DYMISTA (azelastine hydrochloride)
Dymista is a fixed-dose combination nasal spray containing azelastine hydrochloride, an H1-receptor antagonist, and fluticasone propionate, a corticosteroid. It is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older.
How DYMISTA Works
Dymista exhibits the combined pharmacological activity of its two components. 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. It acts on multiple cell types and mediators involved in the allergic response, demonstrating significantly higher affinity for the glucocorticoid receptor than dexamethasone.
Details
- Status
- Prescription
- First Approved
- 2012-05-01
- Patent Cliff
- 2026
- Routes
- NASAL
- Dosage Forms
- SPRAY, METERED
DYMISTA Approval History
What DYMISTA Treats
1 indicationsDYMISTA is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Seasonal Allergic Rhinitis
DYMISTA 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 DYMISTA
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| 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 |
| 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.
DYMISTA FDA Label Details
Indications & Usage
FDA Label (PDF)DYMISTA is indicated for the treatment of Seasonal Allergic Rhinitis.
DYMISTA Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for DYMISTA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2026
- • 2 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 4 similar drugs
- • Same target/indication analysis
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.