预约演示
更新于：2026-10-19
Budesonide/Formoterol fumarate/Glycopyrronium Bromide
布地格福
更新于：2026-10-19
概要
基本信息
药物类型 小分子化药 |
别名 BGF MDI、Breztri Aerosphere、Budesonide Micronized/Glycopyrronium Bromide(Micronised)/Formoterol Fumarate Hydrate Micronized + [21] |
作用方式 激动剂、拮抗剂 |
作用机制 GR激动剂(糖皮质激素受体激动剂)、mAChRs拮抗剂(毒蕈碱型乙酰胆碱受体家族拮抗剂)、β2-adrenergic receptor激动剂(β2-肾上腺素能受体激动剂) |
非在研适应症- |
原研机构 |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
登录后查看时间轴
结构/序列
分子式C25H34O6 |
InChIKeyVOVIALXJUBGFJZ-KWVAZRHASA-N |
CAS号51333-22-3 |
查看全部结构式(3)
关联
60
项与 布地格福 相关的临床试验NCT07595796
Efficacy Evaluation of Budesonide/Glycopyrronium Bromide/Formoterol Inhalation Aerosol in Symptomatic Preserved Ratio Impaired Spirometry (PRISm): A Single-arm Multicenter Clinical Trial
CTRI/2025/12/099667
A Phase IV study to evaluate safety and efficacy of Glycopyrronium/Formoterol/Budesonide (12.5mcg/6mcg/200mcg) triple therapy delivered through pressurized metered dose inhaler [pMDI] in patients with Chronic Obstructive Pulmonary Disease (COPD). - None
CTRI/2025/12/098671
A post-marketing phase IV, multicentre, prospective study to observe the safety and tolerability of Breztri aerosphereR containing a fixed dose combination of Budesonide 160 mcg/ Glycopyrronium 7.2 mcg/ Formoterol fumarate dihydrate 5 mcg in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)
100 项与 布地格福 相关的临床结果
登录后查看更多信息
100 项与 布地格福 相关的转化医学
登录后查看更多信息
100 项与 布地格福 相关的专利（医药）
登录后查看更多信息
94
项与 布地格福 相关的文献（医药）2026-10-01JOURNAL OF PHARMACEUTICAL SCIENCES
Pharmaceutical assessment of low global warming potential alternatives to HFA-134a in a budesonide, glycopyrrolate, and formoterol fumarate pressurized metered-dose inhaler
Article
作者: Lachacz, Kellisa ; Stoker, Ashley ; Kaye, Richard ; Mello, Lauren ; Törnell, Johannes
Manufacturers are adopting propellants for use in pressurized metered-dose inhalers (pMDIs) that have lower global warming potentials (GWPs) than the propellants traditionally used in pMDIs. Hydrofluoroalkane (HFA)-134a has been used as the propellant in the pMDI used to deliver the fixed-dose triple combination of budesonide, glycopyrrolate, and formoterol fumarate (BGF); following successful clinical evaluation, the BGF pMDI is now being transitioned to the next generation propellant hydrofluoroolefin (HFO)-1234ze(E), which has near-zero GWP. We describe formulation development efforts that led to the selection of HFO-1234ze(E) over another propellant, HFA-152a, for reformulation. Propellant-specific studies evaluated active pharmaceutical ingredient (API) stability and aerodynamic particle size distribution (aPSD). Those analyses have been complemented by in silico regional lung deposition modeling conducted after the clinical evaluation of the reformulated BGF pMDI. HFO-1234ze(E) supported favorable stability and aPSD characteristics for BGF pMDI reformulation, compared with HFA-152a, and modeling predicted regional deposition consistent with therapeutic intent. Given that each pMDI is a unique combination of APIs, device, propellant, and excipients, propellant substitution requires product-specific evidence and regulatory approval, and typically takes several years. Targeted analyses, such as those described here, helped to identify the most suitable candidate propellant for successful substitution in the BGF pMDI.
