Efficacy Evaluation of Budesonide/Glycopyrronium Bromide/Formoterol Inhalation Aerosol in Symptomatic Preserved Ratio Impaired Spirometry (PRISm): A Single-arm Multicenter Clinical Trial

Preserved Ratio Impaired Spirometry (PRISm) is characterized by a normal forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio but an FEV1 below 80% of the predicted value. It has a population prevalence of approximately 10% and is associated with marked symptoms, a high risk of acute exacerbations, and increased mortality. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) defines PRISm as a pre-chronic obstructive pulmonary disease (COPD) state, and 20%-30% of patients with PRISm will progress to COPD. Currently, no evidence-based therapy exists for PRISm; management is mainly symptomatic relief, and there is an urgent need for evidence-based support. This single-arm clinical trial preliminarily evaluates the efficacy and safety of budesonide/glycopyrronium/formoterol inhalation aerosol in symptomatic patients with PRISm. Symptomatic smokers who meet the diagnostic criteria for PRISm and have an FEV1/FVC ratio ≥0.7 and <0.8 are enrolled and treated with budesonide/glycopyrronium/formoterol inhalation therapy for 12 weeks. The primary endpoint is the change from baseline in FEV1; secondary endpoints include symptom score (COPD Assessment Test, CAT) and quality of life (St George's Respiratory Questionnaire, SGRQ); safety is assessed by recording adverse events (e.g., cardiovascular events); and exploratory analyses examine the association between biomarkers (e.g., peripheral blood eosinophil count, serum IgE level) and treatment efficacy. The study aims to preliminarily explore the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler therapy for PRISm. Early intervention may delay the progression from PRISm to COPD, reduce the burden of chronic respiratory disease, and have important clinical translational value and public health significance.

开始日期2026-06-01

申办/合作机构

中山大学孙逸仙纪念医院

NCT06531798

/ Recruiting临床4期

Post-marketing Phase IV, Multicenter, Prospective Study to Observe the Safety and Tolerability of Breztri aerosphereTM Containing a Fixed Dose Combination of Budesonide 160 mcg/ Glycopyrronium 7.2 mcg/ Formoterol Fumarate Dehydrate 5 mcg in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

The purpose of this study is to observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD.

开始日期2026-01-30

申办/合作机构

AstraZeneca PLC

CTRI/2025/12/099667

/ Not yet recruiting临床4期

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

开始日期2026-01-22

申办/合作机构

Cipla Ltd.

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

项与布地格福相关的文献（医药）

2026-06-05·MEDICINE

Adverse event mining for Breztri and Trelegy Ellipta based on the three international pharmacovigilance databases

Article

作者: Yun, Lu ; Chen, Kexu ; Xu, Dexiang ; Wang, Junyu

This study aimed to identify adverse drug reaction (ADR) risk signals associated with budesonide/glycopyrrolate/formoterol (Breztri) and fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta) to support clinical decision-making and risk management. ADR reports related to Breztri and Trelegy Ellipta from the FDA Adverse Event Reporting System (FAERS) database, Japanese Adverse Drug Event Report (JADER) database and Canada Vigilance Adverse Reaction database (Q3 2004 to Q2 2024) were analyzed. After deduplication, reports were categorized using Medical Dictionary for Regulatory Activities (MedDRA) to obtain System Organ Class (SOC) and preferred terms (PTs). Disproportionality analysis was conducted using reporting odds ratio (ROR) and proportional reporting ratio methods. Analysis of 394 Breztri and 18,866 Trelegy Ellipta FAERS reports (predominantly consumer-submitted, U.S.-originated) identified 47 signals across 11 SOCs for Breztri (e.g., “Drug delivery system issue” ROR = 411.16, “Intentional device misuse” ROR = 410.69) and 160 signals across 15 SOCs for Trelegy (e.g., “Chronic eosinophilic rhinosinusitis” ROR = 187.65, “Foreign body in mouth” ROR = 107.67), revealing unlabeled risks like administration errors and packaging confusion. JADER data reinforced respiratory risks (Breztri: Chronic obstructive pulmonary disease (COPD) ROR = 516.8; Trelegy: gastrointestinal fungal infection ROR = 413.11) and device-independent safety signals (e.g., Trelegy urinary retention ROR = 28.81), while CVARD highlighted region-specific concerns including Trelegy-associated vasculitis (pulmonary vasculitis n = 29) and Breztri hypertension (ROR = 7.82). Cross-database convergence confirmed core anticholinergic/cardiopulmonary risks, yet divergent signals, FAERS’ device errors, JADER’s infection prominence, and CVARD’s immunological events, underscore geographic heterogeneity in adverse reaction profiles, necessitating tailored risk management strategies for inhaler therapies. Inhalation device-related ADRs were observed, with Breztri showing higher incidence than Trelegy Ellipta, likely due to its more complex device usage. These findings highlight the need for enhanced patient education by healthcare providers to ensure proper device use in COPD treatment. Although core respiratory and anticholinergic risks are globally relevant, infection profiles, device complications, and rare immunological events exhibit significant geographic heterogeneity, necessitating tailored risk mitigation strategies aligned with regional pharmacovigilance patterns.

