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OPC-34712FUM/ Brexpiprazole fumarate
OPC-34712FUM/ Brexpiprazole fumarate is a Serotonin-dopamine activity modulator (SDAM); atypical antipsychotic Small molecule drug developed by Otsuka Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Schizophrenia, Major depressive disorder (adjunctive treatment).
Brexpiprazole is a serotonin-dopamine activity modulator (SDAM) that acts as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors while antagonizing serotonin 5-HT2A receptors.
Brexpiprazole is a serotonin-dopamine activity modulator (SDAM) that acts as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors while antagonizing serotonin 5-HT2A receptors. Used for Schizophrenia, Major depressive disorder (adjunctive treatment).
At a glance
| Generic name | OPC-34712FUM/ Brexpiprazole fumarate |
|---|---|
| Sponsor | Otsuka Pharmaceutical Co., Ltd. |
| Drug class | Serotonin-dopamine activity modulator (SDAM); atypical antipsychotic |
| Target | Dopamine D2 receptor (partial agonist), serotonin 5-HT1A receptor (partial agonist), serotonin 5-HT2A receptor (antagonist) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
Brexpiprazole modulates dopaminergic and serotonergic neurotransmission through multiple receptor interactions. As a partial agonist at D2 receptors, it reduces excessive dopamine signaling in psychotic states while maintaining baseline dopaminergic tone. Its 5-HT1A partial agonism and 5-HT2A antagonism contribute to anxiolytic and antidepressant effects, making it suitable for treating schizophrenia and major depressive disorder.
Approved indications
- Schizophrenia
- Major depressive disorder (adjunctive treatment)
Common side effects
- Akathisia
- Weight gain
- Sedation
- Headache
- Tremor
Key clinical trials
- Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia (PHASE1)
- Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia (PHASE3)
- A Long-term Administration Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia (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:
- OPC-34712FUM/ Brexpiprazole fumarate CI brief — competitive landscape report
- OPC-34712FUM/ Brexpiprazole fumarate updates RSS · CI watch RSS
- Otsuka Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about OPC-34712FUM/ Brexpiprazole fumarate
What is OPC-34712FUM/ Brexpiprazole fumarate?
How does OPC-34712FUM/ Brexpiprazole fumarate work?
What is OPC-34712FUM/ Brexpiprazole fumarate used for?
Who makes OPC-34712FUM/ Brexpiprazole fumarate?
What drug class is OPC-34712FUM/ Brexpiprazole fumarate in?
What development phase is OPC-34712FUM/ Brexpiprazole fumarate in?
What are the side effects of OPC-34712FUM/ Brexpiprazole fumarate?
What does OPC-34712FUM/ Brexpiprazole fumarate target?
Related
- Drug class: All Serotonin-dopamine activity modulator (SDAM); atypical antipsychotic drugs
- Target: All drugs targeting Dopamine D2 receptor (partial agonist), serotonin 5-HT1A receptor (partial agonist), serotonin 5-HT2A receptor (antagonist)
- Manufacturer: Otsuka Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Psychiatry
- Indication: Drugs for Schizophrenia
- Indication: Drugs for Major depressive disorder (adjunctive treatment)
- Compare: OPC-34712FUM/ Brexpiprazole fumarate vs similar drugs
- Pricing: OPC-34712FUM/ Brexpiprazole fumarate cost, discount & access