Delving into the Latest Updates on Fluticasone furoate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Aramisuto, Arnuity Ellipta, Fluticasone furoate (JAN/USAN/INN)

+ [14]

Target

GR

Action

agonists

Mechanism

GR agonists(Glucocorticoid receptor agonists)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesOtorhinolaryngologic Diseases+ [1]

Active Indication

AsthmaPulmonary Disease, Chronic ObstructiveRhinitis, Allergic, Perennial+ [2]

Inactive Indication

Acute sinusitisairway diseaseCardiovascular Diseases+ [9]

Originator Organization

GSK Plc

Active Organization

GSK PlcGlaxo Wellcome UK Ltd.GlaxoSmithKline KK

+ [3]

Inactive Organization

Glaxo Group Ltd.

License Organization-

Drug Highest PhaseApproved

First Approval Date

China (16 Jun 2000),

Rhinitis, Allergic

Regulation-

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Structure/Sequence

Molecular FormulaC27H29F3O6S

InChIKeyXTULMSXFIHGYFS-VLSRWLAYSA-N

CAS Registry397864-44-7

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 Fluticasone furoate

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100 Translational Medicine associated with Fluticasone furoate

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100 Patents (Medical) associated with Fluticasone furoate

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1,931

Literatures (Medical) associated with Fluticasone furoate

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.

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.

01 Oct 2025·EUROPEAN RESPIRATORY JOURNAL

The effect of different inhaled corticosteroid and long-acting bronchodilator combinations on the airway microbiome in patients with severe COPD: a randomised trial (MUSIC)

Article

Author: Dhasmana, Devesh ; Pollock, Jennifer ; Chaudhuri, Rekha ; Rauchhaus, Petra ; Keir, Holly R ; Patel, Manish ; Pembridge, Thomas ; Clarke, Clare ; Choudhury, Gourab ; Band, Margaret ; Veluchamy, Abirami ; Alferes De Lima Headley, Daniela ; Cassidy, Diane ; Chalmers, James D ; Short, Philip M ; Hussain, Furrah ; Finch, Simon ; Paracha, Mohammad ; Smith, Andrew ; Richardson, Hollian

Background:

The microbiome is associated with exacerbation risk, quality of life and mortality in COPD. Inhaled corticosteroid (ICS) treatment has been reported to alter the microbiome through modulating host defence. How ICS alters the microbiome and whether effects are equal between different ICS preparations is debated. The aim of the MUSIC trial was to investigate whether commonly used ICS therapies have different effects on the airway microbiome in COPD.

Methods:

This was a multicentre randomised controlled trial. After a 4-week washout period during which they withdrew from ICS, patients with COPD (forced expiratory volume in 1 s <50% predicted at baseline and/or a history of two or more exacerbations per year) were randomised to one of four treatments (budesonide/formoterol 400/12 µg (BF400), fluticasone/salmeterol 500/50 µg (FS500), fluticasone/salmeterol 250/50 µg (FS250) or aclidinium/formoterol 340/12 µg, twice daily). Patients were followed-up for 3 months with monthly induced sputum, oropharyngeal and nasopharyngeal swabs for bacterial load and 16S rRNA sequencing to characterise the microbiome. Inflammatory markers were measured in sputum and blood. The primary outcome was bacterial load in oropharyngeal swabs comparing BF400 versus FS500, with sputum bacterial load the key secondary end-point.

Results:

122 participants started the washout period. ICS withdrawal was poorly tolerated; 61 participants withdrew before randomisation with 45 experiencing an exacerbation. 61 patients were randomised. No statistically significant differences were observed for the primary comparison of BF400 versus FS500 in oropharyngeal bacterial load. There was, however, a significant increase in sputum bacterial load with FS500 compared to BF400 by month 3. This difference was not seen with FS250. No significant differences in microbiome α-diversity were observed over time. Adverse events were similar between the groups.

Conclusion:

FS500 increased sputum but not upper airway bacterial loads. ICS withdrawal was poorly tolerated in severe COPD.

41

News (Medical) associated with Fluticasone furoate

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."

05 Apr 2024

·www.pharmaceutical-technology.com

GSK expands Asia-Pacific reach for Trelegy Ellipta with Singapore approval

Trelegy Ellipta is approved as a maintenance treatment for COPD and asthma in the US. Image Credit: MAXSHOT.PL / Shutterstock. Singapore’s Health Sciences Authority (HSA) has expanded the label of GlaxoSmithKline (GSK)’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) to include its use as a maintenance therapy for adults with asthma. The Singapore agency also approved a new dosage strength for the inhaled therapy in asthma. In 2019, HSA approved Trelegy Ellipta as a maintenance therapy for relieving moderate to severe exacerbations in patients with chronic obstructive pulmonary disease (COPD). Trelegy Ellipta is approved as a maintenance treatment for COPD in multiple regions including the US, Europe and China. However, the drug has also been approved for treating asthma in a few countries such as the US. Trelegy Ellipta pulled in £2.2bn ($2.8bn) in global sales for GSK in 2023, as per the company’s financials. The drug sales are expected to rise, with Trelegy Ellipta expected to generate approximately $3.8bn in global sales in 2027, according to a GlobalData analysis. GlobalData is the parent company of Pharmaceutical Technology . Last month, GSK announced plans to cap out-of-pocket costs for eligible patients at $35 per month for its COPD and asthma medications in light of the rising drug prices in the US. Trelegy Ellipta is one of the drugs included in GSK’s programme, which will be implemented across the country no later than 1 January 2025. See Also: UK MHRA approves Advanz Pharma antibiotic for complex infections Japan’s PMDA approves Partner’s inhaled Leukine for aPAP Another therapy looking to target both asthma and COPD populations is Amgen and AstraZeneca ’s Tezspire (tezepelumab-ekko). The monoclonal antibody has been approved for treating severe asthma in multiple countries including the US. The companies are evaluating the therapy in patients with moderate to severe COPD in a placebo-controlled Phase II trial (NCT04039113). Data from the trial is expected in H1 this year. Regeneron Pharmaceuticals and Sanofi are also seeking approval for their monoclonal antibody , Dupixent (dupilumab) as a maintenance therapy for COPD. The US Food and Drug Administration (FDA) has set a target action date of 27 June for an approval decision. Dupixent is approved for treating atopic dermatitis , asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis.

Drug ApprovalPhase 2

100 Deals associated with Fluticasone furoate

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External Link

KEGG	Wiki	ATC	Drug Bank
D06315	Fluticasone furoate	R03BA09 R01AD12	DB08906

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Asthma	United States	GlaxoSmithKline Intellectual Property Development Ltd.	20 Aug 2014
Pulmonary Disease, Chronic Obstructive	Australia	GSK Plc	17 Apr 2014
Rhinitis, Allergic, Perennial	Canada	GSK Plc	22 Oct 2007
Rhinitis, Allergic, Seasonal	Canada	GSK Plc	22 Oct 2007
Rhinitis, Allergic	China	Glaxo Wellcome UK Ltd.	16 Jun 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cardiovascular Diseases	Phase 3	United States	GSK Plc	25 Jan 2011
Cardiovascular Diseases	Phase 3	China	GSK Plc	25 Jan 2011
Cardiovascular Diseases	Phase 3	Japan	GSK Plc	25 Jan 2011
Cardiovascular Diseases	Phase 3	Argentina	GSK Plc	25 Jan 2011
Cardiovascular Diseases	Phase 3	Australia	GSK Plc	25 Jan 2011
Cardiovascular Diseases	Phase 3	Austria	GSK Plc	25 Jan 2011
Cardiovascular Diseases	Phase 3	Belarus	GSK Plc	25 Jan 2011
Cardiovascular Diseases	Phase 3	Belgium	GSK Plc	25 Jan 2011
Cardiovascular Diseases	Phase 3	Bosnia and Herzegovina	GSK Plc	25 Jan 2011
Cardiovascular Diseases	Phase 3	Bulgaria	GSK Plc	25 Jan 2011