2026-06-01·RESPIRATORY MEDICINE

Outcomes of patients with COPD before and after initiation of treatment with budesonide/glycopyrrolate/formoterol fumarate: Results from the US ARCTOS study

Article

作者: Evangelista, Christopher ; Germack, Hayley D ; Feigler, Norbert ; Gozalo, Laurence ; Spy, Amanda ; Tkacz, Joseph ; Sethi, Sanjay ; Szymanski, Keith ; Hirpara, Sunny ; McMorrow, Donna

OBJECTIVE:

To assess change in COPD exacerbations, healthcare resource utilization, and costs among patients diagnosed with COPD following initiation of budesonide/glycopyrrolate/formoterol fumarate (BGF), a single inhaler triple therapy for COPD.

METHODS:

This study was a retrospective analysis of the Inovalon MORE2 Registry and 100% Medicare Fee-for-Service claims databases between 1/1/2021-3/31/2024.

INCLUSION CRITERIA:

1) prescription claim for BGF and ≥1 refill within 60 days (earliest prescription = index date), 2) ≥12 months of health plan enrollment preceding and following the index date, 3) diagnosis of COPD, 4) age ≥40 years, 5) absence of cancer and select respiratory diseases, and 6) presence of ≥1 severe or ≥2 moderate COPD exacerbations during baseline. Subgroups were established based on treatment history, baseline blood eosinophil counts and asthma comorbidity. Outcomes included COPD exacerbations, healthcare resource utilization and costs, assessed for statistically significant differences between baseline and follow-up in the overall sample and subgroups.

RESULTS:

A total of 2204 patients were included. Following initiation of BGF, mean per patient per year (PPPY) total COPD exacerbations decreased by 28.7% (3.0 ± 1.7 to 2.1 ± 2.2; p < 0.0001), while mean severe COPD exacerbations decreased by 43.9% (0.3 ± 0.6 to 0.2 ± 0.5; p < 0.0001). PPPY COPD exacerbation-related medical costs decreased by 35.7% ($4664±$9355 to $2998±$8723; p < 0.001). Pre-defined subgroups showed similar changes in outcomes.

CONCLUSIONS:

Results demonstrate that patients with COPD and a history of exacerbations had substantial reductions in exacerbations, healthcare resource utilization, and healthcare costs after initiating BGF across a variety of subgroups including patients treated with ICS/LABA during baseline and across a range of eosinophil counts.

2026-06-01·Pulmonary Therapy

Real-World Outcomes across Baseline Risk Profiles in Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate in Spain: Insights from the ORESTES Study

Article

作者: Sánchez-Covisa, Joaquín ; Fuster Gomila, Antonia ; Khadour Khadour, Hassan ; Murga Arizabaleta, Igor ; Blanco Cid, Nagore ; Galera Martínez, Raúl ; Alcázar-Navarrete, Bernardino ; Fitas, Eunice ; Granados, Galo ; García Clemente, Marta M ; Figueira-Gonçalves, Juan Marco ; Bruguera Avila, Nuria ; Márquez-Martín, Eduardo ; Corregidor-García, Carmen ; Bernabeu Mora, Roberto ; Velasco Garrido, Jose Luis

INTRODUCTION:

Chronic obstructive pulmonary disease (COPD) is a progressive lung disorder characterized by persistent symptoms such as dyspnea and cough, as well as exacerbations. Triple therapy with budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) is recommended for patients not adequately controlled by dual therapy. Key clinical parameters guide COPD management.

METHODS:

The observational, retrospective ORESTES study included adults ≥ 40 years with COPD initiating BGF in routine practice. In this analysis, patients were grouped according to exacerbation history, airflow obstruction (forced expiratory volume in 1 s [FEV₁] % predicted), and blood eosinophil count. Exacerbations, additional COPD medications, and healthcare resource utilization (HCRU) were evaluated.

