Suzetrigine

Depression has become a high-burden mental illness worldwide, and existing serotonin reuptake inhibitor drugs generally have shortcomings such as slow onset of action, sexual dysfunction and other adverse reactions. Lusudroxetine is a new type of triple reuptake inhibitor, which can simultaneously block the transporters of serotonin, norepinephrine and dopamine, and regulate the level of neurotransmitters through multiple pathways. It not only has a faster onset of action than traditional antidepressants, but also can improve the cognitive function and anhedonia symptoms of patients. It is suitable for adult patients with major depressive disorder, and also provides a new treatment option for patients who have poor response or intolerance to existing drugs.

Lusudroxetine is still in the early stage of global commercialization, and there is no public post-marketing market size statistical data. As an innovative mechanism variety in the antidepressant track, it has high market growth expectation due to its obvious clinical advantages. At present, only the original research enterprise in the world has mastered the mature API production technology, and the layout of generic pharmaceutical enterprises is still in the early R&D stage, with a highly concentrated competitive landscape.

The original research enterprise of lusudroxetine is Shionogi & Co., Ltd. of Japan, and the original trade name is Lusudrina. Its core compound patent in Japan will expire in 2033, and the validity period of the compound patent in China is until 2034. The currently approved dosage form of the original research is tablet, with two specifications of 50mg and 100mg. The original research tablet has been included in the reference preparation catalogue of Japan PMDA, and has not been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by China NMPA for the time being. Up to now, no lusudroxetine preparation has been approved for marketing in China, and no valid and approved API registration number has been found on the CDE API registration platform. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full series of impurity reference standards for lusudroxetine. The products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. For most products in stock, orders placed before 16:00 can be shipped on the same day, which can provide stable reference standard support for the API R&D, quality research and generic drug declaration of this variety.