Skip to main content

Schizophrenia therapies in the pipeline

Drugs in development feature a novel mechanism of action


From the Editors


Quarterly Drugs to Watch Report

Anticipated Launches | Q3 2024

Download the PDF


Schizophrenia is a chronic mental illness in which patients may experience symptoms such as hallucinations, delusions, paranoia, disordered thinking, and abnormal behavior and movements. It is associated with reduced life expectancy by 28.5 years.

A 2023 study found that at least twice as many U.S. adults experience schizophrenia spectrum disorders than previously thought. With funding from the Substance Abuse and Mental Health Services Administration, researchers at RTI International found that approximately 1.8 percent, or 3.7 million, adults ages 18 to 65 have these disorders.1

“People with a schizophrenia spectrum disorder experience high levels of disability that present significant challenges in all aspects of their life,” said Principal Investigator Heather Ringelsen, PhD.

Multiple first-generation (“typical”) and second-generation (“atypical”) antipsychotic agents are available in a variety of dosage formulations and routes of administration and with varying administration schedules. The antipsychotic drug market was valued at $18 billion in 2023 and is expected to exceed $37 billion by 2032.2

Adverse events commonly associated with antipsychotics include sedation, sexual dysfunction, anticholinergic effects, weight gain, altered blood glucose, rapid heart rate, and many others. A new drug in development may provide a therapeutic alternative – and increased tolerability – for people with schizophrenia spectrum disorders.

KarXT (Bristol-Myers Squibb/Karuna Pharmaceuticals) is pending FDA approval for the treatment of schizophrenia in adults. It is an oral, twice-daily combination product that consists of xanomeline, a M1/M4 muscarinic agonist; and trospium, a muscarinic receptor agonist. KarXT does not affect dopamine receptors.

If approved, KarXT will be the first agent in a new class of drugs for schizophrenia and may have less risk of certain adverse events associated with existing antipsychotics.

KarXT is also being studied as an adjunctive treatment for schizophrenia and for the treatment of psychosis associated with Alzheimer’s disease, which estimates suggest occurs in up to 50 percent of patients.3