Pipotiazine

Schizophrenia is a chronic, persistent and severe mental disorder. Approximately 30% of patients have poor adherence to oral antipsychotic drugs, which easily leads to repeated disease episodes. Pipotiazine is a first-generation long-acting antipsychotic drug. It exerts a stable antipsychotic effect by blocking central dopamine D2 receptors, and also has a certain sedative effect. After intramuscular injection, its long-acting ester can be slowly released into the circulation, with an action cycle as long as 2 to 4 weeks. It is mainly used for the maintenance treatment of chronic schizophrenia, especially suitable for patients with poor medication adherence who require long-term consolidation treatment after the control of acute phase symptoms. It can effectively reduce the disease recurrence rate and ease the burden of medication management on patients and their families.

As a long-acting antipsychotic drug launched at an early stage, pipotiazine currently accounts for approximately 0.2% of the global psychotropic drug market, with an overall annual compound growth rate of 1.2% in scale. The market demand is concentrated in the long-term treatment scenarios of primary mental health institutions and low-income regions. The domestic market is currently dominated by imported preparations, and no large-scale domestic generic drugs have been launched yet. The annual procurement volume of public medical institutions is approximately 12,000 vials, the price system has remained stable for a long time, and there is no national or local centralized procurement record. Verifiable public market size data are temporarily unavailable.

The original research enterprise of pipotiazine is Bristol Myers Squibb, with the original brand name Modecate. Its core compound patent expired worldwide in 1982. The main marketed dosage form is pipotiazine palmitate injection, with common specifications of 25mg/ml, 50mg/ml and 100mg/ml. The original preparation has been included in the FDA Reference Listed Drug Catalog. As of the search time point, no pipotiazine preparation variety has been approved for marketing in China, and there is no API registration information (status A or status I) of this variety in the database of the Center for Drug Evaluation (CDE) of the National Medical Products Administration. (Data as of September 2024, please refer to the official CDE website for the latest information.)

CATO provides a full set of pipotiazine impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully meet the reference substance needs in the processes of API research and development, quality research and generic drug declaration, effectively shortening the R&D cycle and reducing compliance risks.