布地奈德福莫特罗(Budesonide/Formoterol Fumarate Dihydrate) - 药物靶点：GR x β2-adrenergic receptor_在研适应症：轻度哮喘，哮喘，慢性阻塞性肺疾病_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Budesonide and Formoterol Fumarate、Budesonide/Formoterol、Formoterol Fumarate Hydrate/Budesonide

+ [20]

靶点

GR x β2-adrenergic receptor

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)、β2-adrenergic receptor激动剂(β2-肾上腺素能受体激动剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

+ [8]

非在研机构

Pearl Therapeutics, Inc.Teva Branded Pharmaceutical Products R&D LLC

Orion Oyj

+ [1]

权益机构

杭州畅溪制药有限公司

A.Menarini Industrie Farmaceutiche Riunite Srl

AstraZeneca PLC

+ [6]

最高研发阶段批准上市

首次获批日期

澳大利亚 (2002-05-27),

哮喘慢性阻塞性肺疾病

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C92H124N4O26

InChIKeySTZCUPXZOQOJNR-BQOVXDGUSA-N

CAS号1089666-88-5

关联

243

项与布地奈德福莫特罗相关的临床试验

NCT07433569

/ Recruiting临床1期

Phase I Study to Compare the Pharmacokinetics of Budesonide and Formoterol Delivered With Symbicort Aerosphere® and Symbicort® pMDI in Children 4 to Less Than 12 Years of Age With Asthma

The purpose of this study is to assess the pharmacokinetics (PK) and safety of symbicort aerosphere and symbicort pressurized metered dose inhaler (pMDI) in participants with asthma aged 4 to less than 12 years.

开始日期2026-03-05

申办/合作机构

AstraZeneca PLC

CTR20260268

/ Recruiting临床3期

布地奈德福莫特罗吸入粉雾剂（II）治疗成人哮喘有效性和安全性的多中心、随机、双盲双模拟、阳性药物平行对照临床研究

主要目的：以AstraZeneca AB（阿斯利康）生产的布地奈德福莫特罗吸入粉雾剂（II）（Symbicort Turbuhaler，信必可都保）为阳性对照药品，评价山东京卫制药有限公司生产的布地奈德福莫特罗吸入粉雾剂（II）用于治疗成人支气管哮喘的有效性非劣于阳性对照药品。次要目的：评价布地奈德福莫特罗吸入粉雾剂（II）用于治疗成人支气管哮喘的安全性。

开始日期2026-03-04

申办/合作机构

山东京卫制药有限公司

NCT07352488

/ Not yet recruitingN/AIIT

Effect of Modified Shenling Baizhu Powder on Allergic Asthma With Spleen Deficiency and Dampness Accumulation Syndrome: A Multicenter, Randomized Controlled Trial

Allergic asthma is a common allergic disease characterized by a protracted disease course and recurrent episodes, which severely impairs patients' physical and mental health. There is a paucity of high-quality clinical evidence in the treatment of allergic asthma with traditional Chinese medicine (TCM). This study will enroll patients who are persistent allergic asthma with spleen deficiency and dampness accumulation syndrome. A multicenter, randomized, double-blind, placebo-controlled trial design is adopted. The experimental group will receive Modified Shenling Baizhu Powder in addition to Budesonide and Formoterol Fumarate Powder for Inhalation, while the control group will receive a placebo in addition to the same inhalation therapy. Both groups will undergo an 8 week of treatment followed by a 12 week of follow-up. The primary outcome is Asthma Control Test scores, and the secondary outcomes include acute exacerbations, Asthma Control Questionnaire scores, Asthma Quality of Life Questionnaire scores, pulmonary function, airway inflammatory markers, clinical symptom scores, serum inflammatory markers, immune markers, and use of controller medications.

开始日期2026-01-15

申办/合作机构

河南中医药大学

100 项与布地奈德福莫特罗相关的临床结果

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100 项与布地奈德福莫特罗相关的转化医学

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100 项与布地奈德福莫特罗相关的专利（医药）

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512

项与布地奈德福莫特罗相关的文献（医药）

2026-04-01·Lancet Respiratory Medicine

Budesonide–glycopyrronium–formoterol fumarate dihydrate in uncontrolled asthma (KALOS and LOGOS): twin multicentre, double-blind, double-dummy, parallel-group, randomised, phase 3 trials

Article

作者: Bondoc, Marco ; Springer, Katarzyna ; Shah, Mihir ; Jackson, David J ; Papi, Alberto ; Obasi, Chidi ; Helman, Jesse ; Wise, Robert A ; Bowen, Karin ; Patel, Mehul ; Salter, Patricia ; Movitz, Charlotta ; Chen, Ruchong ; Lugogo, Njira ; Pandya, Hitesh ; Megally, Ayman ; Trasieva, Teodora ; Knappenberger, Katharine

