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+ [15]

Originator Organization

GSK Plc

Active Organization

GlaxoSmithKline Trading Services Ltd.

GSK PlcGlaxoSmithKline Intellectual Property Development Ltd.

+ [3]

Inactive Organization

GlaxoSmithKline Research & Development Ltd.

Glaxo Group 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

Medline/PubMed, Embase, the Cochrane Central Register of Controlled Trials and ClinicalTrials.gov were searched from inception to 20 February 2025. Data extraction and synthesis were performed, estimating risk ratios (RRs) with 95% confidence intervals (CI) or credible intervals (CrI) through pairwise and network meta-analysis (NMA), and an NMA using the Emax model was employed to find the dose–response relationships of the AEs of each ICS. Risk of bias was evaluated across both pairwise and NMAs. The certainty of evidence, based on the GRADE approach, was assessed exclusively for the NMA estimates.

Participants:

Adults diagnosed with asthma or COPD treated with ICSs compared with non-ICS controls or those receiving different types or doses of ICSs.

Main outcome measures:

The primary outcomes were AEs, including pneumonia, oral candidiasis, upper respiratory tract infection (URTI), fracture, diabetes, cataract and plasma cortisol abnormalities. Secondary outcomes included efficacy-related endpoints: asthma exacerbations, COPD exacerbations and all-cause mortality.

Results:

129 trials (120 900 participants) were included. According to pairwise meta-analysis, ICSs were associated with a higher risk of pneumonia (RR 1.49, 95% CI 1.38 to 1.61) and oral candidiasis (RR 2.29, 95% CI 2.01 to 2.60) and with a slightly higher risk of URTI (RR 1.17, 95% CI 1.10 to 1.25), compared with control. Besides, ICSs were linked to a reduced risk of asthma exacerbations (RR 0.30, 95% CI 0.20 to 0.45) and COPD exacerbations (RR 0.90, 95% CI 0.86 to 0.94) vs control. The results of the NMA that explored differences by ICS type showed that beclomethasone and fluticasone increased pneumonia risk compared with control, with absolute risk increases of up to 2.3%. Fluticasone also showed a slightly higher pneumonia risk than budesonide. Besides, mometasone, beclomethasone, budesonide and fluticasone were associated with increased risk of oral candidiasis, with the highest increase observed for mometasone (4.3%). In contrast, ciclesonide consistently showed lower risk across comparisons, reducing oral candidiasis by up to 4.5% with other ICSs. Fluticasone modestly increased URTI, while ciclesonide reduced it. Budesonide and mometasone were also associated with a small increase in cataract risk. Most of the outcomes reported here were supported by moderate- to high-certainty evidence. Furthermore, the dose–response relationship estimated from the Emax model indicated significant associations between fluticasone dose and the risks of pneumonia and URTI, between multiple ICS doses and oral candidiasis and between budesonide dose and cataract.

Conclusions:

ICSs are correlated with the escalated risk of pneumonia, oral candidiasis and URTI in adult patients with asthma or COPD, but ICSs could reduce asthma exacerbations and COPD exacerbations. Fluticasone, beclomethasone, budesonide and mometasone are independently linked to certain AEs, and some Emax dose–response relationships are detected.Our findings may help guide individualised ICS use by informing benefit-risk considerations across various formulations and dosing regimens.

PROSPERO registration number:

CRD42024527797.

01 Jan 2026·ADVANCES IN THERAPY

Real-World Safety and Effectiveness of Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with Asthma: Final Analysis of a Post-Marketing Surveillance in Japan

Article

Author: Ito, Risako ; Morioka, Yoriko ; Komatsubara, Masaki ; Asai, Kazuhisa ; Maruoka, Hiroki

INTRODUCTION:

Fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) is approved for the treatment of asthma in Japan. Currently, data on the safety, particularly on cardiovascular (CV) risk, and effectiveness of FF/UMEC/VI in Japanese real-world clinical practice are limited.

METHODS:

This prospective, multicenter, post-marketing surveillance was undertaken to assess the safety and effectiveness of once-daily single-inhaler triple therapy FF/UMEC/VI (100/62.5/25 or 200/62.5/25 mcg) newly initiated in patients with asthma in Japan between July 2021 and November 2023. The observation period was 1 year after the first FF/UMEC/VI prescription or until termination or withdrawal from treatment. Safety was assessed by incidence of adverse drug reactions (ADRs) including CV events as safety specification to be checked due to risk associated with use of UMEC. Overall assessment of effectiveness (based on lung function, asthma symptoms, and proportion of patients with exacerbation events) and asthma management status was assessed by the investigator.

RESULTS:

Overall, 8.4% (24/286) of patients reported an ADR. The most common ADRs were cough and dysphonia (each 7/286). Urinary retention was reported as a serious ADR in 1 patient, and CV event palpitations were reported in 2 patients. FF/UMEC/VI treatment was deemed effective in 92.5% (260/281) of patients in the effectiveness analysis. Lung function and asthma control test results improved following initiation of FF/UMEC/VI. In the 1 year after initiation, 6.2% (11/178) of patients experienced exacerbation events, while 25.8% (46/178) of patients experienced exacerbation events prior to initiation.

