Cenobamate

In response to the treatment needs of refractory epilepsy among central nervous system diseases, cenobamate provides a new clinical option with its dual mechanism of action. As a third-generation antiepileptic drug, it can act on both γ-aminobutyric acid type A receptors and voltage-gated sodium channels. It can not only enhance the conduction of inhibitory neurotransmitters, but also reduce the abnormal discharge of pathological neurons. It is mainly used for the adjunctive treatment of partial-onset seizures in adults and adolescents over 12 years old, and its clinical benefit is particularly significant for patient groups who have poor response to traditional antiepileptic drugs.

At present, the global market size of antiepileptic drugs has exceeded 28 billion US dollars, among which the proportion of third-generation drugs is increasing year by year, with a compound annual growth rate remaining above 7%. As a new variety approved in recent years, cenobamate has a relatively fast market penetration rate after its launch, and its global sales in 2023 have exceeded 230 million US dollars. Currently, the number of approved generic cenobamate drugs worldwide is less than 5, and there is no generic drug declared for marketing in China, so the market competition pattern is relatively loose. With the gradual improvement of clinical awareness, the future market growth space is considerable.

The original research enterprise of cenobamate is SK Biopharmaceuticals of South Korea, and the original brand name is Xcopri. The expiration time of its core compound patent in the United States is 2037, and the expiration time of the compound patent in China is 2038. The main dosage form approved for the original research drug is tablet, with four specifications including 50mg, 100mg, 200mg and 400mg. It has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in the Chinese Catalog of Reference Preparations for Chemical Drugs. Up to now, there is no registered DMF number for cenobamate active pharmaceutical ingredient in China, and no domestic enterprise has been approved to produce cenobamate preparations. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for cenobamate, and most products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of pharmaceutical enterprises in all stages of API R&D, quality research and registration declaration.