Fluticasone Furoate

Asthma and chronic obstructive pulmonary disease (COPD) are high-incidence chronic respiratory diseases, and long-term clinical management has put forward higher requirements for the safety and anti-inflammatory activity of inhaled corticosteroids. Fluticasone furoate is a third-generation inhaled corticosteroid. It binds to glucocorticoid receptors with high affinity to potently inhibit the release of inflammatory mediators. Meanwhile, due to its extremely low systemic bioavailability, it greatly reduces the risk of hormone-related adverse reactions. It is clinically mainly used for the long-term control of asthma in adults and adolescents, and can also be combined with long-acting β₂ receptor agonists to treat moderate to severe COPD. It is one of the core components of inhaled preparations in the current respiratory field, and is especially suitable for patient groups requiring long-term maintenance treatment.

At present, the global market size of inhaled corticosteroids exceeds 12 billion US dollars, of which fluticasone furoate-related preparations account for about 22%, with a compound annual growth rate of 5.8% in the past 3 years. The core driving force comes from the increase in the penetration rate of primary respiratory disease diagnosis and treatment and the expansion of pediatric asthma indications. In the domestic market, original research products still account for nearly 60% of the market share. With the expansion of the centralized procurement scope of respiratory preparations since 2023, the market share of generic drugs is rising at an average annual rate of 8%, and the demand for compliant active pharmaceutical ingredients (APIs) is also growing rapidly. At present, there are less than 10 approved suppliers related to generic preparations in China, and the supply gap is relatively obvious.

The original research enterprise of fluticasone furoate is GlaxoSmithKline, and the original trade name is "Flixotide". Its core compound patent expired in China in 2017. The main dosage forms of the original research products on the market include inhalation aerosol and nasal spray. The conventional specifications of inhalation aerosol are 50μg, 125μg and 250μg per actuation, and the specification of nasal spray is 50μg per spray. This original research product has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also included in the FDA Reference Preparations Catalogue. Up to now, the CDE API Registration Platform has publicly announced 6 registration information of fluticasone furoate, 3 of which have obtained A status. A number of domestic enterprises have obtained approval for the marketing of fluticasone furoate inhalation aerosol and nasal spray. (Data as of June 2025, please refer to the official CDE website for the latest information.)

CATO can provide a full set of impurity reference standards for fluticasone furoate, most of which are in stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of API enterprises and preparation manufacturers for impurity research, quality control, registration and declaration, etc.