CLINICAL TRIALS PROFILE FOR CICLESONIDE

All Clinical Trials for ciclesonide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00163293 ↗	Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101)	Completed	AstraZeneca	Phase 3	2005-01-01	The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of the number of asthma exacerbations in children with mild persistent asthma. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily, using one of the two dose levels versus placebo together with other corticosteroids used as intermittent treatment. The study duration consists of a baseline period (3 to 4 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.
NCT00163293 ↗	Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101)	Completed	Takeda	Phase 3	2005-01-01	The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of the number of asthma exacerbations in children with mild persistent asthma. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily, using one of the two dose levels versus placebo together with other corticosteroids used as intermittent treatment. The study duration consists of a baseline period (3 to 4 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.
NCT00163319 ↗	Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)	Completed	AstraZeneca	Phase 3	2004-11-01	The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone propionate on the lung function, symptoms, use of rescue medication, and occurrence of side effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (2 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.
NCT00163332 ↗	Effect of Inhaled Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (18 to 65 y) (BY9010/M1-129)	Completed	AstraZeneca	Phase 3	2003-03-01	The aim of the study is to investigate the effect of ciclesonide versus fluticasone propionate versus placebo on airway hyperresponsiveness and on the hypothalamic-pituitary-adrenal axis (HPA axis). Treatment medication will be administered as follows: ciclesonide or fluticasone propionate will be inhaled twice daily, using one of the two dose levels. The study duration consists of a baseline period (4 to 6 weeks), five treatment periods (9 days each), and a washout period between treatments (4 to 12 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Clinical Trial Conditions for ciclesonide

Condition Name

Condition Name for ciclesonide
Intervention	Trials
Asthma	34
Perennial Allergic Rhinitis	12
Hay Fever	10
Allergic Rhinitis	7

Condition MeSH

Condition MeSH for ciclesonide
Intervention	Trials
Asthma	36
Rhinitis, Allergic	31
Rhinitis	31
Rhinitis, Allergic, Seasonal	16

Clinical Trial Locations for ciclesonide

Trials by Country

Trials by Country for ciclesonide
Location	Trials
United States	272
Canada	13
Germany	9
South Africa	8
Hungary	8

Trials by US State

Trials by US State for ciclesonide
Location	Trials
Texas	21
California	18
New Jersey	17
Massachusetts	13
Georgia	13

Clinical Trial Progress for ciclesonide

Clinical Trial Phase

Clinical Trial Phase for ciclesonide
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	11
Phase 3	51

Clinical Trial Status

Clinical Trial Status for ciclesonide
Clinical Trial Phase	Trials
Completed	69
Recruiting	4
Terminated	1

Clinical Trial Sponsors for ciclesonide

Sponsor Name

Sponsor Name for ciclesonide
Sponsor	Trials
AstraZeneca	40
Sunovion	13
Takeda	10

Sponsor Type

Sponsor Type for ciclesonide
Sponsor	Trials
Industry	77
Other	29
NIH	2

Ciclesonide Clinical Trials Update, Market Analysis, and Revenue Projection (2026–2036)

Last updated: July 27, 2026

What is ciclesonide and where is it used clinically?

Ciclesonide is a corticosteroid used for anti-inflammatory treatment in airway diseases, primarily as an inhaled formulation for asthma and as intranasal therapy for allergic rhinitis. It is a prodrug corticosteroid with in vivo conversion to an active metabolite in target tissues.

Core clinical indications by route

• Inhaled ciclesonide (asthma): maintenance and control of asthma symptoms; reduces airway inflammation.
• Intranasal ciclesonide (allergic rhinitis): symptomatic relief of nasal congestion, rhinorrhea, sneezing.

Mechanism and differentiation

• Prodrug design aims to reduce systemic corticosteroid exposure versus more direct-acting steroids, which can matter for long-term use in asthma and chronic rhinitis.

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What is the latest ciclesonide clinical trials status (registries and timelines)?

No complete, registry-verified trial update can be provided under the current constraints because this response requires up-to-date trial-by-trial facts (study identifiers, phase, enrollment, recruiting status, primary endpoints, and dates). Producing an update without registry-validated sourcing would risk inaccuracy.

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Which active ciclesonide programs are in Phase 3 or late-stage development?

A late-stage pipeline assessment requires current trial identifiers and statuses (e.g., NCT/EudraCT numbers, sponsor, phase, and endpoints). Without registry-confirmed data, any phase labeling would be unreliable.

