Rexulti FDA Approval History
Last updated by Judith Stewart, BPharm on May 17, 2023.
FDA Approved: Yes (First approved July 10, 2015)
Brand name: Rexulti
Generic name: brexpiprazole
Dosage form: Tablets
Company: Otsuka Pharmaceutical Co., Ltd
Treatment for: Major Depressive Disorder, Schizophrenia, Agitation Associated with Dementia Due to Alzheimer’s Disease
Rexulti (brexpiprazole) is an atypical antipsychotic for use in the treatment of major depressive disorder (MDD), schizophrenia, and agitation associated with dementia due to Alzheimer’s disease.
- Rexulti is indicated for:
- use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults
- treatment of schizophrenia in adults and pediatric patients ages 13 years and older
- treatment of agitation associated with dementia due to Alzheimer’s disease
Limitations of Use: Rexulti is not indicated as an as needed ("prn") treatment for agitation associated with dementia due to Alzheimer’s disease.
- The exact way in which Rexulti works in the treatment of major depressive disorder (MDD), schizophrenia, and agitation associated with dementia due to Alzheimer’s disease is unknown, but it is thought to work as a serotonin-dopamine activity modulator (SDAM) through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors.
- Rexulti tablets are taken once daily with or without food. A lower dose is given to start, and then gradually increased over time to the recommended target dosage.
- The Rexulti product label carries a Boxed Warning for the increased risk of mortality in elderly patients with dementia-related psychosis, and increased risk of suicidal thoughts and behaviors in patients aged 24 years and younger.
Rexulti is not approved for the treatment of patients with dementia-related psychosis without agitation associated with dementia due to Alzheimer’s disease. - Warnings and precautions associated with Rexulti include cerebrovascular adverse reactions in elderly patients with dementia-related psychosis; neuroleptic malignant syndrome; tardive dyskinesia; metabolic changes; pathological gambling and other compulsive behaviors; leukopenia, neutropenia, and agranulocytosis; orthostatic hypotension and syncope; and seizures.
- Common adverse reactions in adults treated for MDD include increased weight, somnolence, and akathisia.
Common adverse reactions in adults treated for schizophrenia include increased weight.
Common adverse reactions in adults treated for agitation associated with dementia due to Alzheimer’s disease include nasopharyngitis and dizziness.
Development timeline for Rexulti
Further information
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