预约演示
更新于：2025-06-01
Budesonide
布地奈德
更新于：2025-06-01
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、Budesonide gastro-resistant granules、Intestifalk + [69] |
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 |
特殊审评优先审评 (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)、附条件批准 (中国)、孤儿药 (韩国)、孤儿药 (澳大利亚)、附条件批准 (欧盟)、附条件批准 (英国)、快速通道 (韩国)、加速批准 (中国台湾)、加速批准 (美国) |
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结构/序列
分子式C25H34O6 |
InChIKeyVOVIALXJUBGFJZ-KWVAZRHASA-N |
CAS号51333-22-3 |
关联
649
项与 布地奈德 相关的临床试验NCT06860542
Inhaled Budesonide for REcurrence Prevention and Adjuvant THerapy in Checkpoint Inhibitor Pneumonitis
NCT06855043
Pilot Study of Late Surfactant Therapy With Budesonide for Prevention of Bronchopulmonary Dysplasia in Extremely Preterm Infants
CTRI/2025/04/085680
Effect of nebulised budesonide and salbutamol versus ipratropium bromide and salbutamol in the management of acute exacerbation of wheeze moderate to severe in children aged 1 to 5 years A Randomized controlled trial - nil
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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10,475
项与 布地奈德 相关的文献（医药）2025-12-31Journal of Pharmaceutical Policy and Practice
Access to single-inhaler triple medicines for chronic obstructive pulmonary disease in China: a national survey on accessibility and utilisation
Article
作者: Yu, Shule ; Wang, Menglei ; Yang, Qingqing ; Guo, Wei ; Lu, Wei ; Zheng, Fangfang ; Chen, Hongdou ; Wu, Huanhuan ; Li, Wei
Background:
The maintenance medicines for chronic obstructive pulmonary disease (COPD) include inhaled corticosteroids (ICS), long-acting muscarinic antagonists (LAMA) and long-acting β2-agonists (LABA). Budesonide/glycopyrronium/formoterol (BUD/GLY/FOR) and fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) are two representative drugs for prefixed ICS/LAMA/LABA association in a single inhaler and have shown comparable efficacy and safety with other ICS/LAMA/LABA open combination therapies in patients with moderate-to-very severe COPD. This study aimed to investigate the availability, price, affordability, and utilisation of single-inhaler triple medicines for COPD in China.
Methods:
Quarterly data about the use of BUD/GLY/FOR and FF/UMEC/VI from 2020 to 2022 were collected from the Chinese Medicine Economic Information Network. We used the adjusted World Health Organization and Health Action International methodology to calculate the availability and affordability of the two investigated medicines in 596 tertiary general hospitals and 299 secondary general hospitals in 31 provincial administrative regions in China.
Results:
The availability and consumption of BUD/GLY/FOR were significantly higher than those of FF/UMEC/VI during the study period. At the end of 2022, the availability of BUD/GLY/FOR and FF/UMEC/VI in tertiary general hospitals was 69.80% and 52.01% respectively, while in secondary general hospitals, it was 52.51% and 28.76% respectively. Both medications were equally affordable at 1.3 days of the minimum wage after reimbursement in 2022. In the first quarter of 2021, with the inclusion of both drugs in the Medicare catalog, their DDDc decreased significantly, which was accompanied by notable improvements in their availability, affordability and consumption.
Conclusions:
The overall accessibility and consumption of BUD/GLY/FOR and FF/UMEC/VI were improved in China from 2020 to 2022. The implementation of the national drug price negotiation policy reduces the cost of drugs in China and plays an important role in improving the availability of the investigated drugs.
2025-12-01LUNG
Supratherapeutic Inhaled Corticosteroid Use in Patients Initiating on Biologic Therapies for Severe Asthma: A Nationwide Cohort Study
Article
作者: Soendergaard, Marianne Baastrup ; Hansen, Susanne ; Johnsen, Claus Rikard ; Hjortdahl, Frederikke ; Walls, Anne Byriel ; Bonnesen, Barbara ; Håkansson, Kjell Erik Julius ; Bjerrum, Anne-Sofie ; Hilberg, Ole ; Ulrik, Charlotte Suppli ; von Bülow, Anna ; Johansson, Sofie Lock ; Porsbjerg, Celeste ; Rasmussen, Linda Makowska ; Schmid, Johannes Martin
Abstract:
Background:
In severe asthma, intensive (“supratherapeutic”) doses of inhaled corticosteroids (ICS) are often used. The prevalence of supratherapeutic ICS use and its impact on corticosteroid-related comorbidities is poorly understood. We aimed to describe the prevalence of supratherapeutic ICS use in severe asthma, its relation to corticosteroid-related comorbidities, and changes in prescribed and redeemed ICS dose after 12 months of biologic therapy.
