Last reviewed 2026-04-20 · How we verify

Omnaris (CICLESONIDE)

Omnaris works by binding to the glucocorticoid receptor, which then reduces inflammation in the airways.

Omnaris (ciclesonide) is a small molecule glucocorticoid receptor agonist developed by Takeda GmbH and currently owned by Covis. It is FDA-approved for the treatment of allergic rhinitis, asthma, and asthma management. Omnaris works by targeting the glucocorticoid receptor to reduce inflammation in the airways. It has a short half-life of 1.04 hours and low bioavailability of 1%. Omnaris is a patented medication with no generic manufacturers available.

At a glance

Mechanism of action

Ciclesonide, is prodrug, that is enzymatically hydrolyzed to pharmacologically active 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 significance of these findings is unknown.The precise mechanisms of corticosteroid action in asthma are unknown. Inflammation is recognized as an important component in the pathogenesis of asthma. Corticosteroids have been shown to have wide range of inhibitory activities against multiple cell types (e.g., mast cells, eosinophils, basophils, lymphocytes, macrophages, and neutrophils) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in the asthmatic response. These anti-inflammatory actions of corticosteroids may contribute to their efficacy in asthma. Though

Approved indications

• Allergic rhinitis
• Asthma
• Asthma management
• Seasonal allergic rhinitis

Common side effects

• Headache
• Epistaxis
• Nasopharyngitis
• Ear Pain
• Pharyngolaryngeal pain
• Nasal discomfort

Key clinical trials

• Inhaled Ciclesonide Study in Preterm Infants (PHASE1)
• Asthma Research in Children and Adolescents
• PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V (PHASE2,PHASE3)
• Individualizing Treatment for Asthma in Primary Care (PHASE4)
• Periostin-guided Withdrawal of Inhaled Corticosteroids in Patients With Non-eosinophilic Asthma (PHASE4)
• Evaluate the Therapeutic Effect of Inhaled Corticosteroid in Asthmatic Children
• Comparison Between Systemic Exposure to Ciclesonide Nasal Spray, Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide (BY9010/M1-422) (PHASE4)
• A Study of the Safety and Efficacy of Ciclesonide in the Treatment of Non-hospitalized COVID-19 Patients (PHASE3)

Patents

Primary sources

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