Trifluoperazine

As a classic first-generation antipsychotic in the field of schizophrenia treatment, trifluoperazine is a piperazine phenothiazine derivative that exerts its effects by blocking multiple targets such as central dopamine D2 receptors and 5-hydroxytryptamine receptors. Compared with common phenothiazine drugs of the same category, it has stronger antipsychotic activity and weaker sedative effect. It is clinically mainly used for various types of schizophrenia, especially with prominent efficacy for the paranoid type and catatonic type, and can effectively improve positive and negative symptoms such as hallucinations, delusions, apathy and stupor. It can also be used to control symptoms such as nausea and vomiting, and the applicable population covers adult schizophrenia patients and vomiting patients who have poor tolerance to other antiemetics.

The current global market size of trifluoperazine is approximately USD 120 million. Driven by the year-on-year increase in the prevalence of mental illnesses and the improvement of the primary mental health diagnosis and treatment system, the compound annual growth rate in the past three years has remained at around 3.7%. The competitive landscape is dominated by generic drugs, with the original research product accounting for less than 15% of the market. China and India are the core suppliers of trifluoperazine API in the world, accounting for 72% of the global API production capacity in total. The domestic market has been included in the local centralized procurement of multiple provinces, and the winning bid price has dropped by an average of 46% compared with that before the centralized procurement, with the accessibility at the primary level significantly improved.

The original research enterprise of trifluoperazine is GlaxoSmithKline, with the original brand name Stelazine, and its core compound patent expired globally in 1989. The main dosage form of the original research product on the market is tablet, with specifications of 1mg and 5mg, which has been included in the FDA Reference Listed Drug Catalog, and the original research preparation has not been imported into China yet. According to the domestic API registration platform, there are currently 3 enterprises whose trifluoperazine APIs have been approved for registration, all with the status of A, which can be associated with domestic preparation declarations; a number of domestic enterprises have obtained approval for the marketing of trifluoperazine tablets, with specifications covering 1mg and 5mg. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the needs of trifluoperazine quality research and generic drug consistency evaluation, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can meet the needs of various scenarios such as impurity qualitative and quantitative analysis and stability research.