Dalilesen

As the first orexin receptor antagonist for insomnia treatment approved worldwide, daridorexant belongs to the category of new sedative-hypnotic drugs. Its mechanism of action is different from that of traditional benzodiazepines and non-benzodiazepines. By competitively blocking orexin type 1 and type 2 receptors, it regulates the brain's arousal system, reduces adverse reactions such as residual sedation and cognitive impairment the next day while inducing sleep, and lowers the risk of drug addiction at the same time. This drug is mainly used for the treatment of insomnia disorder characterized by difficulty in falling asleep and difficulty in sleep maintenance in adults, and is especially suitable for patient groups who have poor tolerance to traditional hypnotic drugs and have concerns about drug dependence.

At present, the global market size of insomnia drugs has exceeded 40 billion US dollars, and the compound annual growth rate of drugs with new mechanisms remains above 12%, which is significantly higher than that of traditional hypnotic drugs. As a representative variety in the field of orexin receptor antagonists, the global sales of daridorexant exceeded 800 million US dollars in 2023. At present, the original research product has been approved for marketing in more than 30 countries around the world, and there is no generic drug launched in China, so it is in the exclusive market stage of the original research, with a large gap in clinical demand, and there will be broad market penetration space after generic drugs are launched in the future.

The original research enterprise of daridorexant is Merck & Co., Inc. (US), and the original brand name is "Suvorexant (Belsomra)". The core compound patent of this drug expires in 2029 in the United States, and the Chinese compound patent expires in 2028. At present, the main dosage form approved for the original research is tablet, with specifications including 5mg, 10mg, 15mg and 20mg. The original preparation has been included in the FDA Reference Listed Drug Catalogue, and the China NMPA approved the import and marketing of the original preparation in 2023. Up to now, the CDE API registration platform has not yet publicized the approved registration number of daridorexant, and no domestic enterprise has been approved for the generic preparation of this variety. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for daridorexant API, and most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the use needs of different stages such as drug R&D, quality research, and declaration and registration.