BACKGROUND:

Long-acting muscarinic antagonists (LAMA) can be added to inhaled corticosteroid- (ICS)-long-acting β₂-agonist (LABA) therapy for inadequately controlled asthma. We aimed to evaluate the efficacy and safety of budesonide-glycopyrronium-formoterol fumarate dihydrate (BGF) versus budesonide-formoterol fumarate dihydrate using Aerosphere co-suspension delivery technology (BFF_A) and the current suspension formulation (Symbicort, BFF_S).

METHODS:

Two multicentre, randomised, double-blind, double-dummy, phase 3 studies (KALOS and LOGOS) recruited participants aged 12-80 years with inadequately-controlled asthma despite daily medium-dose or high-dose ICS-LABA use from across 378 sites in 20 countries (KALOS), and 324 sites in 15 countries (LOGOS). Participants were randomly assigned (1:1:1:1) to BGF 320 μg, 28·8 μg, 10 μg (BGF 28·8); BGF 320 μg, 14·4 μg, 10 μg (BGF 14·4); BFF_A 320 μg, 10 μg; or BFF_S 320 μg, 9 μg, twice a day via pressurised metered-dose inhaler for 24-52 weeks. Primary lung function endpoints were change from baseline in FEV₁ area under the curve from 0 h to 3 h (AUC_0-3) and in morning pre-dose trough FEV₁ from day 1 to week 24 (over 24 weeks; depending on regional health authority guidance). The primary pooled analysis across both studies was annualised severe exacerbations. The efficacy analysis set and safety set included all randomly assigned participants receiving any amount of study treatment but were analysed according to randomly assigned treatment and received treatment, respectively. The KALOS and LOGOS studies are registered with ClinicalTrials.gov (NCT04609878 and NCT04609904, respectively) and are complete.

FINDINGS:

Between Dec 15, 2020, and March 21, 2025 (KALOS), and between March 1, 2021, and March 20, 2025 (LOGOS), 8820 participants were recruited and 4311 received treatment (1179 received BGF 28·8, 726 received BGF 14·4, 1210 received BFF_A, and 1196 received BFF_S). In each study, the pre-specified multiplicity-adjusted primary endpoints for all regulatory comparisons were met. Least squares mean differences favoured BGF 28·8 for change from baseline in trough FEV₁ and FEV₁ AUC_0-3 across all comparisons (all p<0·05). Least squares mean differences in change from baseline in morning pre-dose trough FEV₁ and in FEV₁ AUC_0-3 over 24 weeks for BGF 28·8 versus BFF_combined were 76 mL (95% CI 57-94; p<0·0001) and 90 mL (72-108; p<0·0001), respectively. BGF 28·8 reduced severe exacerbation rates versus BFF_combined (incidence rate ratio 0·86, 95% CI 0·76-0·97; p=0·012) and versus BFF_S (0·82, 0·71-0·94; p=0·0043). Exacerbation rate ratio for BGF 28·8 versus BFF_A was 0·90 (95% CI 0·78-1·03; p=0·12). 627 (53·2%) adverse events were observed with BGF 28·8, 436 (60·0%) with BGF 14·4, 666 (55·2%) with BFF_A, and 698 (58·4%) with BFF_S. No deaths were treatment related.

INTERPRETATION:

These findings show that BGF improves lung function and reduces severe exacerbation rates in a broad population with asthma inadequately controlled despite medium-dose or high-dose ICS-LABA use. Given that these findings were observed regardless of recent exacerbation history, BGF could benefit individuals with inadequately controlled asthma without requiring a recent episode of acute deterioration on ICS-LABA before escalation.

FUNDING:

AstraZeneca.

2026-04-01·JOURNAL OF ETHNOPHARMACOLOGY

Bufei formula attenuates airway mucus hypersecretion in COPD through inhibition of TRIM56-mediated ITGB4 ubiquitination

Article

作者: Zhang, Qin ; Cheng, Mengmeng ; Wei, Yanxin ; Zhao, Di ; Zhao, Peng ; Xin, Nan ; Li, Jiansheng ; Zhang, Zeyu

ETHNOPHARMACOLOGICAL RELEVANCE:

Bufei Formula (BFF), a traditional Chinese medicine, has been widely utilized in the clinical treatment of chronic obstructive pulmonary disease (COPD), though its underlying mechanisms remain unclear and warrant further investigation.

