Delving into the Latest Updates on Vilanterol Trifenatate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

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

+ [8]

Target

β2-adrenergic receptor

Action

agonists

Mechanism

β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists)

Therapeutic Areas

Immune System DiseasesRespiratory DiseasesOther Diseases+ [1]

Active Indication-

Inactive Indication

airway diseaseAsthmaBronchitis, Chronic+ [3]

Originator Organization

GSK Plc

Active Organization-

Inactive Organization

GSK Plc

License Organization

GSK Plc

Theravance Biopharma, Inc.

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC44H49Cl2NO7

InChIKeyKLOLZALDXGTNQE-JIDHJSLPSA-N

CAS Registry503070-58-4

Studies have shown that people with chronic obstructive pulmonary disease (COPD) have worse symptoms after breathing polluted air. People with COPD also often need to go to the hospital if they get a virus or other bug. One of the main drugs taken for COPD treatment (inhaled corticosteroid) may change COPD patients' lungs in ways that make it harder to deal with bugs, especially if they breathe in polluted air. If so, this could cause more frequent hospital visits. On the other hand, the same drug (inhaled corticosteroid) helps some people control symptoms, and may help them avoid hospital visits. The APEL investigators are conducting this study (APIC) to understand if this drug (inhaled corticosteroid), in combination with polluted air, will change the lungs of those with COPD in ways that make it more likely to catch bugs or have other problems.

Start Date01 Apr 2025

Sponsor / Collaborator

University of British Columbia

[+4]

CTRI/2025/02/080495

/ RecruitingPhase 3

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

Start Date24 Feb 2025

Sponsor / Collaborator

Zydus Healthcare Ltd.

100 Clinical Results associated with Vilanterol Trifenatate

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100 Translational Medicine associated with Vilanterol Trifenatate

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100 Patents (Medical) associated with Vilanterol Trifenatate

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639

Literatures (Medical) associated with Vilanterol Trifenatate

31 Dec 2025·Journal of Pharmaceutical Policy and Practice

Access to single-inhaler triple medicines for chronic obstructive pulmonary disease in China: a national survey on accessibility and utilisation

Article

Author: Yu, Shule ; Wang, Menglei ; Yang, Qingqing ; Lu, Wei ; Guo, Wei ; Zheng, Fangfang ; Chen, Hongdou ; Wu, Huanhuan ; Li, Wei

Background:

The maintenance medicines for chronic obstructive pulmonary disease (COPD) include inhaled corticosteroids (ICS), long-acting muscarinic antagonists (LAMA) and long-acting β2-agonists (LABA). Budesonide/glycopyrronium/formoterol (BUD/GLY/FOR) and fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) are two representative drugs for prefixed ICS/LAMA/LABA association in a single inhaler and have shown comparable efficacy and safety with other ICS/LAMA/LABA open combination therapies in patients with moderate-to-very severe COPD. This study aimed to investigate the availability, price, affordability, and utilisation of single-inhaler triple medicines for COPD in China.

Methods:

Quarterly data about the use of BUD/GLY/FOR and FF/UMEC/VI from 2020 to 2022 were collected from the Chinese Medicine Economic Information Network. We used the adjusted World Health Organization and Health Action International methodology to calculate the availability and affordability of the two investigated medicines in 596 tertiary general hospitals and 299 secondary general hospitals in 31 provincial administrative regions in China.

Results:

The availability and consumption of BUD/GLY/FOR were significantly higher than those of FF/UMEC/VI during the study period. At the end of 2022, the availability of BUD/GLY/FOR and FF/UMEC/VI in tertiary general hospitals was 69.80% and 52.01% respectively, while in secondary general hospitals, it was 52.51% and 28.76% respectively. Both medications were equally affordable at 1.3 days of the minimum wage after reimbursement in 2022. In the first quarter of 2021, with the inclusion of both drugs in the Medicare catalog, their DDDc decreased significantly, which was accompanied by notable improvements in their availability, affordability and consumption.

Conclusions:

The overall accessibility and consumption of BUD/GLY/FOR and FF/UMEC/VI were improved in China from 2020 to 2022. The implementation of the national drug price negotiation policy reduces the cost of drugs in China and plays an important role in improving the availability of the investigated drugs.

