糠酸氟替卡松/三苯乙酸维兰特罗(Fluticasone Furoate/Vilanterol Trifenatate) - 药物靶点：GR x β2-adrenergic receptor_在研适应症：慢性支气管炎，肺气肿，哮喘_专利_临床

概要

基本信息

药物类型

小分子化药

别名

FF/VI、Fluticasone furoate/GW642444、Fluticasone Furoate/Vilanterol

+ [15]

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

免疫系统疾病感染呼吸系统疾病

在研适应症

慢性支气管炎肺气肿哮喘+ [1]

非在研适应症

运动诱发哮喘心血管疾病冠心病+ [7]

原研机构

GlaxoSmithKline Biologicals SA

在研机构

Glaxo Group Ltd.

GSK PlcGlaxoSmithKline Trading Services Ltd.

+ [4]

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

美国 (2013-05-10),

慢性阻塞性肺疾病

最高研发阶段(中国)批准上市

特殊审评特殊审批 (中国)

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结构/序列

分子式C44H49Cl2NO7

InChIKeyKLOLZALDXGTNQE-JIDHJSLPSA-N

CAS号503070-58-4

查看全部结构式(2)

关联

74

项与糠酸氟替卡松/三苯乙酸维兰特罗相关的临床试验

NCT07223294

/ Withdrawn临床3期

A Randomized, Multicenter, Multiple-dose, Double-blind, Placebo-controlled, Parallel-group Design, Clinical Endpoint Bioequivalence Study to Evaluate the Therapeutic Equivalence and Safety of Fluticasone Furoate and Vilanterol Inhalation Powder 100 mcg/25 mcg (Sandoz) and BREO® ELLIPTA® (Fluticasone Furoate and Vilanterol Inhalation Powder) 100 mcg/25 mcg (GlaxoSmithKline) in Adult Participants With Asthma

This is a randomized, multi-center, multiple-dose, double-blind, placebo-controlled, Parallel group design, clinical endpoint bioequivalence study in adult participants with asthma.
The study design includes up to a 2-week Screening period, at least a 2-week Run-in period, a 4-week Treatment period, and a safety follow up call one week later.
Visit 1: Screening Visit 2: Run-in period: All eligible participants will enter a 2-week Run-in period in which training will be provided to the participants on the use of inhalers and participant diary.
Visit 3: Day 1: Randomization to one of the 3 treatment groups to receive one inhalation of the study medication quaque die (QD), in the morning, for 28 ± 2 days.
Visit 4: Day 28: EOT
Participants will be contacted one week after their last site visit for Safety follow-up via phone call (end of study). Participants will be instructed to refrain from taking their current inhaled asthma medications from the start of the Run-in period until the end of treatment (EOT) visit. They will be provided with a salbutamol/albuterol inhaler (rescue medication) for use on an as-needed basis during the entire study duration until the EOT visit.

开始日期2026-04-21

申办/合作机构

Sandoz Group AG

CTRI/2024/03/064848

/ Not yet recruitingN/AIIT

A comparative study of Vilanterol/Fluticasone furoate with Formoterol/Budesonide in the management of stable bronchial asthma - nil

开始日期2024-04-10

申办/合作机构-

CTR20233844

/ TerminatedN/A

糠酸氟替卡松维兰特罗吸入粉雾剂在健康人空腹状态下的生物等效性试验

主要研究目的：以Glaxo Wellcome Production公司生产的糠酸氟替卡松维兰特罗吸入粉雾剂（RELVAR/ELLIPTA）为参比制剂，评价正大天晴药业集团股份有限公司研制的糠酸氟替卡松维兰特罗吸入粉雾剂在空腹状态下的生物等效性（BE）。次要研究目的：观察受试制剂糠酸氟替卡松维兰特罗吸入粉雾剂和参比制剂RELVAR/ELLIPTA在健康试验参与者中的安全性。

开始日期2023-12-03

申办/合作机构

连云港润众制药有限公司

[+1]

100 项与糠酸氟替卡松/三苯乙酸维兰特罗相关的临床结果

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100 项与糠酸氟替卡松/三苯乙酸维兰特罗相关的转化医学

