Data updated: May 26, 2026
FLOVENT DISKUS 250 (fluticasone propionate)
Respiratory
Approved 2000-09-29
FLOVENT DISKUS 250 is indicated for the treatment of Hay Fever; Nasal Congestion; Watery Eyes; Itchy Nose; Runny Nose; Sneezing.
Source: FDA Label • GSK
1
Indication
--
Phase 3 Trials
25
Years on Market
Details
- Status
- Prescription
- First Approved
- 2000-09-29
- Routes
- INHALATION
- Dosage Forms
- POWDER
FLOVENT DISKUS 250 Approval History
2001
2002
2003
2004
2005
2006
2007
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
18 FDA actions from 2000 to 2019
Jun 2014 SUPPL
Mfg
Jun 2013 SUPPL
Mfg
Dec 2012 SUPPL
Mfg
May 2002 SUPPL
Mfg
Apr 2002 SUPPL
Mfg
What FLOVENT DISKUS 250 Treats
6 indicationsFLOVENT DISKUS 250 is approved for 6 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hay Fever
- Nasal Congestion
- Watery Eyes
- Itchy Nose
- Runny Nose
- Sneezing
Source: FDA Label
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Clinical Trial Registry
58 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02476825 | 168769 | Ph 4 | active not recruiting | A Bronchoscopy Study to Assess the Effects of Inhaled Corticosteroids on Adult Healthy Volunteers |
| NCT05535738 | STUDY00000321 | Ph 2, Ph 3 | active not recruiting | Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation |
| NCT01396278 results posted | 1248.7 2010-023169-23 | Ph 2 | terminated | Study on BI 54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Medium Dose Inhaled Corticosteroid (ICS). |
| NCT03040596 | STUDY19040139 | Ph 1 | terminated | The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children |
| NCT05444543 results posted | STUDY20210671 | Ph 4 | completed | Cycling of Topical Steroids for Treatment of EoE (Eosinopilic Esophagitis) |
| NCT02402465 results posted | IRB14-1199 | Ph 4 | completed | Factors Involved in Dymista's Superior Clinical Efficacy in the Treatment of Seasonal Allergic Rhinitis |
| NCT03199976 results posted | TFS01 2015-002985-22 | Ph 4 | terminated | Efficacy of Intermittent Tiotropium in Early Childhood Wheezing |
| NCT04601324 | Allergic Rhinitis Protocol | Ph 4 | withdrawn | Allergic Rhinitis Combination Pharmacotherapy Efficacy Study |
| NCT03926026 results posted | NCX-4251-01 | Ph 2 | completed | Study Evaluating the Safety and Tolerability of NCX 4251 for the Treatment of Acute Exacerbations of Blepharitis |
| NCT02246920 results posted | 71336007 | Ph 3 | terminated | Clinical Equivalence Study of Fluticasone Propionate Nasal Spray, 50 mcg/Actuation vs. Flonase in Allergic Rhinitis Patients |
| NCT05314621 | 21-960-0005 | Ph 4 | completed | A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy Relief in Subjects With Allergic Conjunctivitis |
| NCT01397162 results posted | 1248.5 2010-023167-17 | Ph 2 | terminated | Dose Finding Study on BI54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat® Inhaler in Asthmatic Patients Inadequately Controlled on Short-acting-beta-agonist (SABA) Therapy |
| NCT01397201 results posted | 1248.6 2010-023168-41 | Ph 2 | terminated | Study on BI 54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Low Dose Inhaled Corticosteroid (ICS) |
| NCT02232087 results posted | DDSD-1030-SAFL | Ph 1 | completed | Single Blind Cross-over Dose Response Study in Subjects of Two Inhalers of Salmeterol and Fluticasone Propionate |
| NCT01092143 results posted | 1268.17 | Ph 2 | completed | BI 671800 ED in Steroid-naive Asthmatic Patients |
| NCT02980133 results posted | FSS-AS-30003 2016-003835-39 | Ph 3 | completed | Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler |
| NCT04179461 results posted | ARC 7 | Ph 2 | completed | Personalized Treatment Algorithms for Difficult-to-treat Asthma |
| NCT04242368 | IRB-53836 | Ph 2, Ph 3 | withdrawn | Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis |
| NCT01578278 results posted | S00186 | Ph 2 | completed | Bepotastine Besilate-corticosteroid Nasal Spray Combination Compared to Placebo, Bepotastine Besilate Nasal Spray, and Corticosteroid Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis |
| NCT03591068 results posted | OPN-FLU-NP-3104 | Ph 3 | completed | Efficacy & Safety of OPN-375 Adults With Bilateral Nasal Polyps Using Nasoendoscopic Video |
| NCT03240575 results posted | 1237-0063 | Ph 4 | completed | The ENERGITO® 2 Study Compares 2 Inhaled Medicines for Chronic Obstructive Pulmonary Disease (COPD). One Medicine is a Combination of Tiotropium and Olodaterol (Stiolto®) Taken Using the Respimat® Inhaler and the Other Medicine is a Combination of Fluticasone and Salmeterol Taken Using the Diskus |
