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Brexpiprazole +ADT
Brexpiprazole +ADT is a Atypical antipsychotic (dopamine D2 partial agonist) Small molecule drug developed by Otsuka Pharmaceutical Development & Commercialization, Inc.. It is currently in Phase 3 development for Adjunctive treatment of major depressive disorder in adults with inadequate response to antidepressant monotherapy.
Brexpiprazole is an atypical antipsychotic that acts as a dopamine D2 receptor partial agonist and serotonin 5-HT1A receptor partial agonist, combined with adjunctive antidepressant therapy (ADT) to treat major depressive disorder.
Brexpiprazole is an atypical antipsychotic that acts as a dopamine D2 receptor partial agonist and serotonin 5-HT1A receptor partial agonist, combined with adjunctive antidepressant therapy (ADT) to treat major depressive disorder. Used for Adjunctive treatment of major depressive disorder in adults with inadequate response to antidepressant monotherapy.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Brexpiprazole +ADT |
|---|---|
| Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Drug class | Atypical antipsychotic (dopamine D2 partial agonist) |
| Target | Dopamine D2 receptor, Serotonin 5-HT1A receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Mental Health |
| Phase | Phase 3 |
Mechanism of action
Brexpiprazole modulates dopamine and serotonin neurotransmission through partial agonism at D2 and 5-HT1A receptors, which helps restore balance in neural circuits implicated in depression. When used as an adjunct to antidepressants, it enhances the therapeutic effect of standard antidepressant medications in patients with major depressive disorder who have had an inadequate response to antidepressant monotherapy.
Approved indications
- Adjunctive treatment of major depressive disorder in adults with inadequate response to antidepressant monotherapy
Common side effects
- Akathisia
- Weight gain
- Headache
- Dizziness
- Restlessness
Key clinical trials
- Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder (PHASE4)
- A Trial to Evaluate the Efficacy, Safety & Tolerability of Brexpiprazole in the Maintenance Treatment of Adults With Major Depressive Disorder (PHASE3)
- Study of Brexpiprazole as Adjunctive Treatment of Sleep Disturbances in Patients With Major Depressive Disorder (PHASE3)
- Long-term Safety and Tolerability Study of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder (PHASE3)
- Efficacy and Safety of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment (PHASE3)
- Study of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress (PHASE3)
- A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial (PHASE3)
- Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Brexpiprazole +ADT CI brief — competitive landscape report
- Brexpiprazole +ADT updates RSS · CI watch RSS
- Otsuka Pharmaceutical Development & Commercialization, Inc. portfolio CI
Frequently asked questions about Brexpiprazole +ADT
What is Brexpiprazole +ADT?
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Who makes Brexpiprazole +ADT?
What drug class is Brexpiprazole +ADT in?
What development phase is Brexpiprazole +ADT in?
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What does Brexpiprazole +ADT target?
Related
- Drug class: All Atypical antipsychotic (dopamine D2 partial agonist) drugs
- Target: All drugs targeting Dopamine D2 receptor, Serotonin 5-HT1A receptor
- Manufacturer: Otsuka Pharmaceutical Development & Commercialization, Inc. — full pipeline
- Therapeutic area: All drugs in Psychiatry / Mental Health
- Indication: Drugs for Adjunctive treatment of major depressive disorder in adults with inadequate response to antidepressant monotherapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing