三苯乙酸维兰特罗(Vilanterol Trifenatate) - 药物靶点：β2-adrenergic receptor_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Vilanterol、Vilanterol trifenatate (JAN/USAN)、GSK-642444

+ [8]

靶点

β2-adrenergic receptor

作用方式

激动剂

作用机制

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

治疗领域

免疫系统疾病感染心血管疾病+ [2]

在研适应症-

非在研适应症

气道病变过敏性哮喘哮喘+ [5]

原研机构

GSK Plc

在研机构-

非在研机构

GSK PlcGlaxoSmithKline Research & Development Ltd.

权益机构

GSK Plc

Theravance Biopharma, Inc.

最高研发阶段终止临床3期

首次获批日期-

最高研发阶段(中国)无进展

特殊审评-

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结构/序列

分子式C44H49Cl2NO7

InChIKeyKLOLZALDXGTNQE-JIDHJSLPSA-N

CAS号503070-58-4

关联

115

项与三苯乙酸维兰特罗相关的临床试验

CTRI/2025/12/098826

/ Not yet recruiting临床4期

A prospective, open label, single-arm, multicentre, phase IV clinical trial to assess efficacy and safety of Vilanterol,Glycopyrronium and Fluticasone furoate powder for Inhalation in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) - NIL

开始日期2025-12-20

申办/合作机构

Zydus Healthcare Ltd.

CTRI/2025/04/085135

/ Not yet recruiting临床4期

A prospective, open label, single-arm, multicentre, active post-marketing surveillance study to assess safety and effectiveness of Vilanterol 25 mcg and Fluticasone Furoate 200 mcg powder for inhalation in patients with asthma. - NIL

开始日期2025-05-01

申办/合作机构

Zydus Healthcare Ltd.

CTRI/2025/02/080495

/ Recruiting临床3期

A prospective, randomized, double-blind, parallel, active-controlled, multicentre, phase III clinical trial to assess the efficacy and safety of Vilanterol, Umeclidinium and Fluticasone furoate inhalation as compared to Vilanterol and Fluticasone furoate inhalation in patients with uncontrolled asthma. - NIL

开始日期2025-02-24

申办/合作机构

Zydus Healthcare Ltd.

100 项与三苯乙酸维兰特罗相关的临床结果

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100 项与三苯乙酸维兰特罗相关的转化医学

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100 项与三苯乙酸维兰特罗相关的专利（医药）

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665

项与三苯乙酸维兰特罗相关的文献（医药）

2026-05-01·Respiratory Investigation

Adherence to single-inhaler triple therapies in middle-aged patients with chronic obstructive pulmonary disease: A group-based trajectory analysis

Article

作者: Miyamoto, Atsushi ; Yoshida, Satomi ; Fukasawa, Toshiki ; Kawakami, Koji ; Watanabe, Tetsuya ; Asai, Kazuhisa ; Hirai, Kaho ; Liu, Hao ; Akaike, Takenori

BACKGROUND:

Middle-aged patients with chronic obstructive pulmonary disease (COPD) initiating single-inhaler triple therapy (SITT) exhibit heterogeneous adherence trajectories. To clarify differences in the timing of adherence decline and identify patients at risk of poor adherence, we conducted a descriptive study to classify these patterns.

METHODS:

We identified COPD patients aged 40 to 64 years who initiated fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) or budesonide/glycopyrronium/formoterol (BUD/GLY/FOR) using a Japanese claims database. Group-based trajectory modeling was used to analyze the monthly proportion of days covered over time, with groups classified by similar 360-day adherence trajectories.

RESULTS:

1075 patients were included in the analysis for FF/UMEC/VI and 638 patients for BUD/GLY/FOR. Five adherence groups were identified among patients initiating FF/UMEC/VI: (1) a consistently high group (25.2%), (2) a gradually declining group (12.2%), (3) a rapidly declining adherence group (12.3%), (4) an early-decline/partial-recovery group (6.4%), and (5) an immediately declining group (43.9%). Similarly, five adherence groups were also seen among BUD/GLY/FOR initiators: (1) a consistently high group (17.1%), (2) a gradually declining group (5.0%), (3) a rapidly declining group (12.7%), (4) a moderately stable group (12.9%), and (5) an immediately declining group (52.4%). In both cohorts, higher adherence groups tended to be older and have more comorbidities, while suboptimal adherence groups were more often female, had fewer prior treatments, and began SITT in clinics.

