Karuna Therapeutics has announced the submission of a new drug application (NDA) to the US Food and Drug Administration for KarXT (xanomeline-trospium), an antipsychotic drug developed for the treatment of schizophrenia.

KarXT is an oral, muscarinic agonist that does not rely on the dopaminergic or serotonergic pathway to treat symptoms of serious mental illness such as schizophrenia and psychosis in Alzheimer’s disease. Its novel mechanism of action is thought to provide a differentiated approach to current treatments for schizophrenia.

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Karuna Therapeutics’ CEO Bill Meury said: “KarXT, if approved, will represent the first novel pharmacological approach to treating schizophrenia in several decades and provide a new treatment option for patients and their physicians.”

According to GlobalData, KarXT is forecast to generate $2.6bn in sales by 2029. KarXT’s main competitor is Cerevel Therapeutics’ drug emraclidine, which is also a muscarinic agonist that is currently in Phase II clinical trials. GlobalData forecasts that emraclidine will be worth $1.2bn in 2029.

GlobalData is the parent company of Pharmaceutical Technology.

Schizophrenia is a mental health condition that causes a range of different physiological symptoms. These symptoms can be categorised into positive symptoms such as psychosis and hallucinations, negative symptoms such as losing interest in everyday activities and disconnecting from relationships, and cognitive symptoms.

The NDA submission is based on data from the EMERGENT programme, which evaluated the efficacy and long-term safety data of the drug. KarXT met its primary endpoint in all of its placebo-controlled trials and demonstrated mediation of both positive and negative schizophrenia symptoms, according to Karuna Therapeutics.

In clinical trials, the patients who took KarXT did not experience the unpleasant side effects associated with currently available antipsychotics such as weight gain and changes in metabolic function.