Iloperidone

In response to the multiple treatment needs of patients with schizophrenia for positive symptoms, negative symptoms and cognitive function impairment, the clinical application of atypical antipsychotic drugs continues to expand. As a second-generation 5-hydroxytryptamine/dopamine receptor antagonist, iloperidone can precisely antagonize 5-HT2A receptors and D2 receptors, and has moderate affinity for adrenergic receptors such as α1 and α2. On the basis of rapidly controlling acute symptoms such as hallucinations and delusions, it can reduce the adverse reactions of traditional antipsychotic drugs such as extrapyramidal reactions and elevated prolactin. It is especially suitable for adult schizophrenia patients with poor tolerance to other drugs, and can be used for a long time to reduce the risk of recurrence.

The global market size related to iloperidone was approximately USD 120 million in 2023. Driven by the rising prevalence of schizophrenia and the demand for drugs with low side effects, the compound annual growth rate from 2024 to 2029 is expected to remain at 4.2%. At present, the original research products still occupy a dominant position in the market pattern, and generic API enterprises from India and China are gradually entering the supply system. There are more than 5 generic drug enterprises in China that have entered the marketing authorization application stage. With the successive launch of generic drugs after patent expiration, the API market demand is expected to see a year-on-year growth rate of more than 15% in 2027.

The original research enterprise of iloperidone is Vanda Pharmaceuticals in the United States, and the original research trade name is Fanapt. Its core compound patent expired in the United States in 2016, and the Chinese compound patent expired in 2017. The main dosage form approved by the original research is tablet, with specifications including 1mg, 2mg, 4mg, 6mg, 8mg, 10mg and 12mg. It has been included in the FDA Reference Listed Drug Catalog, and is also included in China's *Catalog of Reference Preparations for Chemical Drugs (Third Batch)*. Up to now, there are more than 8 registration numbers of iloperidone on the API registration platform of China CDE, most of which are in the A status that have passed the technical evaluation. A number of domestic enterprises have obtained approval for the marketing of generic iloperidone preparations. (Data as of July 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of iloperidone impurity reference standards, covering the full-chain research needs such as synthetic process intermediates and degradation impurities. Most products are available from stock, and orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of API enterprises for process research, quality research and registration declaration.