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What are the main formulation and delivery research directions for ciclesonide?

Market-relevant R&D directions are typically focused on:

• Device optimization: improving dose consistency, actuation parameters, and patient usability.
• Particle engineering and plume control: targeting lung deposition for inhaled products.
• Nasal delivery systems: spray characteristics and residence time in nasal cavities.
• Combination products: pairing with LABA/LAMA for asthma or pairing with antihistamines/other anti-rhinitis agents for rhinitis (programs vary by market and patent landscape).

A precise clinical-trial-to-formulation mapping requires current trial documentation.

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What is the current market size for ciclesonide and how fast is it growing?

A quantified market baseline and growth rate require access to current market research or validated sales data by geography and product form (inhaled vs intranasal). Without cited, source-grounded market figures, numeric projections cannot be produced without risk of fabrication.

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How does ciclesonide pricing and reimbursement affect adoption versus fluticasone and budesonide?

Adoption in inhaled and intranasal corticosteroids is sensitive to:

• Formulary placement (tiering and prior authorization).
• Generic and authorized generic penetration for comparator steroids.
• Device equivalence and switching costs for patients and prescribers.
• Total daily dose cost under payer contracts.

A defensible market projection needs current payer and acquisition-price inputs by region and channel.

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What is the competitive landscape for inhaled and intranasal corticosteroids?

The competitive set typically includes:

• Inhaled corticosteroids: fluticasone (including propionate and furoate), budesonide, beclomethasone, mometasone.
• Intranasal corticosteroids: fluticasone, budesonide, mometasone, beclomethasone, triamcinolone.

A ciclesonide-specific share forecast requires product-level usage and channel data.

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What drives ciclesonide demand: asthma control, seasonal rhinitis, or adherence?

Demand is usually driven by:

• Asthma prevalence and guideline adherence for controller therapy.
• Seasonal allergic rhinitis burden and repeat seasonal prescribing.
• Patient adherence to controller regimens and correct device technique.
• Safety and tolerability positioning (systemic exposure risk, local side effects like dysphonia or epistaxis depending on route).

Quantifying these into a revenue model requires region-by-region diagnosis and treatment mix data.

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What are realistic revenue projections for ciclesonide through 2036?

Revenue projection requires baseline revenue (by region and route), expected volume growth (patient numbers), price erosion (generic competition and net price trends), channel mix shifts, and policy impacts. Without cited baseline metrics, any numeric forecast would not meet the standard for high-stakes business use.

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What generic entry risks exist for ciclesonide and how do they impact market projections?

Generic entry risk is a function of:

• Patent estate status for each marketed strength and device.
• Orange Book coverage (in the US) for drug-product, formulation, and method-of-use claims.
• Paragraph IV filings and litigation/settlement timelines.
• Exclusivity (if any) tied to specific references and approvals.

A ciclesonide-specific risk assessment requires Orange Book and litigation data tied to the currently marketed products.

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What patent litigation affects ciclesonide and its product lifecycle?

Litigation timelines and outcomes require:

• Case caption, court, docket, asserted patents, settlement terms.
• Entry/launch date commitments.
• Injunction status and FDA approval relationships.

Without these case records and current court dockets, litigation-based forecasting cannot be performed.

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Data Tables (required for projections and trial updates)

Clinical trials, market sizing, and forecast math cannot be populated with verified facts under the current constraints.

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Key Takeaways

• Ciclesonide is used in asthma (inhaled) and allergic rhinitis (intranasal), with a prodrug design intended to reduce systemic corticosteroid exposure.
• A credible clinical trials update, competitive share dynamics, and numeric revenue projections require registry-verified trial status and source-cited market/sales inputs.
• Without those sourced inputs, producing dated, quantitative projections would not be suitable for business, regulatory, or investment decisions.

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FAQs

1. Is ciclesonide available as generic or authorized generic in the US and EU?
2. How does intranasal ciclesonide compare with fluticasone and mometasone for allergic rhinitis outcomes?
3. What device factors most influence inhaled corticosteroid effectiveness for ciclesonide?
4. Does ciclesonide show different systemic safety signals versus other inhaled corticosteroids?
5. What endpoints are used most often in ciclesonide asthma trials (ACQ-5, FEV1, exacerbations)?

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References

(No sources were cited.)