Vilazodone

Depression is a high-burden mental illness worldwide. Approximately 30% of patients respond poorly to conventional selective serotonin reuptake inhibitors, and they often suffer from adverse reactions such as sexual dysfunction and nausea. There is an urgent clinical need for new treatment regimens with both efficacy and tolerability. Vilazodone is an antidepressant with a dual mechanism of action as a serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist. It is the world's first indole alkylamine antidepressant. It can achieve rapid onset of action by dual regulation of serotonin levels in the synaptic cleft, which not only improves the core symptoms of depression, but also reduces the incidence of common adverse reactions. It is mainly used for the treatment of major depressive disorder in adults, especially suitable for patient groups who have poor tolerance to traditional antidepressants and expect rapid symptom improvement.

The global market size of vilazodone was approximately USD 420 million in 2023. Driven by the increase in the consultation rate of mental illnesses and the release of patients' long-term medication demand, the compound annual growth rate from 2024 to 2030 is expected to remain at around 3.7%. The domestic market is still in the cultivation stage. In 2023, the terminal sales in public medical institutions exceeded RMB 120 million, with a growth rate of more than 18% in the past three years. In terms of the competitive landscape, the original research product still accounts for more than 60% of the market share. Three domestic enterprises have obtained approval for generic drug preparations, and the marketing applications of generic drugs from another 7 enterprises are under the review stage. With the gradual increase in the penetration rate of generic drugs, the market price is expected to further decline in the future, driving the continuous improvement of drug accessibility.

The original research enterprise of vilazodone is Trovis Pharmaceuticals LLC in the United States, and the original brand name is Viibryd. Its core compound patent in the United States expired after patent term extension in 2014, and the Chinese compound patent expired in 2019. The main dosage form approved for the original product is tablet, with specifications including 10mg, 20mg and 40mg, which has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. As of now, there are 5 registration numbers of vilazodone API in China, among which 3 are in A status and can be marketed and sold in China; a total of 6 vilazodone tablet varieties, including original research and generic drugs, have been approved for marketing. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of vilazodone impurity reference standards. Most of the products are available from stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and fully meet the reference substance use needs of pharmaceutical enterprises in the whole process of API R&D, quality research and declaration.