CONCLUSIONS:

We identified distinct adherence patterns among middle-aged COPD patients initiating treatment with FF/UMEC/VI or BUD/GLY/FOR. Understanding the characteristics of these patterns may enable more targeted interventions to improve adherence and patient outcomes.

2026-04-03·Expert Review of Respiratory Medicine

Is dual bronchodilation a cost-effective alternative to ICS/LABA in COPD? A Colombian healthcare system evaluation

Article

作者: Patiño, Diana Guerrero ; Buendía, Jefferson Antonio

BACKGROUND:

Chronic obstructive pulmonary disease (COPD) is a major public health challenge in Colombia, particularly among older adults. Although ICS/LABA combinations like fluticasone/salmeterol (FSC) are widely used, dual bronchodilation with umeclidinium/vilanterol (UMEC/VI) may offer clinical and economic advantages.The objective of this paper is to evaluate the long-term cost-effectiveness of UMEC/VI versus FSC in patients with moderate to severe COPD from the perspective of the Colombian healthcare system.

METHODS:

A Markov model with four health states (moderate, severe, very severe COPD, and death) simulated the disease course over a lifetime horizon. Clinical efficacy and utilities were derived from randomized trials and meta-analyses; costs were sourced from national databases. Deterministic and probabilistic sensitivity analyses assessed uncertainty. The economic advantage of UMEC/VI was primarily driven by its ability to reduce moderate and severe exacerbations, which represent nearly 88% of total COPD-related healthcare costs in Colombia.

RESULTS:

UMEC/VI yielded 8.74 additional QALYs compared to FSC, with an incremental cost of $7,039 USD, resulting in an ICER of $805 per QALY-well below Colombia's WTP threshold of $5,180. Sensitivity analyses confirmed model robustness; UMEC/VI remained cost-effective in 64% of simulations.

CONCLUSION:

UMEC/VI is a highly cost-effective alternative to FSC for moderate to severe COPD in Colombia, offering improved clinical outcomes and economic value for resource-constrained health systems.

2026-04-01·Clinical Respiratory Journal

Temporal and Partial Reversal of Airflow Limitation in Patients With COPD Treated With Single‐Inhaler Long‐Acting Dual Bronchodilators

Article

作者: Han, Junjie ; Tian, Hao ; Chen, Cuicui ; Xue, Liping ; Guo, Yunxin ; Song, Yuanlin ; Lu, Yimeng ; Zhou, Yanan ; Jiang, Weipeng ; Wang, Linlin ; Yang, Yanping

ABSTRACT:

Introduction:

Chronic obstructive pulmonary disease (COPD) is characterized by irreversible airflow limitation. While single‐inhaler long‐acting dual bronchodilators (LADBs) effectively relieve symptoms and improve lung function, their long‐term impact on spirometry outcomes and the potential for meaningful changes in key diagnostic indices in a real‐world setting remain underexplored.

Methods:

This was a single‐country (China), single‐center, retrospective, noninterventional, real‐world study that included 182 patients treated with LADBs (indacaterol/glycopyrronium [IND/GLY] or umeclidinium/vilanterol [UMEC/VI]). The primary outcomes were changes in trough FEV1 and FEV1/FVC from baseline. Secondary outcomes were changes in other spirometry parameters. An exploratory post hoc analysis explored the reversal of FEV1/FVC, defined as a posttreatment trough FEV1/FVC ratio that exceeded 70%.

