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Ciclesonide
Clinical data
Trade namesOmnaris, others
Other names(11β, 16α)-16, 17-[[(R)-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21- (2-methyl-1-oxopropoxy)- pregna-1, 4-diene-3, 20-dione
AHFS/Drugs.comMonograph
MedlinePlusa607008
Pregnancy
category
  • AU: B3
Routes of
administration		Nasal inhalation
ATC code
Legal status
Legal status
Identifiers
  • 2-[(1S, 2S, 4R, 8S, 9S,11S, 12S, 13R)-6-cyclohexyl-11-hydroxy-9, 13-dimethyl-16-oxo-5, 7-dioxapentacyclo [10.8.0.02,9.04, 8.013,18] icosa-14, 17-dien-8-yl]- 2-oxoethyl 2-methylpropanoate
CAS Number
PubChem CID
IUPHAR/BPS
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
CompTox Dashboard (EPA)
ECHA InfoCard100.210.908 Edit this at Wikidata
Chemical and physical data
FormulaC32H44O7
Molar mass540.697 g·mol−1
3D model (JSmol)
  • O=C(OCC(=O)[C@]25O[C@@H](O[C@@H]5C[C@H]1[C@H]4[C@H]([C@@H](O)C[C@@]12C)[C@]/3(/C=C\C(=O)\C=C\3CC4)C)C6CCCCC6)C(C)C
  • InChI=1S/C32H44O7/c1-18(2)28(36)37-17-25(35)32-26(38-29(39-32)19-8-6-5-7-9-19)15-23-22-11-10-20-14-21(33)12-13-30(20,3)27(22)24(34)16-31(23,32)4/h12-14,18-19,22-24,26-27,29,34H,5-11,15-17H2,1-4H3/t22-,23-,24-,26+,27+,29+,30-,31-,32+/m0/s1 checkY
  • Key:LUKZNWIVRBCLON-GXOBDPJESA-N checkY
 ☒NcheckY (what is this?)  (verify)

Ciclesonide, sold under the brand name Omnaris among others, is a glucocorticoid used to treat asthma and allergic rhinitis.

Side effects of the medication include headache, nosebleeds, and inflammation of the nose and throat linings.[6]

It was patented in 1990 and approved for medical use in 2005.[7] The drug was approved for adults and children 12 and over by the US Food and Drug Administration in October 2006.[8] It is on the World Health Organization's List of Essential Medicines.[9]

Society and culture

[edit]

Brand names

[edit]

It is marketed under the brand names Alvesco for asthma and Omnaris, Omniair, Zetonna, and Alvesco for hay fever in the US and Canada.

References

[edit]

Further reading

[edit]
Revisions and contributorsEdit on WikipediaRead on Wikipedia

Ciclesonide

View on Grokipedia
from Grokipedia
Ciclesonide is a synthetic that serves as an anti-inflammatory medication primarily used to manage and . Administered via oral inhalation under brand names like Alvesco, it prevents symptoms such as wheezing, , and chest tightness in adults and adolescents aged 12 years and older by reducing airway . As a (Omnaris) or nasal (Zetonna), it alleviates , sneezing, and itching associated with seasonal and perennial in the same age group. The drug's nature allows minimal systemic absorption, with activation occurring locally in the target tissues to minimize side effects. Ciclesonide exerts its effects through its , desisobutyryl-ciclesonide (des-ciclesonide), which binds to receptors in the of target cells, translocating to the nucleus to inhibit inflammatory genes and mediators like cytokines and . This mechanism suppresses leukocyte infiltration, permeability, and immune responses, providing potent action comparable to or exceeding that of other inhaled corticosteroids like fluticasone. Pharmacologically, ciclesonide demonstrates negligible oral (less than 1%) and high protein binding (>99%), with metabolism primarily via hepatic and enzymes, contributing to its favorable safety profile for long-term use. For , typical dosing starts at 80 mcg inhaled twice daily, increasing to 160 mcg if needed; for , Omnaris involves 100 mcg (2 sprays of 50 mcg) per once daily, while Zetonna involves 37 mcg per once daily. First approved by the U.S. for nasal use in October 2006 (Omnaris) and for inhalation in January 2008 (Alvesco), ciclesonide was developed by Pharma (later acquired by Nycomed and Takeda) to address unmet needs in respiratory and control. An inhalation aerosol formulation (Alvesco HFA) and nasal aerosol (Zetonna, approved 2012) expanded its delivery options. As of 2025, generic versions are available in some markets. During the , inhaled ciclesonide was investigated in clinical trials for outpatient treatment to reduce and in the airways, with studies showing no significant impact on symptom resolution, hospitalization rates, or overall efficacy compared to . Its primary indications remain asthma prophylaxis and management.

