WIXELA INHUB (fluticasone propionate)
Wixela Inhub is a combination of fluticasone propionate (an inhaled corticosteroid) and salmeterol (a long-acting beta2-adrenergic agonist) indicated for the twice-daily treatment of asthma in patients aged 4 years and older. It is intended for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity warrants starting both an ICS and LABA. Additionally, the 250/50 mcg strength is indicated for the maintenance treatment of airflow obstruction and the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Wixela Inhub is a maintenance medication and is not indicated for the relief of acute bronchospasm.
How WIXELA INHUB Works
Wixela Inhub combines two classes of medications with different mechanisms of action. Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity; it binds to human glucocorticoid receptors to inhibit multiple cell types (e.g., mast cells, eosinophils) and mediators (e.g., cytokines, leukotrienes) involved in the inflammation of asthma and COPD. Salmeterol is a long-acting beta2-adrenergic agonist (LABA) that stimulates intracellular adenyl cyclase, leading to increased levels of cyclic AMP. This results in the relaxation of bronchial smooth muscle and inhibition of the release of mediators of immediate hypersensitivity from cells, particularly mast cells.
Details
- Status
- Prescription
- First Approved
- 2019-01-30
- Routes
- INHALATION
- Dosage Forms
- POWDER
WIXELA INHUB Approval History
What WIXELA INHUB Treats
4 indicationsWIXELA INHUB is approved for 4 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
- Chronic Obstructive Pulmonary Disease
- Chronic Bronchitis
- Emphysema
WIXELA INHUB 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.
Drugs Similar to WIXELA INHUB
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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
Active Pipeline
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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.
WIXELA INHUB FDA Label Details
Indications & Usage
FDA Label (PDF)WIXELA INHUB is indicated for the treatment of Asthma; Chronic Obstructive Pulmonary Disease; Chronic Bronchitis; Emphysema.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.