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Aripiprazole (Fixed dose)
Aripiprazole is a partial agonist at dopamine D2 and serotonin 5-HT1A receptors that stabilizes dopamine and serotonin neurotransmission in the brain.
Aripiprazole is a partial agonist at dopamine D2 and serotonin 5-HT1A receptors that stabilizes dopamine and serotonin neurotransmission in the brain. Used for Schizophrenia, Bipolar I disorder (acute manic or mixed episodes), Major depressive disorder (adjunctive treatment).
At a glance
| Generic name | Aripiprazole (Fixed dose) |
|---|---|
| Also known as | Aripiprazole |
| Sponsor | Otsuka Pharmaceutical Co., Ltd. |
| Drug class | Atypical antipsychotic |
| Target | Dopamine D2 receptor, Serotonin 5-HT1A receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
Aripiprazole acts as a partial agonist at dopamine D2 receptors and serotonin 5-HT1A receptors, meaning it can both activate and inhibit these receptors depending on baseline neurotransmitter levels. This unique mechanism allows it to normalize dopaminergic and serotonergic signaling, reducing excessive dopamine activity in psychotic states while maintaining adequate dopamine function in other brain regions. The fixed-dose formulation ensures consistent therapeutic levels for improved treatment adherence.
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
- Sedation
Key clinical trials
- Neurobiological Mechanisms of Pathological Rumination and Effects of Aripiprazole (NA)
- Measurement of Treatment Effects (EARLY_PHASE1)
- Fluoxetine vs Aripiprazole Comparative Trial (FACT) (PHASE4)
- Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder (TD) (PHASE3)
- Aripiprazole as an Adjunct to Atypical Antipsychotics for Weight Reduction and Improvement in Metabolic Profile (PHASE4)
- Use of Galantamine and CDP-choline (Citicoline) to Treat Adults With Schizophrenia (PHASE2)
- Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder (PHASE3)
- Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder (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:
- Aripiprazole (Fixed dose) CI brief — competitive landscape report
- Aripiprazole (Fixed dose) updates RSS · CI watch RSS
- Otsuka Pharmaceutical Co., Ltd. portfolio CI