AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE (azelastine hydrochloride)
Azelastine hydrochloride and fluticasone propionate nasal spray is indicated for the symptomatic relief of seasonal allergic rhinitis in adults and pediatric patients aged 6 years and older. This fixed-dose combination utilizes two distinct pharmacological classes—an H1-receptor antagonist and a corticosteroid—to address the multi-factorial inflammatory and physiological responses triggered by seasonal allergens.
How AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE Works
This medication provides a dual-action approach to allergic rhinitis. Azelastine hydrochloride is a histamine H1-receptor antagonist that inhibits the immediate hypersensitivity reaction. Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity, acting on multiple cell types (e.g., mast cells, eosinophils) and mediators (e.g., cytokines, leukotrienes) to reduce the late-phase allergic response. Together, they target both the mediator-driven and inflammatory components of the allergic cascade.
Details
- Status
- Prescription
- First Approved
- 2017-04-28
- Routes
- NASAL
- Dosage Forms
- SPRAY, METERED
Companies
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE Approval History
What AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE Treats
1 indicationsAZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Seasonal Allergic Rhinitis
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE 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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Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04601324 | Allergic Rhinitis Protocol | Ph 4 | withdrawn | Allergic Rhinitis Combination Pharmacotherapy Efficacy Study |
| NCT05887843 | SAN-0791 2023-000362-34 | Ph 1 | terminated | Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents and Young Adults With Seasonal Allergic Rhinitis |
| NCT04729517 HILARIA | Aİ-2019-01 | Ph 3 | completed | Efficacy and Safety Study of AI201901 in Allergic Rhinitis Patients |
| NCT01915823 results posted | MP 4008 | Ph 3 | completed | Safety and Efficacy Trial of Dymista Nasal Spray in Children Ages 4 to 11 With Seasonal Allergic Rhinitis (SAR) |
| NCT00612118 | IPR110982 | Ph 2 | completed | A Phase II Study Evaluating Intranasal GSK256066 and Azelastine Hydrochloride in Subjects With Seasonal Allergic Rhinitis |
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.
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE FDA Label Details
Indications & Usage
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE is indicated for the treatment of Seasonal Allergic Rhinitis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.