AIM OF THE STUDY:

To investigate the mechanisms by which BFF alleviates COPD airway mucus hypersecretion through the TRIM56-mediated ubiquitination.

MATERIALS AND METHODS:

A cigarette smoke-induced COPD mouse and cigarette smoke extract (CSE)-induced airway epithelial cells were established to evaluate the effect of BFF on airway mucus hypersecretion. The target protein of BFF was identified using DARTS technology. Co-immunoprecipitation (Co-IP) combined with mass spectrometry (MS) was used to identify the downstream proteins of TRIM56.

RESULTS:

BFF can effectively improve lung function and pathological changes, and inhibit inflammation in COPD mice, as well as downregulate the levels of mucin and MUC5AC in the lung. BFF-4, an active fraction derived from BFF, directly inhibits the expression of MUC5AC and TNF-α induced by CSE in epithelial cells. DARTS analysis and single-cell sequencing analysis revealed that TRIM56 is a target of BFF-4, and its mediated ubiquitination contributes to the effects of BFF-4. Moreover, high levels of TRIM56 and ubiquitinated proteins are expressed both in vivo and in vitro. BFF-4 significantly downregulates these expressions. Furthermore, overexpression of TRIM56 and ubiquitinated proteins markedly diminishes the inhibitory effect of BFF-4 on mucin expression. Overexpression of TRIM56 also counteracts the inhibition of ubiquitination by BFF-4. Co-IP-MS analysis revealed that TRIM56 binds to ITGB4, which in turn regulates the expression of MUC5AC. Furthermore, molecular docking identified the top five small molecules with the highest affinity for TRIM56 were identified, suggesting their potential for direct interaction with TRIM56.

CONCLUSION:

BFF-4 effectively ameliorates airway mucus hypersecretion in COPD by inhibiting TRIM56-mediated downregulation of protein ubiquitination, including ITGB4.

2026-03-01·CLINICAL THERAPEUTICS

Safety Assessment of Budesonide/Formoterol: Real-World Pharmacovigilance Analysis Using the FAERS, JADER, and CVAR Databases

Article

作者: Zou, Fan ; Chen, Zhenyong ; Zhu, Chengyu ; Lan, Yuanbo ; Cui, Zhiwei

BACKGROUND:

Asthma and chronic obstructive pulmonary disease are common respiratory disorders with significant global health implications. Budesonide/formoterol (Symbicort) is a fixed-dose inhaler combining budesonide and formoterol fumarate dihydrate, widely used for disease management. While its clinical efficacy is well established, there is an increasing number of adverse drug event (ADE) reports, highlighting the need for thorough real-world safety evaluations.

METHODS:

We performed a retrospective pharmacovigilance study using three major spontaneous reporting systems: the US Food and Drug Administration Adverse Event Reporting System (FAERS), the Japanese Adverse Drug Event Report (JADER), and the Canada Vigilance Adverse Reaction Database (CVARD). We used multiple disproportionality algorithms, including reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker for signal detection. Additionally, subgroup and sensitivity, along with logistic regression, were performed. Weibull distribution and log-rank testing were used to assess event timing.

RESULTS:

A total of 30,689 ADEs were identified in FAERS, spanning 27 system organ classes. Expected signals such as cough, dysphonia, and bronchitis were confirmed. Unexpected events included dyspnea, visual and memory impairment, coronary artery embolism, and asthmatic crisis. Sex-stratified analysis revealed female-specific risks (eg, malaise, bronchitis, alopecia, weight gain) and male-specific risks (eg, dysuria, myocardial infarction). Younger patients (<18 years) were at higher risk for asthmatic crisis, whereas older patients (>65 years) showed a protective effect. The median onset of ADEs was 55 days. Distinctive signals emerged from JADER (eg, pneumonia, liver injury) and CVARD (eg, hemoptysis, hypothyroidism).

CONCLUSIONS:

This multi-database analysis highlights the need for continuous pharmacovigilance for budesonide/formoterol. The identification of novel ADE signals emphasizes the importance of vigilant monitoring, especially during early treatment, to enhance safety and therapeutic outcomes.

343

项与布地奈德福莫特罗相关的新闻（医药）

2026-05-16

·药研苑

艾伯维T细胞衔接器双抗艾可瑞妥获批，用于滤泡性淋巴瘤

药品营销避坑”试读：药品导入期管理视频课（试听）药品生命周期管理（案例）药品立项需要注意什么（案例） 2026年5月15日艾伯维宣布，艾可瑞妥单抗注射液（艾可来®）已获得中国国家药品监督管理局（NMPA）批准，用于联合来那度胺和利妥昔单抗治疗复发或难治性（R/R）滤泡性淋巴瘤（FL）成人患者。本次获批基于全球、开放标签3期临床试验EPCORE FL-1的研究结果。EPCORE FL-1共纳入488名复发或难治性滤泡性淋巴瘤患者。入组患者按1:1比例随机接受艾可瑞妥单抗联合来那度胺（Lenalidomide）和利妥昔单抗（Rituximab），或来那度胺联合利妥昔单抗（R²组），共12个治疗周期。艾可瑞妥单抗前1-3治疗周期，每周一次，第4-12治疗周期，每4周一次；来那度胺每一天次，1-12治疗周期第1-21天；利妥昔单抗第1治疗周期，每周一次，第2-5治疗治疗周期，每月1次。至中位随访第14.8个月，艾可瑞妥单抗+R²组和R²组总缓解率分别为95%和79%（p<0.0001）；中位无进展生存期（PFS），艾可瑞妥单抗+R²组尚未达到（NR），R2组为11.7个月，艾可瑞妥单抗+R²组降低79%的疾病进展和死亡风险（HR 0.21, 95% CI 0.14–0.31, p<0.000）；艾可瑞妥单抗+R²组和R²组16个月无进展生存率分别为85.5%和40.2%。在安全性方面，艾可瑞妥单抗+R²组和R²组≥3级不良事件的发生率分别为90%和68%。艾可瑞妥单抗+R²组细胞因子释放综合征不良事件的严重程度为低级别，1级和2级和发生率分别为21%和5%（Lorenzo Falchi., 2026）。艾可瑞妥单抗（Epcoritamab）为通过受控Fab臂交换，实现同时靶向CD20和CD3的双特异性T细胞衔接器抗体，可通过皮下注射给药。CD20在B细胞上表达，CD3为T细胞的共受体，CD3通过与T细胞受体（TCR）结合，参与信号传导。艾可瑞妥单抗一方面与CD20阳性肿瘤细胞表面CD20结合，另一方面与T细胞CD3结合，引导T细胞杀伤肿瘤细胞。艾可瑞妥单抗的Fc段通过引入L234F、L235E和D265A突变，降低与FcγR和C1q受体的亲和力，以降低抗体依赖细胞介导的细胞毒性。除艾可瑞妥单抗外，目前国内获批用于治疗滤泡性淋巴瘤的CD20/CD3双特异性抗体药物，还包括莫妥珠单抗（Mosunetuzumab），适应症为：单药适用于既往接受过至少两线系统性治疗的复发或难治性滤泡性淋巴瘤（FL）成人患者。此外，CD20/CD3双特异性抗体药物格菲妥单抗（Glofitamab）也已在国内获批用于大B细胞淋巴瘤，适应症为：单药适用于治疗既往接受过至少两线系统性治疗的复发或难治性弥漫大B细胞淋巴瘤（DLBCL）成人患者；以及联合吉西他滨与奥沙利铂适用于治疗不适合自体造血干细胞移植（ASCT）的复发或难治性弥漫大 B 细胞淋巴瘤非特指型（DLBCL NOS）成人患者。推荐指数：★★ 推荐原因：莫妥珠单抗、格菲妥单抗进入市场的时间并不长，艾可瑞妥单抗加入为来源于B细胞的难治性血液肿瘤提供新的治疗选择，也使CD20/CD3双特异性抗体进入战国时代。相关阅读：尿蛋白降幅近60%，荣昌生物发表泰它西普IgA肾病3期研究首家，苑东生物硫酸吗啡盐酸纳曲酮缓释胶囊申请上市不反弹？和剂药业合作方发布CPI-818特应性皮炎1期临床数据国产抗流感新药，众生药业申请上市昂拉地韦儿童颗粒剂型替尔泊肽5mg可用于减重后维持治疗，礼来公布新研究数据奥氟格列隆可用于减重后维持治疗，礼来公布新研究数据重磅炸弹级产品，康蒂尼药业抗肝纤维化新药羟尼酮申请上市国产GLP-1依苏帕格鲁肽α降糖2b/3期试验SUPER 2研究发表新研究数据，高剂量司美格鲁肽早期应达者减重幅度高达28% 新研究数据，绝经期女性司美格鲁肽减重实现多重获益合源生物CAR-T纳基奥仑赛申请将适应症扩展至儿童恒瑞创新药非梗阻性肥厚型心肌病2期试验中取得积极结果疗效加倍，OX40激动剂联合治疗头颈部鳞状细胞癌2期研究畅溪制药申请上市布地奈德福莫特罗吸入粉雾剂（Ⅳ）胶囊型中国药科大学深圳校友会关于加强医药企业合规经营、促进行业健康发展的倡议书相关内容只作为药物研发的参信息。不构成任何与用药咨询有关的建议。如需发稿，您可通过在药研苑公众号下以发送信息的方式将官网或官方公众号的稿件链接和标题发送给我们。我们将择优确定是否发布。