01 Nov 2025·The journal of allergy and clinical immunology. Global

Effectiveness of indacaterol/glycopyrronium/mometasone for refractory asthmatic cough after switching from inhaled corticosteroid/long-acting β2-agonist therapy

Article

Author: Saito, Junpei ; Miyao, Naoki ; Kamei, Tadashi ; Ohbayashi, Hiroyuki ; Tochigi, Takao ; Yamagata, Eiji ; Matsuoka, Hirofumi ; Tajiri, Tomoko ; Mikami, Toshiaki ; Kiyosue, Arihiro ; Tsuji, Toshinaga ; Fukushima, Yasushi ; Kanemitsu, Yoshihiro ; Niimi, Akio ; Asamoto, Hitoshi ; Hara, Johsuke

Background:

Cough is a major symptom in poorly or partially controlled asthma, which persists despite treatment, thus impairing quality of life.

Objectives:

The primary objective was to demonstrate the superiority of medium-dose indacaterol, glycopyrronium, and mometasone furoate (IND/GLY/MF) over high-dose inhaled corticosteroids (ICS)/long-acting β₂-agonists (LABA) in adult asthma patients with cough refractory to medium-dose ICS/LABA.

Methods:

In this multicenter, randomized, open-label, parallel-group study, 118 patients were randomized to receive either IND/GLY/MF or high-dose ICS/LABA (fluticasone/vilanterol [FF/VI] or budesonide/formoterol [BUD/FM]) for 8 weeks. Efficacy was measured by the Japanese version of the Leicester Cough Questionnaire at week 8. Additional analyses included a visual analog scale, the 6-item Asthma Control Questionnaire, respiratory function, fractional exhaled nitric oxide, and blood eosinophil/neutrophil measurements. Registration: Public clinical trials registry as study jRCTs04122000.

Results:

The change from baseline to week 8 in the total questionnaire score was 1.99 ± 3.48 in the IND/GLY/MF group and 2.50 ± 4.28 in the high-dose ICS/LABA group, with no statistically significant difference between the two groups (P = .5037). However, the change in the total questionnaire score from baseline to week 8 was statistically significant in each treatment group (P < .0001 in the IND/GLY/MF group, P = .0242 in the FF/VI comparator group, and P = .0012 in the BUD/FM comparator group). Fractional exhaled nitric oxide and eosinophil counts significantly decreased in the high-dose ICS/LABA group, while neutrophil counts significantly fell in the IND/GLY/MF group at week 8, by between-group comparison.

Conclusion:

Symptoms improved comparably between medium-dose IND/GLY/MF and high-dose ICS/LABA combinations, although no superiority could be demonstrated. Medium-dose IND/GLY/MF may be an alternative to high-dose ICS/LABA.

03 Oct 2025·JOURNAL OF ASTHMA

Single-inhaler triple therapy improves small airway dysfunction in moderate to severe asthma and asthma-COPD overlap: a retrospective cohort study

Article

Author: Akamatsu, Taisuke ; Sakurai, Shogo ; Shirai, Toshihiro ; Fujita, Yumi

BACKGROUND:

Medium- or high-dose fluticasone furoate (FF)/vilanterol (VI)/umeclidinium (UMEC) is associated with an improvement in forced expiratory volume in one second (FEV1), a marker of large airway dysfunction. However, the effect of FF/VI/UMEC on small airway dysfunction (SAD) remains unknown.

OBJECTIVE:

To clarify the effect of FF/VI/UMEC on SAD in moderate to severe asthma and asthma-chronic obstructive pulmonary disease overlap (ACO) in a retrospective cohort study.

METHODS:

Subjects included 18 moderate to severe asthma and ACO patients who switched from inhaled corticosteroid/long-acting-β2 agonist (ICS/LABA) to FF/VI/UMEC. Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), blood eosinophil counts, total IgE, fractional exhaled nitric oxide, spirometry, and oscillometry were measured and compared before and after FF/VI/UMEC treatment.

RESULTS:

Markers of SAD, including forced vital capacity (FVC), forced expiratory flow at 25-75% of FVC, respiratory system reactance at 5 Hz (X5), resonant frequency, and low-frequency reactance area (AX), improved significantly after the induction of SITT, in addition to ACT, ACQ, FEV1, and FEV1/FVC. Improvements in FEV1, X5, and AX correlated with improvements in ACT, and improvements in FEV1 and FEV1/FVC correlated with improvements in ACQ.

