When will KarXT be available on the market? As a potential star drug for the treatment of schizophrenia, KarXT (xanomeline-trospium) attracted public attention so much. Investors and patients have great concern on KarXT release date and KarXT FDA approval timeline. According to the most recent news, Karuna Therapeutics plans to submit a New Drug Application (NDA) for KarXT within this year.
What is KarXT?
KarXT is an oral, investigational M1/M4-preferring muscarinic agonist in development for the treatment of psychiatric and neurological conditions, including schizophrenia and psychosis in Alzheimer’s disease[1]https://karunatx.com/pipeline-programs/karxt/.
KarXT side effects
Regular schizophrenia medicines alter dopamine or serotonin levels in the brain, which cause strong side effects. As a new type of schizophrenia drug, KarXT is with less side effects. First because it does not directly target the dopamine or serotonin pathways in the brain. And also because the use of trospium is helpful to reduce the side effects of xanomeline.
Studies showed it is safe, well-tolerated, and reduces the symptoms of schizophrenia, including social isolation, cognitive impairment, and memory problems. It was also not associated with problematic side effects commonly reported with other antipsychotic drugs.
KarXT clinical train and FDA approval plan
On March 21, 2023, Karuna Therapeutics has reported that the Phase III EMERGENT-3 trial of KarXT in adult schizophrenia patients met its primary endpoint. It is also reported that KarXT was well tolerated, and the side effect was substantially consistent with previous trials. If everything goes as plan, the estimated time KarXT can be available is by the second half of next year.
KarXT in China
According to the public information, Zai Lab has an exclusive license agreement with Karuna Therapeutics for the development, manufacturing, and commercialization of KarXT in Greater China, including mainland China (“China”), Hong Kong, Macau, and Taiwan (collectively “Greater China”). Zai Lab is on track to initiate a bridging study for the treatment of patients with schizophrenia in China in 2023.[2]https://ir.zailaboratory.com/news-releases/news-release-details/zai-lab-partner-karuna-therapeutics-announces-positive-results-0
