Ciclesonide

Ciclesonide is a 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 parent compound.

• OMNARIS Nasal Spray is a corticosteroid indicated for treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older and perennial allergic rhinitis in adults and adolescents 12 years of age and older. ( 1.1 , 1.2 ) 1.1 Treatment of Seasonal Allergic Rhinitis OMNARIS Nasal Spray is indicated for the treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older.ICD-10: J30.9

• OMNARIS Nasal Spray is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of OMNARIS Nasal Spray [see Warnings and Precautions ( 5.3 )] . Patients with a known hypersensitivity to ciclesonide or any of the ingredients of OMNARIS Nasal Spray.contraindicated

Administer OMNARIS Nasal Spray by the intranasal route only. Prior to initial use, OMNARIS Nasal Spray must be gently shaken and then the pump must be primed by actuating eight times. If the product is not used for four consecutive days, it should be gently shaken and reprimed with one spray or until a fine mist appears. Illustrated patient’s instructions for proper use accompany each package of OMNARIS Nasal Spray. For Intranasal Use Only • 2 sprays per nostril once daily. (200 mcg) ( 2.1 , 2.2 ) • Priming Information: Gently shake and prime OMNARIS Nasal Spray before using for the first time or when not used for four consecutive days. ( 2 ) 2.1 Seasonal Allergic Rhinitis Adults and Children (6 Years of Age and Older): The recommended dose of OMNARIS Nasal Spray is 2 sprays per nostril once daily (200 mcg). The maximum total daily dosage should not exceed 2 sprays in each nostril (200 mcg/day). 2.2 Perennial Allergic Rhinitis Adults and Adolescents (12 Years of Age and Older): The recommended dose of OMNARIS Nasal Spray is 2 sprays per nostril once daily (200 mcg). The maximum total daily dosage should not exceed 2 sprays in each nostril (200 mcg/day).

• Epistaxis, Candida albicans infection, nasal septal perforation, impaired wound healing. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid spraying OMNARIS directly onto the nasal septum. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma. ( 5.1 ) • Development of glaucoma or cataracts. Monitor patients closely with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts. ( 5.2 ) • Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients. Use caution in patients with the above because of the potential for worsening of these infections. ( 5.3 ) • Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue OMNARIS Nasal Spray slowly. ( 5.4 ) • Potential reduction in growth velocity in children. Monitor growth routinely in pediatric patients receiving OMNARIS Nasal Spray. ( 5.5 , 8.4 ) 5.1 Local Nasal Effects Epistaxis : In clinical studies of 2 to 52 weeks’ duration, epistaxis was observed more frequently in patients treated with OMNARIS Nasal Spray than those who received placebo [see Adverse Reactions ( 6 )] . Candida Infection : In clinical studies with OMNARIS Nasal Spray, the development of localized infections of the nose and pharynx with Candida albicans has occurred.

Systemic and local corticosteroid use may result in the following: • Epistaxis, nasal septal perforations, Candida albicans infection, impaired wound healing [see Warnings and Precautions ( 5.1 )] • Cataracts and glaucoma [see Warnings and Precautions ( 5.2 )] • Immunosuppression [see Warnings and Precautions ( 5.3 )] • Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction [see Warnings and Precautions ( 5.4 , 5.5 ), Use in Specific Populations ( 8.4 )] The most common adverse reactions (>2% incidence) included headache, epistaxis, nasopharyngitis, ear pain, and pharyngolaryngeal pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Covis Pharma at 1-866-488-4423 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below for adults and adolescents 12 years of age and older are based on 3 clinical trials of 2 to 6 weeks duration and one 52-week trial. In the 3 trials of 2 to 6 weeks duration, 1524 patients (495 males and 1029 females, ages 12 to 86 years old) with seasonal or perennial allergic rhinitis were treated with OMNARIS Nasal Spray 200, 100, 50, or 25 mcg or placebo once daily. The racial distribution in these three trials included 1374 Caucasians, 69 Blacks, 31 Asians, and 50 patients classified as Other.

8.1 Pregnancy Risk Summary There are no data on ONMARIS nasal spray use in pregnant women to assess a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes . There is low systemic exposure following OMNARIS nasal spray administration at the recommended dose [see Clinical Pharmacology ( 12.3 )] . In animal reproduction studies, ciclesonide, administered by the oral route to pregnant rats, during the period of organogenesis, did not cause any evidence of fetal harm at doses up 45 times the maximum recommended human daily intranasal dose (MRHDID) of 200 mcg/day. Teratogenicity, characteristic of corticosteroids, decreased body weight and/or skeletal variations were observed in rabbit fetuses following administration of ciclesonide to pregnant rabbits by the subcutaneous route during the period of organogenesis at doses 0.5 times the MRHDID and higher on a mcg/m 2 basis (see Data ). No evidence of fetal harm was observed in rabbits at doses 0.1 times the MRHDID. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

Metabolism

Absorption : Ciclesonide and des-ciclesonide have negligible oral bioavailability (both less than 1%) due to low gastrointestinal absorption and high first-pass metabolism. The intranasal administration of ciclesonide at recommended doses results in negligible serum concentrations of ciclesonide.

