Karuna Therapeutics announced that the FDA accepted their New Drug Application for KarXT (xanomeline-trospium), a treatment for schizophrenia in adults. KarXT, targeting muscarinic receptors to modulate dopamine signaling in the brain, has shown tolerability and symptom reduction in trials. Notably, it avoids common side effects of current antipsychotics like weight gain and movement disorders. The medication is designed for positive, negative, and cognitive symptoms of schizophrenia and does not directly block dopamine receptors.

The PDUFA action date is set for September 26, 2024. This application is backed by positive data from the EMERGENT clinical trial program, demonstrating significant improvements in schizophrenia symptoms.

Reference: Karuna Therapeutics Announces U.S. Food and Drug Administration Accepts New Drug Application for KarXT for the Treatment of Schizophrenia. Karuna Therapeutics. Updated November 29, 2023. Accessed January 18, 2024. https://investors.karunatx.com/news-releases/news-release-details/karuna-therapeutics-announces-us-food-and-drug-administration