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100 项与糠酸氟替卡松/三苯乙酸维兰特罗相关的专利（医药）

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100

项与糠酸氟替卡松/三苯乙酸维兰特罗相关的文献（医药）

2026-03-01·VALUE IN HEALTH

Informing the US Medicare Drug Price Negotiation for Trelegy Ellipta and Breo Ellipta: Evaluating the Impact of Real-World Evidence

Article

作者: Carlson, Josh J ; Suh, Kangho ; Wright, Abigail C ; Rind, David M ; Richardson, Marina ; Fahim, Shahariar Mohammed ; Tice, Jeffrey A

OBJECTIVES:

The Institute for Clinical and Economic Review (ICER) conducted a special assessment of Trelegy Ellipta and Breo Ellipta for chronic obstructive pulmonary disease to inform the Centers for Medicare and Medicaid Services (CMS) drug price negotiation process. In this manuscript, we examine the type, quality, and impact of the observational evidence included.

METHODS:

We described the type of observational evidence used in ICER's assessment with a primary focus on adherence and persistence data. Risk of bias was assessed using the ROBINS-I.

RESULTS:

Observational data included in ICER's review primarily informed the assessment of differential adherence and persistence between single and multiple inhaler products. The majority of studies were real-world evidence (RWE), utilizing claims or electronic health record data, and were deemed to be at moderate or severe risk of bias. RWE reported that Trelegy Ellipta and Breo Ellipta were associated with greater adherence and persistence compared with generic multiple-inhaler or multiple-daily-dosing alternatives. Persistence data were critical for differentiating between products in the cost-effectiveness analysis; however, persistence was based on prescription refills which is an imperfect measure of treatment continuation.

CONCLUSIONS:

RWE played a critical role in evaluating the comparative clinical and cost-effectiveness of Trelegy Ellipta and Breo Ellipta to inform Centers for Medicare and Medicaid Services drug price negotiations. Differences in persistence informed differential pricing to generic multiple-inhaler or multiple-daily-dosing alternatives, demonstrating how data collected outside of clinical trials can inform value assessments. However, RWE limitations and the lack of evidence linking adherence or persistence to clinical outcomes highlight the need for future research.

2026-02-26·Cureus Journal of Medical Science

An Open-Label, Single-Arm, Multicenter, Prospective, Post-Marketing Study to Evaluate the Effectiveness and Safety of Fluticasone Furoate/Vilanterol (FF/VI) Dry Powder Inhaler (DPI) in the Management of Asthma Patients (PROMISE-OD)

Article

作者: Bhojwani, Divya ; Jhawar, Punit K ; Raparthy, Suresh ; Patil, Saiprasad ; Kumar, Ankit ; Bhagat, Sagar ; Bhushan, Sumit ; Barkate, Hanmant ; Gupta, Sandeepkumar ; Sahoo, Satyajeet ; Raghumanda, Sunil Kumar

BACKGROUND:

A combination of inhaled corticosteroids (ICS) and long-acting β₂-agonists (LABA) is recommended for symptomatic asthma patients. Asthma control with single maintenance and reliever therapy (SMART) in patients remains poor with frequent nighttime awakenings, increased reliever use & severe exacerbations, including non-adherence. Once-daily FF/VI, an ultra LABA/ICS, has proven efficacy and safety in asthma with better adherence than multi-day regimens.

METHODS:

This prospective, multi-center, post-marketing (PROMISE-OD) study evaluated FF/VI DPI (100/25 mcg or 200/25 mcg) over 12 weeks in symptomatic asthma patients (≥12 years) on conventional therapies.

RESULTS:

Among 178 enrolled patients, 177 completed the study (53.9% females & mean age 44.8±15 years). Mean trough FEV1 improved by 180.5±810.7 ml (p=0.003) at week 4 & by 258.8±846.6 ml (p<0.0001) at week 12. The mean ACQ-5 score also reduced by -0.8±0.8 at week 4 and -1.3±0.9 at week 12 (p<0.0001). Adverse events occurred in 15.7% of patients, with no SAEs reported. Rescue medication was low (3.4% at week 4 & 5.1% at week 12). High patient and physician satisfaction was also observed.