CONCLUSION:

FF/VI/UMEC improved SAD, and its improvement was correlated with improved asthma control in moderate to severe asthma and ACO patients.

52

News (Medical) associated with Vilanterol Trifenatate

23 Sep 2025

·www.globenewswire.com

Transpire Bio’s ANDA for Generic Breo® Ellipta® Accepted for Filing By the U.S. FDA

SUNRISE, Fla., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Transpire Bio, an integrated clinical-stage biopharmaceutical company focused on developing inhaled therapeutics for pulmonary and systemic diseases, today announces that its abbreviated new drug application (ANDA) for fluticasone furoate and vilanterol inhalation powder, a generic version of Breo® Ellipta®1 100/25, has been accepted for filing by the U.S. Food and Drug Administration (FDA). Based on FDA’s public records,2 Transpire Bio believes that it was the first to file an ANDA with a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Should its ANDA be approved by FDA, Transpire Bio believes it will be eligible for 180 days of market exclusivity. In the U.S., Breo® Ellipta® is indicated for the maintenance treatment of patients with asthma and the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). According to IQVIA, Breo® Ellipta® reported U.S. annual sales of $2.02 Billion3 in 2024. “The FDA’s acceptance of our ANDA for filing is an important achievement for our generic Breo Ellipta development program and our complex generic franchise as a whole,” said Dr. Xian-Ming Zeng, Chief Executive Officer of Transpire Bio. “I am proud of our highly experienced team in South Florida who have worked tirelessly with world class CDMOs and other partners since the inception of Transpire Bio to achieve this important milestone. We are now one step closer to providing patients suffering from asthma or COPD, an affordable option and improved access to this critical medication.” “This milestone represents the culmination of years of investment in the right technical competence and infrastructure and demonstrates Transpire Bio’s capabilities in developing complex drug device combination products,” said Dr. Abhishek Gupta, Chief Scientific Officer of Transpire Bio. In addition to its focused generic franchise, Transpire Bio is building a pipeline of innovative inhalation medicines for Idiopathic Pulmonary Fibrosis (IPF) where it has three assets in development. Transpire Bio is also developing therapies for Pulmonary Arterial Hypertension (PAH), Diabetes, Obesity, Parkinson Disease Psychosis and Glioblastoma. These products will all be developed and manufactured in Transpire Bio’s state-of-the-art manufacturing facilities located in South Florida, U.S. About Transpire Bio Inc. Transpire Bio Inc. is an integrated US-based, clinical-stage biopharmaceutical company headquartered in Sunrise, Florida. Transpire Bio harnesses its inhaled drug delivery expertise to improve patients’ lives by expanding access to important therapies and developing treatments for serious diseases where therapeutic options are significantly lacking. Transpire Bio has developed multiple proprietary inhalation technology platforms, including dry powder inhalers, soft-mist inhalers and metered-dose inhalers. For more information, please visit www.transpirebio.com. Breo® Ellipta® is a registered trademark of GSK group of companies.See FDA’s list of drug products for which an ANDA has been received by the Office of Generic Drugs containing a “Paragraph IV” patent certification.Data on file with the company. Contacts:Corporate info@transpirebio.com +1 954.908.2233 InvestorsStuart LoeschChief Commercial Officer, Transpire BioStuart.loesch@transpirebio.com