RESULTS:

Among 114 patients with only one moderate exacerbation (and no severe exacerbations) and 363 with ≥ 1 severe and/or ≥ 2 moderate exacerbations in the previous year, the proportion experiencing at least one exacerbation decreased by 43.9% and 35.0% (relative differences), respectively, after BGF initiation. Regarding airflow obstruction, reductions were 22.3% for patients with FEV₁ < 50% predicted (N = 156) and 24.0% for those with FEV₁ ≥ 50% predicted (N = 155). According to blood eosinophil count, decreases were 29.8% (< 100 cells/µL, N = 110) and 25.8% (≥ 100 cells/µL, N = 208). Across all subgroups, reductions in moderate and severe exacerbations ranged from 18.9% to 54.4% and from 10.9% to 45.5%, respectively, except for the expected increases in severe events and related hospitalizations in the group with only one prior moderate exacerbation. Use of rescue medication (including short-acting beta-2 agonists [SABA]), emergency room visits, and hospitalizations generally declined, with reductions across subgroups ranging from 7.8% to 45.5%.

CONCLUSION:

Consistent improvements were observed across all subgroups, with reductions in exacerbations, rescue medication use, and HCRU regardless of prior exacerbation history, lung function, or blood eosinophil levels. These findings suggest that BGF may lead to improvements across a broad disease spectrum, further supporting the hypothesis that earlier introduction may be beneficial.

TRIAL REGISTRATION:

NCT06321731.

297

项与布地格福相关的新闻（医药）

2026-08-06

·新药心谈

中国最大跨国药企阿斯利康与石药集团将组建新合资企业布局生物药生产

*免责声明：部分资料来自网络，仅供医药专业人士参考。任何药品相关描述，都不应理解为对任何品种的处方及诊疗推荐。®标仅展示商品名，并不代表已注册。 **凡有原创标记的文章，未经授权，谢绝转载。 2026年8月5日，阿斯利康（AstraZeneca）与石药集团（CSPC Pharmaceutical）将通过在中国设立一家全新的生物药生产合资企业，进一步深化双方的战略合作。石药集团周三在公告中表示，两家公司已签署合同，在石药总部所在地——中国石家庄，组建一家51%/49%股权的合资生产工厂。石药以51%的出资比例入股，将贡献其人工智能驱动的良好生产规范（GMP）体系，以及药物生产建设与运营能力；这些能力与阿斯利康在全球质量标准与供应链管理方面的深厚经验形成互补。石药表示，该业务初期将聚焦于"为全球市场生产双方约定的生物制剂药物原液（Drug Substance, DS）"，并补充称，两位股东将进一步探索将更多产品纳入生产组合。具体投资规模未立即披露。这笔资金很可能计入阿斯利康计划在2030年前对华总计150亿美元的投资承诺——该计划于2026年初公布。石药此次的合资举措，紧随阿斯利康一系列在华制造扩张行动之后。阿斯利康在华制造版图持续扩张今年3月：阿斯利康宣布将在上海建设商业化细胞治疗生产基地，向中国及其他亚洲市场供应自体CAR-T疗法。此前一年：这家英国制药巨头公布了25亿美元的投入计划，以加强其在北京的布局。该计划的一部分包括与百克生物（BioKangtai）组建合资企业，这将为阿斯利康带来其在华首个疫苗生产基地。青岛生产基地：通过一系列累计约8.86亿美元的投资，阿斯利康正在中国青岛建设一个生产联合体，用于生产慢性阻塞性肺疾病吸入剂Breztri Aerosphere等吸入制剂。多年研发合作的水到渠成此次制造层面的合资，建立在阿斯利康与石药多年研发合作的基础之上。 2024年：阿斯利康向这家总部位于石家庄的公司支付1亿美元首付款，获得一款用于心血管疾病的临床前口服Lp(a)抑制剂。后续合作：两家公司继而达成了一项潜在总金额53亿美元的合作协议，利用石药的AI平台发现针对多种慢性病的新型口服药物。今年早些时候：阿斯利康向石药支付12亿美元首付款，获得每月一次给药的减重产品组合的中国以外地区权益。若一切顺利，该交易总额最终可能膨胀至185亿美元。阿斯利康的中国业务基本盘 2026年上半年，阿斯利康从中国获得35亿美元收入，按固定汇率计算同比下降5%，但其仍是按销售额计在华最大的外资制药企业。就在几天前，这家英国制药巨头还达成了一项潜在15亿美元的收购协议，从迪哲医药（Dizal Pharmaceutical）手中收购FDA批准的EGFR抑制剂Zegfrovy。迪哲医药是阿斯利康于2017年通过分拆其中国创新中心而组建的合资企业。 ✦ END ✦

