Moclobemide

Depression has become one of the most common mental disorders worldwide. The clinical application of traditional monoamine oxidase inhibitors is limited due to their severe adverse reactions, and the emergence of moclobemide has broken this dilemma. As the first reversible and selective monoamine oxidase A (MAO-A) inhibitor, it exerts an antidepressant effect by reversibly inhibiting the activity of MAO-A and increasing the levels of 5-hydroxytryptamine, norepinephrine and dopamine in the brain. In addition, it does not require strict restriction of tyramine intake in diet, and its safety is significantly better than that of older generation drugs. Clinically, it is mainly used to treat various types of depression, including endogenous depression, reactive depression and menopausal depression, especially suitable for elderly patients and depressed people with combined cardiovascular diseases, and can also be used for adjuvant treatment of social anxiety disorder.

The global market size of antidepressant drugs has exceeded 17 billion US dollars. Among them, reversible MAO-A inhibitors, as a细分 category, have maintained a compound annual growth rate of about 4.2% in recent years due to the expansion of the elderly depression population and the increasing clinical demand for treatment-resistant depression. At present, the market is dominated by generic products, with original research products accounting for less than 15%. Europe and India are the main suppliers of active pharmaceutical ingredients (APIs), and there is no verifiable data on large-scale domestic production in China yet.

The original research enterprise of moclobemide is Roche, and the original research trade name is Manerix. Its core compound patent expired globally around 2000, and there is no core patent protection under research at present. The main dosage form approved for the original research product is tablet with a specification of 150mg. This product has been included in the FDA Reference Listed Drug Catalog and also included in the *List of Chemical Drugs* of China. As of now, there is no approved A-status registration number for moclobemide on the domestic CDE API Registration Platform. All moclobemide preparations approved for marketing in China are generic drugs, and there is no imported original research preparation for the time being. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of moclobemide 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. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet various experimental needs of API R&D, quality research and consistency evaluation.