Medical uses

Asthma management

Ciclesonide is indicated for the maintenance treatment of as prophylactic therapy in adults and adolescents aged 12 years and older. It is not indicated for the relief of acute or the management of status asthmaticus, for which short-acting should be used instead. The recommended starting dose for is 80 mcg twice daily in patients previously maintained on therapy alone or on inhaled corticosteroids, while those previously treated with should start at 320 mcg twice daily, with gradual tapering of the systemic under medical supervision. Doses may be titrated downward to the lowest effective amount to control symptoms while minimizing potential adverse effects. After each , patients should rinse their mouth with water and spit it out to reduce the incidence of . Ciclesonide is delivered via a such as Alvesco, which does not require shaking before use. The must be primed by releasing three test sprays into the air if it is new or has not been used for more than 10 days. To administer, patients remove the cap, exhale fully, place the mouthpiece in the mouth, inhale deeply and slowly while actuating the canister once, hold the breath for about 10 seconds, and then exhale gently. The mouthpiece should be cleaned weekly with a dry cloth. Clinical trials in patients aged 12 years and older have shown that ciclesonide significantly improves lung function compared to , with increases in forced expiratory volume in one second (FEV1) of 0.24 L (10.4%) at 80 mcg twice daily in those previously on bronchodilators and 0.19 L (7.5%) at the same dose in those switching from other inhaled corticosteroids. It reduces the frequency of exacerbations—for instance, by approximately 50% at higher doses—and decreases rescue medication use while improving morning . In patients dependent on oral corticosteroids, ciclesonide enables substantial reductions in systemic doses, up to 62% with 640 mcg daily, without loss of control. These benefits are supported by multiple randomized controlled trials demonstrating superiority over and equivalence to other inhaled corticosteroids like and fluticasone in symptom control and exacerbation prevention.

Allergic rhinitis treatment

Ciclesonide intranasal spray is indicated for the treatment of nasal symptoms, such as sneezing, itching, , and , associated with seasonal in adults and children 6 years of age and older, and perennial in adults and adolescents 12 years of age and older. The recommended dosage for adults and adolescents 12 years and older is two sprays (50 mcg per spray) in each once daily, totaling 200 mcg of ciclesonide per day. For children 6 to 11 years of age with seasonal , the same dosage is used. The device must be primed before first use by shaking the bottle well and actuating the pump eight times; if not used for more than four consecutive days, re-prime with one spray. Clinical trials have demonstrated the efficacy of intranasal ciclesonide in reducing symptoms of . In two 2-week for seasonal allergic rhinitis involving adults and adolescents, the 200 mcg daily dose produced a statistically significant reduction in reflective total nasal symptom scores (rTNSS) of -5.73 compared to -4.38 for (p=0.014). For perennial allergic rhinitis, a 6-week trial in adults and adolescents showed a -2.51 change in rTNSS with 200 mcg versus -1.89 for (p<0.001). Symptom relief typically begins within 24 to 48 hours, with maximal benefit achieved over 1 to 2 weeks. These formulations exhibit minimal systemic absorption due to local activation of ciclesonide as a in nasal tissues. Administration involves directing the spray into the nostrils while gently inhaling through the nose, with care to avoid spraying toward the or into the eyes. For seasonal , treatment is typically limited to up to 6 weeks or as needed during the season; for , it may be used continuously under medical supervision as symptoms persist year-round. An alternative formulation, ciclesonide nasal aerosol (e.g., Zetonna), is approved for both seasonal and in patients 12 years and older at a lower dose of 74 mcg daily (one 37 mcg actuation per nostril).