Methods:
Patients from the nationwide Danish Severe Asthma Register (DSAR) receiving biologic therapy > 12 months were included. Supratherapeutic doses were defined as > 1600 µg budesonide daily. Baseline characteristics, comorbidity burden, and change in ICS use after 12 months of biologic therapy was stratified according to ICS use at baseline.
Results:
We included 652 patients in our analyses and 156 (24%) were supratherapeutic ICS users prior to initiation of biologic therapy. Supratherapeutic ICS users had a higher baseline prevalence of cataracts at 14 vs 8.1%; p = 0.025. No differences in other corticosteroid-related comorbidities were observed.No change in prevalence of prescribed supratherapeutic ICS was seen after 12 months of biologic therapy. However, a reduction in ICS adherence among supratherapeutic users was observed with 72% of patients demonstrating > 80% adherence at 12 months, compared to 83% at baseline (p < 0.001).
Conclusion:
Supratherapeutic doses of ICS were used by almost one-fourth of the patients prior to initiation of biologic therapy and were associated with a higher prevalence of cataracts. Physician-driven ICS reduction was rare, yet supratherapeutic ICS users were found to self-regulate ICS therapy when treated with biologic therapy.
2025-12-01LUNG
Efficacy of Nebulized Budesonide and Systemic Corticosteroids During Hospitalization on All-Cause Mortality in AECOPD Patients: A Real-World Study
Article
作者: Meng, Weiwei ; Chen, Yan ; Zhao, Rui ; Zeng, Huihui ; Wu, Jiankang ; Wang, Jiayu ; He, Xue ; Zhao, Zhiqi ; Cui, Yanan ; Xiong, Ruoyan
BACKGROUND:
Guidelines specify steroids as therapy for acute exacerbation of chronic obstructive pulmonary disease (AECOPD). However, the duration of survival benefit associated with steroids and the optimal dosage of nebulized budesonide (NB) during hospitalization remain unclear.
METHODS:
We conducted a retrospective study of hospitalized AECOPD patients. The primary endpoint was all-cause mortality after discharge. Cox regression analysis was used to determine the impact of steroid therapy on survival.
RESULTS:
Wilcoxon analysis showed the positive impact of systemic corticosteroids (SCs) therapy on survival during the early stage of follow-up (P = 0.038). NB therapy was associated with a significantly reduced risk of death within six months after discharge (adjusted Hazard ratio (HR), 0.36; 95% confidence interval (CI) 0.15-0.88). Subgroup analysis suggested that fewer than two AEs in the previous year (adjusted HR 0.05; 95% CI 0.01-0.38), age > = 65 years (adjusted HR 0.31; 95% CI 0.11-0.90), body mass index (BMI) < 25 kg/m2 (adjusted HR 0.33; 95% CI 0.12-0.92), and smoking index > 40 packets/year (adjusted HR 0.17; 95% CI 0.04-0.79) were involved in this association. Finally, treatment with a total dose of NB < = 60 mg during hospitalization reduced six-month mortality compared to treatment without steroids (adjusted HR 0.39; 95% CI 0.17-0.92), but not the total dose of NB > 60 mg.
CONCLUSIONS:
NB therapy for hospitalized AECOPD patients significantly reduced six-month mortality. Subgroup analysis showed that certain populations benefited more from NB therapy, and < = 60 mg NB might be suitable treatment for hospitalized AECOPD patients.
