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OPC-14597 (Aripiprazole)
Aripiprazole is a partial agonist at dopamine D2 and serotonin 5-HT1A receptors that stabilizes dopaminergic and serotonergic neurotransmission.
Aripiprazole is a partial agonist at dopamine D2 and serotonin 5-HT1A receptors that stabilizes dopaminergic and serotonergic neurotransmission. Used for Schizophrenia, Bipolar I disorder (acute manic or mixed episodes), Major depressive disorder (adjunctive treatment).
At a glance
| Generic name | OPC-14597 (Aripiprazole) |
|---|---|
| Sponsor | Otsuka Pharmaceutical Co., Ltd. |
| Drug class | Atypical antipsychotic |
| Target | Dopamine D2 receptor (partial agonist), Serotonin 5-HT1A receptor (partial agonist) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Neurology |
| Phase | Phase 3 |
Mechanism of action
Aripiprazole acts as a partial agonist rather than a full antagonist, meaning it can both activate and inhibit dopamine D2 receptors depending on baseline dopamine levels, providing a stabilizing effect. This unique mechanism reduces excessive dopaminergic activity in hyperactive states while maintaining adequate dopaminergic function in hypoactive states. The drug also has partial agonist activity at 5-HT1A receptors, contributing to its antipsychotic and mood-stabilizing effects.
Approved indications
- Schizophrenia
- Bipolar I disorder (acute manic or mixed episodes)
- Major depressive disorder (adjunctive treatment)
- Autism spectrum disorder (irritability)
Common side effects
- Akathisia
- Headache
- Anxiety
- Insomnia
- Nausea
- Weight gain
- Tremor
- Somnolence
Key clinical trials
- Substance Misuse To Psychosis for Stimulants (PHASE2, PHASE3)
- Cerebellum-based Imaging Neural Markers for Antipsychotic Response
- An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine (PHASE4)
- Pragmatic Trial Comparing Weight Gain in Children With Autism Taking Risperidone Versus Aripiprazole (PHASE4)
- Τhe Combination of Pharmacotherapy With RECOVERYTRSGR and RECOVERYTRSBDGR. (PHASE4)
- C-Cog in Early Course Schizophrenia Study (PHASE4)
- Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia (PHASE3)
- Enhancing Recovery in Early Schizophrenia (PHASE2)
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-14597 (Aripiprazole) CI brief — competitive landscape report
- OPC-14597 (Aripiprazole) updates RSS · CI watch RSS
- Otsuka Pharmaceutical Co., Ltd. portfolio CI