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Phase 1: Aripiprazole
Aripiprazole is a dopamine D2/D3 receptor partial agonist that modulates dopaminergic and serotonergic neurotransmission in the brain.
Aripiprazole is a dopamine D2/D3 receptor partial agonist that modulates dopaminergic and serotonergic 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 | Phase 1: Aripiprazole |
|---|---|
| Sponsor | Shanghai Mental Health Center |
| Drug class | Atypical antipsychotic |
| Target | Dopamine D2/D3 receptor (partial agonist); serotonin 5-HT1A and 5-HT7 receptors |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
Aripiprazole acts as a partial agonist at dopamine D2 and D3 receptors, providing dopaminergic stabilization by increasing activity when dopamine is low and decreasing it when dopamine is high. It also has antagonist activity at serotonin 5-HT7 receptors and 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
- Sedation
Key clinical trials
- Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) (PHASE1, PHASE2)
- Pragmatic Trial of Obsessive-compulsive Disorder (PHASE2)
- Safety and Efficacy of Brexpiprazole in the Treatment of Schizophrenia (PHASE3)
- Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments(SMART-CAT) (PHASE3)
- Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis (PHASE4)
- A 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 (PHASE2)
- A Double-Blind, Randomized Comparative Study of Carliprazine and Aripiprazole in Patients with Acute Schizophrenia (PHASE3)
- Aripiprazole for Bipolar Disorder and Alcohol Use 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:
- Phase 1: Aripiprazole CI brief — competitive landscape report
- Phase 1: Aripiprazole updates RSS · CI watch RSS
- Shanghai Mental Health Center portfolio CI