CONCLUSION:

FF/VI DPI demonstrated significant improvements in lung function and asthma control with high patient satisfaction and a favorable safety profile, establishing it as a promising maintenance therapy for asthma management in Indian patients.

2026-02-01·ADVANCES IN THERAPY

Evaluating Asthma Clinical Remission with Inhaled Therapy: Post Hoc Analyses of CAPTAIN

Article

作者: Weng, Stephen ; Noorduyn, Stephen G ; Burrows, Emmeline ; Slade, David ; Crawford, Jodie ; Oppenheimer, John ; Pavord, Ian D ; Gould, Steven ; Moore, Alison ; Corbridge, Tom ; Lugogo, Njira ; Howarth, Peter ; Hamouda, Mohamed

INTRODUCTION:

Clinical remission (CR) is an emerging treatment goal in asthma. However, evidence showing whether CR is achievable with inhaled therapy is lacking. This post hoc analysis of CAPTAIN evaluated attainability of a composite CR endpoint with inhaled fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) or FF/VI.

METHODS:

CAPTAIN (GSK 205715) was a Phase IIIA, randomized, controlled, 24-52-week trial comparing once-daily single-inhaler FF/UMEC/VI versus FF/VI in adults with uncontrolled moderate-to-severe asthma despite ICS/LABA. CR was defined as a composite endpoint comprising no systemic corticosteroids, no severe exacerbations, ACQ-5 total score < 1.50, and either change from baseline in FEV₁ ≥ 0 ml (lung function stabilization) or ≥ 100 ml (lung function optimization), assessed for patients meeting the CR endpoint at Week 24 (W24) and achieving CR at W52 with FF/UMEC/VI (100/62.5/25, 200/62.5/25 μg) versus FF/VI (100/25, 200/25 μg). Additional analyses assessed the CR endpoint at W24/W52 using ACQ-5 ≤ 0.75 and ≤ 1.00 thresholds. Adjusted odds/risk ratios for CR were calculated for W24.

RESULTS:

More patients met the CR endpoint (lung function stabilization/optimization) with FF/UMEC/VI versus FF/VI at W24 (stabilization: 42-47% vs 31-36%; optimization: 31-36% vs 19-26%) and W52 (stabilization: 43-47% vs 33-34%; optimization: 30-38% vs 21-24%). Using more stringent ACQ-5 thresholds, fewer patients met the CR endpoint with ACQ ≤ 0.75 versus < 1.50 across treatment arms and timepoints. The odds and probability of meeting the CR endpoint versus not meeting the CR endpoint at W24 were greater with FF/UMEC/VI versus FF/VI, regardless of FF dose.

CONCLUSION:

The results of this post hoc analysis demonstrate that CR is achievable with inhaled therapy in moderate-to-severe asthma and is more likely with FF/UMEC/VI than FF/VI. CR should be considered an attainable treatment goal for patients with asthma, irrespective of disease severity or treatment history.

TRIAL REGISTRATION:

ClinialTrials.gov identifier, NCT02924688.

