Flupentixol

For the clinical treatment of psychiatric disorders such as schizophrenia and depressive neurosis, flupentixol is a representative variety of thioxanthene antipsychotics that combines both efficacy and safety. Its mechanism of action is to block dopamine D2 receptors and simultaneously regulate the level of 5-hydroxytryptamine neurotransmitters. It exerts anxiolytic and antidepressant effects at low doses, and can control the positive symptoms of schizophrenia at high doses. Clinically, it is suitable for patients with acute schizophrenic episodes, and can also be used for maintenance treatment in the chronic phase. It is often formulated as a compound preparation with melitracen, which is widely used in the diagnosis and treatment of non-severe psychiatric disorders such as mild to moderate anxiety and depression, and somatization disorders, covering a population ranging from adult patients to elderly patients with underlying diseases complicated by psychiatric symptoms.

At present, the global antipsychotic market is expanding steadily. Among them, thioxanthene drugs, with their low incidence of extrapyramidal reactions, account for an increasing proportion of primary psychiatric medication year by year. According to public data, the annual compound growth rate of the domestic market size of flupentixol-related preparations in the past three years has reached 7.2%, and the overall market size exceeded 1.2 billion yuan in 2023. In terms of the competitive landscape, the original research product has long occupied the major market share. At present, only 3 domestic enterprises have been approved for generic flupentixol preparations, and there is still a certain gap in the supply of active pharmaceutical ingredients (APIs). With the continuous increase in the consultation rate of psychiatric disorders, the generic drug substitution space of this variety is considerable.

The original research enterprise of flupentixol is Lundbeck Pharma from Denmark. The trade name of the original research single-agent preparation is "Fluanxol", and the trade name of the compound preparation composed of flupentixol and melitracen is "Deanxit". Its core compound patent expired globally in 2008. The main dosage form of the original research single-agent preparation is tablet, with specifications of 0.5mg and 5mg. Among them, the 5mg tablet has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalogue of Reference Preparations for Chemical Drugs (10th Batch)* of China. In terms of domestic API registration, the CDE platform currently contains 3 registration numbers for flupentixol APIs, among which 1 is in A status and the other 2 are in I status. Domestic approved flupentixol and melitracen compound preparations and single-agent preparations have been launched on the market. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of flupentixol impurity reference standards, covering the full-chain research requirements such as synthetic starting materials, intermediates, and degradation impurities. 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 the Chinese Pharmacopoeia and FDA, and can fully meet the use needs of pharmaceutical enterprises in different scenarios such as registration and declaration, and quality research.