OMNARIS (ciclesonide)
Omnaris is a nasal spray that treats nasal symptoms associated with seasonal allergies in adults and children six years of age and older. It also helps patients with year-round allergic rhinitis, specifically adults and adolescents twelve and older. This medication is used to manage the inflammation and congestion that occur during allergic reactions.
How OMNARIS Works
This medication works by converting into an active metabolite called des-ciclesonide after it is applied to the nasal passages. This active form has a high affinity for glucocorticoid receptors, allowing it to reduce inflammation by affecting various cell types and chemical mediators involved in the allergic response.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2006-10-20
- Patent Cliff
- 2028
- Routes
- NASAL
- Dosage Forms
- SPRAY, SPRAY, METERED
OMNARIS Approval History
What OMNARIS Treats
1 indicationsOMNARIS is approved for 1 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Allergic Rhinitis
OMNARIS 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 OMNARIS
3 of 18FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04356495 COVERAGEFrance | CHUBX 2020/12 2020-001435-27 | Ph 2, Ph 3 | completed | Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation |
| NCT04870333 PROTECT-V | CCTU0307 2020-004144-28 | Ph 2, Ph 3 | completed | PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V |
| NCT04377711 results posted | ALV-020-001 | Ph 3 | completed | A Study of the Safety and Efficacy of Ciclesonide in the Treatment of Non-hospitalized COVID-19 Patients |
| NCT04435795 CONTAIN results posted | 2021-6696 | Ph 2, Ph 3 | terminated | Inhaled Ciclesonide for Outpatients With COVID19 |
| NCT01455194 CONTRAST results posted | CL-9709-301-RD 2011-000683-99, U1111-1133-6333 | Ph 3 | completed | Effect of High Dose Ciclesonide on Asthma Control |
| NCT02155881 results posted | CIC-RR-001 U1111-1152-9472 | Ph 3 | completed | Efficacy and Safety of Ciclesonide Nasal Spray in Participants With Seasonal Allergic Rhinitis (SAR) in Russia |
| NCT00826969 | BY9010/CH-101 U1111-1137-3949 | Ph 4 | completed | Ciclesonide for the Treatment of Airway Hyperresponsiveness |
| NCT02221375 | 1256.1 | Ph 1 | completed | Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of Butylated Hydroxytoluene and BI 54903 XX Via Respimat® Soft MistTM Inhaler B in Healthy Male Volunteers |
| NCT01248065 VIDA results posted | AsthmaNet 001 1U10HL098115 | Ph 3 | completed | Study of the Effect of Vitamin D as an Add-on Therapy to Corticosteroids in Asthma |
| NCT01171365 SPIRA | 09115 | Ph 4 | completed | Small Particle Steroids in Refractory Asthma |
| NCT01401465 results posted | 060-302 | Ph 3 | completed | Study To Evaluate Patient Preference, Satisfaction And Efficacy Of a Nasal Aerosol Versus an Aqueous Nasal Spray |
| NCT01430260 | HANDOK2010.07 | Ph 4 | completed | Omnaris Versus Levocetirizine Phase 4 Study |
| NCT01333800 | CO-AL-FE-001 | Ph 4 | completed | Cost-effectiveness Study of Beclomethasone Versus Ciclesonide as Controller Medications in Pediatric Asthma |
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.
OMNARIS FDA Label Details
Indications & Usage
FDA Label (PDF)OMNARIS is indicated for the treatment of Allergic Rhinitis.
OMNARIS Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for OMNARIS
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 1 active patents
Trial Analysis
- • 13 total trials
- • Stage: Declining
Competitive Landscape
- • 18 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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment