Perospirone

The global schizophrenia treatment field has long faced the clinical pain point of balancing efficacy and safety, and the iteration of atypical antipsychotics has brought better options for patients. Perospirone is a second-generation atypical antipsychotic. Through high-affinity antagonism against dopamine D2 receptors and 5-hydroxytryptamine 2A receptors, and simultaneous regulation of dopamine release in the prefrontal lobe, it can not only improve the positive symptoms (hallucinations, delusions) and negative symptoms (apathy, social withdrawal) of schizophrenia, but also reduce the risk of adverse reactions such as extrapyramidal reactions and elevated prolactin that are easily caused by traditional antipsychotics. At present, it has become a common clinical regimen for acute phase treatment and maintenance phase recurrence prevention of adult schizophrenia, and is also applicable to the patient group with poor tolerance to other antipsychotics.

The current global market size of perospirone is approximately USD 180 million, with a compound annual growth rate of 4.2% in the past three years. The growth momentum mainly comes from the increase in the consultation rate of mental illnesses in emerging markets and the popularization of generic drugs. In terms of the domestic market, this variety has been included in the National Medical Insurance Category B Catalog, and the terminal sales growth rate has remained above 7% in the past three years; the competition pattern is dominated by generic drugs. At present, more than 8 domestic enterprises have obtained preparation approvals, and the market share of the original research product is less than 20%. With the gradual liberalization of the API supply side, the competitiveness of the downstream generic drug market will further increase.

The original research enterprise of perospirone is Sumitomo Pharma of Japan, and the original brand name is "Concerin". Its core compound patent in Japan expired in 2019, and the compound patent in China expired in 2021. The dosage form approved for the original research product is tablet, with three specifications of 4mg, 8mg and 16mg, which has been included in the Catalogue of Listed Drugs in China as the reference preparation. Up to now, there are more than 12 perospirone API registration information on the API registration platform of China's CDE, among which 8 have been activated in A status and can be used for associated preparation declaration. A number of domestic manufacturers have obtained approval for the marketing of perospirone generic preparations. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for perospirone. Most products are available in stock, supporting the efficient response of same-day delivery for orders placed before 16:00. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs of pharmaceutical enterprises in the whole process from API R&D, quality research to declaration and registration.