93

项与糠酸氟替卡松/三苯乙酸维兰特罗相关的新闻（医药）

2026-06-02

·BioSpace

Innoviva to Participate in Upcoming June 2026 Investor Conferences

BURLINGAME, Calif.--(BUSINESS WIRE)--Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified biopharmaceutical company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today announced that management will participate in the following upcoming investor conferences in June: Goldman Sachs 47 th Annual Global Healthcare Conference Format: Fireside chat Date: Monday, June 8, 2026 Time: 1:20 p.m. Eastern Time BTIG Infectious Disease Day Format: 1x1 meetings Date: Tuesday, June 16, 2026 A live webcast of the Goldman Sachs fireside chat can be accessed under “Events & Presentations” in the Investor Relations section of the Company’s website at . An archived replay of the webcast will be available following the fireside chat date. About Innoviva Innoviva is a diversified biopharmaceutical company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR ® /BREO ® ELLIPTA ® and ANORO ® ELLIPTA ® . Innoviva’s critical care and infectious disease assets under the IST platform include GIAPREZA ® (angiotensin II) for increasing blood pressure in adults with septic or other distributive shock, XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use for the treatment of adults with hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus , XERAVA ® (eravacycline) for the treatment of complicated intra-abdominal infections in adults, ZEVTERA (ceftobiprole), an advanced-generation cephalosporin antibiotic licensed from Basilea Pharmaceutica International Ltd, Allschwil, and NUZOLVENCE ® (zoliflodacin), approved by the FDA for the oral treatment of uncomplicated urogenital gonorrhea in adults and pediatric patients 12 years of age and older weighing at least 35 kg. For more information about Innoviva, go to . For information about Innoviva Specialty Therapeutics, go to . ANORO ® , RELVAR ® and BREO ® are trademarks of the GSK group of companies. ZEVTERA is a trademark of Basilea Pharmaceutica Ltd, Allschwil. Contacts Investor Relations (Internal): Eleanor Barisser Director, Investor Relations & Corporate Communications Eleanor.barisser@inva.com Investors and Media: Argot Partners (212) 600-1902 innoviva@argotpartners.com

2026-06-01

·Business Wire

Innoviva to Participate in Upcoming Investor Conferences

BURLINGAME, Calif.--(BUSINESS WIRE)--Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified biopharmaceutical company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today announced that management will participate in the following upcoming investor conferences in June: Goldman Sachs 47th Annual Global Healthcare Conference Format: Fireside chat Date: Monday, June 8, 2026 Time: 1:20 p.m. Eastern Time BTIG Infectious Disease Day Format: 1x1 meetings Date: Tuesday, June 16, 2026 A live webcast of the Goldman Sachs fireside chat can be accessed under “Events & Presentations” in the Investor Relations section of the Company’s website at https://investor.inva.com/presentations-events. An archived replay of the webcast will be available following the fireside chat date. About Innoviva Innoviva is a diversified biopharmaceutical company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva’s critical care and infectious disease assets under the IST platform include GIAPREZA® (angiotensin II) for increasing blood pressure in adults with septic or other distributive shock, XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use for the treatment of adults with hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus, XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults, ZEVTERA (ceftobiprole), an advanced-generation cephalosporin antibiotic licensed from Basilea Pharmaceutica International Ltd, Allschwil, and NUZOLVENCE® (zoliflodacin), approved by the FDA for the oral treatment of uncomplicated urogenital gonorrhea in adults and pediatric patients 12 years of age and older weighing at least 35 kg. For more information about Innoviva, go to www.inva.com. For information about Innoviva Specialty Therapeutics, go to www.innovivaspecialtytherapeutics.com. ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. ZEVTERA is a trademark of Basilea Pharmaceutica Ltd, Allschwil.

