Delving into the Latest Updates on Umeclidinium Bromide with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

1-[2-(benzyloxy)ethyl]-4-[hydroxy(diphenyl)methyl]-1-azoniabicyclo[2.2.2]octane, Ellipta Incruse, Encruse Ellipta

+ [12]

Target

mAChRs

Action

antagonists

Mechanism

mAChRs antagonists(Muscarinic acetylcholine receptor antagonists)

Therapeutic Areas

Respiratory Diseases

Active Indication

Pulmonary Disease, Chronic Obstructive

Inactive Indication

AsthmaHyperhidrosisHyperhidrosis Palmaris Et Plantaris+ [1]

Originator Organization

GSK Plc

Active Organization

GlaxoSmithKline Trading Services Ltd.GlaxoSmithKline KK

Glaxo Group Ltd.

+ [1]

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

Canada (14 Mar 2014),

Pulmonary Disease, Chronic Obstructive

Regulation-

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Structure/Sequence

Molecular FormulaC29H34BrNO2

InChIKeyPEJHHXHHNGORMP-UHFFFAOYSA-M

CAS Registry869113-09-7

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.

JPRN-UMIN000047506

/ CompletedNot Applicable

Effects of fluticasone furoate, vilanterol and umeclidinium bromide on asthma - Fluticasone furoate, vilanterol and umeclidinium bromide on asthma

Start Date28 Feb 2021

Sponsor / Collaborator

International University of Health & Welfare

JPRN-UMIN000041089

/ CompletedNot ApplicableIIT

Comparative efficacy of fluticasone furoate/umeclidinium/vilanterol(FF/UMEC/VI)versus budesonide/glycopyrrolate/formoterol fumarate(B/G/F) therapies in COPD patients - Comparative efficacy of triple therapies

Start Date01 Nov 2019

Sponsor / Collaborator-

100 Clinical Results associated with Umeclidinium Bromide

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100 Translational Medicine associated with Umeclidinium Bromide

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100 Patents (Medical) associated with Umeclidinium Bromide

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407

Literatures (Medical) associated with Umeclidinium Bromide

01 Feb 2026·RESPIRATORY MEDICINE

Clinical stability under FF/UMEC/VI triple inhaled therapy: A 12-month real life retrospective observational study

Article

Author: Candia, Claudio ; Pennisi, Alfio ; Pennisi, Francesco ; De Simone, Giuseppe ; Maniscalco, Mauro ; Ambrosino, Pasquale

Chronic Obstructive Pulmonary Disease (COPD) remains a leading cause of morbidity and mortality worldwide. For patients with a high disease burden, triple therapy with fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) has demonstrated significant benefits in health-related quality of life (HRQoL), exacerbation reduction, and lung function improvement. Efforts have been made to define clinical stability (CS), yet real-world data on CS during FF/UMEC/VI therapy remain limited. This retrospective study aimed to assess the prevalence of CS after 12 months (T12) of FF/UMEC/VI treatment in COPD patients. CS was defined as the concurrent presence at T12 of: no acute exacerbations in the prior 12 months, a ≥ 2-point improvement in COPD Assessment Test (CAT) score from baseline, and a forced expiratory volume in one second (FEV₁) decline < 100 mL. A total of 47 patients was included. Of them, 10 (21.3%) achieved CS. These individuals had a lower baseline exacerbation rate (P = 0.020) and a trend toward better baseline lung function. They also demonstrated greater improvement in six-minute walking distance compared with non-CS patients (P = 0.048). These findings suggest that CS is attainable in routine clinical practice, with prevalence comparable to that observed in clinical trials. Patients achieving CS tended to have milder disease, indicating potential benefits of earlier FF/UMEC/VI initiation. This might have a relevant impact in clinical practice, especially in the setting of pulmonary rehabilitation. Nonetheless, further multicenter prospective studies are warranted to validate our findings and to identify predictors of treatment success.

