Dotinurad

As a new-generation long-acting partial agonist of dopamine D2/D3 receptors, brexpiprazole stabilizes the signal transduction of dopaminergic neural pathways while reducing the risk of dopamine hypersensitivity, filling the clinical gap of poor long-term adherence in the treatment of schizophrenia. Different from the extrapyramidal reactions, hyperprolactinemia and other adverse reactions easily caused by traditional antipsychotics, this drug has the advantages of mild onset and long duration of effect. It is not only suitable for symptom control in adult patients with schizophrenia in the acute发作 period, but also can be used as a long-acting option for maintenance treatment, significantly reducing the risk of recurrence caused by frequent medication.

At present, the annual growth rate of the global long-acting injectable antipsychotic market for schizophrenia is stable at more than 12%. With better safety characteristics, brexpiprazole quickly occupied about 8% of the segment market share of new-generation long-acting antipsychotics after its launch. The number of schizophrenia patients in China exceeds 10 million, and the clinical penetration rate of long-acting preparations is less than 5%, far lower than the average level of 30% in European and American markets. After its launch in China, this drug is expected to promote the clinical popularization of long-acting antipsychotics, with significant market growth space.

The original research enterprise of brexpiprazole is Lundbeck, and the original trade name is Rexulti. The expiration date of its core compound patent in the United States is 2033, and the compound patent in China will expire in 2031. At present, the main approved dosage forms of the original drug are oral tablets and once-monthly intramuscular long-acting injectables. The specifications of oral dosage forms include 0.25mg, 0.5mg, 1mg, 2mg, 3mg and 4mg, and the specifications of long-acting injectables are 60mg/vial, 90mg/vial and 120mg/vial. The oral dosage form of this variety has been included in the FDA Reference Listed Drug Catalog, and no original research preparation has been approved for marketing in China. There is no API registration information of this variety in the database of the Center for Drug Evaluation of the National Medical Products Administration. (Data as of October 2024, please refer to the official CDE website for the latest information)

In response to the R&D and quality control needs of brexpiprazole, CATO provides a full set of impurity reference standards for this API. 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 the Chinese Pharmacopoeia and FDA, and can fully support the whole R&D process including drug declaration, quality research and stability investigation.