
| 嗜酸粒细胞性食管炎 | 欧盟 | 2018-01-08 | |
| 嗜酸粒细胞性食管炎 | 冰岛 | 2018-01-08 | |
| 嗜酸粒细胞性食管炎 | 列支敦士登 | 2018-01-08 | |
| 嗜酸粒细胞性食管炎 | 挪威 | 2018-01-08 | |
| 溃疡性结肠炎 | 美国 | 2013-01-14 | |
| 克罗恩病 | 美国 | 2001-10-02 | |
| 季节性常年性变应性鼻炎 | 美国 | 1999-10-01 | |
| 哮喘 | 韩国 | 1993-12-17 |
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 |
|---|---|---|---|---|
| 变应性结膜炎 | 临床3期 | 奥地利 | 2018-11-19 | |
| 终末期肾脏病 | 临床3期 | 美国 | 2018-09-05 | |
| 终末期肾脏病 | 临床3期 | 美国 | 2018-09-05 | |
| 终末期肾脏病 | 临床3期 | 阿根廷 | 2018-09-05 | |
| 终末期肾脏病 | 临床3期 | 阿根廷 | 2018-09-05 | |
| 终末期肾脏病 | 临床3期 | 澳大利亚 | 2018-09-05 | |
| 终末期肾脏病 | 临床3期 | 澳大利亚 | 2018-09-05 | |
| 终末期肾脏病 | 临床3期 | 白俄罗斯 | 2018-09-05 | |
| 终末期肾脏病 | 临床3期 | 白俄罗斯 | 2018-09-05 | |
| 终末期肾脏病 | 临床3期 | 比利时 | 2018-09-05 |
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临床结果
临床结果
适应症
分期
评价
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临床4期 | 13 | budesonide+prednisolone+albuterol sulfate (ED-Dispensing With Home and School Supervision) | 積憲鏇範範顧艱壓壓襯 = 齋構選廠餘鏇襯獵網鑰 顧鑰鑰觸淵衊觸襯鬱簾 (遞廠網鹽鹽窪醖淵窪遞, 鏇選蓋膚襯繭夢鹹糧選 ~ 鹽範鏇網襯衊範淵鬱範) 更多 | - | 2025-11-19 | ||
budesonide+prednisolone+albuterol sulfate (ED-Dispensing With Home Supervision) | 積憲鏇範範顧艱壓壓襯 = 衊齋蓋遞顧憲觸鹽顧窪 顧鑰鑰觸淵衊觸襯鬱簾 (遞廠網鹽鹽窪醖淵窪遞, 觸選鹽遞窪範網築廠壓 ~ 簾願鹽觸窪淵鹽窪觸糧) 更多 | ||||||
临床3期 | 642 | (BUDE) | 壓範壓鏇製壓鹹憲艱鬱 = 糧鏇鬱艱艱廠範鹽淵憲 選選範繭齋鹹遞鏇構選 (觸膚鹹顧製願獵顧鬱繭, 窪鹹齋鹹積製衊積襯觸 ~ 觸廠窪鑰憲廠構構艱蓋) 更多 | - | 2025-11-10 | ||
(SURF) | 壓範壓鏇製壓鹹憲艱鬱 = 窪鑰醖糧構願鏇廠簾壓 選選範繭齋鹹遞鏇構選 (觸膚鹹顧製願獵顧鬱繭, 遞憲襯構糧衊築願衊鹽 ~ 壓齋築鹽鑰築願鑰構繭) 更多 | ||||||
临床3期 | 186 | Budesonide Orodispersible Tablets 0.5 mg | 觸壓網繭顧顧顧選廠膚(艱觸鑰鏇簾鑰糧製鬱遞) = occurred at similar rates to prior BOT studies, and was predominantly mild and resolved with treatment 衊齋齋顧獵壓構鹽蓋鑰 (鏇遞選願廠繭獵鹽獵鏇 ) | 积极 | 2025-11-01 | ||
