Valbenazine

Tardive dyskinesia is a common refractory adverse reaction resulting from long-term use of antipsychotic drugs. Patients often present with involuntary and repetitive abnormal movements, and there has been a long-term lack of targeted treatment options in clinical practice. Valbenazine is a selective inhibitor of vesicular monoamine transporter 2 (VMAT2). It reversibly binds to VMAT2 to reduce the storage and release of presynaptic dopamine and regulate the overactivity of dopaminergic nerve signals. Without affecting the transport of other neurotransmitters, it significantly improves the severity of symptoms of tardive dyskinesia. It is currently one of the few targeted therapeutic drugs approved worldwide for this indication, and can also be used for symptom control of Huntington's disease-associated chorea in adults.

The global number of patients with tardive dyskinesia exceeds 3 million. With the annual increase in the clinical use of antipsychotic drugs, the market demand for valbenazine continues to expand. In 2023, the global market size has exceeded 1.2 billion US dollars, with a compound annual growth rate remaining above 18%. At present, the global market is still dominated by the original research product, with the United States and Europe as the core consumption regions. In China, due to the late launch of this drug, no generic drug has been approved, and the market is in a stage where clinical needs are not fully met. With the subsequent improvement in the awareness of relevant indications and the advancement of generic drug applications, the domestic market has great growth potential.

The original research enterprise of valbenazine is Neurocrine Biosciences, and the original research trade name is Ingrezza. Its core compound patent in the United States will expire in 2027, and the compound patent in China will expire in 2028. The main dosage form approved for the original research product is oral capsule, with two specifications of 40 mg and 80 mg. It has been included in the FDA Reference Listed Drug Catalog, and has not yet been included in the *Catalogue of Chemical Drugs* of China. There is no domestic registration information of approved valbenazine active pharmaceutical ingredient (API) for marketing. Only the original research imported preparation was approved for marketing by the National Medical Products Administration in 2024, and no application for domestic preparation has been accepted. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of valbenazine impurity reference standards, which fully cover intermediate impurities, degradation impurities and enantiomeric impurities that may be generated during the synthesis process. Most of the products are in stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of pharmaceutical enterprises in API synthesis process research, quality research and generic drug application.