CONCLUSION:

FF/UMEC/VI was well tolerated and effective in the treatment of patients with asthma in Japan. ADRs were reported in 8.4% of patients and the incidence of CV events was low. No new safety concerns were identified.

01 Jan 2026·OTOLARYNGOLOGY-HEAD AND NECK SURGERY

Price and Adoption of Exhalation Delivery System With Fluticasone, 2018‐2023

Article

Author: Scangas, George A. ; Erickson, Taylor S. ; Phillips, Katie M. ; Rathi, Vinay K. ; Bhat, Akash M. ; Workman, Alan D.

Abstract:

FDA approved an exhalation delivery system with fluticasone (EDS‐FLU) for treatment of chronic rhinosinusitis with (2017) and without (2024) nasal polyposis. Concerns have emerged that high prices may limit access, but little is known about the extent of adoption. We analyzed publicly available Securities and Exchange Commission filings and Medicare Part D spending data to characterize EDS‐FLU utilization, spending, and prices between 2018 and 2023. During this period, annual EDS‐FLU utilization and spending increased 10.3‐fold (32,869 to 339,400 prescriptions) and 12‐fold ($21.1 million to $252.9 million), respectively. Despite reductions in the manufacturer net price ($272.98 to $228.34 per prescription after rebates/discounts; relative difference −16.4%), the Medicare Part D point‐of‐sale price increased ($642.72 to $745.11; relative difference 15.9%). In 2023, pharmacy markup ($516.77) over acquisition costs accounted for 69.4% of the point‐of‐sale net price. Policy reforms limiting price inflation by pharmaceutical supply chain intermediaries are necessary to promote access and lower drug spending.

44

News (Medical) associated with Fluticasone furoate

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

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

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

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
Dyspnea	Phase 3	Italy	GlaxoSmithKline Research & Development Ltd.	18 Apr 2011
Mediastinal Diseases	Phase 3	Italy	GlaxoSmithKline Research & Development	08 Mar 2011
Stiffness	Phase 3	Norway	GlaxoSmithKline Research & Development Ltd.	03 Mar 2011
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

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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	wmudweqkwe(osemajoebl) = qmenryngtc wricjebhzq (ocqyfiblds )	-	16 May 2025
				Fluticasone Furoate/Vilanterol	wmudweqkwe(osemajoebl) = agaashjerq wricjebhzq (ocqyfiblds )
ATS2025	Phase 3	Pulmonary Disease, Chronic Obstructive	4,151	Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI)	tbuzpynadz(tygokemiqf) = fmuamroaqa esbimoeajh (jxztggxakd ) View more	Positive	16 May 2025
				Fluticasone Furoate/Vilanterol (FF/VI)	tbuzpynadz(tygokemiqf) = sllrnpehop esbimoeajh (jxztggxakd ) View more
ATS2025	Phase 3	Asthma	-	FF/VI 100/25	ceshsdndas(ryuotqzfyo) = sklmexrxgn chqotcecyx (yptljmwohq )	Positive	16 May 2025
				FF/VI 200/25	ceshsdndas(ryuotqzfyo) = tzecgkcwuc chqotcecyx (yptljmwohq )
ELLITHE (ERS2024)	Not Applicable	Pulmonary Disease, Chronic Obstructive	617	Fluticasone furoate+Umeclidinium+Vilanterol	udwalraadm(qzsvxtrqrw) = rfrcudrncn mdgfdklfky (qflwgcrwul ) 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)	tfzrbjgqtd(wzpgprylvu): 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)	nmgcauzkjp(jaopgvbwhr) = whnejvuntc iuoadsazif (pbhjityqoi )	Positive	09 Sep 2023
ATS2023	Not Applicable	Asthma	-	Fluticasone Furoate/Vilanterol	eoffskbzlw(aqlvcdaabg) = 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) ubpnktgtwz (dloccjasmd )	-	21 May 2023
NCT05736874 (CTgov)	Phase 3	COVID-19	1,407	Fluticasone (Arm C - Fluticasone)	xqdxlizuez(gicwaowkxj) = vsqislpktk iopbwzipji (shmgqrnsfb, tbxishhvyg - hkevbyztrl) View more	-	12 Apr 2023
				Placebo (Arm C - Placebo)	xqdxlizuez(gicwaowkxj) = qrhdfampci iopbwzipji (shmgqrnsfb, hhspksxwuz - ajrecajdsw) View more
NCT02889809 (114971, CTgov)	Phase 4	Asthma \| Childhood asthma	477	Placebo+Montelukast	ntfeabptsd(gkkervcgfs) = ibtuigmnyq zelfbzszrv (icyekbsoew, 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)	kvdhuumxus(fuokpefuba) = fxpcbscjau hhlemnlvpz (avwacqkmyc, 2.415) View more	-	03 Feb 2021
				Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray (Reference)	kvdhuumxus(fuokpefuba) = zxfmfeyzzq hhlemnlvpz (avwacqkmyc, 2.409) View more