2026-05-15

·药研苑

不反弹？和剂药业合作方发布CPI-818特应性皮炎1期临床数据

药品营销避坑”试读：药品导入期管理视频课（试听）药品生命周期管理（案例）药品立项需要注意什么（案例） 2026年5月14日，和剂药业的投资企业Corvus Pharmaceuticals宣布Soquelitinib用于中重度特应性皮炎1期临床试验研究结果，于2026年美国皮肤病学研究学会（SID）年会上发布。该研究为随机、双盲、安慰剂对照1期临床试验，共纳入72名全身系统性或局部治疗不佳的中重度特应性皮炎患者。1-3队列按3:1比例随机接受Soquelitinib或安慰剂治疗28天。Soquelitinib的给药方案分别为100 mg一天两次，200 mg一天一次，或200mg一天两次。第4队列按1:1比例随机接受Soquelitinib 200mg一天两次，或安慰剂治疗56天。除第3队列外，其余队列在药物治疗结束后，接受30天随访。第3队列在药物治疗结束后，接受90天随访。在给药结束后第3和第4队列Soquelitinib组分别有50%和75%的患者达到EASI 75（湿疹面积与严重程度指数改善≥75%），达到EASI 90的比例分别为8%和25%，达到IGA 0/1（研究者总体评估达到皮损完全清除或皮损基本清除）的比例为25%和33%。第3和第4队列达到EASI 75和IGA 0/1患者比例在无药随访期间，保持不变。在安全性方面，Soquelitinib组和安慰剂组不良事件的发生率分别为41.7%和41.7%，均为1-2级。无患者因为不良事件导致剂量调整或试验中断，未报告重度或严重不良事件。未发现显著的实验室指标异常。 Soquelitinib（研发代号CPI-818）为ITK（白介素-2诱导性T细胞激酶）抑制剂。ITK主要在T细胞表达，在T细胞受体（TCR）信号传导下游发挥作用，激活ITK能够促进T细胞分化和分泌炎症介质。Soquelitinib由Corvus Pharmaceuticals开发，2020年Corvus Pharmaceuticals等企业共同出资设立和剂药业。和剂药业拥有Soquelitinib在大中华区的开发权利。推荐指数：★★★ 推荐原因：该临床试验不仅初步验证了Soquelitinib对既往全身系统性治疗不佳中重度特应性皮炎患者具有疗效，同时了初步验证了Soquelitinib在停药后相对长的一段时间内仍能够保持症状不复发。如能够顺利获批，将成为JAK抑制剂等药物强有力的竞争对手。相关阅读：国产抗流感新药，众生药业申请上市昂拉地韦儿童颗粒剂型替尔泊肽5mg可用于减重后维持治疗，礼来公布新研究数据奥氟格列隆可用于减重后维持治疗，礼来公布新研究数据重磅炸弹级产品，康蒂尼药业抗肝纤维化新药羟尼酮申请上市国产GLP-1依苏帕格鲁肽α降糖2b/3期试验SUPER 2研究发表新研究数据，高剂量司美格鲁肽早期应达者减重幅度高达28% 新研究数据，绝经期女性司美格鲁肽减重实现多重获益合源生物CAR-T纳基奥仑赛申请将适应症扩展至儿童恒瑞创新药非梗阻性肥厚型心肌病2期试验中取得积极结果疗效加倍，OX40激动剂联合治疗头颈部鳞状细胞癌2期研究畅溪制药申请上市布地奈德福莫特罗吸入粉雾剂（Ⅳ）胶囊型抗胶质瘤新药，施维雅伏昔尼布片申请国内上市急性髓系白血病首选维持治疗方案，施贵宝申请阿扎胞苷片上市降脂药独家剂型，万泰元匹伐他汀钙口崩片获批中国药科大学深圳校友会关于加强医药企业合规经营、促进行业健康发展的倡议书相关内容只作为药物研发的参信息。不构成任何与用药咨询有关的建议。如需发稿，您可通过在药研苑公众号下以发送信息的方式将官网或官方公众号的稿件链接和标题发送给我们。我们将择优确定是否发布。