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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	uzivbjrwqd(xbxkuhgtmm) = kytuoqxuuk vmgjxndbnm (mknpqokuki )	-	16 May 2025
				Fluticasone Furoate/Vilanterol	uzivbjrwqd(xbxkuhgtmm) = fcvoypvyqr vmgjxndbnm (mknpqokuki )
ATS2025	Phase 3	Pulmonary Disease, Chronic Obstructive	4,151	Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)	unszkynvul(dylhfykgop) = dnhkvveeyl gwmjfyrseq (fkjiarhnzq ) View more	Positive	16 May 2025
				Fluticasone Furoate/Vilanterol (FF/VI)	unszkynvul(dylhfykgop) = ajssbebyxb gwmjfyrseq (fkjiarhnzq ) View more
ATS2025	Phase 3	Asthma	-	FF/VI 100/25	qnvmamvqrg(wzzzspfcbt) = xfjhigxkfh jehktaqnoy (bohvxptndv )	Positive	16 May 2025
				FF/VI 200/25	qnvmamvqrg(wzzzspfcbt) = dxqadxieak jehktaqnoy (bohvxptndv )
TARhiC (AAAAI2024)	Not Applicable	Rhinitis, Allergic, Perennial Maintenance	87	Fluticasone propionate/azelastine (FP/Aze 50/137 μg each nostril twice daily)	flsjugrleg(xnlzapyvwj): mean difference = 1.26 (95% CI, 0.59 - 1.93), P-Value = <0.001	Positive	23 Feb 2024
				Fluticasone furoate (FF 55 μg each nostril once daily)
ATS2023	Not Applicable	Asthma	-	Fluticasone Furoate/Vilanterol	amktgzixim(wnqjtssaaw) = 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) fkdxauaqst (nlhanhjvdb )	-	21 May 2023
NCT05736874 (CTgov)	Phase 3	COVID-19	1,407	Fluticasone (Arm C - Fluticasone)	plabksqzhi(usgpvzvlmi) = vaxhgmvoza nzghthmpgr (hkuakwozvh, xchsvpqzbo - oqngzdbhpd) View more	-	12 Apr 2023
				Placebo (Arm C - Placebo)	plabksqzhi(usgpvzvlmi) = jmikbzstpn nzghthmpgr (hkuakwozvh, jmrhtaiohw - lbvyolppzm) View more
NCT02889809 (114971, CTgov)	Phase 4	Asthma \| Childhood asthma	477	Placebo+Montelukast	iezlmprcio(qvarfkljoj) = tnmguxuqwh pgypyeikld (alqcttmwhk, 0.1090) View more	-	04 Jan 2022
NCT02164513 (IMPACT, Pubmed \| Am J Respir Crit Care Med)	Phase 3	Pulmonary Disease, Chronic Obstructive	-	Fluticasone Furoate/Umeclidinium/Vilanterol 100/62.5/25µg	qsibrhrkjm(xaxovlbuem): hazard ratio = 0.89 (95% CI, 0.67 - 1.16), P-Value = 0.387	Positive	15 Jun 2020
				Fluticasone Furoate/Vilanterol 100/25µg
NCT02991859 (GSK study 203162, ERS2019)	Phase 2	Asthma	54	Fluticasone furoate (FF)	kfehtwuncs(hwijsuczmo) = wppmfsydxc apieictvkc (iygndzbhyk, 18 - 129)	-	28 Sep 2019
				Fluticasone propionate (FP)	kfehtwuncs(hwijsuczmo) = htpqbwtkmm apieictvkc (iygndzbhyk, 448 - 2610)
NCT02666287 (Pubmed \| Clin Pharmacol Drug Dev)	Phase 1	Pulmonary Disease, Chronic Obstructive	48	BAT/FF	pcclyvbywi(dreedcxoxe): P-Value = 0.79 View more	-	01 Feb 2019
				FF