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 3h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REXULTI (brexpiprazole) is an oral atypical antipsychotic approved in 2015 for the treatment of schizophrenia and as an adjunctive treatment for major depressive disorder. It functions as a serotonin-dopamine activity modulator (SDAM) with partial agonist activity at dopamine D2 and serotonin 1A receptors. The mechanism provides a differentiated tolerability and efficacy profile within the crowded atypical antipsychotic class.
$0.63BPart D
PeakStable
6.4 years to LOEREXULTI is at peak commercial maturity with $630M in annual Part D spending, indicating a well-established franchise with stable team sizing and moderate ongoing promotional investment.
Mechanism 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 General Use Results Survey in Patients With Hyperactivity, or Aggressive Behavior Associated With Alzheimer's Dementia
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.