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Cariprazine Flexible Dose
Cariprazine is a dopamine D2/D3 receptor partial agonist that modulates dopaminergic and serotonergic neurotransmission to treat psychiatric disorders.
Cariprazine is a dopamine D2/D3 receptor partial agonist that modulates dopaminergic and serotonergic neurotransmission to treat psychiatric disorders. Used for Schizophrenia, Bipolar I disorder (acute mania and maintenance treatment), Major depressive disorder (adjunctive treatment).
At a glance
| Generic name | Cariprazine Flexible Dose |
|---|---|
| Sponsor | AbbVie |
| Drug class | Atypical antipsychotic |
| Target | Dopamine D2 receptor, Dopamine D3 receptor, Serotonin 5-HT1A receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
Cariprazine selectively binds to dopamine D2 and D3 receptors with preferential affinity for D3, acting as a partial agonist to normalize abnormal dopaminergic signaling in the brain. It also has activity at serotonin 5-HT1A and 5-HT7 receptors. This multi-target mechanism helps reduce positive and negative symptoms in psychotic and mood disorders while potentially minimizing extrapyramidal side effects compared to typical antipsychotics.
Approved indications
- Schizophrenia
- Bipolar I disorder (acute mania and maintenance treatment)
- Major depressive disorder (adjunctive treatment)
Common side effects
- Akathisia
- Headache
- Nausea
- Insomnia
- Restlessness
- Extrapyramidal symptoms
- Weight gain
- Somnolence
Key clinical trials
- A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder. (PHASE3)
- Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9) (PHASE4)
- Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder (PHASE3)
- Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD (PHASE3)
- Adjunct Treatment With Cariprazine for Adults With Attention-deficit/Hyperactivity Disorder (PHASE4)
- Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder (PHASE3)
- Safety and Efficacy of Cariprazine in Schizophrenia (PHASE3)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |