Afoxolaner

The high incidence of global pet ectoparasitosis continues to drive the upgrade of clinical demand for new anthelmintic drugs. Afoxolaner, a special anthelmintic API for veterinary use of the isoxazoline class, selectively blocks the signal transmission of glutamate-gated chloride channels and γ-aminobutyric acid receptors, can rapidly paralyze and kill arthropod parasites such as fleas and ticks, and has no adverse effects on the central nervous system of mammals. It is one of the core active ingredients of current anthelmintic drugs for dogs and cats, suitable for companion animals of all ages for routine deworming, and can also be used for the clinical treatment of parasitic infections such as canine scabies and demodex mites.

According to public industry data, the global pet anthelmintic drug market size exceeded 12 billion US dollars in 2023, with isoxazoline products accounting for more than 40% and the compound annual growth rate remaining above 8%. The growth rate of the domestic pet medical market is more significant. In 2023, the market size of the pet deworming category reached 6.8 billion yuan, among which the growth rate of afoxolaner-related preparations exceeded 20%. The current market pattern is still dominated by original research products of foreign enterprises. With the acceleration of the review and approval of domestic veterinary drugs for pets, the layout progress of domestic generic pharmaceutical enterprises is accelerating, and the demand for domestic substitution of upstream afoxolaner API continues to rise.

The original research enterprise of afoxolaner is Boehringer Ingelheim, and the original research trade name is "NexGard". The expiration date of its core compound patent in China is 2029. The main dosage form approved for the original research is oral chewable tablet, with specifications including 11.3mg, 28.3mg, 68mg, 136mg and 272mg, which are suitable for dogs of different weights. This original research product has been included in the FDA Reference Listed Drug Catalog, and no original afoxolaner preparation has been approved for marketing in China. Up to now, a number of domestic enterprises have submitted afoxolaner API registration applications on the CDE API registration platform, and there is no registration number that has passed the A-status approval. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the demand for impurity research in the R&D and production links of afoxolaner, CATO provides a full set of impurity reference standards for this API, which can cover the whole process scenarios such as method validation, stability research and release testing. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, which can help R&D and production enterprises shorten the impurity research cycle and reduce compliance risks.