Contraindications and precautions

Absolute contraindications

Ciclesonide is absolutely contraindicated in patients with known to ciclesonide, its desisobutyryl-ciclesonide, or any excipients in the formulation, as this may lead to serious allergic reactions including , , or urticaria. The drug must not be used as primary for status asthmaticus or other acute episodes of that require intensive measures, since ciclesonide lacks immediate bronchodilatory effects and intensive interventions such as systemic corticosteroids or bronchodilators are necessary in these scenarios.

Ciclesonide inhalation (Alvesco) is approved by the FDA for the maintenance treatment of as prophylactic in adults and adolescents aged 12 years and older. For , ciclesonide (Omnaris) is approved for seasonal in adults and children aged 6 years and older and for perennial in adults and adolescents aged 12 years and older, while the nasal formulation (Zetonna) is approved for patients aged 12 years and older. and have not been established in children younger than 6 years for nasal use or 12 years for inhaled use, primarily due to concerns over potential growth suppression associated with inhaled corticosteroids. Although clinical studies have shown no detectable effect on growth velocity in prepubertal children treated with ciclesonide for up to one year, routine monitoring of height is recommended in pediatric patients using inhaled or nasal formulations to detect any potential systemic effects.

Pregnancy

There are no adequate data from prospective studies on the developmental risks of ciclesonide in pregnant women. In animal reproduction studies, of ciclesonide to pregnant rats and rabbits at doses up to 900 mcg/kg/day revealed no teratogenic effects, though reduced fetal body weights were observed at high doses. In , it is categorized as TGA B3, based on limited from pregnant women without an increase in malformations but with evidence of fetal harm in at high exposures. Due to the lack of sufficient human , ciclesonide should be used during only if the potential benefit justifies the potential risk to the .

Lactation

Inhaled and nasal ciclesonide exhibit low systemic , resulting in minimal levels in . Expert consensus from the of Medicine's LactMed database considers inhaled, nasal, and even oral corticosteroids, including ciclesonide, acceptable for use during due to negligible infant exposure and no observed adverse effects in breastfed infants. Nonetheless, caution is advised, and mothers may consider pumping and discarding milk for a period after dosing if concerned about potential exposure, though this is not routinely required.

Geriatrics

No specific dose adjustment is required for geriatric patients using ciclesonide inhalation or nasal formulations, though dose selection should be cautious, starting at the lower end of the dosing range due to the greater frequency of decreased hepatic, renal, or cardiac function and concomitant or other in this population. Elderly patients may face a higher risk of infections associated with use, necessitating close monitoring. In patients with hepatic impairment, systemic exposure to the desisobutyryl-ciclesonide may increase (up to 2.7-fold in severe cases), but no dose adjustment is needed; monitoring for adverse effects is recommended.

Renal Impairment

No dosage adjustment is necessary for patients with renal impairment, as renal excretion accounts for less than 20% of the elimination of ciclesonide's , des-ciclesonide. Specific studies in renally impaired patients have not been conducted, but the minimal renal involvement supports standard dosing.