上市批准合格传染病产品

2026-05-31

·新药导航

500 亿呼吸药被外资垄断 80%！卡脖子的，竟是一个几块钱的阀门

这里是新药导航，一个帮你匹配临床试验机会的科普号。覆盖肿瘤、呼吸、免疫、代谢等领域。如果你去药店买一瓶布洛芬，国产的和进口的除了价格不同，药效几乎一样。但如果你去买一瓶沙丁胺醇气雾剂，情况完全不同。你手上的那个小罐子——不起眼的金属罐体、一个塑料咬嘴、一个计量阀门——几乎肯定是进口的。因为直到今天，国内能自主生产吸入装置的药企，一只手就数得过来。这是一个非常残酷的现实：中国500亿的呼吸吸入制剂市场，外资企业占了接近80%。GSK、阿斯利康、勃林格殷格翰三家加起来，拿走了这个市场的大半个蛋糕。而剩下的20%里，还有相当一部分是国产企业的仿制药通过集采勉强挤进去的。为什么？不是什么高深的分子结构，而是一个小小的阀门。一、吸入制剂：被低估的工业明珠很多人以为吸入剂就是把药做成喷雾喷进肺里。如果这么简单，国产替代早就完成了。事实是：吸入制剂是目前所有药物剂型中，研发和生产壁垒最高的品类之一——难度仅次于注射剂，甚至在某些维度上超过注射剂。1. 装置本身就是高技术壁垒吸入装置的核心是“雾化效率”。药物的颗粒大小决定了它能到达肺部的哪个位置： >> >10微米：卡在口腔和咽喉（无效） >> 5-10微米：到达大气道（部分有效） >> 1-5微米：到达小气道和肺泡（有效治疗） >> <1微米：随呼气排出（无效）要让药物颗粒精确落在1-5微米的范围内，并保持每批次的一致性，涉及精密工程、材料科学、流体力学、气溶胶科学等交叉学科。一个小小的计量阀，出厂价不过几块钱，但它的精密度要求堪比航天零件。2. 三种主流装置，各有各的难 pMDI（压力定量吸入器）：最普遍也最难。药液悬浮在抛射剂中，每次按压释放固定剂量。难点在于阀门精密度、抛射剂与药物的相容性、罐体内壁涂层工艺。GSK的pMDI阀门由一家叫Bespak的英国公司垄断了全球60%的供应。 DPI（干粉吸入器）：不需要抛射剂，靠患者吸气气流驱动。葛兰素史克的Diskus和Ellipta、阿斯利康的Turbuhaler——每个装置的设计都包含了数百项专利。光是Ellipta的计数器和剂量释放机构，就能写一本200页的专利说明书。 SMI（软雾吸入器）：勃林格殷格翰的Respimat是独家产品。它的“软雾”技术让药雾在口腔内不沉积、不被患者呼出气流带走，肺部沉积率高达60%——pMDI通常只有10-20%。这个装置本身就是一个竞争壁垒。二、GSK/AZ/BI三巨头的垄断版图全球呼吸吸入制剂市场呈现典型的寡头格局。三家公司占据了全球80%以上的市场份额，而且这个格局已经维持了20年。GSK（葛兰素史克）：江湖老大舒利迭（沙美特罗替卡松粉吸入剂）曾经是全球销量最大的呼吸产品，年销售额峰值超过80亿美元。虽然舒利迭近年面临仿制药冲击，但GSK迅速用新一代产品Ellipta系列（如Breo、Anoro）完成了迭代，继续稳坐头把交椅。Ellipta装置内置了GSK累计数十年、数百项专利的技术护城河。AZ（阿斯利康）：全面进攻普米克（布地奈德）、信必可（布地奈德福莫特罗）是呼吸科的经典药物。AZ在pMDI和DPI两条线都有布局，而且近年在生物制剂方向加大了投入（如抗IL-5单抗Fasenra用于重度哮喘）。AZ的优势在于：既有全品类的吸入装置矩阵，又有强大的学术推广能力。BI（勃林格殷格翰）：技术流玩家 BI的Respimat软雾吸入装置是业界公认的技术标杆。思力华（噻托溴铵）是慢阻肺维持治疗的基石药物之一。BI的非典型之处在于：它是这三家里唯一保持私有化的，不追求短期财报，而是长期押注技术壁垒。三、国内追赶：从仿制到突围国产替代的进程比想象中慢，但绝不是零。1. 仿制药先行：集采打开了缺口 2018年第一批集采就有吸入制剂纳入。正大天晴的布地奈德、健康元的沙丁胺醇、恒瑞的吸入用七氟烷——通过这些仿制药，国内企业先学会了批量化生产。但注意：这些主要是雾化吸入溶液（不需要装置技术），真正的高壁垒pMDI和DPI仿制药，进展要慢得多。2. 装置自研：最难的硬骨头长风药业是最值得关注的国产吸入制剂研发企业之一。其自主研发的装置已经实现了部分产品的国产替代。另一个值得关注的方向是“跨界降维打击”——一些原本做精密仪器、微机电系统（MEMS）的中国企业，开始进入吸入装置供应链。如果中国企业的精密制造能力继续提升，阀门、罐体、涂层这些“卡脖子”环节可能被逐一攻克。3. 生物制剂的新赛道在传统吸入制剂领域国产超越外资很难，但生物制剂提供了“弯道超车”的可能性。抗IL-5、抗IL-4R、抗TSLP等单抗药物正在改变重度哮喘和部分慢阻肺患者的治疗格局。这些生物制剂不涉及吸入装置技术，主要通过注射给药。国内百济神州、信达、康诺亚等都在布局。四、集采：国产替代的催化剂集采对呼吸吸入制剂的影响深度超过了大多数人的预期。以布地奈德雾化混悬液为例——这是呼吸科用量最大的吸入制剂之一。集采前，阿斯利康的普米克单支价格约14元。集采后，正大天晴的仿制药中选价格降到每支1.5元。降幅超过90%。这对患者是好消息：以前一个月的雾化吸入治疗费用近千元，现在只要几十块钱。但对企业的冲击也是巨大的：阿斯利康的普米克在中国市场年销售额从高峰时的70亿迅速下滑。但真正的高壁垒产品——如舒利迭的仿制药替卡松/沙美特罗、信必可的仿制药布地奈德/福莫特罗——目前仍然没有实现充分的国产替代。主要原因就是前面讲的：装置专利和技术壁垒。集采能挤掉水分，但挤不掉技术鸿沟。五、对患者来说意味着什么？1. 价格更便宜，已是不争的事实雾化溶液、部分吸入剂的集采降价已经惠及大量患者。以前一个月几千块的药费，现在可能降低到几百块。对需长期用药的慢阻肺和哮喘患者来说，这是真正的实惠。2. 选择面在变宽，但高端产品仍有限基础药物的国产替代正在推进中，但如果你的治疗需要使用新一代装置（如Ellipta、Respimat），目前基本只有原研产品可选。好消息是，随着国内企业对装置研发的投入增加，未来5-10年应该能看到明显突破。3. 生物制剂可能是“暗线” 对于重度哮喘和部分慢阻肺患者，生物制剂的获批可能比吸入装置国产化更有意义。目前国内已有度普利尤单抗（达必妥）、贝那利珠单抗等获批，价格正在逐步降低。4. 你需要做的坚持规范治疗，不要因为品牌焦虑影响用药依从性。国产仿制药和进口原研药在有效成分上是一致的，只要医生推荐、使用了正确的吸入装置技术，治疗效果有保障。 “500亿的市场，国产替代的路还很长。但对患者来说，多一个选择，就多一分底气。”写在最后回到那个小小的阀门。一个计量阀，成本几块钱，但它代表了精密制造、材料科学、气溶胶物理的交叉组合。中国制药工业在化学分子合成上已经达到世界一流水平，但在“把药送进肺里”这道工序上，还有一座需要翻过的大山。不过，这座山正在被一点一点挖平。长风药业自研的装置、精密制造企业进入供应链、生物制剂开辟新赛道——国产替代的可能性正在多维度展开。也许五年前我们会说“不可能”，但现在，我们可以说“还需要时间”。如果你也对医药行业投资、国产替代逻辑感兴趣，欢迎在评论区聊聊你看好的方向。好了今天的分享就到这里了，欢迎大家评论区留言、讨论，如果有什么希望了解的，也欢迎评论区留言，也欢迎来连接我~ 我是晓琳，制药行业11年工作经验，专注于新药临床试验，分享医药相关知识，希望对你有所帮助。如果你有需要，可以来链接我，暗号：临床试验~