2026-08-06

·制药经理人

一进一退：阿斯利康牵手石药设立生物药合资企业，百时美施贵宝合并谈判宣告终止！

2026年8月5日，阿斯利康与石药集团正深化双方合作，将在中国设立一家全新生物制剂生产合资企业。石药集团于周三发布公告称，两家企业已签署协议，将在石药集团总部所在地中国石家庄成立一家股权比例 51 比 49 的合资生产基地。 CSPC, which contributes 51% of the capital, will offer its AI‑driven good manufacturing practice system, as well as drug manufacturing construction and operational capabilities, which will be combined with AstraZeneca’s experience in global quality standards and supply chain management. 出资 51% 的石药集团，将输出其人工智能驱动的 GMP 生产体系，以及制药工厂建设与运营能力；同时结合阿斯利康在全球质量标准与供应链管理方面的经验。 The business will initially focus on producing “mutually agreed biologics drug substances for the global markets,” CSPC said, adding that the two owners will further explore adding more products to the mix. 石药集团表示，该合资企业初期将聚焦生产 “双方约定的、面向全球市场的生物药原料药”，两家股东还将进一步探索扩充更多生产产品。 The exact size of investment was not immediately disclosed. The money will likely count toward the $15 billion total that AZ committed to investing in China through 2030, as part of a plan unveiled at the beginning of 2026. 本次投资具体金额暂未对外披露。该笔投资或将计入阿斯利康 2026 年初公布的计划，即到 2030 年对中国累计投入 150 亿美元的总投资当中。 The latest CSPC enterprise follows a string of manufacturing expansions by AZ in China. 本次和石药集团的合作项目，是阿斯利康在中国一系列生产布局扩张的延续。 In March, AZ announced it would build a commercial cell‑therapy manufacturing base in Shanghai to supply autologous CAR‑T therapies to China and other Asian markets. 今年 3 月，阿斯利康宣布将在上海建设商业化细胞治疗生产基地，为中国及其他亚洲市场供应自体 CAR‑T 细胞治疗产品。 A year before that, the British pharma outlined a $2.5 billion outlay to boost its presence in Beijing. Part of that initiative includes a joint venture with BioKangtai that will give AZ its first vaccine manufacturing facility in China. 在此前一年，这家英国药企公布 25 亿美元投入，扩大在北京的业务布局。该规划包含与百康泰成立合资企业，这将为阿斯利康带来其在中国的首个疫苗生产工厂。 Through a series of investments now totaling about $886 million, AZ is building a production compound in Qingdao, China, for inhalants such as chronic obstructive pulmonary disease inhaler Breztri Aerosphere. 阿斯利康通过总规模约 8.86 亿美元的多笔投资，正在中国青岛建设生产园区，用于生产慢阻肺吸入剂 Breztri Aerosphere 等吸入类制剂。 The latest manufacturing tie‑up also follows years of R&D collaborations between AZ and CSPC. In 2024, AZ paid the Shijiazhuang‑based company $100 million upfront for a preclinical oral Lp (a) inhibitor for cardiovascular disease. 本次生产领域合作，也建立在阿斯利康与石药集团多年研发合作的基础之上。2024 年，阿斯利康向这家总部位于石家庄的企业支付 1 亿美元首付款，获得一款心血管疾病临床前口服 Lp (a) 抑制剂。 The two firms followed with a potential $5.3 billion pact to use CSPC’s AI platform to discover new oral drugs for a range of chronic diseases. 双方随后达成最高价值 53 亿美元合作协议，依托石药集团人工智能平台，针对多种慢性疾病开发全新口服药物。 Earlier this year, AZ handed CSPC $1.2 billion in upfront cash for the ex‑China rights to a portfolio of once‑monthly weight loss programs. The deal value could eventually swell to $18.5 billion if everything pans out. 今年早些时候，阿斯利康向石药集团支付 12 亿美元首付款，拿下多款每月一次减重疗法的中国境外权益；若全部里程碑达成，这笔交易总价值最高可达 185 亿美元。 With $3.5 billion in revenue from China in the first half of 2026, AZ remains the largest foreign pharma in the country by sales, even though the number represents a 5% decline in constant currencies. 2026 年上半年阿斯利康中国区营收 35 亿美元，按固定汇率计算同比下滑 5%，但依旧是中国市场营收规模最大的外资药企。 Just a few days ago, the British pharma struck a potential $1.5 billion deal to acquire the FDA‑approved EGFR inhibitor Zegfrovy from Dizal Pharmaceutical, a joint venture that AZ formed in 2017 by spinning out its China innovation center. 就在数日之前，这家英国药企达成最高 15 亿美元交易，从迪哲医药收购已经获得 FDA 批准的 EGFR 抑制剂 Zegfrovy；迪哲医药是阿斯利康 2017 年分拆中国创新中心设立的合资公司。阿斯利康与百时美施贵宝合并谈判已终止英国《金融时报》率先披露，阿斯利康与百时美施贵宝开展早期合并磋商，若交易落地，将诞生总规模近 4000 亿美元的全球制药巨头。后续媒体报道传出双方谈判已经破裂。 According to people familiar with the matter, AstraZeneca has held early‑stage merger discussions with Bristol Myers Squibb that would create one of the world’s largest pharmaceutical groups with a combined value of nearly $400bn. 据知情人士透露，阿斯利康已与百时美施贵宝开展早期合并谈判，若达成交易，将组建总价值接近 4000 亿美元的全球大型制药集团之一。 The two sides have now walked away from those discussions, according to media reports. 据媒体报道，双方现已终止相关谈判。 Neither company has issued formal statements confirming or denying the merger talks. 两家企业均未发布正式声明证实或否认本次合并谈判。 Sources later told Reuters that there were no active merger discussions between AstraZeneca and Bristol Myers Squibb. 后续消息人士向路透社表示，阿斯利康与百时美施贵宝之间不存在正在推进的合并磋商。 The potential all‑share or partially cash transaction would have ranked among the largest deals ever in the global healthcare sector. 这笔潜在的全股票或部分现金交易，原本有望跻身全球医疗行业有史以来规模最大的交易行列。 News of the talks and their collapse triggered share price swings for both drugmakers. 谈判启动以及谈判破裂的消息，引发两家制药企业股价出现波动。 Investors had raised concerns over deal valuation, product‑pipeline integration and potential regulatory hurdles for such a large‑scale combination. 投资者此前对该笔大规模并购的交易估值、产品管线整合以及潜在监管障碍表达了担忧。