Chronic overdosage may result in signs or symptoms of hypercorticism [see Warnings and Precautions ( 5.4 )] . There are no data available on the effects of acute or chronic overdosage with OMNARIS Nasal Spray.

• Oct 20, 2006NDANDA022004Azurity
• Jan 10, 2008NDANDA021658Covis

1. 1Asthma5,80944%
2. 2Dyspnoea4,57234%
3. 3Wheezing3,67228%
4. 4Therapeutic Product Effect Incomplete2,58719%
5. 5Cough2,54419%
6. 6Obstructive Airways Disorder1,80113%
7. 7Loss Of Personal Independence In Daily Activities1,77213%
8. 8Pneumonia1,72913%
9. 9Drug Ineffective1,53812%
10. 10Productive Cough1,49411%
11. 11Sleep Disorder Due To A General Medical Condition1,47011%
12. 12Fatigue1,2719.5%
13. 13Chest Discomfort1,1999.0%
14. 14Malaise1,1368.5%
15. 15Condition Aggravated1,0648.0%

The 10 most recently updated of 87 ClinicalTrials.gov registrations naming Ciclesonide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation
  Completed · Phase 2 · Phase 3 · Interventional · 412 enrolled · University Hospital, Bordeaux
  NCT04356495updated 2026-05-12
• Inhaled Ciclesonide Study in Preterm Infants
  Recruiting · Phase 1 · Interventional · 30 enrolled · Venkatesh Sampath
  NCT06589245updated 2026-03-27
• Asthma Research in Children and Adolescents
  Active not recruiting · Observational · 525 enrolled · Parc de Salut Mar
  NCT04480242updated 2025-07-31
• PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V
  Completed · Phase 2 · Phase 3 · Interventional · 2,240 enrolled · Cambridge University Hospitals NHS Foundation Trust
  NCT04870333updated 2025-06-20
• Individualizing Treatment for Asthma in Primary Care
  Completed · Phase 4 · Interventional · 103 enrolled · DARTNet Institute
  NCT06272370updated 2025-04-20
• Periostin-guided Withdrawal of Inhaled Corticosteroids in Patients With Non-eosinophilic Asthma
  Completed · Phase 4 · Interventional · 20 enrolled · Hvidovre University Hospital
  NCT03141424updated 2025-03-17
• Evaluate the Therapeutic Effect of Inhaled Corticosteroid in Asthmatic Children
  Unknown · Observational · 100 enrolled · National Taiwan University Hospital
  NCT03487809updated 2023-09-21
• A Study of the Safety and Efficacy of Ciclesonide in the Treatment of Non-hospitalized COVID-19 Patients
  Completed · Phase 3 · Interventional · 400 enrolled · Covis Pharma S.à.r.l.
  NCT04377711updated 2023-02-09
• Comparison Between Systemic Exposure to Ciclesonide Nasal Spray, Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide (BY9010/M1-422)
  Completed · Phase 4 · Interventional · 30 enrolled · Covis Pharma S.à.r.l.
  NCT00458835updated 2023-02-09
• Early Treatment of Vulnerable Individuals With Non-Severe SARS-CoV-2 Infection
  Unknown · Phase 2 · Phase 3 · Interventional · 600 enrolled · ANRS, Emerging Infectious Diseases
  NCT04920838updated 2023-01-31

Frequently asked questions

How does Ciclesonide work?

Ciclesonide is a 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 parent compound.

What is Ciclesonide used for?

According to FDA labeling, Ciclesonide carries indications including: OMNARIS Nasal Spray is a corticosteroid indicated for treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older and perennial allergic rhinitis in adults and adolescents 12 years of age and older. ( 1.1 , 1.2 ) 1.1 Treatment of Seasonal Allergic Rhinitis OMNARIS Nasal Spray is indicated for the treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Ciclesonide?

Ciclesonide is classified as Corticosteroids, Glucocorticoids, Glucocorticoid Receptor Agonists, Decreased Prostaglandin Production, Decreased Vascular Permeability.

What are the brand names for Ciclesonide?

Ciclesonide is marketed under brand names including Alvesco, Omnaris, Zetonna.

What are the contraindications for Ciclesonide?

Ciclesonide labeling lists contraindications including: OMNARIS Nasal Spray is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of OMNARIS Nasal Spray [see Warnings and Precautions ( 5.3 )] . Patients with a known hypersensitivity to ciclesonide or any of the ingredients of OMNARIS Nasal Spray.. Always consult the full prescribing information and a clinician.