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 ; Guo, Wei ; Lu, Wei ; Zheng, Fangfang ; Wu, Huanhuan ; Chen, Hongdou ; 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 Dec 2025·ADVANCES IN THERAPY

Visualizing Improvements in Airway Dysfunction After Inhaled Therapy in Patients With Uncontrolled Asthma: A Narrative Review

Review

Author: Parraga, Grace ; Tcherner, Sam ; Mozaffaripour, Ali ; Yamashita, Cory

Clinical trials investigating asthma therapies typically rely on pulmonary function tests including spirometry markers, such as forced expiratory volume in 1 s, to evaluate efficacy. While these measures provide insights into the action of bronchodilators on global lung function, their specific effects on the airways and the relationship between clinical improvements and airway dysfunction remains poorly understood. In recent years, pulmonary functional imaging methods, such as hyperpolarized ¹²⁹Xe magnetic resonance imaging (MRI), have enabled the analysis of airway dysfunction in patients with asthma utilizing ventilation defect percent (VDP). In this narrative review, we summarize clinical evidence about the impact of inhaled bronchodilator therapies on airway dysfunction in patients with asthma, focusing on studies that utilized ¹²⁹Xe MRI to visualize and quantify MRI VDP. ¹²⁹Xe MRI VDP has been shown to be a well-tolerated and sensitive technique for enabling the visualization and quantification of airway functional changes over time in patients with asthma. This has been shown not only in a controlled clinical trial environment but also in a real-world setting, in patients with both controlled and poorly controlled asthma. A recent study evaluating single-inhaler triple therapy in patients with uncontrolled moderate-severe asthma, despite inhaled corticosteroid/long-acting β₂-agonist maintenance therapy, demonstrated that daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 200/62.5/25 µg) led to significantly improved ¹²⁹Xe MRI VDP after only 6 weeks, which was in line with broader central/distal airway function and quality of life improvements. These results highlight the capacity of ¹²⁹Xe MRI VDP to detect early responses to treatment. In addition, the mechanistic insights provided by ¹²⁹Xe MRI VDP also indicated that these benefits are likely due to the combination of UMEC (a long-acting muscarinic antagonist) and an efficacious inhaled corticosteroid, addressing undertreated inflammatory bronchoconstriction, helping to restore airway caliber and function that more closely resemble the airways of a healthy individual.Videos available for this article.

49

News (Medical) associated with Umeclidinium Bromide

27 Jan 2026

·www.biospace.com

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

SUNRISE, Fla., Jan. 27, 2026 (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, umeclidinium, and vilanterol inhalation powder, a generic version of Trelegy® Ellipta® 1 100/62.5/25, 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 with a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Should Transpire Bio be the first to ANDA against the RLD, the company may become 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 the GSK Annual Report, Trelegy® Ellipta® recorded U.S. annual net sales of nearly $2.7 Billion 3 in 2024. “The FDA’s acceptance for filing of our ANDA for fluticasone furoate, umeclidinium, and vilanterol inhalation powder, a generic version of Trelegy® Ellipta®, is another major milestone in advancing our complex generic franchise,” said Dr. Xian-Ming Zeng, Chief Executive Officer of Transpire Bio. “Our highly experienced team in South Florida continues to work tirelessly to achieve important milestones like this. We are now one step closer to providing patients suffering from asthma or COPD with an affordable option and improved access to this critical medication.” “This milestone is a result of Transpire Bio’s deep scientific and technical competence, and demonstrates Transpire Bio’s strong 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), with three assets in development. Transpire Bio is also developing therapies for Pulmonary Arterial Hypertension (PAH), Diabetes, Obesity, and neurological diseases. 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 list of drug products for which an ANDA has been received by the Office of Generic Drugs containing a “Paragraph IV” patent certification GSK Annual Report 2024 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 and soft-mist inhalers. For more information, please visit . Corporate Inquiries info@transpirebio.com +1 954.908.2233 Investor Inquiries Stuart Loesch Chief Commercial Officer, Transpire Bio Stuart.Loesch@transpirebio.com

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 Umeclidinium Bromide

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External Link

KEGG	Wiki	ATC	Drug Bank
D10181	Umeclidinium Bromide	R03BB07	DB09076

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pulmonary Disease, Chronic Obstructive	Canada	GSK Plc	14 Mar 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hyperhidrosis Palmaris Et Plantaris	Phase 2	United States	GSK Plc	07 Mar 2016
Hyperhidrosis Palmaris Et Plantaris	Phase 2	Canada	GSK Plc	07 Mar 2016
Primary Axilary Hyperhidrosis	Phase 2	United States	GSK Plc	23 Nov 2015
Primary Axilary Hyperhidrosis	Phase 2	Canada	GSK Plc	23 Nov 2015
Asthma	Phase 2	United States	GSK Plc	03 Apr 2012
Asthma	Phase 2	Argentina	GSK Plc	03 Apr 2012
Asthma	Phase 2	Chile	GSK Plc	03 Apr 2012
Asthma	Phase 2	Russia	GSK Plc	03 Apr 2012
Asthma	Phase 2	Thailand	GSK Plc	03 Apr 2012
Hyperhidrosis	Phase 1	Netherlands	GSK Plc	02 Sep 2013

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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	Pulmonary Disease, Chronic Obstructive	4,151	Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)	erxrixiryz(hmpdzgjrlj) = hehgisgctn kjennvwhxr (bahhrzzczd ) View more	Positive	16 May 2025
				Fluticasone Furoate/Vilanterol (FF/VI)	erxrixiryz(hmpdzgjrlj) = fpwbpjvfwn kjennvwhxr (bahhrzzczd ) View more
ATS2025	Phase 3	Asthma \| Inflammation Maintenance blood eosinophils \| fractional exhaled nitric oxide	-	Fluticasone Furoate/Umeclidinium/Vilanterol	ufekhpktak(crruwcwqej) = dmqouvgjjp nmlhvjnnno (pderkxdmgt )	-	16 May 2025
				Fluticasone Furoate/Vilanterol	ufekhpktak(crruwcwqej) = bzshgqoizo nmlhvjnnno (pderkxdmgt )
ATS2025	Phase 3	Asthma	-	FF/VI 100/25	koyvrfmzba(ycpqykzayn) = iuettwdakn zofmtzlhxz (ijuuativif )	Positive	16 May 2025
				FF/VI 200/25	koyvrfmzba(ycpqykzayn) = fwnodcbgue zofmtzlhxz (ijuuativif )
NCT03034915 (EMAX, Pubmed \| Adv Ther)	Phase 4	Pulmonary Disease, Chronic Obstructive	2,696	Umeclidinium/vilanterol	dojdlmtmop(uaaghsrntb) = gmworgjjla icpusenkpq (bjfeboawmj )	-	04 Aug 2021
				Umeclidinium	dojdlmtmop(uaaghsrntb) = qudmvzbsnn icpusenkpq (bjfeboawmj )
NCT02164513 (IMPACT, Pubmed \| Am J Respir Crit Care Med)	Phase 3	Pulmonary Disease, Chronic Obstructive	-	Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25µg	dihxrjgvfe(lfhpkvvaof): hazard ratio = 0.89 (95% CI, 0.67 - 1.16), P-Value = 0.387	Positive	15 Jun 2020
				Fluticasone Furoate/Vilanterol 100/25µg
NCT03012061 (GSK study ID: 205832, Pubmed \| Respir Res)	Phase 2	Asthma	421	UMEC 31.25 mcg	qnqsgrufro(qrdumnlwoo) = olmbovljtm xoprioomvq (lzutgqhjwh ) View more	Positive	12 Jun 2020
				UMEC 62.5 mcg	qnqsgrufro(qrdumnlwoo) = fjlgmktmdm xoprioomvq (lzutgqhjwh ) View more
NCT02184611 (Pubmed) Manual	Phase 3	Pulmonary Disease, Chronic Obstructive	306	Umeclidinium	lyhvyivjdf(eblvvbilrn): difference = 154 (95% CI, 113 - 194), P-Value = <0.001 View more	Positive	17 Apr 2020
				Placebo
NCT03034915 (EMAX, CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	2,696	Placebo+UMEC/VI (UMEC/VI 62.5/25 mcg+ Placebo)	jygnimufjj(ydkjcurgnw) = nbjeruurvr lurlnndomk (mmnkylggym, 0.0081) View more	-	15 Jul 2019
				Placebo+UMEC (UMEC 62.5 mcg + Placebo)	jygnimufjj(ydkjcurgnw) = cqvvhkmvwa lurlnndomk (mmnkylggym, 0.0085) View more
NCT02184611 (CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	308	Placebo	uqnfihlzak(kcfixkzqjr) = xagprrhsfv hkitakuygw (jynwoimihd, 0.0171) View more	-	28 Jun 2019
NCT03012061 (GSK study ID: 205832, CTgov)	Phase 2	Asthma	425	Placebo (Placebo QD)	kprebzkcdq(gbonkebqhl) = tpmijnkpmx nmpqvplsbv (wzlimvfwir, 0.0298) View more	-	19 Jun 2019
				FF+UMEC (UMEC 31.25 mcg QD)	kprebzkcdq(gbonkebqhl) = swddtdmowl nmpqvplsbv (wzlimvfwir, 0.0304) View more