细胞疗法疫苗免疫疗法引进/卖出

2026-08-02

·空之客

【医苑观畴】2026年二季度海外药企进展更新：阿斯利康AZN

1 整体表现 AZN结束了五年多的业绩单调增长态势，于是市值也首度出现大幅回撤，从$300b多掉回$250b左右。边际增速持续回落，本季度收入同比增长仅5%、EPS同比甚至开始下滑；其中，心血管板块和中国市场都在持续下滑，全不复前些年各个维度都齐头并进之势。全年指引基本维持不变，收入同比增长预计5-10%、核心业务EPS同比增长预计10-15%，也就意味着下半年要在利润端更多发力。 2 已上市产品 AZN在Osimertinib翻身之后，过去的十年里确实呈现出多核驱动齐头并进的理想态势，然而随着这一批重磅品种陆续进入生命周期的末期，整体业绩增速一下子就降下来了，Dapagliflozin率先进入专利悬崖，让人不由得担心会不会成为第一张倒下的多米诺骨牌。 AZN作为新一代肿瘤一哥，似乎也有步ROG后尘的趋势，多个肿瘤板块的重磅品种近期开始出现触顶迹象：Osimertinib在LAURA、FLAURA、ADAURA、FLAURA2等系列试验支持下占住了EGFRm NSCLC各线的中坚地位后，单季基本上止步于$1.9b；Durvalumab还在继续发挥余热，近期基于MATTERHORN试验结果，联用FLOT化疗的胃癌围手术期治疗陆续在美欧获批，单季已经超过$1.8b；Acalabrutinib还在勉力维持1L CLL的领跑地位，单季突破$1b大关，拭目以待这个季度与泽布替尼的差距是否会继续扩大；Enhertu在去年底获批的DESTINY-Breast09加持下，再次突破瓶颈，单季涨到$1.4b；Capivasertib好像爬到单季$200m多就有点乏力，而Dato-DXd还远没成气候。心血管板块的形势随着唯一大腿Dapagliflozin的专利悬崖到来而急转直下，峰值$8b多的大坑短期根本找不到填上的办法。公司将全村的希望寄托在刚刚获批的Baxdrostat，也反复重申了峰值至少$5b的预期，但毕竟远水不解近渴。吸入板块确实相对乏力，老品种Symbicort和Pulmicort停滞下滑，Breztri单季也就刚爬到$350m、看看哮喘适应症获批的后劲如何，Airsupra则还难堪大任。自免板块还没有那么闪耀的超重磅品种：IL5单抗Benralizumab依靠EGPA适应症的持续放量，单季也就在$500m多、LTM累计$2.1b；TSLP单抗Tezepelumab上市第四年，即使有CRwNP获批的加持，单季刚快到$400m、LTM累计超过$1.3b。在gMG和PNH等适应症竞争日趋激烈以及Part D铁拳打击下，C5 franchise实在难有作为，Ravulizumab+Eculizumab只能维持在单季$1.7b、LTM累计$6.7b，距离当初收购Alexion的$39b对价实在渐行渐远；TTR ASO产品Eplontersen目前单季还不到$100m，要命的事ATTR-CM三期还挂了…… 3 在研管线本号的老读者们应该了解，笔者曾长期倾心于AZN的战略清洗稳健和执行井然有序，然而在以AZD-9291和DS-8201为代表的这波神之一手之后，好像有点失去了灵性，后续管线肉眼可见地爆发力弱了好几档，总给人凋零之感。在肿瘤I/O+ADC主线叙事里，手头几乎没有硬资产，CLDN18.2总也只能覆盖个边缘瘤种，什么PD1/TIGIT和PD1/CTLA4更是遗老遗少感满满；在心血管代谢方向，小分子GLP1和PCSK9只能说勉强在线、未必成得了支柱，ASI是为数不多可能打开局面的资产；在自免方向，CD19 TCE和BCMA/CD19 Fast CAR-T个人依然没看出多高的确定性，反而IL33在同行衬托下有脱颖而出之势（虽然从一季报到二季报悄悄从$3-5b给挪到了>$5b档）。