Adverse effects

Common adverse effects

Ciclesonide, when administered via for management, is associated with several common mild to moderate adverse effects observed in clinical trials. The most frequently reported include , occurring in up to 11% of patients at higher doses (160 mcg twice daily), nasopharyngitis in up to 10.5%, and in up to 5.5%, with incidences generally comparable to (7.3% for , 7.5% for nasopharyngitis, and 3% for ). Other notable effects encompass pharyngolaryngeal pain (up to 4.7%), (up to 8.7%), and (up to 3.1%), all of which typically resolve spontaneously without intervention. , a local effect due to the corticosteroid's deposition, affects approximately 1% of users (32 cases in 3,038 patients across trials), and its incidence can be minimized by rinsing the with after each . For intranasal administration in treatment, common adverse effects are primarily localized to the nasal passages. Epistaxis (nosebleeds) occurs in about 2.9% of patients in short-term trials (2-6 weeks) but rises to 11.4% in longer-term use (26 weeks), while nasal discomfort is reported in 3.2% and in 3.1%. affects around 2% of users, and nasal ulceration or erosion is less common, with an overall incidence of mucosal or septal disorders at 0.8%. These effects, similar in frequency to in pivotal trials, often resolve without specific treatment, though maintaining nasal and avoiding direct spraying on the can help prevent or ulceration. Across both routes, long-term clinical data indicate that the overall incidence of these adverse effects remains low and does not differ significantly from placebo, reflecting ciclesonide's prodrug activation that limits systemic exposure.

Serious adverse effects

Ciclesonide, when administered via inhalation or nasal spray, carries risks of systemic corticosteroid effects, including adrenal suppression and insufficiency, particularly in patients transitioning from oral corticosteroids or using high doses for extended periods. Symptoms of adrenal insufficiency may include fatigue, weakness, nausea, and hypotension, necessitating gradual tapering of therapy and monitoring of adrenal function through periodic tests such as morning plasma cortisol levels. Cushing's syndrome and features such as moon face or buffalo hump can also occur with excessive systemic exposure, though the drug's low oral bioavailability helps minimize these risks compared to other inhaled corticosteroids. In pediatric patients, long-term use of ciclesonide has been associated with growth retardation, with potential reductions in growth velocity observed in children and adolescents; routine monitoring via height measurements is recommended, and the lowest effective dose should be used to mitigate this effect. Chronic administration may lead to decreased density, increasing the risk of , especially in high-risk groups such as postmenopausal women or those with a history of fractures; assessments are advised for long-term users. Immunosuppression from ciclesonide elevates the risk of infections, including opportunistic ones such as oropharyngeal , , and reactivation of or viral infections like herpes zoster. Patients with active or quiescent infections should be closely monitored, and exposure to contagious diseases like or should be avoided, as these can result in severe or fatal outcomes in susceptible individuals. Ocular adverse effects, including the development of cataracts and , have been reported with prolonged high-dose use of ciclesonide, particularly in patients with a family history of these conditions; regular eye examinations, including intraocular pressure measurements, are essential for long-term users to detect changes early. Hypersensitivity reactions, though rare, can manifest as or involving swelling of the lips, tongue, or , requiring immediate discontinuation and appropriate intervention. Post-marketing has identified these reactions but no new major safety signals as of recent reviews.

Pharmacology

Pharmacodynamics

Ciclesonide is a that undergoes enzymatic hydrolysis by esterases to its pharmacologically , desisobutyryl-ciclesonide (also known as des-CIC or RDC), primarily in the target tissues of the lungs or . This activation process results in des-CIC exhibiting a high affinity for the (GR), approximately 120 times greater than that of the parent compound ciclesonide and about 12 times greater than dexamethasone. Upon binding to the cytoplasmic GR, the des-CIC-GR complex translocates to the nucleus, where it modulates gene transcription by binding to glucocorticoid response elements and suppressing the activity of pro-inflammatory transcription factors such as . This nuclear action inhibits the expression of multiple inflammatory genes, leading to reduced production of pro-inflammatory cytokines including interleukin-1 (IL-1), interleukin-6 (IL-6), and tumor factor-alpha (TNF-α), as well as decreased recruitment and activation, and diminished hypersecretion in airway tissues. The therapeutic effects of ciclesonide stem from this targeted anti-inflammatory mechanism, which provides high topical potency at the site of administration while minimizing systemic exposure. The active metabolite des-CIC demonstrates low oral bioavailability (<1%), ensuring that any swallowed portion of the drug remains largely inactive and is not absorbed systemically in significant amounts. Consequently, ciclesonide exhibits a favorable safety profile with reduced risk of glucocorticoid-related systemic adverse effects compared to other inhaled corticosteroids. Unlike bronchodilators, ciclesonide lacks direct airway relaxation properties and does not provide immediate symptom relief. Instead, it is intended for long-term control of and is commonly used in with short- or long-acting beta2-agonists to achieve comprehensive or management.

