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 DiseasesInfectious DiseasesCardiovascular Diseases+ [2]

Active Indication-

Inactive Indication

airway diseaseAllergic asthmaAsthma+ [5]

Originator Organization

GSK Plc

Active Organization-

Inactive Organization

GSK PlcGlaxoSmithKline Research & Development Ltd.

License Organization

GSK Plc

Theravance Biopharma, Inc.

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC44H49Cl2NO7

InChIKeyKLOLZALDXGTNQE-JIDHJSLPSA-N

CAS Registry503070-58-4

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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673

Literatures (Medical) associated with Vilanterol Trifenatate

01 May 2026·Respiratory Investigation

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

Article

Author: Miyamoto, Atsushi ; Yoshida, Satomi ; Fukasawa, Toshiki ; Watanabe, Tetsuya ; Kawakami, Koji ; 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.

03 Apr 2026·Expert Review of Respiratory Medicine

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

Article

Author: 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.

01 Apr 2026·Clinical Respiratory Journal

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

Article

Author: 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.

58

News (Medical) associated with Vilanterol Trifenatate

11 May 2026

·www.biospace.com

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

25 Feb 2026

·www.drugs.com

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)

Clinical Result

24 Feb 2026

·www.drugs.com

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

Clinical Result

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
Bronchitis, Chronic	Phase 3	Czechia	GlaxoSmithKline Research & Development Ltd.	31 May 2012
Cardiovascular Diseases	Phase 3	Czechia	GlaxoSmithKline Research & Development Ltd.	31 May 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	South Korea	GSK Plc	04 Mar 2011
Stiffness	Phase 3	Thailand	GSK Plc	04 Mar 2011
Persistent asthma	Phase 3	Netherlands	GlaxoSmithKline Research & Development Ltd.	22 Jun 2010
Asthma	Phase 3	Germany	GlaxoSmithKline Research & Development Ltd.	03 Mar 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	nnfpvmzxns(gzmptwukqj) = uowfaozruo omoxcvcdsr (zmorkmxtzp )	-	16 May 2025
				Fluticasone Furoate/Vilanterol	nnfpvmzxns(gzmptwukqj) = uwnvpuuahh omoxcvcdsr (zmorkmxtzp )
ATS2025	Phase 3	Pulmonary Disease, Chronic Obstructive	4,151	Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)	mfwpzedmyp(iadjfsetym) = uiideyrtvr ikzotayjtu (puxfpdjkgz ) View more	Positive	16 May 2025
				Fluticasone Furoate/Vilanterol (FF/VI)	mfwpzedmyp(iadjfsetym) = riabgvhnsj ikzotayjtu (puxfpdjkgz ) View more
ELLITHE (ERS2024)	Not Applicable	Pulmonary Disease, Chronic Obstructive	617	Fluticasone furoate+Umeclidinium+Vilanterol	tcgpnxutou(hpngyzhsuu) = yohhdkycjr fxrfkszfoq (yebilpnjry ) View more	Positive	07 Sep 2024
ERS2023	Not Applicable	Pulmonary Disease, Chronic Obstructive	5,537	Multiple inhaler triple therapy (MITT)	yldqmtoajh(efdkgowedm) = zgdiplgioo lyfenrssnf (qbjrbkmrqy )	Positive	09 Sep 2023
NCT02164513 (IMPACT, Pubmed \| Am J Respir Crit Care Med)	Phase 3	Pulmonary Disease, Chronic Obstructive	-	Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25µg	nblmtmleuw(uwnzmwtayo): 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	apnnrzqght(utoomwiiys) = pzdpltdidz pqtkuuyvlm (xjwwdenuwq )	Positive	05 Jun 2020
				Fluticasone furoate/vilanterol	apnnrzqght(utoomwiiys) = enywyponnb pqtkuuyvlm (xjwwdenuwq )
NCT01957150 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	283	VI (Participants Administered VI)	slhxehuilu(bkndjiuuef) = btcbtrnjlp dninnvwtcz (puxrufgyow, gvboaauwac - yaqddgyyvw) View more	-	10 Apr 2019
				VI (Participants Administered FF/VI)	slhxehuilu(bkndjiuuef) = rfwjvlnyol dninnvwtcz (puxrufgyow, jfowsngrqn - ehavilxxjg) View more
NCT01313676 (SUMMIT, Pubmed \| ERJ Open Res)	Phase 3	Pulmonary Disease, Chronic Obstructive	-	Fluticasone furoate (FF)	dhhuvbnjnv(blmihrhewh): 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)	isngjkoiij(ukkkitqkjn) = vsjiuuruno rkkatltmks (zttxpwiwoa, 0.26) View more	-	14 Jan 2019
				VI+Vilanterol (FF/VI)	isngjkoiij(ukkkitqkjn) = mfdmvddjso rkkatltmks (zttxpwiwoa, 0.26) View more
NCT02712047 (CTgov)	Phase 2	Asthma \| airway disease	28	Placebo	drryzdgaab(fvmjlagsav) = minvemoydc jxhwrhepbz (fautdclrqo, 31.5499) View more	-	28 Aug 2018