近期最大的里程碑事件自然是醛固酮合成酶抑制剂Baxdrostat获得FDA批准治疗顽固或难治性高血压，在BaxHTN和Bax24两个三期临床中，针对接受3-4种基础降压药的难治患者，坐姿SBP和24h动态SBP分别能相对降低9.8mmHg和14.0mmHg，应该说是高血压领域多年难得一见的惊艳结果（与之相比隔壁AGT RNAi可略低一头）。 CVM板块另一个期待已久的临床读出，来自与诚益合作的小分子GLP1药物Elecoglipron。在针对non-T2D受试者的二期临床VISTA试验中，最高剂量75mg组（每周剂量滴定）与安慰剂相比，26周的减重幅度为10.5% vs 0.6%，36周的减重幅度为11.8% vs 0.3%，因AE停药比例也还有6%，与Orforglipron并未拉开显著差距；在针对T2D受试者的二期临床SOLSTICE试验中，最高剂量75mg组（每两周剂量滴定）与安慰剂相比，26周减重幅度为7.7% vs 1.7%，因AE停药比例高达11%，同样并没有与口服Semaglutide拉开差距。然而另一个心血管板块长期被寄予厚望的临床则是大翻车了，Eplontersen在治疗ATTR-CM的三期临床CARDIO-TTRansform试验中未能达到主要终点，虽然也不知道为啥隔壁ALNY只因为miss了两个点的增长预期就跌成那样。肿瘤板块也有重要进展，从康诺亚引进的CLDN18.2 ADC管线Sone-Ve在治疗CLDN18.2表达量超过25%的胃癌患者的三期临床中，在3L+和2L+患者中达到OS终点的显著性，但在2L+患者中未达到PFS终点的显著性。另一款与中国公司合作的肿瘤药物舒沃替尼，在已经中美获批2L EGFR Exon20ins NSCLC且在1L适应症读出积极三期临床结果（这个试验代号WU-KONG28真酷）后，AZN决定以$600m upfront + $900m milestone从其中国子公司迪哲迎回舒沃替尼的全球权利。肿瘤资产里还有一项重要进展，Dato-DXd凭借去年ESMO上公布的三期临床TROPION-Breast02试验结果，成为首个FDA批准用于治疗1L TNBC的TROP2 ADC。自免板块最受关注的仍是C5单抗Ravulizumab公布了治疗IgAN的三期临床I-CAN试验的中期分析具体结果，治疗组与安慰剂组相比，给药34周后的24h UPCR降幅为46.6% vs 5.6%，并据此结果申报了该适应症的sBLA。此外，Ravulizumab在青少年gMG的三期临床也达到主要终点，但在干细胞移植后的血栓性微血管病的三期临床中未达到主要终点。除此以外，还值得关注的进展包括：Benralizumab获批HES嗜酸性粒细胞增多综合征，STEAP2 TCE进入临床二期，225Ac-PSMA核药进入临床二期；有趣的是，基于曾经听起来非常合理的EGFR/cMET双抗组合的ADC和核药管线同时被终止。阿斯利康AZN往期季报分析：【医苑观畴】主流技术方向谁说了算：2022年上半年全球大药企核心产品管线进展总览【医苑观畴】主流技术方向谁说了算：2022年下半年全球大药企核心产品管线进展总览【医苑观畴】2023年上半年全球大药企核心进展总览【医苑观畴】2024年一季度海外药企进展更新：阿斯利康AZN 【医苑观畴】2024年二季度海外药企进展更新：阿斯利康AZN 【医苑观畴】2025年一季度海外药企进展更新：阿斯利康AZN 【医苑观畴】2025年二季度海外药企进展更新：阿斯利康AZN 【医苑观畴】2026年一季度海外药企进展更新：阿斯利康AZN