Ciclesonide is a administered via or intranasal spray, exhibiting a pharmacokinetic profile characterized by low systemic exposure due to its activation primarily at the site of action in the lungs or nasal passages. The parent compound undergoes rapid conversion to its , desisobutyryl-ciclesonide (des-CIC), which drives the therapeutic effects while minimizing unwanted systemic activity.

Absorption

Following , ciclesonide demonstrates an absolute of approximately 22% for the parent drug, with the hydrofluoroalkane (HFA) formulation enhancing deposition to 50-60% of the delivered dose, thereby promoting targeted delivery to the lower airways. The active metabolite des-CIC exhibits negligible oral (<1%), attributable to extensive first-pass metabolism in the and liver, which limits systemic absorption from swallowed portions of the dose. Intranasal administration yields a similar profile, with low systemic absorption and peak plasma concentrations of des-CIC occurring 1-2 hours post-dose.

Distribution

Both ciclesonide and des-CIC are highly bound to plasma proteins, with binding exceeding 99%, resulting in minimal free fractions available for systemic distribution. The volume of distribution is approximately 2.9 L/kg for ciclesonide and 12.1 L/kg for des-CIC, indicating substantial tissue penetration, particularly in the lungs where up to 55% of the inhaled dose localizes to small airways and alveoli.

Metabolism

Ciclesonide is rapidly hydrolyzed by esterases in the and nasal tissues to form the active des-CIC, with this conversion occurring predominantly at the site of administration to reduce systemic exposure to the parent compound. Des-CIC is subsequently metabolized in the liver primarily by , with minor contributions from , to inactive metabolites, ensuring efficient clearance of the active form.

Excretion

Elimination of ciclesonide and its metabolites occurs mainly via the fecal route, with approximately 66% excreted in through biliary elimination following intravenous administration; renal accounts for less than 10-20% of the dose. The terminal half-life of des-CIC is 6-7 hours, while the parent drug has a shorter of about 0.71 hours, with steady-state plasma concentrations achieved after approximately one week of daily dosing.

Chemistry

Chemical structure

Ciclesonide is a synthetic with the molecular formula C32_{32}H44_{44}O7_{7} and a of 540.70 g/mol. Its systematic IUPAC name is 2-[(1S,2S,4R,6R,8S,9S,11S,12S,13R)-6-cyclohexyl-11-hydroxy-9,13-dimethyl-16-oxo-5,7-dioxapentacyclo[10.8.0.02,9^{2,9}.04,8^{4,8}.013,18^{13,18}]icosa-14,17-dien-8-yl]-2-oxoethyl 2-methylpropanoate. The molecule features a pregnane skeleton, characteristic of corticosteroids, with a Δ1,4^{1,4}- system between C1-C2 and C4-C5, a group at C3, and another at C20 of the side chain. At C11, there is a β-hydroxy group, while the C21 position bears an isobutyryl (2-methylpropanoyloxy) side chain, rendering ciclesonide a that undergoes enzymatic to its active form primarily in the lungs. Additionally, positions C16 and C17 are bridged by a cyclic involving (R)-cyclohexylmethylene dioxy, which enhances its and tissue targeting. Ciclesonide exhibits defined at multiple chiral centers, including 8S, 9S, 11S, 13R, and others as specified in its IUPAC designation, which is crucial for its selective binding affinity to the . This configuration aligns with the structural requirements for potent activity while minimizing systemic effects.

Physical and chemical properties

Ciclesonide is a white to yellow-white powder. It exhibits low in , with a reported value of less than 0.1 mg/mL, rendering it practically insoluble, while it demonstrates good solubility in organic solvents including , , acetone, , and . The compound's is reflected in its (logP) of approximately 4.1, which facilitates penetration through lipid membranes. Ciclesonide has a ranging from 202 to 209 °C and a pKa value of about 14.8, indicating it behaves as a very weak . It remains stable under standard conditions (25 °C, with excursions permitted between 15 and 30 °C), but shows sensitivity to light exposure, in aqueous environments, and treatment, oxidation, and elevated temperatures. For pharmaceutical applications, ciclesonide is incorporated into hydrofluoroalkane (HFA)-propelled metered-dose inhalers with as a or formulated as hypotonic aqueous suspensions for delivery devices, requiring protection from freezing and storage in upright positions to maintain integrity.

History

Development and discovery

Ciclesonide was developed by Altana Pharma, a German pharmaceutical company later acquired by Takeda, during the 1990s as an innovative inhaled corticosteroid designed as a prodrug to reduce systemic exposure while targeting respiratory inflammation. This approach aimed to overcome drawbacks of prior inhaled corticosteroids, such as significant oral bioavailability and resulting hypothalamic-pituitary-adrenal (HPA) axis suppression from swallowed portions of the drug. The compound's invention led to a key patent filing on September 7, 1990, with US Patent No. 5,482,934 granted for pregna-1,4-diene-3,20-dione-16,17-acetal-21 esters, encompassing ciclesonide and related formulations for applications. Preclinical investigations confirmed the prodrug's activation mechanism, with in vitro studies demonstrating enzymatic by esterases to its , desisobutyryl-ciclesonide, while minimal activation occurred in oropharyngeal or systemic tissues. In animal models, including rats, ciclesonide exhibited superior lung retention of the active form and reduced systemic effects, showing 44-fold lower potency in HPA axis suppression compared to fluticasone propionate after intratracheal administration, alongside comparable efficacy in airway and models. These findings highlighted ciclesonide's potential to address limitations of earlier agents like beclomethasone, which demonstrated greater systemic activity in similar preclinical setups. Early development in the further emphasized asthma-focused animal models to validate its localized action. More recently, in 2025, preclinical research has advanced toward combination therapies, developing spray-dried dry powder formulations of ciclesonide with long-acting beta-agonists such as indacaterol to enhance delivery efficiency and adherence in management.

Regulatory approvals

Ciclesonide's regulatory pathway was supported by multiple phase III clinical trials conducted between 2004 and 2005, which established its efficacy for management. These trials, involving patients with persistent , demonstrated that once-daily inhaled ciclesonide at 320 μg was non-inferior to at equivalent doses in improving lung function, reducing symptoms, and minimizing rescue medication use, as measured by forced expiratory volume in one second (FEV1) and control scores. For nasal formulations, phase III studies showed significant symptom relief compared to in patients with seasonal and perennial , with reductions in total nasal symptom scores by approximately 20-30% over 2-6 weeks, alongside improvements in quality-of-life metrics. The European Medicines Agency (EMA) granted approval for inhaled ciclesonide (as Alvesco) in 2005 for the maintenance treatment of mild to severe persistent asthma in adults. In the United States, the Food and Drug Administration (FDA) approved the nasal spray formulation (Omnaris) in October 2006 for allergic rhinitis in adults and adolescents aged 12 years and older, followed by approval of the inhaled formulation (Alvesco) in January 2008 for asthma prophylaxis in the same age group. The FDA later approved the dry powder nasal aerosol (Zetonna) in January 2012, expanding options for allergic rhinitis treatment with once-daily dosing at 74 μg. Regulatory expansions included extensions to pediatric populations in various regions; for instance, approvals for inhaled ciclesonide were broadened to children aged 6 to 11 years in by 2020, based on pharmacokinetic and efficacy data bridging from adult and adolescent trials. In 2021, the added ciclesonide to its Model List of (22nd list) for use in management, recognizing its role in resource-limited settings as a therapeutic equivalent to . Post-marketing surveillance has not identified major safety issues leading to withdrawals or label changes for systemic risks, with ongoing monitoring confirming a favorable profile similar to other inhaled corticosteroids, including low rates of hypothalamic-pituitary-adrenal axis suppression. As of 2025, updates include expanded veterinary applications, such as FDA approval of ciclesonide inhalation spray (Aservo EquiHaler) for severe equine asthma since 2020, with recent studies affirming its efficacy in reducing bronchoalveolar lavage fluid inflammation in racehorses with moderate asthma without altering systemic biomarkers. Limited clinical trials from 2020 to 2025 explored ciclesonide's role in COVID-19, with some demonstrating reduced airway inflammation markers in outpatients, though overall symptom resolution benefits were not consistently superior to placebo.

Society and culture

Brand names

Ciclesonide is available under various brand names, primarily differentiated by formulation type and geographic region. The inhaled for maintenance therapy is marketed as Alvesco, originally developed by Takeda Pharmaceuticals and currently distributed by Covis Pharma in the United States and . It is delivered via a hydrofluoroalkane (HFA) in strengths of 80 mcg and 160 mcg per actuation, with recommended daily doses ranging from 160 to 320 mcg administered twice daily. For intranasal aqueous suspension used in , the primary brand in the United States is Omnaris, also distributed by Covis Pharma following from Pharmaceuticals. It is formulated as a delivering 50 mcg per actuation, typically administered as two sprays per once daily. Generic versions of ciclesonide have entered markets following patent expirations, with availability in the since around 2015 for certain formulations. In the United States, no generic versions are approved as of November 2025, with patents for both inhaled and nasal products expiring in 2028. Ciclesonide is available by prescription only in the United States, where formulations such as the nasal spray Omnaris and the inhaled Alvesco require a doctor's order. In the European Union, Canada, and Australia, it is similarly classified as a prescription medication, approved by the EMA, Health Canada, and TGA respectively for treating allergic rhinitis and asthma. As a non-controlled substance, ciclesonide does not fall under any scheduling requirements for narcotics or substances of abuse. It is included on the World Health Organization's Model List of , recognizing its importance for managing respiratory conditions. In , the categorizes it as pregnancy category B3, indicating limited data from human use but no increased risk of malformations observed in animal studies. In the United States, the monthly cost for an Alvesco inhaler (typically one canister providing 30-60 days of treatment) ranges from approximately $157 with discounts to $290-$340 without , though no generic versions were available as of late 2025, potentially limiting cost reductions. The global ciclesonide market, driven by rising prevalence of and , was valued at around $683 million in 2023 and is projected to grow at a of 2.1%, reaching approximately $710 million by 2025. Despite its WHO status, access to ciclesonide remains limited in low- and lower-middle- countries due to challenges and higher costs relative to income levels, exacerbating gaps in treatment for chronic respiratory diseases.

References

  1. https://medlineplus.gov/druginfo/meds/a609004.html
  2. https://go.drugbank.com/drugs/DB01410
  3. https://www.drugs.com/history/omnaris.html
  4. https://pubmed.ncbi.nlm.nih.gov/18681495/
  5. https://reference.medscape.com/drug/alvesco-ciclesonide-inhaled-343436
  6. https://www.drugs.com/history/alvesco.html
  7. https://www.drugs.com/history/zetonna.html
  8. https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2786012
  9. https://pubmed.ncbi.nlm.nih.gov/41054293/
  10. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021658s006lbl.pdf
  11. https://pmc.ncbi.nlm.nih.gov/articles/PMC1661651/
  12. https://pmc.ncbi.nlm.nih.gov/articles/PMC3321670/
  13. https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022004s005lbl.pdf
  14. https://pmc.ncbi.nlm.nih.gov/articles/PMC3121337/
  15. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202129s004s005s006lbl.pdf
  16. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021658s011lbl.pdf
  17. https://www.medicines.org.uk/emc/product/13890/smpc#CONTRAINDICATIONS
  18. https://www.medicines.org.uk/emc/product/13890/smpc#SPECIAL-WARNINGS
  19. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202129s009lbl.pdf
  20. https://publications.aap.org/pediatrics/article/121/1/e1/71005/Assessment-of-the-Long-term-Safety-of-Inhaled
  21. https://www.tga.gov.au/sites/default/files/auspar-omnaris.pdf
  22. https://www.ncbi.nlm.nih.gov/books/NBK501458/
  23. https://www.drugs.com/breastfeeding/ciclesonide.html
  24. https://pmc.ncbi.nlm.nih.gov/articles/PMC2730082/
  25. https://www.drugs.com/pro/ciclesonide-nasal-spray.html
  26. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9f6112fb-78ef-43cf-8ae3-36370eb45468
  27. https://www.fda.gov/media/107042/download
  28. https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022124lbl.pdf
  29. https://pmc.ncbi.nlm.nih.gov/articles/PMC3048607/
  30. https://pmc.ncbi.nlm.nih.gov/articles/PMC3331580/
  31. https://pubmed.ncbi.nlm.nih.gov/15139796/
  32. https://pubmed.ncbi.nlm.nih.gov/20110036/
  33. https://pubmed.ncbi.nlm.nih.gov/17412829/
  34. https://journals.lww.com/lungindia/fulltext/2021/02000/is_there_a_role_for_inhaled_ciclesonide_in_the.1.aspx
  35. https://pubmed.ncbi.nlm.nih.gov/15878996/
  36. https://patents.google.com/patent/US5482934A/en
  37. https://www.researchgate.net/publication/7861983_Preclinical_Profile_of_Ciclesonide_a_Novel_Corticosteroid_for_the_Treatment_of_Asthma
  38. https://pubmed.ncbi.nlm.nih.gov/40345602/
  39. https://pubmed.ncbi.nlm.nih.gov/16427266/
  40. https://pubmed.ncbi.nlm.nih.gov/22370530/
  41. https://www.sciencedirect.com/science/article/pii/S1808869418305767
  42. https://www.sciencedirect.com/science/article/pii/S095461111000421X
  43. https://pdf.hres.ca/dpd_pm/00058252.PDF
  44. https://www.idafoundation.org/media/wysiwyg/PDF/WHO-MHP-HPS-EML-2021.pdf
  45. https://bi-animalhealth.com/equine/respiratory-health/aservo-equihaler
  46. https://onlinelibrary.wiley.com/doi/10.1111/jvim.17267
  47. https://www.bmj.com/content/375/bmj-2021-068060
  48. https://www.epo.org/en/boards-of-appeal/decisions/t161914eu1
  49. https://www.drugpatentwatch.com/p/tradename/OMNARIS
  50. https://www.goodrx.com/omnaris/what-is
  51. https://www.mayoclinic.org/drugs-supplements/ciclesonide-nasal-route/description/drg-20069835
  52. https://www.canadianpharmacyking.com/Drug/Omnaris
  53. https://www.canadadrugsdirect.com/products/alvesco
  54. https://www.drugs.com/pregnancy/ciclesonide.html
  55. https://www.drugs.com/pregnancy/ciclesonide-nasal.html
  56. https://list.essentialmeds.org/medicines/664
  57. https://www.goodrx.com/alvesco
  58. https://www.medicalnewstoday.com/articles/drugs-alvesco-cost
  59. https://www.talktomira.com/post/asthma-inhalers-cost-without-insurance-in-2021
  60. https://www.drugs.com/availability/generic-alvesco.html
  61. https://introspectivemarketresearch.com/reports/ciclesonide-market/
  62. https://pmc.ncbi.nlm.nih.gov/articles/PMC11187362/
  63. https://accesstomedicinefoundation.org/medialibrary/2022_access-to-medicine-index.pdf
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