Substance / Medication

Brexpiprazole

Overview

Active Ingredient
brexpiprazole
RxNorm CUI
1658314

Indications

REXULTI is indicated for: Limitations of Use: Clinical Studies (14.3) ] REXULTI is not indicated as an as needed ("prn") treatment for agitation associated with dementia due to Alzheimer's disease [see. Adjunctive treatment to antidepressants for 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

Labeler: Otsuka America Pharmaceutical, Inc.Updated: 2025-06-18T00:00:00.000ZFull label on DailyMed

Contraindications

When this intervention should not be used

REXULTI is contraindicated in patients with a known hypersensitivity to brexpiprazole or any of its components. Reactions have included rash, facial swelling, urticaria, and anaphylaxis.

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.

Clinical Trials

5 trials linked to this intervention

5
Total Trials
1
Recruiting
4
With Results

Research Evidence

Published studies and systematic reviews

Sort:
Efficacy and tolerability of brexpiprazole augmentation of SSRI therapy in PTSD: A systematic review and meta-analysis of randomized controlled trials.
Kotochinsky Martin, Alessi Mateus Rodrigues, Vieira Gustavo Hayasaki et al. · J Psychiatr Res · 2026
PMID: 41172929Meta-Analysis
Brexpiprazole for the Treatment of Agitation in Older Adults with Alzheimer's Disease: A Systematic Review, Bayesian Meta-analysis, and Meta-regression.
da Silva Anderson Matheus Pereira, Falcão Luciano, Ribeiro Gonçalves Ocilio et al. · CNS Drugs · 2025
PMID: 40886227Meta-Analysis
Effects of brexpiprazole on patient life engagement in schizophrenia:analysis of Positive and Negative Syndrome Scale data.
Ismail Zahinoor, Meehan Stine Rasmussen, Farovik Anja et al. · Curr Med Res Opin · 2025
PMID: 39749727Meta-Analysis
Comparison of brexpiprazole, aripiprazole, and placebo for Japanese major depressive disorder: A systematic review and network meta-analysis.
Kishi Taro, Sakuma Kenji, Saito Takeo et al. · Neuropsychopharmacol Rep · 2024
PMID: 38219278Meta-AnalysisFull text (PMC)
Efficacy and safety of brexpiprazole for the treatment of agitation in Alzheimer's disease: a meta-analysis of randomized controlled trials.
Marinheiro Gabriel, Dantas Julyana Medeiros, Mutarelli Antonio et al. · Neurol Sci · 2024
PMID: 38763935Meta-Analysis
Systematic literature review and network meta-analysis of lurasidone, brexpiprazole and cariprazine for schizophrenia.
Phalguni Angaja, McCool Rachael, Wood Hannah et al. · Int Clin Psychopharmacol · 2023
PMID: 35916575Meta-Analysis
Optimal dose of brexpiprazole for augmentation therapy of antidepressant-refractory depression: A systematic review and dose-effect meta-analysis.
Furukawa Yuki, Oguro Saki, Obata Satomi et al. · Psychiatry Clin Neurosci · 2022
PMID: 35716011Meta-Analysis
Efficacy and safety of brexpiprazole in acute management of psychiatric disorders: a meta-analysis of randomized controlled trials.
Antoun Reyad Ayman, Girgis Eriny, Mishriky Raafat · Int Clin Psychopharmacol · 2020
PMID: 32141908Meta-Analysis

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Quick Facts

Type
Substance / Medication
Fully Specified Name
Brexpiprazole (substance)
SNOMED CT
716069007
UMLS CUI
C3885614
RxNorm CUI
1658314
Labeler
Otsuka America Pharmaceutical, Inc.

Clinical Data

This intervention maps to 3 entities in the Healos knowledge graph.

3
Conditions
0
Biomarkers
0
Specialists
0
Symptoms
5
Clinical Trials

Data is sourced from SNOMED CT, UMLS, and the Healos clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.