Results:

Single‐inhaler LADB therapy significantly improved lung function, including FEV1, FVC, FEV1/FVC, RV, and parameters of small airway function. The least‐square mean change in trough FEV1 and FEV1/FVC post‐treatment was 0.154 L [95% CI: 0.09, 0.218] and 1.929% [95% CI: 0.694, 3.164], respectively, at 24 weeks. Posttreatment FEV1 exhibited a characteristic pattern: an initial increase, followed by a peak, a subsequent slight decline, and eventual stabilization. Patients with lower GOLD grades experienced greater improvement in key spirometry parameters. Notably, 21 patients (11.5%) achieved a reversal of the FEV1/FVC ratio to over 70%. Exploratory logistic regression showed that a better baseline lung function, especially FEV1/FVC ratio, was associated with an increased likelihood of achieving this threshold (OR = 1.52 [95% CI: 1.29, 1.89]).

Conclusion:

This study demonstrated significant and sustained improvements in lung function in this real‐world cohort of COPD patients managed with LABA/LAMA monotherapy. A subset of patients achieved a posttreatment FEV1/FVC ratio above 70%, indicating a potentially meaningful change in airflow limitation after LADB therapy.

75

项与三苯乙酸维兰特罗相关的新闻（医药）

2026-05-11

·BioSpace

Transpire Bio’s ANDA for Generic High-Strength Trelegy® Ellipta® Accepted for Filing by the U.S. FDA

SUNRISE, Fla. , May 11, 2026 /PRNewswire/ -- Transpire Bio Inc., an integrated clinical-stage biopharmaceutical company developing inhaled therapeutics for pulmonary and systemic diseases, today announces that its abbreviated new drug application (ANDA) for fluticasone furoate, umeclidinium, and vilanterol inhalation powder, a generic version of the high-strength Trelegy ® Ellipta ®1 (200 mcg/62.5 mcg/25 mcg) product, has been accepted for filing by the U.S. Food and Drug Administration (FDA). Based on the FDA's public records, 2 Transpire Bio believes that it was the first company to ANDA for the high-strength product with a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Should Transpire Bio's ANDA be approved by the FDA, Transpire Bio believes it will be eligible for 180 days of market exclusivity. In the U.S., Trelegy ® Ellipta ® is indicated for the maintenance treatment of asthma in patients 18 years and older and the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). According to IQVIA, Trelegy ® Ellipta ® reported U.S. annual sales of $8 Billion in 2025. 3 "The FDA's acceptance of our ANDA filing for the substitutable generic version of high-strength Trelegy ® Ellipta ® is another major milestone in advancing our development program and our complex generic franchise as a whole," said Dr. Xian-Ming Zeng, Chief Executive Officer of Transpire Bio. "Our highly experienced team in South Florida continues to meet and exceed each challenge put in front of them. With our first two ANDAs for generic Breo ® and Trelegy ® now confirmed as first-to-file, and this ANDA as our potentially third first-to-file, we move one step closer to providing patients suffering from asthma or COPD with an affordable option and improved access to this critical medication." "This milestone demonstrates Transpire Bio's strong capabilities in developing complex drug device combination products. We are extremely proud of the deep scientific and technical competence of our Transpire Bio team to constantly execute against our strategic plan," said Dr. Abhishek Gupta, Chief Scientific Officer of Transpire Bio. In addition to its focused complex generic franchise, Transpire Bio is building a pipeline of innovative inhalation medicines for Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF), with three assets in development. Transpire Bio is also developing therapies for Pulmonary Arterial Hypertension (PAH), Diabetes, Obesity, Parkinson's Disease Psychosis, and Glioblastoma. These products are being developed and manufactured in Transpire Bio's state-of-the-art manufacturing facilities located in South Florida, U.S. Trelegy ® Ellipta ® is a registered trademark of the GSK group of companies. FDA’s “Paragraph IV” patent certification list IQVIA NPA (US SMART Edition). Data on file. About Transpire Bio Inc. Transpire Bio Inc. is an integrated US-based, clinical-stage biopharmaceutical company headquartered in Sunrise, Florida. Transpire Bio is innovating by applying its deep inhalation drug formulation and delivery expertise to respiratory and systemic diseases where currently available options are significantly lacking. Transpire Bio has developed multiple proprietary inhalation technology platforms, including dry-powder inhalers and soft-mist inhalers, and is progressing a pipeline of innovative inhalation medicines for Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis (PPF), Pulmonary Arterial Hypertension (PAH), Diabetes, Obesity, Parkinson's Disease Psychosis, and Glioblastoma. For more information, please visit . View original content to download multimedia: SOURCE Transpire Bio

