China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has announced that a New Drug Application (NDA) filing for its KarXT (xanomeline and trospium chloride) in adult schizophrenia has been accepted for review by the National Medical Products Administration (NMPA). This milestone underscores Zai Lab’s commitment to advancing innovative treatments for psychiatric conditions, including schizophrenia and Alzheimer’s-related psychosis.
KarXT: Mechanism of Action
KarXT is a combination of an oral M1/M4-preferring muscarinic acetylcholine receptor agonist and a muscarinic acetylcholine receptor antagonist. This innovative combination is designed to treat psychiatric conditions by preferentially stimulating muscarinic receptors in the central nervous system, which play a crucial role in these conditions. Unlike traditional antipsychotic medicines that primarily target dopamine or serotonin receptors, KarXT offers a novel therapeutic approach.
Exclusive License and Development
Zai Lab holds an exclusive license from Karuna Therapeutics, Inc., a company later acquired by Bristol Myers Squibb, to develop, manufacture, and commercialize KarXT in Greater China (mainland China, Hong Kong, Macau, and Taiwan). This strategic partnership positions Zai Lab to bring this innovative treatment to patients in the region, addressing significant unmet medical needs.
US Approval of Cobenfy
On a related note, Cobenfy (xanomeline, trospium) was approved for marketing in the US in September of last year for schizophrenia. The approval was notable for its lack of category warnings and precautions for atypical antipsychotic drugs, or black box warnings, highlighting the potential safety profile of this class of medications.-Fineline Info & Tech
