NDANASALSPRAY, METERED
Approved
Oct 2008
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
3
Data completeness
4/8 — Partial
ASTEPRO (azelastine hydrochloride) by Viatris is hydrochloride, a phthalazinone derivative, exhibits histamine h 1 -receptor antagonist activity in isolated tissues, animal models, and humans. First approved in 2008.
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ASTEPRO is an azelastine hydrochloride nasal spray, a phthalazinone derivative and selective histamine H1-receptor antagonist approved for allergic rhinitis. It works by blocking histamine-mediated allergic responses in the nasal cavity, with the active metabolite desmethylazelastine contributing additional H1-antagonist activity. The racemic formulation is administered as a metered nasal spray for topical delivery.
LOE Approaching1.7 years to LOE
Product approaching loss of exclusivity (2028) with moderate competitive pressure; brand teams are likely focused on lifecycle extension and transition planning rather than growth initiatives.
Mechanism of Action
hydrochloride, a phthalazinone derivative, exhibits histamine H 1 -receptor antagonist activity in isolated tissues, animal models, and humans. Azelastine hydrochloride Nasal Spray is administered as a racemic mixture with no difference in pharmacologic activity noted between the enantiomers in in…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Study to Find Out How Long it Takes Azelastine Hydrochloride 0.15% Nasal Spray to Relieve Symptoms in Patients Suffering From Allergic Rhinitis
Started Feb 2020
110 enrolled
Allergic Rhinitis
Clinical Equivalence of Azelastine Hydrochloride and Fluticasone Propionate, 137/50 mcg Nasal Spray to Dymista™
Started Aug 2014
1,535 enrolled
Seasonal Allergic Rhinitis
A Phase II Study Evaluating Intranasal GSK256066 and Azelastine Hydrochloride in Subjects With Seasonal Allergic Rhinitis
Started Feb 2008
70 enrolled
Allergic RhinitisRhinitis, Allergic, Seasonal
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.