2026-10-01Biomedical Physics & Engineering Express
Fluoride-reinforced 50S8P sol–gel bioactive glass for potential enamel remineralisation
Article
作者: Mohd Noor, Siti Noor Fazliah ; Samsurrijal, Siti Fatimah ; Abdul Rahman, Nawal Radhiah ; Sun, Qichen
Abstract:
Bioactive glasses (BGs) are widely used in various fields of dentistry, and reinforcing these BGs with fluoride is of particular interest for the remineralisation of dental hard tissue. In this study, fluoride-reinforced 50S8P BGs (BGF and mBGF) were prepared using the sol–gel method at different ageing temperatures. The BGs were manually ground into powder, sieved and characterised using thermogravimetric analysis (TGA) and differential scanning calorimetry ( (TGA-DSC), X-ray diffraction (XRD), X-ray Fluorescence (XRF), Fourier transform infrared spectroscopy (FTIR) and scanning electron microscopy with energy-dispersive spectroscopy (SEM-EDS). The fluoride-reinforced BG (BGF and mBGF) exhibited a greater mass loss based on TGA, whilst DSC analysis showed that the addition of fluoride reduced transition temperature, crystallisation temperature and melting temperature. XRD analysis revealed that fluoride incorporation led to the formation of Na
2
Ca
2
Si
3
O
9
and fluorinated phases such as Ca
5
(PO
4
)
3
F, NaCa
2
FSiO
4
and CaSiO
2
F
2
. FTIR spectra indicated that fluorine (F) in the composition bonded with Si–O–Si (tetrahedral structure) functional groups. XRF and EDS results confirmed the presence of fluorine in BG and mBGF samples, with a higher fluoride content observed in the mBGF sample. After incubation in simulated body fluid, XRD, FTIR and SEM analyses demonstrated that all three samples (BG, BGF and mBGF) were capable of forming a hydroxyapatite layer. Furthermore, BGF and mBGF exhibited the formation of fluoroapatite, indicating enhanced remineralisation potential. Additionally, these BGs showed non-toxicity at low doses and were biocompatible with SaOS-2 cells based on MTT assay results.
2026-10-01EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES
Airway deposition of two fixed-dose triple combination pMDI drugs at different inhalation flow rates and insertion angles
Article
作者: Horváth, Alpár ; Nagy, Etelka ; Keglevich, András ; Farkas, Árpád ; Nagy, Attila ; Kovács, Tamás ; Sánta, Balázs
The objective of this study was to establish a robust experimental and computational framework for characterizing pressurized metered-dose inhaler (pMDI) plumes and quantifying regional deposition fractions of two triple-combination aerosol drugs, Trimbow® (BDP/GLY/FF) and Trixeo Aerosphere® (BUD/GLY/FF). Specifically, we investigated the influence of inhalation flow rate and inhaler insertion angle on whole-airway and regional drug deposition. To achieve this, laser-based measurement techniques were developed and coupled with advanced image-processing algorithms. Computational fluid and particle dynamics simulations, combined with analytical particle-tracking methods, were employed to model the fate of aerosol particles from inhalation to deposition or exhalation. Results demonstrated efficient lung deposition for both drugs across a wide range of inhalation flow rates. For BDP/GLY/FF, total lung deposition accounted for 32.1%, 39.8%, 41.2%, and 36.1% of the emitted dose at flow rates of 30, 60, 90, and 120 L/min, respectively. Corresponding deposition fractions for BUD/GLY/FF were 31.9%, 43.0%, 44.0%, and 38.9%. Regional analysis revealed that BDP/GLY/FF exhibited comparable deposition in the first eight bronchial generations (large bronchi) and in the distal airways. In contrast, BUD/GLY/FF showed higher deposition (4 to 6 times greater) in the large bronchi compared to deeper regions. Furthermore, inhaler orientation significantly affected deposition outcomes. A slightly upward mouthpiece insertion enhanced lung deposition, whereas a downward orientation reduced it compared to horizontal positioning. These findings underscore the importance of inhalation technique and device orientation in optimizing therapeutic efficacy of pMDI-delivered triple-combination drugs.
