Breaking through to depression symptom relief with the #1 branded atypical antipsychotic1,2*
*#1 prescribed branded AAP per June 2025 IQVIA data for both new-to-brand prescriptions and total prescriptions.
VRAYLAR can help
your patients go from
getting through tobreaking through
When adult major depressive disorder (MDD) patients with a partial response to an antidepressant (ADT) or bipolar I (BP-I) patients feel stuck, VRAYLAR can help them break through to relief—when added to an ADT for MDD and as monotherapy for depressive and acute manic/mixed episodes of BP-I.1
VRAYLAR is indicated for adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults, treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults, acute treatment of manic or mixed episodes associated with bipolar I disorder in adults and pediatric patients 10 years of age and older, and treatment of schizophrenia in adults and pediatric patients 13 years of age and older.1
Proven to treat the most common forms of depression—major depressive disorder (adjunctive) and bipolar I depression.1-3†
Adaptive receptor activity to modulate dopamine and serotonin
VRAYLAR is the only partial agonist approved for MDD (adjunctive) and BP-I depressive and acute manic or mixed episodes in adults1
The mechanism of action of VRAYLAR is unknown. The efficacy is thought to be mediated through a combination of partial agonist activity at central dopamine D2 and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors.1
Robust evidence in the most common forms of depression1-3†
Across 4 clinical trials in adults, VRAYLAR is proven to treat MDD (adjunctive) and BP-I depression at the starting dose of 1.5 mg/day1‡
Well-established tolerability§||
Safety profile studied across 5 clinical trials in adults with MDD (adjunctive) and BP-I depression
In two 6-week adjunctive MDD trials, VRAYLAR + ADT demonstrated1,2:
- Mean weight change of 1.5 lb¶
In 3 BP-I depression trials1,2:
- Mean weight change of 1.5 lb#
#1
Leading the way in unrestricted patient access**††
VRAYLAR has the #1 unrestricted combined coverage across all channels, inclusive of national commercial, Medicare Part D, and Medicaid, among branded oral atypical antipsychotics2**††‡‡§§
†Most common forms of depression that include a major depressive episode (MDE) according to DSM-5.
‡Starting dose is 1.5 mg/day. May increase dose to 3 mg/day on Day 15, depending on clinical response and tolerability.1
§The most common adverse reactions in 6-week adult adjunctive MDD studies (≥5% and at least twice that of placebo) were akathisia, nausea, and insomnia. In these studies, 4% of VRAYLAR-treated patients discontinued treatment due to an adverse reaction, versus 2% of placebo-treated patients.1,2
||The most common adverse reactions in adult BP-I depression studies (≥5% and at least twice that of placebo) were nausea, akathisia, restlessness, and EPS. In these studies, 6% of VRAYLAR-treated patients discontinued treatment due to an adverse reaction, versus 5% of placebo-treated patients.1
¶Weight gain may occur. In two 6-week MDD studies, 2% of people taking VRAYLAR + ADT had a weight increase of ≥7% vs 1% of those taking placebo + ADT. The mean weight changes reported in this study were VRAYLAR 1.5 mg/day + ADT (n=502) = +1.5 lb; VRAYLAR 3 mg/day + ADT (n=503) = +1.5 lb; placebo + ADT (n=503) = +0.4 lb.1
#Weight gain may occur. In BP-I depression studies, 3% of people taking VRAYLAR had a weight increase of ≥7% vs 1% of those taking placebo. The mean weight changes reported in these studies were VRAYLAR 1.5 mg/day (n=467) = +1.5 lb; VRAYLAR 3 mg/day (n=465) = +0.9 lb; placebo (n=463) = -0.2 lb.1
**Excluding branded products that have available generics.
††Unrestricted implies no step edit.
‡‡Source: Managed Markets Insight and Technology, LLC, a trademark of MMIT. Database as of December 2025. Applicable to the atypical antipsychotic market basket.
§§Coverage requirements and benefit designs vary by payer and may change over time. Please consult with payers directly for the most current reimbursement policies.
Combined 10 years of clinical and real-world experience across 4 adult indications1‖‖
12
Clinical Trials Inclusive of All Indications1¶¶
OVER
1.7 MILLION
Patients Treated With VRAYLAR2##
##Since 2015. Inclusive of all indications.
100,000
Prescribing Clinicians2##
‖‖VRAYLAR (cariprazine) is approved in adults as adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD; approved 2022), for the treatment of depressive episodes associated with bipolar I disorder (bipolar depression; approved 2019), for the acute treatment of manic or mixed episodes associated with bipolar I disorder (approved 2015), and for the treatment of schizophrenia (approved 2015).1,4,5
¶¶The most common adverse reactions observed in VRAYLAR adult trials (≥5% and at least twice the rate of placebo): major depressive disorder (two 6-week studies) (VRAYLAR 1.5 mg/day + ADT or 3 mg/day + ADT vs placebo + ADT)—akathisia (7%, 10% vs 2%), nausea (7%, 6% vs 3%), and insomnia (9%, 10% vs 5%); bipolar I depression (VRAYLAR 1.5 mg/day or 3 mg/day vs placebo)—nausea (7%, 7% vs 3%), akathisia (6%, 10% vs 2%), restlessness (2%, 7% vs 3%), and EPS (4%, 6% vs 2%); bipolar I mania (VRAYLAR 3-6 mg/day vs placebo)—EPS (26% vs 12%), akathisia (20% vs 5%), vomiting (10% vs 4%), dyspepsia (7% vs 4%), somnolence (7% vs 4%), and restlessness (7% vs 2%); schizophrenia (VRAYLAR 1.5-3 mg/day and 4.5-6 mg/day vs placebo)—EPS (15%, 19% vs 8%) and akathisia (9%, 13% vs 4%).1
VRAYLAR remains committed to supporting access and affordability for patients
94%of claims for a filled VRAYLAR prescription cost patients $10 or less2***
Lower out-of-pocket cost may mean patients are more likely to stay on track with their treatment6†††
***Based upon paid commercial, Medicare Part D, Medicaid, Cash/Savings Card, and Federal claims data from national providers for a filled 30-day VRAYLAR prescription for the period September 2024-August 2025. Patient’s actual out-of-pocket cost may vary depending on their insurance coverage and eligibility for support programs.
†††The objective of the systematic literature review of 71 articles published between January 2010 and August 2020 was to assess the impact of patient drug cost-sharing on medication adherence, clinical outcomes, resource utilization, and healthcare costs. The analysis observed increased cost-sharing was associated with worse adherence (84% of studies), persistence (79% of studies), or discontinuation (58% of studies). Limitations include that the type (eg, deductible, coinsurance, and copay) and magnitude (eg, $5, $50, or >$5,000 deductible) of cost-sharing were not homogeneous and outcome definitions varied (eg, proportion of days covered, medication possession ratios, or specific thresholds for treatment adherence, etc), making comparisons across publications difficult.6
ADT=antidepressant therapy; AE=adverse event; BP-I=bipolar I disorder; DSM=Diagnostic and Statistical Manual of Mental Disorders; EPS=extrapyramidal symptoms; MDD=major depressive disorder; MOA=mechanism of action.