2026-02-25

·drugs

Umeclidinium-Vilanterol Tied to Better Outcomes Than Other LAMA-LABA Inhalers in Symptomatic COPD

WEDNESDAY, Feb. 25, 2026 -- Umeclidinium-vilanterol is associated with improved clinical outcomes compared with glycopyrrolate-formoterol and tiotropium-olodaterol in symptomatic patients with chronic obstructive pulmonary disease (COPD), according to a study published online Feb. 23 in JAMA Internal Medicine . Gerard T. Portela, Ph.D., from Brigham and Women’s Hospital in Boston, and colleagues evaluated the comparative effectiveness and safety of once-daily umeclidinium-vilanterol dry powder inhalers, twice-daily glycopyrrolate-formoterol metered-dosed inhalers, and once-daily tiotropium-olodaterol soft mist inhalers. The analysis included claims data from 55,817 matched pairs (aged 40 years and older) newly treated with long-acting muscarinic antagonist–long-acting β 2 -agonist (LAMA-LABA) inhalers and continuously enrolled in a large commercial health insurance or Medicare Advantage plan during a 183-day baseline period. The researchers found that umeclidinium-vilanterol was associated with a lower risk for a first moderate or severe COPD exacerbation versus glycopyrrolate-formoterol (hazard ratio [HR], 0.86; 95 percent confidence interval, 0.81 to 0.91; number needed to treat [NNT], 17). Umeclidinium-vilanterol also was associated with a lower risk compared with tiotropium-olodaterol (HR, 0.97; 95 percent confidence interval, 0.94 to 0.99; NNT, 100). Compared with glycopyrrolate-formoterol, tiotropium-olodaterol tended to be associated with a lower risk for a first moderate or severe COPD exacerbation (HR, 0.94; 95 percent confidence interval, 0.89 to 1.00). Across all three groups, the risks for first major adverse cardiovascular event, urinary tract infection, and pneumonia hospitalization were similar. "Patients, prescribers, and health systems may consider once-daily umeclidinium-vilanterol dry powder inhalers over alternatives among new users of LAMA-LABA therapy," the authors write. Several authors disclosed ties to the pharmaceutical industry. Abstract/Full Text (subscription or payment may be required)

临床结果

2026-02-24

·drugs

Dry Powder Inhalers: A Double Win for COPD and Environment

TUESDAY, Feb. 24, 2026 — Dry powder inhalers might provide a double benefit for people battling chronic obstructive pulmonary disease (COPD), a new study says. These inhalers not only lead to slightly better lung health among COPD patients, but also are less harmful to the environment, researchers reported Feb. 23 in JAMA Internal Medicine . The most commonly prescribed dry powder inhaler for COPD outperformed the most common metered-dose inhaler, researchers found. Metered-dose inhalers rely on propellants to deliver drugs to the lungs — potent greenhouse gases that contribute to climate change, researchers noted. “The inhalers we studied are the first line treatment for many patients with COPD, so it’s reassuring to see evidence that lower-emission inhalers may also be associated with slightly better clinical outcomes,” said senior researcher Dr. William Feldman , a pulmonologist and health services researcher at UCLA Health. “These findings highlight the opportunity to reduce health care-related emissions while potentially improving patient care,” he said in a news release. For the new study, researchers compared nearly 9,500 COPD patients using a dry powder inhaler against the same number using a metered-dose inhaler. Patients using a dry powder inhaler must breathe in their medicine, rather than having it pushed into the lungs by an aerosol spray. Results showed that a dry powder inhaler loaded with umeclidinium and vilanterol produced a 14% lower risk of moderate or severe COPD flare-ups, compared to a metered-dose inhaler loaded with glycopyrrolate and formoterol . A soft mist inhaler loaded with tiotropium and olodaterol also did slightly better, lowering flare-up risk by 6% compared to a metered-dose inhaler among nearly 9,600 matched pairs. Soft mist inhalers also don’t rely on propellants. “This combination makes a strong case for using the dry powder inhaler when possible,” Feldman said. “Although some patients may require metered-dose inhalers, dry powder inhalers and soft mist inhalers are a safe and effective option for most patients with COPD.” Sources UCLA, news release, Feb. 23, 2026

临床结果

100 项与三苯乙酸维兰特罗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09697	三苯乙酸维兰特罗	-	DB09082

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
慢性支气管炎	临床3期	捷克	GlaxoSmithKline Research & Development Ltd.	2012-05-31
心血管疾病	临床3期	捷克	GlaxoSmithKline Research & Development Ltd.	2012-05-31
僵硬	临床3期	美国	GSK Plc	2011-03-04
僵硬	临床3期	德国	GSK Plc	2011-03-04
僵硬	临床3期	挪威	GSK Plc	2011-03-04
僵硬	临床3期	菲律宾	GSK Plc	2011-03-04
僵硬	临床3期	韩国	GSK Plc	2011-03-04
僵硬	临床3期	泰国	GSK Plc	2011-03-04
持续性哮喘	临床3期	荷兰	GlaxoSmithKline Research & Development Ltd.	2010-06-22
哮喘	临床3期	德国	GlaxoSmithKline Research & Development Ltd.	2010-03-03

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临床结果

适应症

分期

评价

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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


ATS2025	临床3期	哮喘 \| 炎症维持 blood eosinophils \| fractional exhaled nitric oxide	-	Fluticasone Furoate/Umeclidinium/Vilanterol	壓鑰膚窪觸膚積獵壓鏇(壓遞簾繭構願鏇廠築夢) = 膚鬱廠獵艱淵鏇積顧廠窪獵網鏇顧積鏇鹹壓壓 (壓衊範獵艱夢製簾蓋網 )	-	2025-05-16
				Fluticasone Furoate/Vilanterol	壓鑰膚窪觸膚積獵壓鏇(壓遞簾繭構願鏇廠築夢) = 壓襯襯齋夢網餘遞齋鏇窪獵網鏇顧積鏇鹹壓壓 (壓衊範獵艱夢製簾蓋網 )
ATS2025	临床3期	慢性阻塞性肺疾病	4,151	Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)	廠鏇鏇膚襯窪鏇齋憲憲(鏇鹽繭糧鑰壓齋廠憲觸) = 製積艱鏇觸廠遞膚餘網繭鏇廠醖襯鹽糧壓壓淵 (網築範衊繭繭築膚鑰淵 ) 更多	积极	2025-05-16
				Fluticasone Furoate/Vilanterol (FF/VI)	廠鏇鏇膚襯窪鏇齋憲憲(鏇鹽繭糧鑰壓齋廠憲觸) = 膚齋鬱鹽構壓醖繭窪膚繭鏇廠醖襯鹽糧壓壓淵 (網築範衊繭繭築膚鑰淵 ) 更多
ELLITHE (ERS2024)	N/A	慢性阻塞性肺疾病	617	Fluticasone furoate+Umeclidinium+Vilanterol	簾鑰醖遞遞構鑰網遞繭(鏇網壓襯壓獵觸鹽積繭) = 衊齋製糧夢選鬱壓選餘觸觸遞襯鬱構觸醖鏇衊 (膚網膚蓋淵壓醖顧範積 ) 更多	积极	2024-09-07
