Alfaxalone

As a classic steroidal sedative drug in the field of animal anesthesia, alfaxalone selectively agonizes the γ-aminobutyric acid A (GABAA) receptor in the central nervous system to enhance the conduction effect of inhibitory neurotransmitters, enabling rapid and stable anesthesia induction and maintenance, with rapid recovery and low accumulation risk. At present, it is widely used in surgical anesthesia of companion animals such as dogs and cats, and can also be used for sedation procedures in exotic animals. It is one of the intravenous anesthetics preferentially recommended for global veterinary clinical practice.

The expansion of the global pet diagnosis and treatment market continues to drive the growth of demand for alfaxalone. In 2023, the global market size of alfaxalone API was approximately USD 120 million, with a compound annual growth rate of 8.7% in the past three years. The current market supply is dominated by European and Chinese enterprises. Among them, European manufacturers account for about 45% of the market share of high-end original research supporting markets. Domestic manufacturers, relying on their cost and compliance advantages, have maintained an annual export growth rate of more than 12% in the past five years. With the steady increase in the volume of global pet sterilization and specialized surgeries, the market size is expected to exceed USD 180 million by 2028.

The original research enterprise of alfaxalone is Organon of the Netherlands, with the original brand name "Alfaxan (alfaxan)". Its core compound patent expired globally in 2011, and the formulation patents in major markets also expired successively in 2017. The main formulation approved by the original research is injection, with specifications of 2 mg/mL and 10 mg/mL. It has been included in the FDA Reference Listed Drug Catalog for Animal Drugs, and is also included in the European Pharmacopoeia monograph. At present, 5 domestic enterprises have obtained A status for their alfaxalone APIs through registration on the CDE platform, and another 11 veterinary injection products containing alfaxalone have been approved for marketing, covering the demand for routine surgical anesthesia in pet clinical practice. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of alfaxalone impurity reference standards. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully support the needs of the whole process of API R&D, quality research and registration declaration.