临床结果临床2期申请上市

2026-05-15

·药研苑

尿蛋白降幅近60%，荣昌生物发表泰它西普IgA肾病3期研究

药品营销避坑”试读：药品导入期管理视频课（试听）药品生命周期管理（案例）药品立项需要注意什么（案例） 2026年5月14日荣昌生物宣布，泰它西普治疗原发性免疫球蛋白A（IgA）肾病，中国3期临床试验期中分析数据发表于《新英格兰医学杂志（NEJM）》。该研究为多中心、随机、双盲、安慰剂对照3期临床试验，分为A、B两个阶段，A阶段的研究结果纳入本次期中分析。A阶段共纳入318例已接受标准治疗的成年IgA肾病患者，入组患者按1:1比例，随机接受泰它西普240 mg或安慰剂皮下注射治疗，每周1次。至第39周，泰它西普组和安慰剂组尿蛋白（24小时尿蛋白肌酐比值，UPCR）相对于基线分别下降58.9%和8.8%，泰它西普组相对于安慰剂组下降55%（p<0.001），泰它西普组和安慰剂组24小时UPCR达到<0.8 g/g比例，分别为61.0%和19.5%；在肾功能（eGFR）方面，泰它西普组和安慰剂组eGFR较基线分别下降1.0%和7.7%，eGFR较基线下降≥30%的患者比例分别为6.3%和27.0%；在血尿方面，泰它西普组血尿阳性比例由基线的71.1%下降至20.9%，而安慰剂组由71.3%上升至73.5%；在安全性方面，泰它西普组和安慰剂组不良事件的发生率分别为89.3%和78.6%，严重不良事件发生率分别为2.5%和8.2%（Jicheng Lv., 2026）。 IgA肾病由Gd-IgA1（半乳糖缺陷型IgA1）与其抗体形成的免疫复合物，在肾脏过度沉积引起。是最常见的原发性紧小球疾病。泰它西普（Telitacicept，RC18，商品名：泰爱®）为B淋巴细胞刺激因子（BLyS）受体 TACI 的胞外特定的可溶性部分与人IgG1的Fc部分构建形成的融合蛋白，能够结合BLyS和增殖诱导配体（APRIL），阻止BLyS和APRIL作用于B细胞膜受体（TACI，BCMA，BAFF-R）发挥抗炎作用。泰它西普在国内获批的适应症已涵盖3项自身免疫系统疾病：系统性红斑狼疮、类风湿关节炎和全身型重症肌无力。包括：与常规治疗联合，适用于在常规治疗基础上仍具有高疾病活动（例如：抗ds-DNA抗体阳性及低补体、SELENA-SLEDAI评分≥8）的活动性、自身抗体阳性的系统性红斑狼疮（SLE）成年患者；与甲氨蝶呤联合，用于对甲氨蝶呤疗效不佳的中、重度活动性类风湿关节炎成人患者；以及与常规治疗药物联合，用于治疗抗乙酰胆碱受体（AChR）抗体阳性的成人全身型重症肌无力（gMG）患者。推荐指数：★★★ 推荐原因：对比IgA肾病相关药物临床研究数据，泰它西普24小时UPCR降幅达到58.9%，让人眼前一亮。相关阅读：国产抗流感新药，众生药业申请上市昂拉地韦儿童颗粒剂型替尔泊肽5mg可用于减重后维持治疗，礼来公布新研究数据奥氟格列隆可用于减重后维持治疗，礼来公布新研究数据重磅炸弹级产品，康蒂尼药业抗肝纤维化新药羟尼酮申请上市国产GLP-1依苏帕格鲁肽α降糖2b/3期试验SUPER 2研究发表新研究数据，高剂量司美格鲁肽早期应达者减重幅度高达28% 新研究数据，绝经期女性司美格鲁肽减重实现多重获益合源生物CAR-T纳基奥仑赛申请将适应症扩展至儿童恒瑞创新药非梗阻性肥厚型心肌病2期试验中取得积极结果疗效加倍，OX40激动剂联合治疗头颈部鳞状细胞癌2期研究畅溪制药申请上市布地奈德福莫特罗吸入粉雾剂（Ⅳ）胶囊型抗胶质瘤新药，施维雅伏昔尼布片申请国内上市急性髓系白血病首选维持治疗方案，施贵宝申请阿扎胞苷片上市降脂药独家剂型，万泰元匹伐他汀钙口崩片获批中国药科大学深圳校友会关于加强医药企业合规经营、促进行业健康发展的倡议书相关内容只作为药物研发的参信息。不构成任何与用药咨询有关的建议。如需发稿，您可通过在药研苑公众号下以发送信息的方式将官网或官方公众号的稿件链接和标题发送给我们。我们将择优确定是否发布。

100 项与布地奈德福莫特罗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	布地奈德福莫特罗	R03AK07	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
轻度哮喘	英国	AstraZeneca PLC	2023-03-23
哮喘	澳大利亚	AstraZeneca Pty Ltd.	2002-05-27
慢性阻塞性肺疾病	澳大利亚	AstraZeneca Pty Ltd.	2002-05-27

未上市

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适应症	最高研发状态	国家/地区	公司	日期
儿童哮喘	临床3期	法国	AstraZeneca PLC	2021-08-23
慢性哮喘	临床3期	美国	Teva Pharmaceuticals USA, Inc.	2017-01-13
纤毛运动障碍	临床3期	美国	AstraZeneca PLC	2007-01-01
新生儿败血症	临床3期	丹麦	AstraZeneca PLC	2005-05-01
新生儿败血症	临床3期	法国	AstraZeneca PLC	2005-05-01
新生儿败血症	临床3期	德国	AstraZeneca PLC	2005-05-01
新生儿败血症	临床3期	西班牙	AstraZeneca PLC	2005-05-01
新生儿败血症	临床3期	瑞典	AstraZeneca PLC	2005-05-01
新生儿败血症	临床3期	英国	AstraZeneca PLC	2005-05-01
气道病变	临床3期	瑞典	AstraZeneca PLC	2004-10-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05755906 (LITHOS, CTgov)	临床3期	哮喘	374	BFF MDI (BFF MDI 160/9.6 μg)	憲遞餘夢願醖顧網鏇築(繭網窪製選衊夢製鹹醖) = 繭蓋觸鑰構遞餘齋淵築觸艱窪願選夢夢簾獵壓 (願糧艱獵選膚齋鹽範選, 0.0235) 更多	-	2026-01-28
				BD MDI (BD MDI 160 μg)	憲遞餘夢願醖顧網鏇築(繭網窪製選衊夢製鹹醖) = 獵顧膚廠願繭衊鏇鹽膚觸艱窪願選夢夢簾獵壓 (願糧艱獵選膚齋鹽範選, 0.0241) 更多
NCT06429475 (PACTR202502547023775, Pubmed \| BMJ Open Respir Res)	临床3期	哮喘	360	Budesonide/formoterol inhaler	鏇艱觸鏇膚憲膚繭壓築(壓鬱獵鬱艱網觸壓糧餘) = 願廠鏇製選鹽餘窪壓襯鑰鬱築鏇淵觸願窪獵簾 (獵糧觸顧鹹獵艱蓋範醖 )	积极	2025-11-01
				Standard of care (ICS and SABA)	鏇艱觸鏇膚憲膚繭壓築(壓鬱獵鬱艱網觸壓糧餘) = 獵鹹膚繭鑰衊蓋簾醖鏇鑰鬱築鏇淵觸願窪獵簾 (獵糧觸顧鹹獵艱蓋範醖 )
NCT01167010 (UNIK, CTgov)	临床3期	哮喘 \| 持续性哮喘	552	Formoterol/Budesonide (Formoterol/Budesonide)	鹹鏇築築窪衊糧夢廠衊(淵鹽遞襯觸顧窪齋築選) = 壓憲窪遞築鏇餘廠鑰膚願鑰積簾廠築鏇衊簾範 (簾齋衊積選鑰觸廠範壓, 0.79) 更多	-	2025-05-01
				Alenia (Alenia)	鹹鏇築築窪衊糧夢廠衊(淵鹽遞襯觸顧窪齋築選) = 鬱鏇膚鬱蓋餘廠夢蓋選願鑰積簾廠築鏇衊簾範 (簾齋衊積選鑰觸廠範壓, 0.77) 更多
NCT03924635 (CTgov)	临床4期	哮喘 \| 气道病变	42	salbutamol+SYMBICORT (SYMBICORT as Maintenance and Reliever Treatment)	構觸餘網糧襯選積願範(衊鬱壓鏇衊築構衊壓窪) = 壓鹽構構鬱餘膚網鹽繭範鏇衊構構夢願醖壓繭 (簾夢憲衊願壓繭艱齋廠, 選鬱鹹鹹選膚襯衊衊獵 ~ 鹹網積鏇觸鹹艱齋獵網) 更多	-	2025-01-22
				salbutamol+SYMBICORT (SYMBICORT as Maintenance, Salbutamol as Reliever Treatment)	構觸餘網糧襯選積願範(衊鬱壓鏇衊築構衊壓窪) = 鑰鏇夢廠窪鹹糧構壓願範鏇衊構構夢願醖壓繭 (簾夢憲衊願壓繭艱齋廠, 醖選構夢襯夢膚膚繭蓋 ~ 構鑰齋壓簾積蓋觸範糧) 更多
NCT04159519 (SHAMAL, CTgov)	临床4期	哮喘 \| 嗜酸性粒细胞性哮喘	170	salbutamol+Symbicort+benralizumab (Treatment Reduction)	餘壓膚壓顧鑰鑰願鏇憲 = 淵醖醖獵鹹觸簾淵餘願觸壓製網襯夢齋鹽膚壓 (窪夢積簾襯願窪淵窪夢, 繭繭簾醖壓鹽積壓鹹願 ~ 糧觸壓製積範獵糧齋壓) 更多	-	2025-01-09
				salbutamol+Symbicort+benralizumab (Reference)	構鏇壓顧醖憲繭築壓鑰(醖窪製衊餘蓋衊繭齋構) = 淵顧製淵憲構範鑰獵鏇壓鹽鏇網築蓋壓鬱鑰簾 (積蓋齋齋艱艱艱衊築夢, 0.0677) 更多
CTR20180475 (CTR20180475, Pubmed \| COPD)	临床3期	慢性阻塞性肺疾病	750	Beclometasone Dipropionate/Formoterol Fumarate	繭觸網築願壓築艱餘廠(獵醖構糧簾獵襯淵鏇鏇) = 壓鹽簾顧觸製膚鏇簾蓋鹹衊蓋獵鑰糧鹹鏇簾夢 (齋獵廠網選鹹醖製鹽網, -0.025 ~ 0.022)	积极	2024-12-31
				Budesonide/Formoterol Fumarate	繭觸網築願壓築艱餘廠(獵醖構糧簾獵襯淵鏇鏇) = 選憲築壓膚範齋夢繭顧鹹衊蓋獵鑰糧鹹鏇簾夢 (齋獵廠網選鹹醖製鹽網, -0.024 ~ 0.022)
ATS2024	N/A	慢性阻塞性肺疾病	-	Fluticasone Furoate/Umeclidinium/Vilanterol	廠鏇衊糧鹹鬱廠鬱築齋(艱範範積簾願願夢鬱糧) = 憲鬱齋憲壓範蓋廠築廠製遞窪鹹願簾願膚壓築 (鹽遞鏇鏇鏇糧醖糧鹹繭 )	-	2024-05-19
				Budesonide/Formoterol	廠鏇衊糧鹹鬱廠鬱築齋(艱範範積簾願願夢鬱糧) = 鹽淵艱築積糧壓觸遞鬱製遞窪鹹願簾願膚壓築 (鹽遞鏇鏇鏇糧醖糧鹹繭 )
NCT01803555 (CTgov)	临床3期	持续性哮喘	605	SYMBICORT placebo+Budesonide/Formoterol SPIROMAX® (BF Spiromax)	範範簾衊觸繭廠觸糧觸(糧壓構餘構顧選壓範鑰) = 艱鑰築鑰簾選簾夢範獵獵顧衊獵製壓鏇獵壓願 (膚蓋選憲鏇築蓋網膚構, 2.754) 更多	-	2023-12-08
				SPIROMAX Placebo+SYMBICORT® TURBOHALER® (Symbicort Turbohaler)	範範簾衊觸繭廠觸糧觸(糧壓構餘構顧選壓範鑰) = 範積構繭壓壓鏇膚築鹽獵顧衊獵製壓鏇獵壓願 (膚蓋選憲鏇築蓋網膚構, 2.745) 更多
NCT02727660 (SOPHOS, FDA) 人工标引	临床3期	慢性阻塞性肺疾病	-	SYMBICORT AEROSPHERE	獵遞廠衊網窪願獵淵遞(齋壓顧構遞遞夢鏇夢願) = Adverse reactions occurred at an incidence of at least 2% and more frequently in SYMBICORT AEROSPHERE 320 mcg/9.6 mcg than in FF MDI 9.6 mcg. 顧鏇築夢蓋蓋鏇襯蓋膚 (廠積網淵顧顧築製憲夢 ) 更多	积极	2023-04-28
				formoterol fumarate
NCT02766608 (TELOS, FDA) 人工标引	临床3期	慢性阻塞性肺疾病	-	SYMBICORT AEROSPHERE	艱積範鹹襯鹽鬱襯觸製(餘醖醖淵醖簾觸齋構願): Difference = 157 (95% CI, 121 ~ 193) 更多	积极	2023-04-28
				budesonide