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
-	-	R03AL11	-

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
哮喘	韩国	AstraZeneca Korea Co. Ltd.	2021-11-09
慢性支气管炎	日本	AstraZeneca KK	2019-06-18
慢性阻塞性肺疾病	日本	AstraZeneca KK	2019-06-18
肺气肿	日本	AstraZeneca KK	2019-06-18

未上市

10 条进展最快的记录,

后查看更多信息

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	阿斯利康投资（中国）有限公司	2015-08-20
中度慢性阻塞性肺疾病	临床3期	美国	AstraZeneca Dunkerque Production SCS	2015-08-20
中度慢性阻塞性肺疾病	临床3期	美国	Pearl Therapeutics, Inc.	2015-08-20
中度慢性阻塞性肺疾病	临床3期	日本	Pearl Therapeutics, Inc.	2015-08-20
中度慢性阻塞性肺疾病	临床3期	日本	阿斯利康投资（中国）有限公司	2015-08-20
中度慢性阻塞性肺疾病	临床3期	日本	AstraZeneca Dunkerque Production SCS	2015-08-20
中度慢性阻塞性肺疾病	临床3期	加拿大	阿斯利康投资（中国）有限公司	2015-08-20
中度慢性阻塞性肺疾病	临床3期	加拿大	Pearl Therapeutics, Inc.	2015-08-20
中度慢性阻塞性肺疾病	临床3期	加拿大	AstraZeneca Dunkerque Production SCS	2015-08-20
严重慢性阻塞性肺疾病	临床3期	美国	AstraZeneca Dunkerque Production SCS	2015-08-20

