NDAINHALATIONAEROSOL, METERED
Approved
Jan 2008
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
6/8 — Strong
ALVESCO (ciclesonide) by Azurity is metabolite, c21-desisobutyryl-ciclesonide (des-ciclesonide or rm1) following oral inhalation. First approved in 2008.
Drug data last refreshed 4h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALVESCO (ciclesonide) is an inhaled corticosteroid approved in 2008 for the treatment of asthma. It is a prodrug that undergoes hepatic metabolism to its active metabolite des-ciclesonide (RM1), which exhibits 120-fold greater glucocorticoid receptor affinity than the parent compound. Ciclesonide works by inhibiting multiple inflammatory cell types and mediators involved in the asthmatic response, with maximum clinical benefit typically achieved within 4 weeks of initiation.
$0.035BPart D
LOE Approaching1.3 years to LOEWith LOE approaching in 2028 and $35M in annual Part D spending, the brand team is likely contracting and focused on lifecycle extension or transition planning rather than growth initiatives.
Mechanism of Action
metabolite, C21-desisobutyryl-ciclesonide (des-ciclesonide or RM1) following oral inhalation. Des-ciclesonide has anti-inflammatory activity with affinity for glucocorticoid receptors that is 120 times greater than the parent compound and 12 times greater than dexamethasone. The clinical…
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
Observational Study on Efficacy of Alvesco(Ciclesonide) in Asthma Children and Adolescent in Real Practice
Started Jul 2010
274 enrolled
Asthma
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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.