ALVESCO (ciclesonide)
Alvesco is an inhaled medication used for the long-term management of asthma in adults and adolescents aged 12 and older. It helps patients by providing ongoing preventative therapy to maintain airway stability rather than providing immediate relief during an acute attack. Because its effects are not instant, it is prescribed as a daily maintenance routine to help control symptoms over time.
How ALVESCO Works
Once inhaled, this prodrug converts into an active metabolite that binds to glucocorticoid receptors to produce anti-inflammatory effects. It works by inhibiting various immune cells and chemical mediators, such as histamine and cytokines, that contribute to the asthmatic response. This reduction in airway inflammation helps manage the condition, though patients may not see the full benefit for four weeks or longer.
Details
- Status
- Prescription
- First Approved
- 2008-01-10
- Patent Cliff
- 2028
- Routes
- INHALATION
- Dosage Forms
- AEROSOL, METERED
ALVESCO Approval History
What ALVESCO Treats
1 indicationsALVESCO is approved for 1 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
ALVESCO 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 ALVESCO
3 of 20FDA-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.
ALVESCO FDA Label Details
Indications & Usage
FDA Label (PDF)ALVESCO is indicated for the treatment of Asthma.
ALVESCO Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for ALVESCO
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.