OMNARIS
LOE Approachingciclesonide
NDANASALSPRAY
Approved
Nov 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
OMNARIS (ciclesonide) is pro-drug that is enzymatically hydrolyzed to a pharmacologically active metabolite, c21-desisobutyryl-ciclesonide (des-ciclesonide or rm1) following intranasal application. First approved in 2007.
Drug data last refreshed 23h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OMNARIS (ciclesonide) is an intranasal corticosteroid spray approved in 2007 for allergic rhinitis. It functions as a pro-drug that is enzymatically converted to its active metabolite (des-ciclesonide) in the nasal mucosa, which binds the glucocorticoid receptor with 120-fold higher affinity than the parent compound. The mechanism reduces multi-cell allergic inflammation including mast cells, eosinophils, and lymphocyte-mediated mediator release.
$0.923MPart D
LOE ApproachingProduct is approaching loss of exclusivity with modest Medicare Part D utilization (1,989 claims in 2023), signaling contraction phase requiring defensive commercial strategy and reduced team expansion.
Mechanism of Action
pro-drug that is enzymatically hydrolyzed to a pharmacologically active metabolite, C21-desisobutyryl-ciclesonide (des-ciclesonide or RM1) following intranasal application. Des-ciclesonide has anti-inflammatory activity with affinity for the glucocorticoid receptor that is 120-times higher than the…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Inhaled Ciclesonide Study in Preterm Infants
Started Sep 2025
30 enrolled
Bronchopulmonary Dysplasia
Efficacy and Safety of Ciclesonide Nasal Spray in Participants With Seasonal Allergic Rhinitis (SAR) in Russia
Started Aug 2014
80 enrolled
Seasonal Allergic Rhinitis
Effect of High Dose Ciclesonide on Asthma Control
Started Nov 2011
520 enrolled
Bronchial Asthma
Efficacy, Safety & Tolerability of Ciclesonide 200mcg Spray 4 Weeks Treatment for Intermittent & Persistent Rhinitis
Started Aug 2011
1,630 enrolled
Perennial RhinitisSeasonal Rhinitis
Omnaris Versus Levocetirizine Phase 4 Study
Started Jan 2011
349 enrolled
Allergic Rhinitis
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.