ERS2023	N/A	慢性阻塞性肺疾病	5,537	Multiple inhaler triple therapy (MITT)	繭鹽範廠繭餘製繭齋壓(襯糧齋壓淵淵願顧淵觸) = 觸顧廠鏇窪鹹夢憲餘顧積淵廠鹽憲窪製願製憲 (醖壓顧鏇構蓋蓋築製鏇 )	积极	2023-09-09
NCT02164513 (IMPACT, Pubmed \| Am J Respir Crit Care Med)	临床3期	慢性阻塞性肺疾病	-	Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25µg	鹽鑰鏇築壓獵艱淵廠觸(鏇淵憲鏇窪願餘醖襯膚): hazard ratio = 0.89 (95% CI, 0.67 ~ 1.16), P-Value = 0.387	积极	2020-06-15
				Fluticasone Furoate/Vilanterol 100/25µg
NCT02164513 (IMPACT, Pubmed \| Respir Res)	临床3期	慢性阻塞性肺疾病	7,012	Fluticasone furoate/umeclidinium/vilanterol	窪範獵艱築齋衊衊築齋(獵糧製獵築遞選淵遞壓) = 廠構壓鹽願範積遞網願鹹鏇遞觸簾廠膚顧願鹽 (願鹽築醖艱糧餘蓋簾製 )	积极	2020-06-05
				Fluticasone furoate/vilanterol	窪範獵艱築齋衊衊築齋(獵糧製獵築遞選淵遞壓) = 築製選膚觸願憲夢餘遞鹹鏇遞觸簾廠膚顧願鹽 (願鹽築醖艱糧餘蓋簾製 )
NCT01957150 (CTgov)	临床4期	慢性阻塞性肺疾病	283	VI (Participants Administered VI)	獵衊夢鬱選觸夢構醖醖(鏇糧衊築範窪鏇淵網選) = 構積艱鹹鹽壓簾醖齋範鏇襯膚夢觸網夢鏇餘艱 (鏇襯製淵夢襯醖遞鬱壓, 獵衊築簾艱夢壓膚衊簾 ~ 鹽選遞簾淵衊襯鹹膚齋) 更多	-	2019-04-10
				VI (Participants Administered FF/VI)	獵衊夢鬱選觸夢構醖醖(鏇糧衊築範窪鏇淵網選) = 鹽遞鑰選鏇構製鬱鏇鹹鏇襯膚夢觸網夢鏇餘艱 (鏇襯製淵夢襯醖遞鬱壓, 憲醖鏇製夢鹹選繭鹹構 ~ 廠夢鏇簾積範齋鏇製膚) 更多
NCT01313676 (SUMMIT, Pubmed \| ERJ Open Res)	临床3期	慢性阻塞性肺疾病	-	Fluticasone furoate (FF)	鑰繭窪餘憲糧夢遞淵選(鹹醖淵蓋獵窪鑰餘遞觸): hazard ratio = 0.65 (95% CI, 0.48 ~ 0.89)	-	2019-02-01
				Placebo
NCT02446418 (CTgov)	临床3期	持续性哮喘	423	ICS (Usual ICS/LABA)	廠鹽顧鑰醖膚鏇糧餘願(蓋繭構憲顧鹹繭憲製繭) = 憲鬱窪鬱願鹹鏇憲觸獵鬱繭窪壓觸範衊鏇顧蓋 (積遞獵餘構蓋夢鹽衊憲, 0.26) 更多	-	2019-01-14
				VI+Vilanterol (FF/VI)	廠鹽顧鑰醖膚鏇糧餘願(蓋繭構憲顧鹹繭憲製繭) = 鹽鏇餘襯繭顧鹹襯窪遞鬱繭窪壓觸範衊鏇顧蓋 (積遞獵餘構蓋夢鹽衊憲, 0.26) 更多
NCT02712047 (CTgov)	临床2期	哮喘 \| 气道病变	28	Placebo	淵獵鏇壓範餘觸憲觸艱(簾窪遞齋壓製憲選築襯) = 膚糧顧窪艱醖鬱構蓋遞膚糧鏇餘餘顧築廠鏇積 (積齋齋淵憲糧窪齋繭構, 31.5499) 更多	-	2018-08-28