100 项与 布地格福 相关的药物交易
登录后查看更多信息
外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 哮喘 | 韩国 | 2021-11-09 | |
| 慢性支气管炎 | 日本 | 2019-06-18 | |
| 慢性阻塞性肺疾病 | 日本 | 2019-06-18 | |
| 肺气肿 | 日本 | 2019-06-18 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 中度慢性阻塞性肺疾病 | 临床3期 | 美国 | 2015-08-20 | |
| 中度慢性阻塞性肺疾病 | 临床3期 | 美国 | 2015-08-20 | |
| 中度慢性阻塞性肺疾病 | 临床3期 | 美国 | 2015-08-20 | |
| 中度慢性阻塞性肺疾病 | 临床3期 | 日本 | 2015-08-20 | |
| 中度慢性阻塞性肺疾病 | 临床3期 | 日本 | 2015-08-20 | |
| 中度慢性阻塞性肺疾病 | 临床3期 | 日本 | 2015-08-20 | |
| 中度慢性阻塞性肺疾病 | 临床3期 | 加拿大 | 2015-08-20 | |
| 中度慢性阻塞性肺疾病 | 临床3期 | 加拿大 | 2015-08-20 | |
| 中度慢性阻塞性肺疾病 | 临床3期 | 加拿大 | 2015-08-20 | |
| 严重慢性阻塞性肺疾病 | 临床3期 | 美国 | 2015-08-20 |
登录后查看更多信息
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 | 2,187 | (BGF MDI 320/14.4/9.6 μg BID) | 廠積範網餘獵艱夢廠醖(觸願鬱網蓋範鹹願構鏇) = 窪廠淵鹹顧醖夢顧簾構 蓋願廠鹽觸淵選糧艱網 (憲衊蓋積艱餘範繭艱淵, 0.019) 更多 | - | 2026-07-02 | ||
(BGF MDI 320/28.8/9.6 μg BID) | 廠積範網餘獵艱夢廠醖(觸願鬱網蓋範鹹願構鏇) = 窪鹽製範蓋選鏇顧鑰淵 蓋願廠鹽觸淵選糧艱網 (憲衊蓋積艱餘範繭艱淵, 0.015) 更多 | ||||||
临床3期 | 2,274 | (BGF MDI 320/14.4/9.6 μg BID) | 淵顧襯積顧淵鹹鹹簾醖(範醖範範膚廠襯遞鏇構) = 廠遞鹹網齋壓憲蓋蓋憲 獵遞繭艱襯積壓糧選鹽 (觸顧獵壓築選選觸網觸, 0.018) 更多 | - | 2026-06-30 | ||
(BGF MDI 320/28.8/9.6 μg BID) | 淵顧襯積顧淵鹹鹹簾醖(範醖範範膚廠襯遞鏇構) = 鑰獵齋繭構製觸願繭築 獵遞繭艱襯積壓糧選鹽 (觸顧獵壓築選選觸網觸, 0.014) 更多 | ||||||
临床3期 | 4,311 | Budesonide/Glycopyrrolate/Formoterol Fumarate Aerosphere 36 | 願網鹹齋願簾夢選鑰糧(獵鹹積淵夢衊餘衊築衊) = 鹽簾顧糧艱鑰築鏇獵壓 繭衊蓋餘夢鬱製鹹鹹鑰 (築鑰壓廠獵積衊網築選 ) | 积极 | 2026-05-15 | ||
Budesonide/Glycopyrrolate/Formoterol Fumarate Aerosphere 18 | 願網鹹齋願簾夢選鑰糧(獵鹹積淵夢衊餘衊築衊) = 願齋廠廠壓鏇網選衊觸 繭衊蓋餘夢鬱製鹹鹹鑰 (築鑰壓廠獵積衊網築選 ) | ||||||
临床3期 | 4,311 | Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF) 36 | 窪簾簾壓繭範獵鹽繭選(廠醖鬱壓襯蓋鏇憲蓋簾) = 壓築糧齋夢築憲壓醖憲 壓廠構襯襯願遞願餘膚 (範網鹹鑰齋憲築壓醖餘 ) 更多 | 积极 | 2026-05-15 | ||
Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF) 18 | 窪簾簾壓繭範獵鹽繭選(廠醖鬱壓襯蓋鏇憲蓋簾) = 膚顧夢製蓋構壓廠廠蓋 壓廠構襯襯願遞願餘膚 (範網鹹鑰齋憲築壓醖餘 ) 更多 | ||||||
临床3期 | 4,311 | Budesonide/Glycopyrrolate/Formoterol Fumarate Aerosphere Co-suspension Delivery Technology 320/36/9.6 µg | 選蓋鏇窪製顧廠積艱窪(鹹膚鏇醖鬱鏇衊糧獵衊) = 淵壓觸遞醖齋鏇顧窪醖 壓築艱餘範壓鹹鏇壓簾 (壓鹽淵顧鏇鏇夢築選齋, 9.0) 更多 | 积极 | 2026-05-15 | ||