| NCT04332978 LB1108 | LB1108 | Ph 3 | completed | Topical Nasal Fluticasone Propionate in the Control of Allergic Rhinitis SymptomsPerene |
| NCT03207243 results posted | 207597 2017-001072-34 | Ph 2 | completed | Efficacy and Safety Study of GSK3772847 in Subjects With Moderately Severe Asthma |
| NCT03112577 | R3500-AS-1633 2016-003165-26, SAR440340 | Ph 1 | completed | Study of REGN3500 and Dupilumab in Patients With Asthma |
| NCT03443843 | 19880 | Ph 4 | completed | A Study to Evaluate Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure |
| NCT03055988 results posted | 1237.36 2015-002641-66 | Ph 4 | completed | Cardiovascular Function in COPD Patients |
| NCT00995657 | PAW003 | Ph 4 | completed | Dose Response of Fractional Exhaled Nitric Oxide (FeNO) to Inhaled Steroids in Mild-to-moderate Asthma |
| 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 |
| NCT01622569 results posted | OPN-FLU-NP-3101 | Ph 3 | completed | Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi Directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-Week Open-Label Extension Phase to Assess Safety |
| NCT01624662 results posted | OPN-FLU-NP-3102 | Ph 3 | completed | Efficacy and Safety Study of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Using a Novel Bi-directional Device |
| NCT01915914 results posted | 117291 | Ph 4 | completed | A Randomized, Open-label, Comparative Study to Evaluate an Intermittent Dosing Regimen of Fluticasone Propionate 0.05% Cream (Twice Per Week) in Reducing the Risk of Relapse When Added to Regular Daily Moisturization Using PHYSIOGEL Lotion in Paediatric Subjects With Stabilized Atopic Dermatitis |
| NCT01018186 results posted | 106839 | Ph 3 | completed | Fluticasone Furoate/GW642444 Inhalation Powder Long-Term Safety Study |
| NCT01623310 results posted | OPN-FLU-CS-3203 | Ph 3 | completed | 12-Month OL Intranasal Fluticasone Propionate BID Using OptiNose Device |
| NCT00843193 results posted | 106870 | Ph 2 | completed | Efficacy and Safety Study of GSK679586 in Patients With Severe 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 |
| NCT01307462 FAM for BOS results posted | 2367.00 NCI-2011-00203, U54CA163438 | Ph 2 | completed | Targeted Therapy of Bronchiolitis Obliterans Syndrome |
| NCT01563029 results posted | 106855 | Ph 2 | completed | A Dose-ranging Study of Fluticasone Furoate (FF) |
| NCT02523820 | ID10-57-18 | Ph 3 | completed | Nebulized Corticosteroid for Post Extubation Stridor in Children |
| NCT00814216 | CQAV680A2201 EudraCT number: 2008-005168-15 | Ph 2 | completed | Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma Patients |
| NCT00612820 | IPR110723 | Ph 2 | completed | A Phase II Study Evaluating Intranasal GSK256066 and Fluticasone Propionate in Subjects With Seasonal Allergic Rhinitis (SAR) |
| NCT01623323 results posted | OPN-FLU-CS-3204 | Ph 3 | completed | Study Evaluating the Safety of Intranasal Administration of 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Chronic Sinusitis With or Without Nasal Polyps |
| NCT02466347 | MCPE14014M1 | Ph 1 | completed | Bioequivalence Study of Synflutide HFA Inhaler and Seretide Evohaler in Healthy Volunteers Without Charcoal Block |
| NCT01969721 results posted | 1237.11 2013-000808-41 | Ph 3 | completed | Characterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients |
| NCT00869596 | 0000-128 2009_565 | Ph 1 | completed | Study of Biomarkers of Airway Inflammation (0000-128) |
| NCT02466503 | MCPE14015M1 | Ph 1 | completed | Bioequivalence Study of Synflutide HFA Inhaler and Seretide Evohaler in Healthy Volunteers With Charcoal Block |
| NCT00975195 results posted | 352.2046 2007-002522-29 | Ph 4 | completed | Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease |
| NCT01516073 | 191-091 | Ph 2 | completed | 12-Week Study in Adult Subjects With Asthma |
| NCT01103934 results posted | 10-184-B | Ph 4 | completed | Vitamin D Plus Fluticasone Propionate |
| NCT01817790 results posted | RH01619 | Ph 3 | completed | Assessment of Fluticasone Propionate on Ocular Allergy Symptoms |
| NCT00883168 results posted | MP4006 | Ph 3 | completed | A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies |
Showing 50 of 58 trials
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Trial Timeline
Full development history with FDA approval milestones
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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.
FLOVENT DISKUS 250 FDA Label Details
Indications & Usage
FDA Label (PDF)FLOVENT DISKUS 250 is indicated for the treatment of Hay Fever; Nasal Congestion; Watery Eyes; Itchy Nose; Runny Nose; Sneezing.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.