Data updated: May 26, 2026
FLONASE SENSIMIST ALLERGY RELIEF (fluticasone furoate)
Respiratory
Approved 2007-04-27
3
Indications
--
Phase 3 Trials
19
Years on Market
Details
- Status
- Over-the-counter
- First Approved
- 2007-04-27
- Patent Cliff
- 2028
- Routes
- NASAL
- Dosage Forms
- SPRAY, METERED
FLONASE SENSIMIST ALLERGY RELIEF Approval History
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
14 FDA actions from 2007 to 2025 · 2 indication expansions
May 2015 SUPPL
Label
Aug 2012 SUPPL
Efficacy
Oct 2011 SUPPL
Label
Sep 2011 SUPPL
Label
Jul 2009 SUPPL
Label
Apr 2007 ORIGINAL
New Ingredient
What FLONASE SENSIMIST ALLERGY RELIEF Treats
3 FDA approvalsOriginally approved for its first indication in 2007 . Covers 3 distinct patient populations.
- Other (3)
Other
(3 approvals)- • Approved indication (Apr 2007)
- • Approved indication (Aug 2012)
- • Approved indication (Aug 2016)Label
📋
Clinical Trial Registry
25 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| 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| NCT03363191 | 206962 | Ph 4 | withdrawn | The Efficacy of Fluticasone Furoate/Vilanterol Versus (vs) Fluticasone Furoate on Asthma |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 |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
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.
FLONASE SENSIMIST ALLERGY RELIEF FDA Label Details
View full patent landscape →
3 OB patents · 3 families ·
102 international docs across 24 countries
FLONASE SENSIMIST ALLERGY RELIEF Patents & Exclusivity
Latest Patent: Oct 2028
Patents (3 active)
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for FLONASE SENSIMIST ALLERGY RELIEF
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 3 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.