Fluocortolone

As a segmented variety of glucocorticoid drugs, fluocortolone binds to glucocorticoid receptors, inhibits the synthesis and release of inflammatory mediators, and reduces the chemotactic activity of immune cells, with triple effects of anti-inflammation, anti-allergy and immunosuppression. In clinical practice, it is mainly used for the local treatment of inflammatory skin diseases such as allergic dermatitis, eczema and neurodermatitis, and can also be used as a component of ophthalmic preparations to treat non-infectious ocular inflammations such as allergic conjunctivitis and iridocyclitis. The applicable population covers adults and child patients without contraindications to hormone use. Compared with some traditional glucocorticoids, it has a lower risk of systemic absorption and better local medication safety.

At present, the global market size of topical glucocorticoids is approximately 17 billion US dollars, among which the compound annual growth rate of fluorine-containing medium-potency hormones maintains at around 3.8%. With the advantage of low HPA axis inhibition, the market share of fluocortolone in the dermatological topical preparation market in Europe, Japan and other regions is steadily increasing. The domestic market is currently in the introduction period, and the clinical demand for related preparations mainly relies on imports. The development of local generic drugs is still in the early stage, and the supply gap of API is relatively obvious. With the annual increase in the consultation rate of inflammatory skin diseases in recent years, its market growth potential has gradually emerged.

The original research enterprise of fluocortolone is Bayer, with the original brand name of Ultralan. Its core compound patents in major markets such as Europe and Japan expired before 2000. The main dosage forms of the original marketed products include 0.1% cream and 0.1% eye ointment, and the relevant dosage forms have been included in the reference preparation catalogs of the European Union and Japan. Up to now, China NMPA has not approved the marketing of fluocortolone-related preparations, and no validly registered DMF numbers have been found on the CDE API registration platform. The generic drug development of relevant varieties is still in the pre-clinical research stage. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full range of fluocortolone impurity reference standards. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most categories support spot supply. Spot orders paid before 16:00 can be shipped on the same day, which can fully meet the needs of impurity qualitative and quantitative analysis and quality research in the drug development stage.