This study focuses on the long-term safety evaluation of KarXT in people with Bipolar-I Disorder who experience mania or mania with mixed features. Mania is a condition where a person experiences unusually high energy levels, reduced need for sleep, and sometimes impulsive or risky behavior. The medication being studied, KarXT, contains two active substances: trospium chloride and xanomeline tartrate, and is taken as oral capsules.

The purpose of this research is to determine if KarXT is safe and well-tolerated when used for an extended period by people with manic episodes related to Bipolar-I Disorder. The study will monitor how participants respond to the treatment over time and track any side effects that may occur during the treatment period.

During this open-label extension study, all participants will receive the study medication KarXT. The treatment period will last for approximately 51 weeks, during which participants will take the medication daily. Throughout the study, healthcare providers will regularly monitor participants’ health and well-being through various assessments and check-ups to ensure their safety.