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 diseaseAllergic asthma+ [13]

Originator Organization

GSK Plc

Active Organization

GlaxoSmithKline Trading Services Ltd.GlaxoSmithKline Intellectual Property Development Ltd.

GSK Plc

+ [4]

Inactive Organization

Glaxo Group Ltd.GlaxoSmithKline Research & Development Ltd.GlaxoSmithKline Research & Development

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

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.

01 May 2026·ANNALS OF ALLERGY ASTHMA & IMMUNOLOGY

Relative particle size and distribution of inhaled triple therapies

Article

Author: Zambelli, Enrico ; Agazzi, Ruben ; Piraino, Alessio ; Lipworth, Brian

BACKGROUND:

Many patients with asthma or chronic obstructive pulmonary disease have small airways dysfunction, the presence of which has clinical implications including poor disease control and worse health status. It is, therefore, important to evaluate the ability of an inhaled product used for the treatment of asthma or chronic obstructive pulmonary disease to penetrate the small airways.

OBJECTIVE:

To compare the aerodynamic particle size distribution of 3 triple combination inhalers: beclomethasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/G), budesonide/formoterol fumarate/glycopyrronium (BUD/FF/G), and fluticasone furoate/vilanterol/umeclidinium (FLU/VI/UMEC).

METHODS:

Parameters evaluated via a Next Generation Impactor analysis included particle size as mass median aerodynamic diameter and extrafine particle fraction (eFPF; diameter < 2 µm) calculated as a percentage of the delivered dose. The mass of each component was evaluated using high-performance liquid chromatography assays (FF as the dihydrate salt, G as the bromide salt, VI as the trifenatate salt, and UMEC as the bromide salt).

RESULTS:

Mass median aerodynamic diameter values for all 3 components of BDP/FF/G were consistent (1.1 µm) and were lower than BUD/FF/G (3.02-3.36 µm) and FLU/VI/UMEC (1.96-4.13 µm). Mean eFPFs of the 3 components of BDP/FF/G were also consistent (39.0%-39.9%) and were higher than those of the other 2 therapies (BUD/FF/G, 10.5%-16.2%; FLU/VI/UMEC, 6.8%-27.7%), especially for the BDP component, which was 3.8-fold higher than BUD and 5.8-fold higher than FLU.

CONCLUSION:

BDP/FF/G delivers consistently smaller particles than either BUD/FF/G or FLU/VI/UMEC, translating into a commensurate higher eFPF, in turn suggesting greater potential to target the small airways.

01 Apr 2026·BMJ Open Respiratory Research

Differential association of fluticasone furoate and budesonide with clinically detected COVID-19: a retrospective cohort study

Article

Author: Yoshinoya, Kiyokazu ; Muto, Toru ; Kijima, Takashi ; Sakamoto, Hiroyuki ; Tsunemi, Masaki ; Ishimura, Eiji ; Hayashi, Tetsuya ; Kuribayashi, Kozo

Objectives:

To assess whether fluticasone furoate (FF) use, compared with budesonide (BUD), is associated with fewer clinically detected COVID-19 events among inhaled corticosteroids (ICS) users, and to explore virus-specificity using influenza as a comparator outcome. We hypothesised that FF may provide strong local anti-inflammatory effects with limited systemic immunosuppression.

Design:

Retrospective cohort with outpatient follow-up over 4 years.

Setting:

Single Japanese medical centre.

Participants:

334 adults (102 ICS users; 232 non-ICS) followed from July 2020 to July 2024.

Main outcome measures:

Clinically detected COVID-19 (primary) and influenza (secondary). The primary exposure comparison was FF versus BUD among ICS users; ICS versus non-ICS was analysed secondarily (exploratory). Cox proportional hazards and logistic regression are adjusted for demographics, comorbidities, vaccination and systemic corticosteroids.

Results:

Seventy-nine COVID-19 and 14 influenza events occurred. Among ICS users, FF was associated with fewer clinically detected COVID-19 events than BUD (adjusted HR 0.12, 95% CI 0.02 to 0.73; crude 6.5% vs 32.3%; Fisher’s exact p=0.0047). Under symptom-based testing, ICS users also had fewer clinically detected COVID-19 events than non-ICS users (adjusted HR 0.46, 95% CI 0.22 to 0.94), although this comparison is limited by baseline imbalance and should be interpreted as exploratory and non-causal.

Conclusions:

Under symptom-triggered testing, FF was associated with fewer clinically detected COVID-19 events than BUD in the head-to-head comparison among ICS users. The ICS versus non-ICS comparison is exploratory due to confounding by indication and structural imbalance. These findings are hypothesis-generating and warrant prospective studies with systematic testing and stronger designs.

46

News (Medical) associated with Fluticasone furoate

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

03 Mar 2026

·www.einpresswire.com

FDA approves first generic of Flovent HFA for treatment of asthma

[3/3/2026] Today, the U.S. Food and Drug Administration approved the first generic of Flovent HFA (fluticasone propionate) inhalation aerosol, 44 micrograms per actuation, for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older. Flovent HFA is an inhaled corticosteroid used as maintenance treatment for asthma. It works by reducing inflammation in the lungs, helping to prevent asthma symptoms such as wheezing and shortness of breath. "Today's approval of the first generic fluticasone propionate inhalation aerosol represents an important step in expanding access to affordable asthma treatment," said Iilun Murphy, M.D., Director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research. "Generic medications provide patients with safe, effective, and more affordable treatment options. The FDA remains committed to facilitating the development and approval of generic drugs to increase patient access to essential medicines." Asthma affects almost 25 million Americans , 4.6 million of whom are children. There are an estimated 10 million asthma attacks per year, and 3,500 children and adults die each year from asthma. By making available a generic fluticasone propionate inhalation aerosol product, FDA has provided clinicians and the American public another available and valuable treatment option. “Between 5 and 10% of Americans and just over 6% of children have an asthma diagnosis. Flovent is a highly effective preventive medication, which, when used regularly, has been linked to a reduction in asthma-related hospitalizations and admissions to intensive care. As of today, with the approval of the first generic metered dose inhaler form of the medication we anticipate increased availability and reduced costs of treating this prevalent and at times very serious condition” says Acting Director or CDER, Tracy Beth Høeg, M.D., Ph.D. “I am proud of the work CDER has done to bring this generic to market.” The prescribing information for the generic fluticasone propionate inhalation aerosol includes the same contraindications, warnings, and precautions as Flovent HFA. Fluticasone should not be used as a primary treatment in status asthmaticus or in other acute episodes of asthma requiring intensive measures or in people with hypersensitivity to any of the product components. Fluticasone carries warnings such as oropharyngeal candidiasis and immunosuppression. The prescribing information should be consulted for a full description of warnings and precautions and adverse effects associated with the drug. The FDA granted approval of fluticasone propionate inhalation aerosol to Glenmark Specialty SA. Please contact the manufacturer for information about the medicine’s availability. Flovent HFA is a registered trademark of GlaxoSmithKline. For more information about generic drugs, visit https://www.fda.gov/drugs/buying-using-medicine-safely/generic-drugs . Content current as of: 03/03/2026 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

20 Feb 2026

·www.pharmaceutical-technology.com

Ex-Trump official-ran Altesa secures $75m in Series B funding round

Altesa will now progress its antiviral to a mid-stage trial. Credit: Kateryna Kon/ShutterStock.com Altesa BioSciences has closed an oversubscribed $75m Series B funding round to advance the clinical development of its antiviral, vapendavir. With funding from lead investor Forbion, as well as contributions from Sanofi and other venture capitalists, Altesa will progress vapendavir to Phase IIb trials in rhinovirus, a disease widely known as the common cold. Under the co-leadership of former US assistant health secretary, Brett Giroir and ex-GSK chief medical officer (CMO), Dr Katharine Knobil, the biotech will initiate the multinational CARDINAL study, which aims to enrol 900 patients with chronic obstructive pulmonary disease (COPD) to evaluate how treatment with vapendavir may impact the severity of rhinoviral-driven exacerbations within the disease. The trial is expected to begin in Q2 2026. According to Altesa, vapendavir could have the potential to prevent “up to 50% of COPD exacerbations” by stopping the common cold from infecting and reproducing within a host’s cells. The American Lung Association (ALA) currently cites respiratory diseases like cold and flu as the most common cause of exacerbations in COPD. Alongside its potential to reduce exacerbations, Knobil hopes that vapendavir can improve symptoms and maintain patient quality of life, while hastening the resolution of illness and potentially allowing patients to avoid advanced medical intervention. Vapedavir will head to Phase IIb with positive early-stage data under its belt, as the antiviral was found to diminish illness duration, inflammatory markers and both upper and lower airways symptoms in the Phase I Challenge study (NCT05962645). GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence COPD market takes a breath of fresh air Until recently, the COPD market was dominated by inhaled small molecule therapies, with combination options like GSK’s Telegy Ellipta (fluticasone furoate, umeclidinium bromide and vilanterol trifenatate) securing a strong share of the indication’s sales. However, the COPD approval of Sanofi and Regeneron’s biologic, Dupixent (dupilumab) as an add-on maintenance therapy marked the start of a biologics revolution – with GSK’s Nucala (mepolizumab) following in Dupixent’s footsteps in May 2025 and several candidates making their way through clinical trials. According to GlobalData’s Pharmaceutical Intelligence Center, there are currently 15 ongoing clinical trials evaluating eight biologics in COPD. GlobalData, the parent company of Pharmaceutical Technology , forecasts that the COPD market will be worth $30.2bn in 2033 .

Phase 2Drug ApprovalPhase 1

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
Tracheitis	Phase 3	Denmark	GSK Plc	03 Jul 2015
Bronchitis, Chronic	Phase 3	Czechia	GlaxoSmithKline Research & Development Ltd.	31 May 2012
Stiffness	Phase 3	Argentina	GSK Plc	30 Jun 2011
Stiffness	Phase 3	France	GSK Plc	30 Jun 2011
Stiffness	Phase 3	Germany	GSK Plc	30 Jun 2011
Stiffness	Phase 3	Italy	GSK Plc	30 Jun 2011
Stiffness	Phase 3	Norway	GSK Plc	30 Jun 2011
Stiffness	Phase 3	Russia	GSK Plc	30 Jun 2011
Stiffness	Phase 3	Ukraine	GSK Plc	30 Jun 2011
Cardiovascular Diseases	Phase 3	United States	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	koebvbsjhn(oaihovslzg) = gemxkcotxj hxrqemflvd (cyzgyeqenq )	-	16 May 2025
				Fluticasone Furoate/Vilanterol	koebvbsjhn(oaihovslzg) = ekyachofcb hxrqemflvd (cyzgyeqenq )
ATS2025	Phase 3	Pulmonary Disease, Chronic Obstructive	4,151	Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)	tbcfqrwicw(krbgwhqcmo) = pmwwscozvn biqfguoejb (tueeuqrhos ) View more	Positive	16 May 2025
				Fluticasone Furoate/Vilanterol (FF/VI)	tbcfqrwicw(krbgwhqcmo) = kqnjqwwrnv biqfguoejb (tueeuqrhos ) View more
ATS2025	Phase 3	Asthma	-	FF/VI 100/25	jchqgzguha(zfqburirxk) = vevrzxrpta ihjzwipnnw (ibcbxrarsf )	Positive	16 May 2025
				FF/VI 200/25	jchqgzguha(zfqburirxk) = zriqcbkmbu ihjzwipnnw (ibcbxrarsf )
ELLITHE (ERS2024)	Not Applicable	Pulmonary Disease, Chronic Obstructive	617	Fluticasone furoate+Umeclidinium+Vilanterol	etpwdpmhtj(wiqeamvwmz) = ipvqqvpowi ymteqcvile (eztwpafweo ) View more	Positive	07 Sep 2024
TARhiC (AAAAI2024)	Not Applicable	Rhinitis, Allergic, Perennial Maintenance	87	Fluticasone propionate/azelastine (FP/Aze 50/137 μg each nostril twice daily)	juhymjdkar(akqypdjfyr): 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)
ERS2023	Not Applicable	Pulmonary Disease, Chronic Obstructive	5,537	Multiple inhaler triple therapy (MITT)	malfjmupao(kuyttnhcsj) = oecxqaikib qmbqwhvfdt (bahcgsjzzx )	Positive	09 Sep 2023
ATS2023	Not Applicable	Asthma	-	Fluticasone Furoate/Vilanterol	nmflcesmac(zdclgjzule) = 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) foylqajogk (qwkobqlaxe )	-	21 May 2023
NCT05736874 (CTgov)	Phase 3	COVID-19	1,407	Fluticasone (Arm C - Fluticasone)	rznvlnqrmw(zqtwbrigxl) = ekwuurxehm mmlmrvvyrx (zyrvgtqlnm, zcybeoambo - gucaygtrwr) View more	-	12 Apr 2023
				Placebo (Arm C - Placebo)	rznvlnqrmw(zqtwbrigxl) = xbnanvnxnx mmlmrvvyrx (zyrvgtqlnm, jktyfyxjdh - urvtrcfidz) View more
NCT02889809 (114971, CTgov)	Phase 4	Asthma \| Childhood asthma	477	Placebo+Montelukast	dzsfcseuel(xdbtgrqjur) = vhjtleopgo uiqkzmleoe (cwhszygzys, 0.1090) View more	-	04 Jan 2022
NCT01279057 (CTgov)	Phase 3	Rhinitis, Allergic, Seasonal	727	Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) (Test)	duysxpsips(ciuwcmvzjj) = boxqtstmev gmezxrifuc (jitiesykvi, 2.415) View more	-	03 Feb 2021
				Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray (Reference)	duysxpsips(ciuwcmvzjj) = czognfnqhe gmezxrifuc (jitiesykvi, 2.409) View more