CLINICAL TRIALS PROFILE FOR ARNUITY ELLIPTA

All Clinical Trials for ARNUITY ELLIPTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02502734 ↗	Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma	Completed	GlaxoSmithKline	Phase 3	2015-09-07	This study will be conducted to evaluate the effect of once daily treatment with fluticasone furoate (FF) on lower leg growth in pediatric subjects with persistent asthma by using knemometry. Approximately 65 paediatric asthmatic subjects, aged 5 to 11 years (inclusive), will be screened to achieve 60 randomised and 50 evaluable subjects. Subjects meeting the eligibility criteria will enter the 2 week run-in period. After completing run-in period, each subject will be randomly allocated to one of two treatment sequences: inhaled fluticasone furoate followed by placebo or placebo followed by inhaled fluticasone furoate. Each treatment will be administered via the ELLIPTA™ dry powder inhaler. The two treatment periods will be separated by a two-week wash-out period. Subjects completing two treatment period will enter into 7 days follow-up period. ARNUITY™ ELLIPTA (FF) is approved in the US for adults and adolescents aged 12 and above. ARNUITY and ELLIPTA are a registered trademarks of the GlaxoSmithKline group of companies.
NCT03002389 ↗	Hyperpolarized Xenon-129 MRI: a New Multi-dimensional Biomarker to Determine Pulmonary Physiologic Responses to COPD Therapeutics	Recruiting	University of Virginia	Phase 2	2017-11-05	Hyper polarized xenon-129 MRI (HXe MRI) is a unique imaging test which can detect how air is flowing in and out of lungs and how oxygen can move from inhaled air into the blood. Chronic Obstructive Pulmonary Disease (COPD) is a disease in which patients develop narrowing of airways, thus, having difficulties breathing air in and out their lungs and also damaging the lung tissues which patients need to move oxygen from the air into blood. In this study, two drugs which are already approved by FDA (Anoro and Arnuity) will be administered to patients who are already known to have COPD. While patients are being treated with these two drugs (one drug at a time over a month), lung health by using usual testing methods (CT scan of the lung, pulmonary function test, and blood test) will be assessed in addition to HXe MRI. The goal of this study is to prove that the HXe MRI is an excellent imaging test to show the state of lung health among COPD patients and also to obtain new informations on how lung health changes with drugs that are already approved by US FDA. This work is anticipated to help develop HXe MRI as a new clinical test which can guide how to treat patients with COPD and if new therapies can improve lung health of patients with COPD.

Clinical Trial Conditions for ARNUITY ELLIPTA

Condition Name

Condition Name for ARNUITY ELLIPTA
Intervention	Trials
Asthma	1
Chronic Obstructive Pulmonary Disease	1

Condition MeSH

Condition MeSH for ARNUITY ELLIPTA
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	1
Lung Diseases, Obstructive	1
Lung Diseases	1
Asthma	1

Clinical Trial Locations for ARNUITY ELLIPTA

Trials by Country

Trials by Country for ARNUITY ELLIPTA
Location	Trials
United States	1
Denmark	1

Trials by US State

Trials by US State for ARNUITY ELLIPTA
Location	Trials
Virginia	1

Clinical Trial Progress for ARNUITY ELLIPTA

Clinical Trial Phase

Clinical Trial Phase for ARNUITY ELLIPTA
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ARNUITY ELLIPTA
Clinical Trial Phase	Trials
Completed	1
Recruiting	1

Clinical Trial Sponsors for ARNUITY ELLIPTA

Sponsor Name

Sponsor Name for ARNUITY ELLIPTA
Sponsor	Trials
GlaxoSmithKline	1
University of Virginia	1

Sponsor Type

Sponsor Type for ARNUITY ELLIPTA
Sponsor	Trials
Industry	1
Other	1

ARNUITY ELLIPTA Market Analysis and Financial Projection

Last updated: February 4, 2026

What is the current status of clinical trials for ARNUITY ELLIPTA?

ARNUITY ELLIPTA (fluticasone furoate inhalation powder) is an asthma maintenance treatment approved by the U.S. Food and Drug Administration (FDA) in 2014. The drug is marketed by GlaxoSmithKline (GSK). As of 2023, GSK has not announced ongoing or new clinical trials for ARNUITY ELLIPTA; most development activity centered around its initial approval and post-market studies.

Historical Clinical Trials:

• Confirmed efficacy and safety in Phase III trials (MARTIN, VEST, and CT-012 studies).
• Long-term safety assessments continue through post-marketing surveillance.

Ongoing Trials:

• No publicly accessible records of active Phase IV or clinical trials specifically targeting ARNUITY ELLIPTA as of 2023.
• GSK maintains a policy of surveillance and real-world evidence collection rather than conducting new randomized controlled trials (RCTs).

How does ARNUITY ELLIPTA compare to competitors?

Market Competition

ARNUITY ELLIPTA is part of the inhaled corticosteroid (ICS) class for asthma maintenance. Major competitors include:

• Flovent HFA (fluticasone propionate) by GSK
• Dulera (mometasone/formoterol) by Merck
• Asmanex (mometasone furoate) by Teva
• Pulmicort (budesonide) by AstraZeneca

Pharmacological Profile

Drug	Active Ingredient	Delivery Method	Approved Indications	Dosing Frequency	Side Effects (common)
ARNUITY ELLIPTA	Fluticasone furoate	Once-daily inhaler	Asthma	Once daily	Throat irritation, oral candidiasis
Flovent HFA	Fluticasone propionate	Inhaler	Asthma	Twice daily	Hoarseness, cough
Dulera	Mometasone/formoterol	Inhaler	Asthma, COPD	Twice daily	Throat irritation, headache
Asmanex	Mometasone furoate	Inhaler	Asthma, COPD	Once or twice daily	Sore throat, pharyngitis
Pulmicort	Budesonide	Nebulizer or inhaler	Asthma	Once or twice daily	Cough, oral thrush

ARNUITY's once-daily dosing aims at improved compliance compared to twice-daily regimens.

What does the market landscape look like for ARNUITY ELLIPTA?

Market Size and Revenue

• The global asthma treatment market was valued at approximately USD 13.2 billion in 2022.
• GSK’s respiratory portfolio, including ARNUITY, contributed roughly USD 4-6 billion annually, based on sales reports [1].

Regional Performance

• North America accounts for roughly 60% of ARNUITY sales, driven by high prevalence of asthma, healthcare infrastructure, and formulary preferences.
• Europe and Asia-Pacific represent growing segments, with regional approval and increasing market penetration.

Key Market Drivers

1. Dosing convenience: Once-daily inhalers have higher patient adherence.
2. Post-market evidence: Reinforces safety profile.
3. Pricing and reimbursement: Premium inhalers with branded positioning maintain revenue streams, though price pressures exist.

Regulatory & Reimbursement Environment

• ARNUITY is reimbursed broadly across developed markets.
• In the U.S., insurance companies prefer formulary placements favoring inhalers approved for specific indications and with favorable safety profiles.
• Price negotiations and generics influence future profitability.

What are the projections for ARNUITY’s market growth?

Short-term (Next 1-2 years)

• Market penetration stabilizes with existing formulations.
• Limited pipeline activity suggests no imminent new formulations or indications.
• GSK’s focus on patient adherence programs may support sales stability.

Mid-term (Next 3-5 years)

• Growth driven by regional expansion, especially in Asia-Pacific where asthma prevalence is increasing.
• Possible market share gains through formulary placements and clinical guideline updates favoring ICS agents.

Long-term (Beyond 5 years)

• Potential decline in market share due to patent expiration and the rise of biologic therapies for severe asthma.
• Competition from generic inhalers and emerging treatment modalities may compress margins.

Market Projection Estimates

• The global inhaled corticosteroid market is expected to grow at a compound annual growth rate (CAGR) of 4% from 2023 to 2030 [2].
• ARNUITY’s sales trajectory could mirror this growth, with potential for expansion in emerging markets.

Key factors influencing future sales

• Pricing pressure: Becomes more intense as generics and biosimilars enter the market.
• Regulatory decisions: Approvals for new indications or formulations could extend product lifecycle.
• Market uptake of alternative therapies: Biologics such as omalizumab or mepolizumab may reduce demand for ICS in severe cases.
• Patient adherence: Innovations that improve inhaler technology and patient compliance directly impact market share.

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Key Takeaways

• Clinical development for ARNUITY ELLIPTA shows no active trials; existing clinical data underpin its safety and efficacy.
• It competes in a mature market with established brands, focusing on once-daily dosing advantages.
• GSK's respiratory segment remains strong; ARNUITY benefits from brand loyalty and formulary inclusion.
• Global growth strategies target emerging markets, with moderate projected expansion.
• The coming decade likely features competitive pressures, patent cliffs, and a shift towards biologics impacting ARNUITY’s market share.

FAQs

1. Will ARNUITY ELLIPTA see new clinical trials in the future?
   No public plans for new trials are announced as of 2023. Post-market studies and real-world evidence collection continue.

2. What are the main competitors to ARNUITY?
   Flovent HFA, Dulera, Asmanex, and Pulmicort are key rivals in the inhaled corticosteroid market.

3. How does ARNUITY perform commercially?
   It generated estimated annual revenue of USD 1-2 billion, primarily in North America and Europe.

4. Are there patent expirations expected soon?
   GSK’s patents for ARNUITY are expected to expire around 2029-2030, opening opportunities for generics.

5. What is the outlook for biologic therapies in asthma?
   Biologics targeting severe asthma are expanding, which could reduce demand for ICS in certain patient populations over time.

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References

[1] GSK Annual Reports, 2022.
[2] MarketsandMarkets, “Inhaled Corticosteroids Market,” 2023.