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
查看全部结果
N/A | 15 | Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF) | 顧糧構網築繭繭糧選網(觸窪夢鑰願鬱選選願鏇) = 獵範繭醖憲鏇壓壓鹽範 壓遞夢鑰簾願憲鑰簾製 (選築糧壓憲網願鏇積鹹, 0.7) 更多 | - | 2025-05-16 | ||
N/A | - | - | AIRSUPRA® (albuterol 90µg/budesonide 80µg) MDI alone | 選鏇鑰憲壓鹽廠網積艱(選夢願網觸繭醖醖鹽窪) = 簾積獵鏇構鹽襯範網簾 齋襯繭積觸觸衊顧廠鹹 (壓製壓蓋網鬱壓齋壓構, 1.7) 更多 | - | 2025-05-16 | |
AIRSUPRA® (albuterol 90µg/budesonide 80µg) MDI + AeroChamber2go | 選鏇鑰憲壓鹽廠網積艱(選夢願網觸繭醖醖鹽窪) = 窪衊餘蓋遞獵顧壓夢鑰 齋襯繭積觸觸衊顧廠鹹 (壓製壓蓋網鬱壓齋壓構, 1.7) 更多 | ||||||
临床1/2期 | 25 | (0.025 mg/kg Budesonide) | 艱糧鏇壓憲築衊鹽繭淵 = 夢積餘鬱蓋選製獵憲願 觸觸壓鹽鏇糧窪憲獵膚 (網鏇膚夢願艱襯簾壓願, 鹹繭範衊餘構構糧壓鏇 ~ 願遞淵選網夢鹹憲廠蓋) 更多 | - | 2025-04-04 | ||
(0.050 mg/kg Budesonide) | 艱糧鏇壓憲築衊鹽繭淵 = 艱築顧鬱艱鏇醖夢構遞 觸觸壓鹽鏇糧窪憲獵膚 (網鏇膚夢願艱襯簾壓願, 膚膚鬱構糧壓遞糧夢積 ~ 糧獵膚夢餘窪觸淵窪觸) 更多 | ||||||
临床3期 | 131 | Budesonide Oral Suspension 2.0 mg twice daily | 構窪壓餘築獵鬱築蓋鏇(選鹹窪鹽顧鑰獵積蓋齋) = 3.1% (4/131) 糧觸餘積鹹鏇壓遞糧觸 (鹹餘觸膚觸鬱衊範鹹襯 ) 更多 | 积极 | 2025-02-01 | ||
Placebo-Budesonide Oral Suspension 2.0 mg twice daily | |||||||
临床2期 | 10 | 繭積夢構鹹鏇壓鹹醖憲 = 衊窪觸範遞鏇餘獵夢餘 網選窪積糧觸襯簾艱願 (簾構壓遞齋顧簾築簾鏇, 襯蓋鹽蓋選鏇夢餘廠鹹 ~ 膚醖衊糧糧築鑰糧壓壓) 更多 | - | 2025-01-22 | |||
临床3期 | 119 | (Retreatment - Previously Treated With Nefecon in Nef-301 Study) | 觸淵襯繭餘壓觸襯壓憲(憲顧製構積憲衊廠願窪) = 壓淵製繭齋鏇糧構鹽膚 遞壓鏇簾夢選夢鹽獵壓 (齋餘壓願範鹽範壓鹹淵, 醖餘膚蓋膚鹽夢淵衊艱 ~ 窪襯構艱餘襯齋範齋醖) 更多 | - | 2025-01-03 | ||
Placebo (Delayed Treatment - Previously Treated With Placebo in Nef-301 Study) | 觸淵襯繭餘壓觸襯壓憲(憲顧製構積憲衊廠願窪) = 鏇範壓膚壓淵簾繭願觸 遞壓鏇簾夢選夢鹽獵壓 (齋餘壓願範鹽範壓鹹淵, 願齋顧鹽鑰網壓願齋製 ~ 鬱遞選窪憲願鏇鏇窪襯) 更多 | ||||||
N/A | - | PTCy-based GVHD prophylaxis + Budesonide | 壓艱鏇積製製壓膚壓鏇(鑰獵憲醖醖醖壓遞醖鏇) = 襯襯窪選蓋構襯願蓋餘 顧鹽鹽衊膚選鬱顧鏇鹽 (製網顧壓淵艱醖構窪選, 1.68 ~ 11.74) 更多 | - | 2024-12-09 | ||
临床3期 | 365 | (Nefecon) | 衊遞鬱構夢繭願鹽醖獵(淵觸廠夢願壓蓋夢簾蓋) = 膚糧襯鹽鬱衊蓋簾鬱膚 願蓋鹹觸膚遞繭壓願鑰 (醖窪繭網襯網艱鑰積艱, 艱獵構構構窪醖積製獵 ~ 鹽蓋鬱構鑰蓋膚鏇網願) 更多 | - | 2024-12-03 | ||
Placebo oral capsule (Placebo Oral Capsule) | 衊遞鬱構夢繭願鹽醖獵(淵觸廠夢願壓蓋夢簾蓋) = 窪鑰積獵淵顧觸艱鑰鏇 願蓋鹹觸膚遞繭壓願鑰 (醖窪繭網襯網艱鑰積艱, 膚鹹鬱遞鏇蓋齋齋積餘 ~ 積餘製鬱簾齋鑰壓醖憲) 更多 | ||||||
临床3期 | 186 | Budesonide Orodispersible Tablets 0.5 mg | 遞構鬱窪膚鑰鏇鬱衊範(獵簾膚蓋觸製獵窪願範) = occurred at similar rates to prior BOT studies, and was predominantly mild and resolved with treatment 鹹餘選壓鹹網網鑰醖構 (顧蓋網齋鏇願範繭壓襯 ) | 积极 | 2024-12-01 | ||
Budesonide Orodispersible Tablets 1.0 mg |
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