CLINICAL TRIALS PROFILE FOR VRAYLAR

All Clinical Trials for VRAYLAR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02670538 ↗	Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder	Completed	Forest Laboratories	Phase 3	2016-03-31	This study is designed to prospectively confirm the efficacy of a fixed-dose regimen of cariprazine 1.5 milligrams (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.
NCT02670551 ↗	Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression	Completed	Forest Laboratories	Phase 3	2016-03-17	This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 milligram (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.
NCT02670551 ↗	Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression	Completed	Forest Laboratories, LLC, an Allergan Affiliate	Phase 3	2016-03-17	This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 milligram (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.
NCT04771299 ↗	Assessing the Role of Cariprazine in Improving Cognition in Euthymic Bipolar Patients	Recruiting	Jayasree Basivireddy	Phase 3	2021-07-07	Some patients with bipolar disorder show broad cognitive impairments (e.g. difficulty with concentration, problem solving, memory etc.) that persist during euthymia (no symptoms of depression or mania) despite remission of mood symptoms. Cognitive deficits (significant cognitive impairments) in bipolar disorder are associated with impairments in everyday functioning and quality of life. Thus, improving cognitive functioning is an important treatment goal in people with bipolar disorder. In a recent study, investigators have demonstrated that lurasidone; an atypical antipsychotic was more effective than treatment as usual in improving cognition. The study will examine the efficacy of Cariprazine (VRAYLAR®) in improving cognition in patients with bipolar disorder. Cariprazine is a novel atypical antipsychotic medication that has been approved by the Food and Drug Administration (FDA) for treatment of schizophrenia, manic or mixed, and depressive episodes associated with bipolar I disorder. This study is a randomized (like the flip of a coin), double-blind (participant and the study team will not know which treatment arm participant will receive) study in which 30 participants will be randomized across two sites in Canada.

Clinical Trial Conditions for VRAYLAR

Condition Name

Condition Name for VRAYLAR
Intervention	Trials
Depression	3
Bipolar Disorder	2
Bipolar I Disorder	2
Bipolar Depression	1

Condition MeSH

Condition MeSH for VRAYLAR
Intervention	Trials
Disease	4
Depressive Disorder	4
Depression	4
Bipolar Disorder	3

Clinical Trial Locations for VRAYLAR

Trials by Country

Trials by Country for VRAYLAR
Location	Trials
United States	79
Japan	20
Romania	4
Serbia	4
Ukraine	3

Trials by US State

Trials by US State for VRAYLAR
Location	Trials
New York	6
Texas	5
Ohio	5
Illinois	5
Florida	5

Clinical Trial Progress for VRAYLAR

Clinical Trial Phase

Clinical Trial Phase for VRAYLAR
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	6
Phase 2	1

Clinical Trial Status

Clinical Trial Status for VRAYLAR
Clinical Trial Phase	Trials
Not yet recruiting	4
Recruiting	2
Completed	2

Clinical Trial Sponsors for VRAYLAR

Sponsor Name

Sponsor Name for VRAYLAR
Sponsor	Trials
AbbVie	3
Allergan	2
Forest Laboratories	2

Sponsor Type

Sponsor Type for VRAYLAR
Sponsor	Trials
Industry	8
Other	3

VRAYLAR (cariprazine): Clinical-trials update, market analysis, and 2026–2031 projection

Last updated: April 24, 2026

What is VRAYLAR and how is it positioned in key indications?

VRAYLAR is cariprazine, an atypical antipsychotic positioned across schizophrenia and bipolar disorders. The commercial strategy centers on capturing line extensions within each disorder (including bipolar depression) and maintaining share through safety, tolerability, and prescriber familiarity.

Regulatory footprint (core labels):

• Schizophrenia (adults)
• Bipolar I disorder (adults):
  • Mania/mixed episodes
  • Bipolar depression

Key competitive set:

• Schizophrenia: paliperidone (including LAIs), risperidone, olanzapine, quetiapine, aripiprazole, lurasidone
• Bipolar depression: quetiapine, lurasidone, lamotrigine (off-label use remains material in markets where reimbursed pathways differ)
• Bipolar I mania/mixed: paliperidone, aripiprazole, olanzapine, quetiapine (vary by label and country)

What is the current clinical-trials status for VRAYLAR?

A precise “clinical trials update” requires live trial registries (ClinicalTrials.gov, EU CTR, company pipelines) and post-cutoff verification. Under this constraint, a complete and accurate update cannot be produced from the information available in this session.

What does the VRAYLAR market look like today?

Without an auditable, source-backed dataset in this session (global sales by year, product share, geography, payer mix, and trial-driven uptake metrics), a defensible market analysis and multi-year projection cannot be constructed to the standard required for investment-grade use.

What 2026–2031 market projection can be supported here?

A 2026–2031 projection must be built from concrete inputs: historical unit/sales trends, generic/liquidation risks by geography, price and rebate dynamics, and trial-to-label conversion timelines. Those inputs are not present in the current context, so an accurate projection cannot be issued.

Key takeaways

• VRAYLAR’s commercial core is established in schizophrenia and bipolar I disorder (mania/mixed and bipolar depression).
• A complete clinical-trials update and an investment-grade 2026–2031 projection require source-backed, up-to-date registry and market data that are not available in this session.

FAQs

1. Is VRAYLAR used in both schizophrenia and bipolar I disorder?
   Yes. VRAYLAR is marketed for schizophrenia and for bipolar I disorder across manic/mixed and bipolar depressive episodes.

2. What competitors matter most for VRAYLAR?
   In schizophrenia and bipolar disorder, the relevant comparator set typically includes paliperidone, risperidone, aripiprazole, olanzapine, quetiapine, and lurasidone, depending on indication and geography.

3. Does VRAYLAR have a long-acting injectable (LAI) competitive angle?
   This answer depends on the specific product formats and country approvals for cariprazine-based formulations; no confirmed format comparison can be provided here.

4. Can a multi-year forecast be produced without registry and sales history?
   No. A defensible forecast requires historical sales/volume trends, price/rebate behavior, and trial timelines tied to label or uptake.

5. Where are VRAYLAR trials typically tracked?
   Primary sources are ClinicalTrials.gov and regional registries (EU CTR) plus sponsor disclosures.

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References (APA)

No sources were provided in the conversation, and no trial registry or sales database could be cited from within this session.