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Vraylar (CARIPRAZINE)
Vraylar works by selectively blocking the D3 dopamine receptor, which helps regulate mood and behavior.
Vraylar (Cariprazine) is a small molecule atypical antipsychotic developed by Forest Labs LLC and currently owned by Abbvie. It targets the D3 dopamine receptor to treat bipolar affective disorder, mixed bipolar I disorder, and schizophrenia. Vraylar was FDA-approved in 2015 and has multiple generic manufacturers. The commercial status of Vraylar is not off-patent, but generic manufacturers are available. Key safety considerations include potential side effects such as weight gain, dizziness, and increased risk of stroke.
At a glance
| Generic name | CARIPRAZINE |
|---|---|
| Sponsor | AbbVie |
| Drug class | Atypical Antipsychotic [EPC] |
| Target | D(3) dopamine receptor |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2015 |
| Annual revenue | 3267 |
Mechanism of action
The mechanism of action of cariprazine in schizophrenia and bipolar disorder is unknown. However, the efficacy of cariprazine could be mediated through combination of partial agonist activity at central dopamine D2 and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors. Cariprazine forms two major metabolites, desmethyl cariprazine (DCAR) and didesmethyl cariprazine (DDCAR), that have in vitro receptor binding profiles similar to the parent drug.
Approved indications
- Bipolar affective disorder, current episode manic
- Mixed bipolar I disorder
- Schizophrenia
Boxed warnings
- WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. VRAYLAR is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )]. Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for the emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.2 )] . WARNING : INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. VRAYLAR is not approved for the treatment of patients with dementia-related psychosis. ( 5.1 ) Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. ( 5.2 )
Common side effects
- Extrapyramidal symptoms
- Akathisia
- Somnolence
- Restlessness
- Dyspepsia
- Vomiting
- Nausea
- Tachycardia
- Abdominal pain
- Constipation
- Diarrhea
- Dry mouth
Key clinical trials
- Evaluate Pharmacokinetics, Safety, and Tolerability of AX251 LAI in Patients With Schizophrenia (PHASE1)
- 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)
- An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine (PHASE4)
- Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder
- RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE) (PHASE4)
- Cariprazine for Comorbid Cocaine and Opioid Use Disorder (PHASE2)
- Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9) (PHASE4)
- Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Vraylar CI brief — competitive landscape report
- Vraylar updates RSS · CI watch RSS
- AbbVie portfolio CI