Ciclesonide

The long-term management of chronic airway inflammatory diseases such as allergic rhinitis and asthma has always been a key area of clinical concern. As a third-generation inhaled corticosteroid, ciclesonide adopts a unique prodrug design and exerts local anti-inflammatory effects only after being activated by esterases in the lungs, which greatly reduces the risk of systemic adverse reactions. It is mainly used clinically for the maintenance treatment of asthma in adults and adolescents over 12 years old, and can also relieve the nasal symptoms of seasonal and perennial allergic rhinitis. Its characteristic of achieving long-acting anti-inflammatory effects at low doses provides a safer option for patients who are intolerant to the adverse reactions of traditional hormones.

The global number of asthma patients exceeds 300 million, and the prevalence of allergic rhinitis even reaches 10%-25%, driving the continuous expansion of the inhaled preparation market. The global market size of ciclesonide has exceeded 1.2 billion US dollars, with a compound annual growth rate maintained at around 7%. The domestic market is still dominated by original research products at present. With the continuous release of medication demand in the respiratory field and the advancement of the consistency evaluation of generic drugs, the enthusiasm of local enterprises for deployment continues to rise, and the market growth potential is great.

The original research enterprise of ciclesonide is Nycomed Pharma, a Swiss company, with the original brand name "Alvesco". Its core European patent expired in 2018, and the US compound patent will expire in 2024. The originally marketed dosage forms include inhaled aerosol and nasal spray, among which the inhaled aerosol has two specifications: 80μg per actuation and 160μg per actuation. At present, the original researched inhaled ciclesonide aerosol has been included in the China Listed Drug Catalogue and is used as a reference preparation. No approved ciclesonide API registration number has been found on the domestic API registration platform for the time being, and only the original preparation has been approved for import and marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for ciclesonide API. Most of the products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for pharmaceutical enterprises in generic drug research and development, quality research and consistency evaluation work.