lumateperone (Caplyta)
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Indications
- schizophrenia
- improves positive & negative symptoms
- FDA-approved for bipolar depression[2]
- FDA-approved as add-on treatment for adults with major depression[3]
Adverse effects
- somnolence or sedation (24% vs 10%*)
- dry mouth (6% vs 2%*)
- potential adverse reactions associated with antipsychotics
- neuroleptic malignant syndrome, tardive dyskinesia, falls, seizures, cognitive impairment, motor impairment, dysphagia, body temperature dysregulation
- orthostatic hypotension & syncope
- leukopenia, neutropenia, agranulocytosis
* vs placebo
- boxed warning:
- increased risk of death in elderly with dementia-related psychosis.
Drug interactions
- avoid concurrent use with CYP3A4 inducers including phenobarbital, or moderate-strong CYP3A4 inhibitors such as telithromycin (Ketek)
- drug interaction(s) of antipsychotics & dopamine receptor agonists
- drug interaction(s) of antipsycotics with benzodiazepines
- drug interaction(s) of gabapentinoid with psychotropic agent
Mechanism of action
- function unknown,
- thought to have a triple mechanism of action that targets serotonin, dopamine, & glutamate neurotransmitter pathways
More general terms
References
- ↑ Hlavinka E. FDA Approves Novel Schizophrenia Drug - Lumateperone also in development for other neuropsychiatric disorders. MedPage Today December 23, 2019 https://www.medpagetoday.com/psychiatry/schizophrenia/84073
- ↑ 2.0 2.1 Brooks M FDA Grants New Indication to Lumateperone (Caplyta) for Bipolar Depression. Medscape. December 20, 2021 https://www.medscape.com/viewarticle/965134
- ↑ 3.0 3.1 Sneha S K US FDA expands use of J&J's Caplyta as add-on depression drug Reuters. November 6, 2025 https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-expands-use-jjs-caplyta-add-on-depression-drug-2025-11-06/