Levamisole

As a classic drug with dual effects of deworming and immunomodulation, levamisole is an imidazothiazole derivative. Its mechanism of action is to inhibit the activity of nematode succinate dehydrogenase, block the energy metabolism of parasites, and at the same time regulate the immune function of the body and restore the activity of damaged T cells and macrophages. In clinical practice, in addition to being widely used in the deworming treatment of parasitic infections such as roundworm, hookworm and pinworm, it is also used as an immune adjuvant drug for the adjuvant treatment of people with low immune function such as some tumors, recurrent respiratory tract infections and chronic hepatitis B, and has high application value in primary medical care and veterinary fields.

The global levamisole market size is about 230 million US dollars, with an annual compound growth rate maintained at around 3.2%, and the demand mainly comes from veterinary deworming and low-frequency human immune adjuvant scenarios. In the domestic market, generic drugs account for more than 95%, and the core production capacity is concentrated in API enterprises in East China and North China. The price of preparations winning the centralized procurement bid has dropped by nearly 70% compared with the original research, achieving high accessibility at the clinical end, and there is no publicly verifiable accurate growth rate data for subdivided fields for the time being.

The original research enterprise of levamisole is Janssen-Cilag, and the original research trade name is Ergamisol. The core compound patent in the US market expired in 1983, and the original compound patent in China has expired. The originally approved dosage forms are mainly tablets, with conventional specifications including 25mg and 50mg, which have been included in the FDA Reference Listed Drug Catalog, and also included in the China Listed Chemical Drugs Catalog. As of the retrieval time, there are 17 levamisole API registration numbers on the API registration platform of China CDE, among which 11 are in status A (approved for use in marketed preparations), and more than 30 domestic enterprises have been approved to produce levamisole preparations such as tablets and liniments. (Data as of July 2024, please refer to the official CDE website for the latest information)

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