Agomelatine

In the clinical treatment of adult depression, traditional antidepressants often have limitations such as slow onset of action, impact on sleep structure, and sexual function-related side effects. As the world's first melatonin receptor agonist antidepressant, agomelatine provides a brand-new solution to this clinical pain point. Its mechanism of action features dual regulation: it can not only activate MT1 and MT2 melatonin receptors to regulate biological rhythms, but also antagonize 5-HT2C receptors to exert antidepressant effects. While rapidly improving the core symptoms of depression, it can simultaneously adjust the disordered sleep rhythm, and has no obvious common adverse reactions such as weight gain and sexual dysfunction. It is especially suitable for adult depression patients with sleep disorders, and can also be used for maintenance treatment after the relief of depressive symptoms to reduce the risk of recurrence.

The current global antidepressant market size has exceeded 15 billion US dollars, among which the proportion of drugs with novel mechanisms is increasing year by year. With its unique clinical advantages, agomelatine has maintained a steady and continuous growth in global sales after its launch, and its global market size exceeded 800 million US dollars in 2023. In terms of the domestic market, with the improvement of public awareness of depression and the implementation of centralized drug procurement policies, the clinical penetration rate of this drug has risen rapidly. In 2023, its terminal sales in domestic public medical institutions exceeded 1.2 billion yuan. At present, more than 20 domestic enterprises have obtained the approval documents for generic preparations, and the market demand on the API supply side continues to expand along with the volume growth of generic drugs. There is no verifiable specific data on the API market size for the time being.

The original developer of agomelatine is Les Laboratoires Servier of France, with the original brand name "Valdoxan". Its core European compound patent expired in 2011, its Chinese compound patent was declared invalid and thus not actually protected, and its preparation patent expired in 2022. The main dosage form approved for the original drug is tablet, with a specification of 25mg. It has been included in the China Catalogue of Reference Preparations for Chemical Drugs, and is also a reference preparation recognized by the FDA. Up to now, there are more than 30 registration entries of agomelatine API on the API Registration Platform of China CDE, among which the registration status of multiple enterprises is "A" (marketable). More than 20 domestic enterprises have obtained the marketing approval for agomelatine 25mg tablets. (Data as of July 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for agomelatine, and most products are kept in regular stock. Spot orders placed before 16:00 can be shipped on the same day. All products comply with the regulatory requirements of multiple countries and regions such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of pharmaceutical enterprises from API R&D, quality research to production application.