100 项与糠酸氟替卡松/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
-	糠酸氟替卡松/三苯乙酸维兰特罗	R03AK10	-

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
慢性支气管炎	日本	GlaxoSmithKline KK	2016-12-02
肺气肿	日本	GlaxoSmithKline KK	2016-12-02
哮喘	日本	GlaxoSmithKline KK	2013-09-20
慢性阻塞性肺疾病	美国	Glaxo Group Ltd.	2013-05-10

未上市

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
短暂性脑缺血发作	临床3期	美国	GSK Plc	2012-04-01
短暂性脑缺血发作	临床3期	加拿大	GSK Plc	2012-04-01
短暂性脑缺血发作	临床3期	捷克	GSK Plc	2012-04-01
短暂性脑缺血发作	临床3期	德国	GSK Plc	2012-04-01
短暂性脑缺血发作	临床3期	波兰	GSK Plc	2012-04-01
短暂性脑缺血发作	临床3期	罗马尼亚	GSK Plc	2012-04-01
心肌梗塞	临床3期	美国	GSK Plc	2012-04-01
心肌梗塞	临床3期	加拿大	GSK Plc	2012-04-01
心肌梗塞	临床3期	捷克	GSK Plc	2012-04-01
心肌梗塞	临床3期	德国	GSK Plc	2012-04-01

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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


NCT04937387 (CTgov)	临床3期	哮喘	359	Fluticasone Furoate [FF]+Vilanterol [VI] (Fluticasone Furoate [FF] 100 Microgram[ug] / Vilanterol [VI] 25 ug)	製膚簾醖衊簾膚壓窪艱(選製積鑰憲壓鹽獵衊築) = 網遞構獵壓憲獵鹽膚鑰鬱簾憲餘選膚鏇觸選憲 (衊淵淵網齋願襯窪願齋, 0.0321) 更多	-	2025-08-11
				Fluticasone Furoate [FF]+Vilanterol [VI]+Umeclidinium [UMEC] (Fluticasone Furoate [FF] 100 ug/ Umeclidinium [UMEC] 62.5 ug/ Vilanterol [VI] 25 ug)	製膚簾醖衊簾膚壓窪艱(選製積鑰憲壓鹽獵衊築) = 顧餘壓齋夢網製蓋襯齋鬱簾憲餘選膚鏇觸選憲 (衊淵淵網齋願襯窪願齋, 0.0316) 更多
ATS2025	N/A	哮喘	177	Vilanterol/Fluticasone Furoate (VI/FF) DPI	鹹觸鹹糧糧簾淵積鬱鬱(壓鹹網願繭網鏇製醖構) = 願憲鬱簾衊窪廠繭憲網獵憲蓋繭蓋構構襯鹽廠 (築簾淵鬱鏇醖衊願構鹹 ) 更多	积极	2025-05-16
ATS2023	N/A	哮喘	-	Fluticasone Furoate/Vilanterol	築衊夢窪簾構醖顧鹹簾(選遞齋繭襯蓋壓觸獵壓) = Similar proportions of participants experienced ≥1 on-treatment adverse event (AE) in both populations (5-17 year-olds: n=181/454 [40%] receiving FF/VI versus n=163/448 [36%] receiving FF; 5-11 year-olds: n=133/337 [39%] receiving FF/VI versus n=122/336 [36%] receiving FF) 廠衊觸製鏇簾選鏇鹽鏇 (觸廠鹽築積鹽餘窪糧積 )	-	2023-05-21
ATS2022	N/A	慢性阻塞性肺疾病 \| 哮喘	3,426	Fluticasone furoate/vilanterol 100 µg/25 µg	餘襯膚衊觸廠顧顧觸鑰(餘積艱膚鬱糧壓獵積願) = 憲蓋繭廠遞齋選餘鏇鏇簾憲淵糧鏇憲膚選衊膚 (積顧願窪範糧築窪襯糧 ) 更多	积极	2022-05-15
				Fluticasone furoate/vilanterol 200 µg/25 µg	餘襯膚衊觸廠顧顧觸鑰(餘積艱膚鬱糧壓獵積願) = 襯糧簾憲襯艱選齋餘築簾憲淵糧鏇憲膚選衊膚 (積顧願窪範糧築窪襯糧 ) 更多
NCT01551758 (HZC115151, Pubmed \| Ther Adv Respir Dis)	临床3期	慢性阻塞性肺疾病	2,802	Fluticasone furoate/vilanterol 100/25 µg	繭憲網願襯鏇壓顧淵積(憲鏇膚襯膚遞範鬱獵繭) = 齋網鑰製衊遞觸衊餘壓淵餘襯鹹餘願願壓願選 (鏇選觸廠齋壓餘鏇範繭 ) 更多	-	2021-01-01
				fluticasone furoate/vilanterol	繭憲網願襯鏇壓顧淵積(憲鏇膚襯膚遞範鬱獵繭) = 糧範夢鏇夢鹹蓋製鬱積淵餘襯鹹餘願願壓願選 (鏇選觸廠齋壓餘鏇範繭 ) 更多
NCT03380429 (CTgov)	临床4期	哮喘	437	Relvar/Breo+salbutamol (Cohort 1: Data on Maintenance Use Supplied to Par and HCP)	衊鏇夢憲窪淵醖齋鹹餘(鏇構齋壓糧醖選廠膚構) = 壓範醖範鬱鹽構糧網願選積齋選製鹹襯簾遞衊 (夢鏇顧鏇蓋鑰鏇構廠鹽, 3.19) 更多	-	2020-02-05
				Relvar/Breo+salbutamol (Cohort 5: No Data Supplied to Par or HCP)	衊鏇夢憲窪淵醖齋鹹餘(鏇構齋壓糧醖選廠膚構) = 鹽鹽選衊膚鑰簾膚製選選積齋選製鹹襯簾遞衊 (夢鏇顧鏇蓋鑰鏇構廠鹽, 3.19) 更多
NCT01706198 (Asthma Salford Lung Study, Pubmed \| J Asthma)	临床3期	哮喘维持	4,233	Fluticasone furoate/vilanterol	餘簾範廠衊蓋遞襯願鏇(窪淵遞網餘窪積積襯鑰) = 構膚顧網鏇鹹鹹窪廠願繭顧鬱醖窪願顧膚遞艱 (鏇顧網鏇齋鏇獵廠鹹繭 )	积极	2019-07-01
				Fluticasone propionate/salmeterol	餘簾範廠衊蓋遞襯願鏇(窪淵遞網餘窪積積襯鑰) = 廠膚鏇憲觸膚廠齋壓繭繭顧鬱醖窪願顧膚遞艱 (鏇顧網鏇齋鏇獵廠鹹繭 )
NCT01957150 (CTgov)	临床4期	慢性阻塞性肺疾病	283	VI (Participants Administered VI)	艱製憲醖簾糧簾築選網(憲憲顧衊廠製繭淵齋齋) = 鏇壓夢齋壓觸願衊繭餘鏇窪網糧鏇構願鏇觸淵 (遞築網膚獵蓋鬱觸餘壓, 範觸鬱觸網淵窪蓋遞鏇 ~ 淵選鏇鹹積製鹽膚範齋) 更多	-	2019-04-10
				VI (Participants Administered FF/VI)	艱製憲醖簾糧簾築選網(憲憲顧衊廠製繭淵齋齋) = 顧膚鬱醖簾餘壓願製築鏇窪網糧鏇構願鏇觸淵 (遞築網膚獵蓋鬱觸餘壓, 艱壓鬱糧蓋齋積餘壓齋 ~ 鬱衊鑰積構製襯鹹簾積) 更多
NCT01313676 (SUMMIT, Pubmed \| ERJ Open Res)	临床3期	慢性阻塞性肺疾病	-	Fluticasone furoate (FF)	觸餘膚淵簾齋鬱淵鹹餘(構餘衊積簾糧糧鹹繭鏇): hazard ratio = 0.65 (95% CI, 0.48 ~ 0.89)	-	2019-02-01
				Placebo
NCT01706198 (Asthma Salford Lung Study \| Salford Lung Study in Asthma \| Asthma Salford Lung \| SLS asthma, CTgov)	临床3期	哮喘	4,233	fluticasone furoate + vilanterol+inhaled corticosteroid with or without a long acting beta2-agonist	選簾夢鬱夢膚齋糧願衊 = 構觸憲鏇網繭繭鹽淵觸衊選顧選廠簾壓醖顧築 (範積選鹹淵壓醖窪觸衊, 鏇艱糧艱鬱膚膚網齋淵 ~ 鏇鑰鹽醖蓋糧衊膚構遞) 更多	-	2019-01-24