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04609904 (LOGOS, CTgov)	临床3期	哮喘	2,187	BGF (BGF MDI 320/14.4/9.6 μg BID)	鏇膚鑰艱蓋壓顧製夢齋(餘餘鑰觸壓醖壓襯鹹淵) = 淵範製襯遞鏇艱鏇鹽蓋鏇齋遞餘觸衊鏇觸鹹醖 (淵觸鑰夢憲積繭願鏇窪, 0.019) 更多	-	2026-07-02
				BGF (BGF MDI 320/28.8/9.6 μg BID)	鏇膚鑰艱蓋壓顧製夢齋(餘餘鑰觸壓醖壓襯鹹淵) = 遞衊糧醖選餘餘鑰夢顧鏇齋遞餘觸衊鏇觸鹹醖 (淵觸鑰夢憲積繭願鏇窪, 0.015) 更多
NCT04609878 (KALOS, CTgov)	临床3期	哮喘	2,274	BGF (BGF MDI 320/14.4/9.6 μg BID)	簾糧衊淵壓網製蓋顧簾(夢鬱積鹽壓積鑰積願鹽) = 膚鹹窪遞淵製網繭鏇廠鏇築築壓範壓齋鹹淵壓 (鹽網築憲構壓鑰衊窪壓, 0.018) 更多	-	2026-06-30
				BGF (BGF MDI 320/28.8/9.6 μg BID)	簾糧衊淵壓網製蓋顧簾(夢鬱積鹽壓積鑰積願鹽) = 製簾膚鹹網簾獵構簾齋鏇築築壓範壓齋鹹淵壓 (鹽網築憲構壓鑰衊窪壓, 0.014) 更多
NCT04609878 \| NCT04609904 (KALOS, Pubmed \| Lancet Respir Med)	临床3期	哮喘	8,820	Budesonide-glycopyrronium-formoterol fumarate dihydrate 320 µg, 28.8 µg, 10 µg	鹹網艱醖廠鑰糧構鹹齋(獵衊糧糧簾壓製鬱廠鹹) = 衊齋憲衊艱鹽願遞築鹽網簾糧憲衊壓餘積淵糧 (鬱醖憲壓繭繭網鏇廠蓋 )	积极	2026-04-01
				Budesonide-glycopyrronium-formoterol fumarate dihydrate 320 µg, 14.4 µg, 10 µg	鹹網艱醖廠鑰糧構鹹齋(獵衊糧糧簾壓製鬱廠鹹) = 壓製積襯觸鑰顧鬱糧製網簾糧憲衊壓餘積淵糧 (鬱醖憲壓繭繭網鏇廠蓋 )
KALOS (AAAAI2026)	临床3期	哮喘	4,311	Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF) 320/36/9.6	醖鑰構鹹憲餘鹽願築鑰(壓顧艱積網憲鏇製窪鹹) = 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)]). 鬱築襯範廠憲鑰淵鹽蓋 (獵製觸鏇獵廠鑰窪醖蓋 ) 更多	积极	2026-02-27
				Symbicort (BUD/FORM) 320/9
NCT05573464 (CTgov)	临床3期	慢性阻塞性肺疾病	559	BGF MDI HFA 320/14.4/9.6 μg	鑰窪鹹鹹鏇獵鏇齋窪獵 = 襯艱憲鹽醖鏇鬱製餘觸鑰築簾網廠鹽顧願製窪 (製製壓遞觸廠壓鹽繭夢, 簾網襯夢選齋鹽襯簾窪 ~ 鹽壓衊鹹鬱壓襯齋簾窪) 更多	-	2025-09-19
NCT05477108 (CTgov)	临床1期	慢性阻塞性肺疾病	108	BGF (Treatment A)	鏇壓鹹鹽鬱鹹鹽築齋齋(獵憲膚築衊獵遞鹹範築) = 醖鹽壓願壓夢蓋窪廠餘願糧構憲壓製夢醖艱遞 (簾淵鏇構憲範網繭窪築, 61.09) 更多	-	2025-05-28
				BGF (Treatment B (Replicate 1))	鏇壓鹹鹽鬱鹹鹽築齋齋(獵憲膚築衊獵遞鹹範築) = 蓋餘範範築淵構獵積觸願糧構憲壓製夢醖艱遞 (簾淵鏇構憲範網繭窪築, 63.42) 更多
MITOS EROS+CP (US) Study (ATS2025)	N/A	哮喘-慢性阻塞性肺疾病重叠综合征	8,837	Prompt initiation of Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)	憲淵憲糧願網膚壓積餘(構壓夢醖顧艱齋醖窪簾) = 鹹餘顧網夢觸鏇範構範獵構蓋顧醖網餘繭淵淵 (簾繭齋餘願襯鹹願蓋遞, 1.30 ~ 1.45)	积极	2025-05-16
				Delayed initiation of Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)	憲淵憲糧願網膚壓積餘(構壓夢醖顧艱齋醖窪簾) = 築艱窪鏇鏇廠糧鹹夢鑰獵構蓋顧醖網餘繭淵淵 (簾繭齋餘願襯鹹願蓋遞, 1.85 ~ 1.94)
NCT04609878 (KALOS, Company_Website) 人工标引	临床3期	哮喘	-	Breztri Aerosphere	淵積壓壓齋築積顧獵願(顧鑰遞衊選鹹糧壓廠窪) = met all primary endpoints 壓鹹廠壓艱膚餘窪遞餘 (簾齋繭鏇鹽憲鹽窪鬱簾 ) 达到	积极	2025-05-02
				Budesonide and formoterol fumarate
NCT04609904 (LOGOS, Company_Website) 人工标引	临床3期	哮喘	-	Breztri Aerosphere	蓋醖糧選獵鑰夢鬱選製(鏇鏇構網憲鬱築膚網繭) = met all primary endpoints 憲淵願憲觸餘衊鑰醖蓋 (餘壓願鬱壓願襯糧壓襯 ) 达到	积极	2025-05-02
				Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg
NCT05569421 (CTgov)	临床1期	慢性阻塞性肺疾病	108	BAB+BGF (Treatment A)	願餘簾膚憲夢鏇壓衊窪(壓衊獵製糧範糧顧憲範) = 網壓觸襯築艱廠鹽觸築願選繭網願膚築鏇製遞 (繭艱鏇壓築齋膚廠憲獵, 46.71) 更多	-	2025-04-29
				BAB+BGF (Treatment B (Replicate 1))	願餘簾膚憲夢鏇壓衊窪(壓衊獵製糧範糧顧憲範) = 構艱壓鑰選顧構獵顧簾願選繭網願膚築鏇製遞 (繭艱鏇壓築齋膚廠憲獵, 40.78) 更多