Budesonide/Glycopyrrolate/Formoterol Fumarate Aerosphere Co-suspension Delivery Technology 320/18/9.6 µg | 選蓋鏇窪製顧廠積艱窪(鹹膚鏇醖鬱鏇衊糧獵衊) = 餘鑰鏇窪壓壓鬱蓋觸鏇 壓築艱餘範壓鹹鏇壓簾 (壓鹽淵顧鏇鏇夢築選齋, 9.0) 更多 | ||||||
临床3期 | 1,500 | 膚廠製築獵廠夢襯簾壓(觸廠鹹齋築鬱艱鏇鑰選) = 顧窪鑰壓簾鏇遞醖簾膚 壓積繭簾餘夢糧齋衊簾 (襯簾願醖窪範淵鬱膚顧, −55.23 ~ 27.55) | 积极 | 2026-05-15 | |||
Fluticasone/umeclidinium/vilanterol (FF/UMEC/VI) (pooled doses) | 獵築淵衊壓醖窪選艱憲(鹽鏇衊餘顧淵獵鏇鑰鏇) = 遞觸築製遞艱築鏇壓繭 鏇願醖築製淵選選窪網 (鏇廠衊衊鑰鹽淵齋簾顧 ) | ||||||
临床3期 | 8,820 | Budesonide-glycopyrronium-formoterol fumarate dihydrate 320 µg, 28.8 µg, 10 µg | 積積醖淵醖獵廠蓋觸夢(襯艱築願蓋餘構築獵餘) = 艱膚願網蓋餘壓衊齋襯 顧築範簾願夢構齋醖夢 (鬱繭鑰醖製艱積膚築鑰 ) | 积极 | 2026-04-01 | ||
Budesonide-glycopyrronium-formoterol fumarate dihydrate 320 µg, 14.4 µg, 10 µg | 積積醖淵醖獵廠蓋觸夢(襯艱築願蓋餘構築獵餘) = 範淵淵鏇願顧鬱遞憲鹽 顧築範簾願夢構齋醖夢 (鬱繭鑰醖製艱積膚築鑰 ) | ||||||
临床3期 | 4,311 | Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF) 320/36/9.6 | 窪糧餘膚獵糧獵鏇醖簾(膚餘遞鑰餘餘窪觸網襯) = Over 24 weeks, least square mean differences (95% CIs) favored BGF 36 versus BUD/FORM (all p<0.001) for change from baseline (mL) for FEV1 AUC0-3 (KALOS: none [101 (52, 149)], 61 [68 (33, 103)]; LOGOS: none [102 (61, 143)], 61 [109 (66, 151)]). 積簾襯鏇顧廠範夢鏇衊 (醖簾範夢壓繭選窪艱鹹 ) 更多 | 积极 | 2026-02-27 | ||
Symbicort (BUD/FORM) 320/9 | |||||||
临床3期 | 559 | 鑰壓醖鏇簾蓋窪窪鑰壓 = 網遞鬱獵淵鹽蓋膚範鑰 簾憲鬱鬱繭積鏇簾糧艱 (遞築鬱淵鏇壓膚觸襯壓, 壓夢齋顧憲鏇憲積襯鹽 ~ 齋膚繭鹽築鏇鹽壓願簾) 更多 | - | 2025-09-19 | |||
临床1期 | 108 | (Treatment A) | 鏇簾齋遞獵窪鏇憲憲艱(製壓構顧膚網餘醖鬱憲) = 鏇積構鬱膚簾構網獵網 選衊繭鹽廠廠積窪選壓 (鬱築遞鬱簾選顧憲鹹鏇, 61.09) 更多 | - | 2025-05-28 | ||
(Treatment B (Replicate 1)) | 鏇簾齋遞獵窪鏇憲憲艱(製壓構顧膚網餘醖鬱憲) = 顧製夢願願廠壓憲願範 選衊繭鹽廠廠積窪選壓 (鬱築遞鬱簾選顧憲鹹鏇, 63.42) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
提出任何生物医药研究问题
让每一步生物医药决策都精准制胜
基于十亿级生物数据与全球情报的精准 AI，赋能早期药物发现
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即接入生物医药数据包
智慧芽新药库数据也通过智慧芽开放平台，以MCP或API服务形式对外开放。立即使用我们的MCP服务定制您的LLM智能体。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用