BMS’ KarXT: A Breakthrough in Schizophrenia Treatment with Potential for Alzheimer’s Disease Psychosis

Acquisition and Development:
Bristol Myers Squibb (BMS) acquired Karuna Therapeutics for $14 billion to bolster its neurological drug portfolio, particularly with KarXT (xanomeline-trospium), a potential first-in-class treatment for adult schizophrenia and Alzheimer’s disease psychosis.

Mechanism of Action:
KarXT is a dual M1/M4 muscarinic acetylcholine receptor agonist, offering a novel approach to treating schizophrenia without the side effects associated with traditional antipsychotics, such as weight gain and extrapyramidal symptoms.

Clinical Trials:
KarXT has shown efficacy in three registrational trials (EMERGENT-1, EMERGENT-2, and EMERGENT-3) and has a favorable long-term metabolic profile, with most patients experiencing stability or improvements in metabolic parameters over 52 weeks of treatment.

FDA Approval:
The FDA has set a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024, for KarXT’s new drug application (NDA) for the treatment of schizophrenia in adults.

Market Potential:
Analysts project that KarXT could generate more than $6 billion in peak annual sales if approved for all indications, including schizophrenia, Alzheimer’s disease psychosis, and bipolar I disorder.

Additional Indications:
BMS believes KarXT also has potential in treating bipolar I disorder and Alzheimer’s disease agitation, further expanding its market potential.

Launch Plans:
BMS is prepared to launch KarXT in late October 2024 if approved, with a focus on expanding its use across various serious mental illnesses.