Bristol-Myers Squibb has announced promising results from the EMERGENT-4 and EMERGENT-5 open-label Phase 3 clinical trials, highlighting the sustained improvement in symptoms experienced by adult patients with schizophrenia when treated with the oral capsule Cobenfy (xanomeline and trospium chloride) over a 52-week period. Notably, Cobenfy was recognized earlier this year by Evaluate as one of the top 10 potential breakthrough therapies anticipated for approval in 2024.
Cobenfy is composed of two active ingredients, xanomeline and trospium chloride. It is designed to selectively activate muscarinic acetylcholine receptors in the brain while minimizing effects on peripheral receptors. Xanomeline targets muscarinic receptors M1 and M4, which are linked to alleviating negative symptoms such as apathy and reduced social drive, as well as enhancing cognitive capabilities. It is also effective in mitigating additional psychiatric symptoms, including hallucinations and delusions. Trospium chloride, a quaternary ammonium compound, acts as a muscarinic receptor antagonist to counteract peripheral side effects related to xanomeline.
In September, the FDA approved Cobenfy for the treatment of adults with schizophrenia, marking a significant milestone as the first antipsychotic drug targeting cholinergic receptors, a departure from the traditionally dopamine-targeted therapies for schizophrenia. This approval signifies the first new mechanism drug for schizophrenia treatment in several decades, potentially opening new avenues in psychiatric therapy.