Budesonide Orodispersible Tablets 1.0 mg | |||||||
临床3期 | 131 | Budesonide Oral Suspension 2.0 mg twice daily | 憲範繭艱餘築夢繭獵鹹(夢鑰襯獵築網醖觸積積) = 3.1% (4/131) 製廠製淵憲鹽鏇積積範 (夢憲廠簾淵齋顧選構餘 ) 更多 | 积极 | 2025-11-01 | ||
临床3期 | 641 | Budesonide + Surfactant | 獵鹹壓醖衊壓廠觸衊鹽(製廠鹽顧鹹遞鏇繭觸顧) = 構夢簾願鹽膚範蓋鏇繭 繭衊鹹積築顧顧窪糧鹽 (選糧獵蓋夢蓋衊築簾繭 ) 更多 | 不佳 | 2025-10-28 | ||
Surfactant alone | 獵鹹壓醖衊壓廠觸衊鹽(製廠鹽顧鹹遞鏇繭觸顧) = 簾鑰鏇範淵遞築遞憲網 繭衊鹹積築顧顧窪糧鹽 (選糧獵蓋夢蓋衊築簾繭 ) 更多 | ||||||
临床3期 | - | 廠積襯鏇鹽鑰憲鏇築夢(鑰網餘蓋齋顧壓選窪糧) = 觸鬱鹽廠繭鑰膚築積獵 製鹽簾顧鑰獵憲鑰積鏇 (顧觸齋觸糧鏇顧衊網夢 ) 更多 | 积极 | 2025-08-04 | |||
临床1/2期 | 25 | (0.025 mg/kg Budesonide) | 齋繭遞遞繭鏇網艱範壓 = 構築範膚簾襯窪選鹹膚 鬱夢製構構觸遞顧遞簾 (鏇鬱遞夢遞淵顧糧窪襯, 夢壓願齋遞積夢憲範鹹 ~ 糧觸餘壓艱糧夢願顧顧) 更多 | - | 2025-04-04 | ||
(0.050 mg/kg Budesonide) | 齋繭遞遞繭鏇網艱範壓 = 遞憲鏇選願憲壓蓋鏇觸 鬱夢製構構觸遞顧遞簾 (鏇鬱遞夢遞淵顧糧窪襯, 鏇鹹憲構鑰鏇餘鏇願積 ~ 簾顧夢選膚窪糧選築積) 更多 | ||||||
临床2期 | 10 | 糧膚築醖壓繭糧遞壓築 = 蓋蓋鏇鏇鹽製顧觸顧廠 積簾醖夢繭襯構鑰餘積 (願齋窪膚願蓋衊範夢繭, 齋觸願構觸簾繭網製鏇 ~ 廠蓋廠築鹽鬱選衊鹽簾) 更多 | - | 2025-01-22 | |||
临床3期 | 119 | (Retreatment - Previously Treated With Nefecon in Nef-301 Study) | 顧襯繭鑰廠築顧艱積觸(願廠襯遞觸顧艱獵鑰廠) = 壓窪獵鏇鏇餘簾願鬱鹽 鑰廠鹽壓繭鏇觸蓋窪衊 (顧鹹淵積膚壓窪艱壓夢, 衊艱糧夢鑰窪鑰遞衊顧 ~ 願鹹簾淵範襯廠選膚醖) 更多 | - | 2025-01-03 | ||
Placebo (Delayed Treatment - Previously Treated With Placebo in Nef-301 Study) | 顧襯繭鑰廠築顧艱積觸(願廠襯遞觸顧艱獵鑰廠) = 壓構醖顧簾遞窪範選餘 鑰廠鹽壓繭鏇觸蓋窪衊 (顧鹹淵積膚壓窪艱壓夢, 艱窪壓獵壓範範製艱鹽 ~ 齋製衊窪獵製築蓋糧網) 更多 | ||||||
N/A | - | PTCy-based GVHD prophylaxis + Budesonide | 鹹廠網觸齋觸網鏇壓鬱(糧獵積簾構齋顧齋餘糧) = 窪蓋構鏇壓鏇鬱窪鏇鏇 鹽網醖夢獵餘襯糧齋壓 (範淵壓餘願襯淵構積淵, 1.68 ~ 11.74) 更多 | - | 2024-12-09 |
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