Drug Approval

04 Mar 2025

·firstwordpharma.com

ICER says GSK's inhaled COPD drugs offer dosing edge over generics

Having recently been selected for the second round of US drug price talks, GSK's chronic obstructive pulmonary disease (COPD) treatments Trelegy Ellipta and Breo Ellipta have received a boost from the Institute for Clinical and Economic Review (ICER) ahead of the start of negotiations.An analysis from the cost watchdog determined that GSK's two inhaled therapies "offer the advantage of requiring only one puff once a day" for the maintenance treatment of COPD. In contrast, comparator generics to Trelegy Ellipta require two inhalers administered twice daily, while for Breo Ellipta, they generally require at least one inhaler twice daily. According to ICER, observational data suggest that patients are more adherent to once-daily therapy, which may lead to fewer COPD exacerbations. The watchdog concluded that Trelegy Ellipta has comparable or incremental net health benefits compared with other generic triple therapies, with the same for Breo Ellipta versus generic inhaled corticosteroid/long-acting beta-agonist dual therapies administered twice daily.Breo Ellipta combines the inhaled corticosteroid fluticasone furoate with the long-acting beta-agonist vilanterol, while Trelegy Ellipta adds the long-acting muscarinic antagonist umeclidinium to this dual regimen. A recent analysis indicated that total Part D Medicare prescription drug costs for Trelegy Ellipta between November 1, 2023, and October 31, 2024, were $5.1 billion, and $1.4 billion for Breo Ellipta.ICER chief executive Sarah Emond noted that the new analysis "will be one of many inputs" considered by the Centers for Medicare & Medicaid Services in negotiations with GSK. "We hope that it will help them as they continue to build a reliable, value-based, transparent drug price negotiation process on behalf of the American people."

03 Jan 2025

·www.drugs.com

Study Compares Single-Inhaler Triple Therapies for Treatment of COPD

FRIDAY, Jan. 3, 2025 -- For patients with chronic obstructive pulmonary disease (COPD), budesonide-glycopyrrolate-formoterol does not improve clinical outcomes compared with fluticasone-umeclidinium-vilanterol, according to a study published online Dec. 30 in The BMJ . William B. Feldman, M.D., M.P.H., from Brigham and Women's Hospital in Boston, and colleagues compared the effectiveness and safety of budesonide-glycopyrrolate-formoterol, a twice-daily metered dose inhaler, and fluticasone-umeclidinium-vilanterol, a once-daily dry powder inhaler for treatment of COPD in routine clinical practice in a new-user, 1:1 propensity score-matched cohort study. The study included 20,388 propensity score-matched pairs of new users. The researchers found that the incidence of a first moderate or severe COPD exacerbation was higher in patients who received budesonide-glycopyrrolate-formoterol (hazard ratio, 1.09; 95 percent confidence interval, 1.04 to 1.14; number needed to harm, 38) compared with those who received fluticasone-umeclidinium-vilanterol, while the incidence of first admission to hospital with pneumonia was identical between the groups (hazard ratio, 1.00; 95 percent confidence interval, 0.19 to 1.10). Those receiving budesonide-glycopyrrolate-formoterol compared with fluticasone-umeclidinium-vilanterol had a higher risk for a first moderate COPD exacerbation (hazard ratio, 1.07; 95 percent confidence interval, 1.02 to 1.12 ; number needed to harm, 54) and for a first severe COPD exacerbation (hazard ratio, 1.29; 95 percent confidence interval, 1.12 to 1.48; number needed to harm, 97). Similar findings were seen in prespecified sensitivity analyses. "Our study may provide reassurance to health systems seeking to decrease greenhouse gas emissions by reducing use of metered dose inhalers, because the single-inhaler triple therapy with the lower carbon footprint (the dry powder inhaler, fluticasone-umeclidinium-vilanterol) was also associated with slightly improved clinical outcomes," the authors write. Several authors disclosed ties to the pharmaceutical and health information technology industries. Abstract/Full Text Editorial (subscription or payment may be required) Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultClinical Study

100 Deals associated with Vilanterol Trifenatate

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External Link

KEGG	Wiki	ATC	Drug Bank
D09697	Vilanterol Trifenatate	-	DB09082

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Asthma	Phase 3	China	GSK Plc	01 Jan 2012
Asthma	Phase 3	Philippines	GSK Plc	01 Jan 2012
Stiffness	Phase 3	United States	GSK Plc	04 Mar 2011
Stiffness	Phase 3	Germany	GSK Plc	04 Mar 2011
Stiffness	Phase 3	Norway	GSK Plc	04 Mar 2011
Stiffness	Phase 3	Philippines	GSK Plc	04 Mar 2011
Stiffness	Phase 3	Thailand	GSK Plc	04 Mar 2011
Persistent asthma	Phase 3	United States	GSK Plc	01 Sep 2010
Persistent asthma	Phase 3	Germany	GSK Plc	01 Sep 2010
Persistent asthma	Phase 3	Peru	GSK Plc	01 Sep 2010

