Ziprasidone

For chronic disabling mental disorders such as schizophrenia, the core demand of clinical treatment is to control positive symptoms while taking into account the improvement of negative symptoms and reducing metabolic adverse reactions. Ziprasidone is a second-generation atypical antipsychotic drug. Through high-affinity antagonism on dopamine D2 receptors and 5-hydroxytryptamine 2A receptors, as well as moderate inhibition on the reuptake of 5-hydroxytryptamine and norepinephrine, it can simultaneously relieve positive symptoms such as hallucinations and delusions, negative symptoms such as apathy, and cognitive impairment symptoms of schizophrenia. Compared with traditional antipsychotic drugs, it has lower risks of weight gain and abnormal blood lipid and blood glucose, and is suitable for acute phase treatment and maintenance phase relapse prevention of schizophrenia in adults, and can also be used for the intervention of manic episodes of bipolar affective disorder.

In recent years, the global ziprasidone-related market size has maintained a steady growth rate of about 3%, and the total market size in 2023 was approximately USD 1.2 billion, of which the generic drug market accounted for more than 85%. The Chinese market is one of the fastest growing regions. In 2023, the terminal sales of public medical institutions were close to RMB 900 million. At present, more than 10 domestic enterprises have obtained the approval documents of ziprasidone preparations, the supply of active pharmaceutical ingredients is mainly dominated by domestic substitution, and the imported original research product accounts for less than 10% of the market share. After the implementation of volume-based procurement, the price of preparations has dropped by more than 70%, and the accessibility for patients has been greatly improved.

The original research enterprise of ziprasidone is Pfizer, and the original research trade name is "Zeldox". The expiration date of its core compound patent in the United States was 2012, and the Chinese compound patent also expired in 2012. The main dosage forms approved for the original research product include ziprasidone hydrochloride capsules (specifications: 20mg, 40mg, 60mg, 80mg) and ziprasidone mesylate for injection (specification: 30mg). Both dosage forms have been included in the Catalogue of Marketed Drugs of China as reference preparations, and are also included in the FDA Reference Preparations Catalogue. At present, there are more than 20 domestic registration numbers of ziprasidone active pharmaceutical ingredients, most of which are in A status, which can be associated with the declaration and production of domestic preparations. A number of generic drug varieties such as ziprasidone hydrochloride capsules and ziprasidone for injection have been approved for marketing in China. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of ziprasidone impurity reference standards, which can cover all reference materials required for research such as synthetic process impurities and degradation impurities. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the various needs of pharmaceutical enterprises for active pharmaceutical ingredient quality research, consistency evaluation and daily release testing.