NDAORALTABLET
Approved
Jul 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
REXULTI (brexpiprazole) by Otsuka. Approved for atypical antipsychotic [epc]. First approved in 2015.
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REXULTI (brexpiprazole) is an oral atypical antipsychotic approved in 2015 for three indications: adjunctive treatment of major depressive disorder, treatment of agitation associated with dementia due to Alzheimer's disease, and treatment of schizophrenia. It works through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. The drug demonstrates high oral bioavailability (95%) and achieves steady-state concentrations within 10-12 days, with metabolism primarily through CYP3A4 and CYP2D6 enzymes.
$0.6BPart D
6.9 years to LOEMechanism of Action
Pharmacologic Class:
Atypical Antipsychotic
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
REXULTI Drug General Use-results Survey (Excessive Motor Activity or Physically/Verbally Aggressive Behavior Due to Rapid Changes in Mood, Irritability, and/or Outbursts Associated With Dementia Due to Alzheimer's Disease)
Started Apr 2025
200 enrolled
Alzheimer Disease
Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia
Started Oct 2023
59 enrolled
Schizophrenia
Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders
Started Jul 2023
40 enrolled
PsychosisDepression
A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline
Started Sep 2022
34 enrolled
Post-traumatic Stress Disorder (PTSD)
Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety
Started Aug 2022
0Major Depressive Disorder (MDD)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.