ARNUITY ELLIPTA (fluticasone furoate)
Arnuity Ellipta (fluticasone furoate) is an inhaled corticosteroid indicated for the once-daily maintenance treatment of asthma in patients aged 5 years and older. It functions by reducing airway inflammation to improve lung function and prevent exacerbations. It is not a rescue medication and should not be used for the relief of acute bronchospasm.
How ARNUITY ELLIPTA Works
Fluticasone furoate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It acts as an agonist at the human glucocorticoid receptor with high binding affinity (approximately 1.7 times that of fluticasone propionate). At the cellular level, it activates glucocorticoid response elements and inhibits pro-inflammatory transcription factors, such as NFkB. These actions lead to the suppression of multiple inflammatory cell types (e.g., mast cells, eosinophils, lymphocytes) and mediators (e.g., cytokines, histamine, leukotrienes) involved in the asthmatic response. Clinical efficacy is not immediate; maximum improvement in lung function may require 1 to 2 weeks of consistent daily use.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-08-20
- Patent Cliff
- 2026
- Routes
- INHALATION
- Dosage Forms
- POWDER
ARNUITY ELLIPTA Approval History
What ARNUITY ELLIPTA Treats
1 indicationsARNUITY ELLIPTA is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
ARNUITY ELLIPTA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
26 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03002389 | 19569-19352 | Ph 2 | active not recruiting | Hyperpolarized Xenon-129 MRI: a New Multi-dimensional Biomarker to Determine Pulmonary Physiologic Responses to COPD Therapeutics |
| NCT02889809 results posted | 114971 | Ph 4 | completed | Effects of a Orally Inhaled Fluticasone Furoate on Growth Velocity in Prepubertal, Paediatric Subjects With Asthma Over a Year |
| NCT03012061 results posted | 205832 2016-002843-40 | Ph 2 | completed | Phase IIb Study of Umeclidinium (UMEC) Bromide Versus Placebo in Subjects With Asthma |
| NCT03898466 | Bio ID 366 | Ph 4 | completed | Effect of Fluticasone Furoate on Methacholine Challenge |
| NCT02446418 results posted | 116492 | Ph 3 | completed | A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent Asthma |
| NCT03315000 | VIL-2017 | Ph 4 | completed | Effect of Vilanterol on Methacholine Challenge Results |
| NCT01313676 results posted | 113782 | Ph 3 | completed | Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol on Survival in Subjects With Chronic Obstructive Pulmonary Disease |
| NCT03363191 | 206962 | Ph 4 | withdrawn | The Efficacy of Fluticasone Furoate/Vilanterol Versus (vs) Fluticasone Furoate on Asthma |
| NCT01086384 results posted | 106837 | Ph 3 | completed | Asthma Exacerbation Study |
| NCT02502734 results posted | 107112 | Ph 3 | completed | Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma |
| NCT01159912 results posted | 112059 | Ph 3 | completed | Evaluating the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Asthma in Adults and Adolescents |
| NCT01013701 results posted | NA_00029405 | Ph 4 | terminated | Compare the Effects of Fluticasone Furoate Nasal Spray vs Placebo in Patients With Nasal Polypoid Disease |
| NCT01000597 | 113477 | Ph 1 | completed | Study to Look at and Compare How Inhaled and Intravenous Fluticasone Furoate is Processed by the Body in Healthy Caucasian, Japanese, Korean and Chinese Subjects |
| NCT01299558 | 102934 | Ph 1 | completed | Study to Look at and Compare How Inhaled and Intravenous Fluticasone Furoate and GW642444 Are Processed by the Body in Healthy Subjects |
| NCT01563029 results posted | 106855 | Ph 2 | completed | A Dose-ranging Study of Fluticasone Furoate (FF) |
| NCT02064504 | 201010 | Ph 1 | completed | Study to Determine the Pharmacokinetics of GSK961081 and Fluticasone Furoate When Administered Alone or in Combination |
| NCT01332292 results posted | 102942 | Ph 2 | completed | Pharmacokinetics and PharmacoDynamics of GW685698 in Paedeatric Asthmatic Patients |
| NCT01128569 results posted | 113090 | Ph 2 | completed | Randomised Study Comparing the Effects of Inhaled Fluticasone Furoate (FF)/Vilanterol (VI; GW642444M) Combination and FF on an Allergen Induced Asthmatic Response |
| NCT01128595 results posted | 113126 | Ph 2 | completed | Randomised Study Comparing the Effects of Inhaled FF/GW642444M Combination, FF and GW642444M on an Allergen Induced Asthmatic Response |
| NCT01453023 results posted | 112777 | Ph 2 | completed | Inhaled Fluticasone Furoate/Vilanterol Safety and Tolerability, PK and PD Study |
| NCT01630135 results posted | 116364 | Ph 3 | completed | Study FFR116364, a Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis |
| NCT01622231 results posted | 116365 | Ph 3 | completed | Study FFR116365, an Open-label Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis |
| NCT01431950 results posted | 114496 | Ph 3 | completed | Evaluating the Efficacy and Safety of Fluticasone Furoate in the Treatment of Asthma in Adults and Adolescents |
| NCT01691885 results posted | 116601 | Ph 3 | completed | RELOVAIR® Lung Deflation Study |
| NCT00603044 results posted | 15868B 15868B | Ph 4 | completed | Mechanism of Action of Fluticasone Furoate in Childhood Obstructive Sleep Apnea Syndrome |
| NCT00791973 results posted | 16367B (OC 3) | Ph 4 | completed | Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ARNUITY ELLIPTA FDA Label Details
Indications & Usage
FDA Label (PDF)ARNUITY ELLIPTA is indicated for the treatment of Asthma.
ARNUITY ELLIPTA Patents & Exclusivity
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment