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Drug

Brexpiprazole

Approved · EMA
Late-stage development

Also known as Rexulti.

RxNorm1658314ChEMBLCHEMBL2105760UNII2J3YBM1K8C
3
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)

Clinical trial2026-06-11Results expected Q4 2028 · ClinicalTrials.gov

A Pharmacogenetic Human Laboratory Investigation of Brexpiprazole in Alcohol Use Disorder

Clinical trial2026-05-01Results expected Q3 2026 · ClinicalTrials.gov

A Long-term, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Flexible-Dose Brexpiprazole as Maintenance Treatment in Adolescents (13-17 Years Old) With Schizophrenia

Clinical trial2026-02-04Results posted · ClinicalTrials.gov

A Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Trial of Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder

Clinical trial2025-08-28Results posted · ClinicalTrials.gov

A Phase 3, Multicenter, Randomized, Double-blind Trial of Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder

Clinical trial2025-06-13Results posted · ClinicalTrials.gov

A Phase 3, Multicenter, Randomized, Double-blind Trial of Fixed-Dose Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder

Clinical trial2025-05-30Results posted · ClinicalTrials.gov

A Multi-center, Randomized, Controlled Trial of Brexpiprazole for the Treatment of Co-occurring Schizophrenia and Substance Use Disorder

Clinical trial2025-05-23Results posted · ClinicalTrials.gov

Low-Dose Adjunctive Brexpiprazole in the Treatment of Bipolar I Depression: An Open-Label Study

Clinical trial2025-02-01Primary completion · ClinicalTrials.gov

A Phase 2/3 Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Evaluate the Efficacy and Safety of Brexpiprazole (OPC-34712) in the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

Clinical trial2024-11-14Results posted · ClinicalTrials.gov

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-group Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication

Clinical trial2024-11-12Results posted · ClinicalTrials.gov

A Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Adult Subjects With Borderline Personality Disorder

Clinical trial2024-10-03Results posted · ClinicalTrials.gov

Approval: Rxulti (EMA)

Regulatory2018-07-26EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Brexpiprazole
Aliases & brands
Rexulti
RxNorm CUI
1658314
ChEMBL ID
CHEMBL2105760
UNII
2J3YBM1K8C
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2018-07-26
Latest approval
2018-07-26
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2018-07-26Approval
Approval: Rxulti (EMA)

Indication: Rxulti is indicated for the treatment of schizophrenia in adult and adolescents aged 13 years and older.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

56 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
56
registered trials across all phases
LATEST COMPLETION 2025
3
Active studies
3
Recruiting
45
Late-stage (III+)
45
Completed
8
Discontinued
PHASE DISTRIBUTIONn = 56
Phase 15Phase 26Phase 2 / 33Phase 336Phase 46

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)

RecruitingPH IVNova Scotia Health Authorityn=4002029

A Multi-center, Randomized, Controlled Trial of Brexpiprazole for the Treatment of Co-occurring Schizophrenia and Substance Use Disorder

CompletedPH IVUniversity of Massachusetts, Worcestern=502024

A Phase 4, Multicenter, Single-arm, Open-label, Interventional fMRI Trial to Assess the Effect of Brexpiprazole as Adjunctive Therapy on Functional Brain Network Organization in Adults With Major Depressive Disorder and Symptoms of Anxiety

WithdrawnPH IVOtsuka Pharmaceutical Development & Commercialization, Inc.2023

A Phase 4, Multicenter, Open-label, Interventional Trial to Assess the Effects on Engagement of Flexible-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy for the Treatment of Adults With Major Depressive Disorder

CompletedPH IVOtsuka Pharmaceutical Development & Commercialization, Inc.n=1222022

A Double-Blind, Placebo-Controlled Study of Brexpiprazole Plus Ketamine in Treatment-Resistant Depression (TRD)

CompletedPH IVMassachusetts General Hospitaln=512019

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Long-term, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Flexible-Dose Brexpiprazole as Maintenance Treatment in Adolescents (13-17 Years Old) With Schizophrenia

CompletedPH IIIOtsuka Pharmaceutical Development & Commercialization, Inc.n=2952025

A Multi-center, Randomized, Controlled Trial of Brexpiprazole for the Treatment of Co-occurring Schizophrenia and Substance Use Disorder

CompletedPH IVUniversity of Massachusetts, Worcestern=502024

A Phase 3, Multicenter, Randomized, Double-blind Trial of Fixed-Dose Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder

CompletedPH IIIOtsuka Pharmaceutical Development & Commercialization, Inc.n=5912023

A Phase 3, Multicenter, Randomized, Double-blind Trial of Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder

CompletedPH IIIOtsuka Pharmaceutical Development & Commercialization, Inc.n=4502023

A Phase 2/3 Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Evaluate the Efficacy and Safety of Brexpiprazole (OPC-34712) in the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

CompletedPH II/IIIOtsuka Pharmaceutical Co., Ltd.n=4102023

A Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial to Evaluate the Efficacy of Brexpiprazole Monotherapy for the Treatment in Adolescents (13-17 Years Old) With Schizophrenia

CompletedPH IIIOtsuka Pharmaceutical Development & Commercialization, Inc.n=3162023
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.