ASTEPRO (azelastine hydrochloride)
ASTEPRO is indicated for the treatment of Hay Fever; Upper Respiratory Allergy; Nasal Congestion; Runny Nose; Sneezing; Itchy Nose.
Details
- Status
- Discontinued
- First Approved
- 2008-10-15
- Patent Cliff
- 2028
- Routes
- NASAL
- Dosage Forms
- SPRAY, METERED
ASTEPRO Approval History
What ASTEPRO Treats
6 indicationsASTEPRO is approved for 6 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hay Fever
- Upper Respiratory Allergy
- Nasal Congestion
- Runny Nose
- Sneezing
- Itchy Nose
ASTEPRO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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 ASTEPRO
3 of 20FDA-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.
ASTEPRO FDA Label Details
Indications & Usage
FDA Label (PDF)ASTEPRO is indicated for the treatment of Hay Fever; Upper Respiratory Allergy; Nasal Congestion; Runny Nose; Sneezing; Itchy Nose.
ASTEPRO Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for ASTEPRO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 4 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 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.