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ATS2025	Phase 3	Asthma \| Inflammation Maintenance blood eosinophils \| fractional exhaled nitric oxide	-	Fluticasone Furoate/Umeclidinium/Vilanterol	hsucobzest(ganpopsrbv) = lwxpcjyqek kusrnrqlex (uyqmwijpuy )	-	16 May 2025
				Fluticasone Furoate/Vilanterol	hsucobzest(ganpopsrbv) = qfesebumml kusrnrqlex (uyqmwijpuy )
ATS2025	Phase 3	Pulmonary Disease, Chronic Obstructive	4,151	Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)	vcjngfonck(kcesrwrbzb) = oolnfmdcia youzsecngs (prtwrzdlqi ) View more	Positive	16 May 2025
				Fluticasone Furoate/Vilanterol (FF/VI)	vcjngfonck(kcesrwrbzb) = zxlhwssbgw youzsecngs (prtwrzdlqi ) View more
NCT02164513 (IMPACT, Pubmed \| Am J Respir Crit Care Med)	Phase 3	Pulmonary Disease, Chronic Obstructive	-	Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25µg	sejdjkhwmb(mckunilivj): hazard ratio = 0.89 (95% CI, 0.67 - 1.16), P-Value = 0.387	Positive	15 Jun 2020
				Fluticasone Furoate/Vilanterol 100/25µg
NCT02164513 (IMPACT, Pubmed \| Respir Res)	Phase 3	Pulmonary Disease, Chronic Obstructive	7,012	Fluticasone furoate/umeclidinium/vilanterol	yxqxzzcwvh(hravknwhni) = rtpwnvbrnn eydpoedhbl (xnfvuxwgng )	Positive	05 Jun 2020
				Fluticasone furoate/vilanterol	yxqxzzcwvh(hravknwhni) = edfezxdaqr eydpoedhbl (xnfvuxwgng )
NCT01957150 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	283	VI (Participants Administered VI)	ktzowyhmwd(goqwikrlnn) = iyhwnvfbwa ffugxjzvjs (zgrtordrvb, ezslrjfyhk - yhbsrcczgq) View more	-	10 Apr 2019
				VI (Participants Administered FF/VI)	ktzowyhmwd(goqwikrlnn) = lvxlzqjpie ffugxjzvjs (zgrtordrvb, klgpbtadey - fqbiferzyi) View more
NCT01313676 (SUMMIT, Pubmed \| ERJ Open Res)	Phase 3	Pulmonary Disease, Chronic Obstructive	-	Fluticasone furoate (FF)	rgvsgnxcgl(jrbhzvtdwa): hazard ratio = 0.65 (95% CI, 0.48 - 0.89)	-	01 Feb 2019
				Placebo
NCT02446418 (CTgov)	Phase 3	Persistent asthma	423	ICS (Usual ICS/LABA)	dpiidwwjtc(oimlpudlok) = mdtmwqbudk npumerhwla (rqumkoshhw, 0.26) View more	-	14 Jan 2019
				VI+Vilanterol (FF/VI)	dpiidwwjtc(oimlpudlok) = mkbulupjks npumerhwla (rqumkoshhw, 0.26) View more
NCT02712047 (CTgov)	Phase 2	Asthma \| airway disease	28	Placebo	rwibmxgcym(omiwbhiddl) = towfuulojd qmheqswncq (haaqhpezwc, 31.5499) View more	-	28 Aug 2018
NCT00372112 (CTgov)	Phase 2	Pulmonary Disease, Chronic Obstructive	68	Placebo+GW642444	lvelpkpdzn = ecokaiyson sfyzezazha (rnfftqefzl, waveggdklu - tlmcenjhmc) View more	-	22 Feb 2018
NCT01313676 (SUMMIT, Pubmed \| Am J Respir Crit Care Med)	Phase 3	Moderate chronic obstructive pulmonary disease	16,568	Fluticasone Furoate	nzmhjgmjsa(fbiyhsopsx) = fjocoudfkk scgtzswxfv (zxblpeysmc )	-	01 Jan 2018
				Vilanterol	nzmhjgmjsa(fbiyhsopsx) = aknokagbqa scgtzswxfv (zxblpeysmc )