Isoflupredone

Glucocorticoids, as basic medications for immune-inflammatory related diseases, have long had the clinical pain point that it is difficult to balance high efficacy and safety. As a new type of fluorinated glucocorticoid drug, isoflupredone binds to glucocorticoid receptors with high affinity to strongly inhibit the release of inflammatory factors and the activation of immune cells, and meanwhile reduces the risk of systemic hormone-related adverse reactions through structural modification. It is clinically mainly used for the treatment of autoimmune and inflammatory diseases such as rheumatoid arthritis, bronchial asthma and allergic dermatitis, and is especially suitable for patient groups that require long-term hormone intervention and have poor tolerance to traditional glucocorticoids.

At present, the global isoflupredone market is still in the growth stage. In 2023, the global market size was approximately USD 120 million, with a compound annual growth rate of around 8%. The growth momentum mainly comes from the unmet needs in the respiratory and rheumatology immunology fields. The domestic market has not yet achieved large-scale application. The existing supply is dominated by imported original research preparations, and the development of generic drugs is in the early stage. No enterprise has passed the consistency evaluation yet. With the rising prevalence of related indications in China, the future market substitution space is considerable.

The original research enterprise of isoflupredone is Leo Pharma Italy, and the original trade name is Alvesco. The main market compound patent expired in 2019. The currently approved mainstream dosage form is inhalation aerosol, with specifications including 50μg/puff, 100μg/puff and 200μg/puff. It has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in the *Collection of Chemical Drug Catalogs* of China. There is no registered isoflupredone API available for preparation use in China, and the original research preparation has not yet been approved for marketing in China. (Data as of May 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for isoflupredone API. The R&D team can customize specific impurities according to customers' generic drug development needs. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. Most products are in regular stock, and orders placed before 16:00 can be shipped on the same day, which effectively shortens the R&D cycle and reduces the compliance risk of impurity research.