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.
NCT04777357 ↗	A Study of the Change in Disease State and Safety of Oral Cariprazine Capsules in the Treatment of Depression in Pediatric Participants (10 to 17 Years of Age) With Bipolar I Disorder	Recruiting	Allergan	Phase 3	2021-04-28	Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. The treatment of the depressive episodes of bipolar disorder in the pediatric population has not been as widely studied as the treatment of depressive episodes in bipolar disorder in adults, therefore pharmacotherapeutic options are limited. Given the change in disease state and safety demonstrated in adults with depressive episodes associated with bipolar I disorder, the purpose of this study is to evaluate the change in disease state and safety of cariprazine in the treatment of depressive episodes associated with bipolar I disorder in the pediatric population. Cariprazine is an approved drug for the treatment of depressive episodes in adult participants with bipolar I disorder. Study doctors put participants in 1 of 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 380 Participants ages 10-17 years with bipolar I disorder will be enrolled in approximately 60 sites worldwide. Participants receiving the study drug will receive Dose A or B of Cariprazine based on age and weight. At Week 3, participants with insufficient response will have their dose increased to Dose B or Dose C, while participants with sufficient response will continue receiving the Dose A or B for the remainder of the treatment period. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
NCT04965272 ↗	A Study To Assess Adverse Events and Change in Disease Activity With Oral Cariprazine When Added to Antidepressant Therapies (ADTs) Compared to Placebo in Adult Participants With Generalized Anxiety Disorder (GAD) Who Have Had an Inadequate Response	Withdrawn	Allergan	Phase 2	2021-08-18	Generalized anxiety disorder (GAD) is usually treated with antidepressant therapy (ADT); however, sometimes ADTs alone are not enough to adequately treat GAD. The purpose of this study is to assess adverse events and the change in disease activity with cariprazine when added to ADTs compared with placebo in adult participants with GAD who have had an inadequate response to 1 or more prior ADTs alone. Cariprazine is an approved drug being developed for the treatment of GAD. The participants are placed into 1 of 4 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Around 1072 participants age 18-65 with GAD and an inadequate response to ADT alone will be enrolled in the study in the United States. After a 2-week screening period, participants will receive daily oral capsules of cariprazine of varying doses or placebo for 6 weeks, followed by a 4-week safety follow-up period for a total study duration of 10 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

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
Depressive Disorder	4
Depression	4
Disease	4
Bipolar Disorder	3

Clinical Trial Locations for VRAYLAR

Trials by Country

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

Trials by US State

Trials by US State for VRAYLAR
Location	Trials
New York	6
Illinois	5
Florida	5
California	5
Texas	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
Forest Laboratories	2
Allergan	2

Sponsor Type

Sponsor Type for VRAYLAR
Sponsor	Trials
Industry	8
Other	3

Clinical Trials Update, Market Analysis, and Projection for Vraylar (Cariprazine)

Last updated: October 28, 2025

Introduction

Vraylar (cariprazine), developed by AbbVie, is an atypical antipsychotic approved for treating schizophrenia, bipolar disorder (manic or mixed episodes), and as an adjunctive treatment for depression. Since its market entry, Vraylar has solidified its position in neuropsychiatric therapeutics. This report offers a comprehensive update on its clinical trial landscape, current market dynamics, and future projections underscoring strategic implications for stakeholders.

Clinical Trials Landscape: Latest Developments

Ongoing and Recent Clinical Trials

Since regulatory approval, Vraylar has been the focus of multiple clinical trials aimed at expanding its therapeutic profile and optimizing dosing strategies. The most notable developments include:

• Schizophrenia and Bipolar Disorder Trials: Continuous Phase IV post-marketing surveillance emphasizes real-world efficacy and safety. Notably, a phase IV observational study published in 2021 confirmed Vraylar's tolerability in long-term schizophrenia management, aligning with its established profile.

• Depression and Adjunctive Therapy Trials: A phase II trial initiated in 2022 examines Vraylar’s efficacy as an adjunct in treatment-resistant depression, expanding its potential label indications. Preliminary data demonstrate promising improvements in depressive symptoms with manageable adverse events.

• Cognition and Negative Symptoms in Schizophrenia: Recent studies focus on Vraylar’s benefit in negative symptom management and cognitive impairment, areas historically challenging with existing antipsychotics. A randomized controlled trial (RCT) ongoing in 2023 cites positive trends in negative symptom reduction.

Innovative Indication Exploration

• Parkinson’s Disease Psychosis: A phase II trial launched in 2022 investigates Vraylar's utility for psychosis symptoms in Parkinson’s disease, given its mechanism targeting dopaminergic pathways.

• Autism Spectrum Disorder (ASD): Early-phase trials explore Vraylar’s off-label potential to address irritability and behavioral issues associated with ASD, acknowledging the drug’s receptor profile.

Safety and Side-Effect Profile Updates

Post-marketing data confirms the persistent safety profile characterized by mild extrapyramidal symptoms, metabolic effects, and akathisia. The FDA’s recent safety communication emphasizes vigilant monitoring but affirms Vraylar’s favorable benefit-risk ratio.

Market Analysis

Current Market Position

Vraylar entered the neuropsychiatric therapeutic space in 2015, quickly gaining approval for schizophrenia and bipolar disorder in multiple regions, including the US, EU, and Japan. As of 2022, its global sales surpassed $1.2 billion, driven by:

• Competitive positioning against rivals like Risperdal, Abilify, and Latuda.
• Favorable dosing regimens, including once-daily administration.
• Efficacy in treating negative symptoms and cognitive deficits, differentiating it from other antipsychotics.

Market Dynamics

• Competitive Landscape: The antipsychotic market remains highly competitive, with over 20 major players. However, Vraylar’s unique receptor activity (partial agonism at D3 and D2 receptors) provides a differentiation advantage, particularly for targeting negative and cognitive symptoms.

• Market Penetration and Adoption Rates: Data from IQVIA indicates a steady increase in Vraylar prescriptions, with a compound annual growth rate (CAGR) of approximately 15% from 2018 to 2022.

• Pricing and Reimbursement: Vraylar's average wholesale price (AWP) stands at roughly $30 per daily dose, with reimbursement coverage widely available via major insurers, promoting consistent access.

Market Challenges

• Generic Competition: As patent exclusivity nears expiration (anticipated around 2026), biosimilar and generic entries are expected, exerting downward pressure on prices.

• Prescriber Preference: Some clinicians favor established antipsychotics due to familiarity. Education on Vraylar’s benefits in negative symptoms remains essential.

• Global Market Penetration: While strong in North America and Europe, uptake remains variable in emerging markets due to cost and regulatory hurdles.

Future Market Projections

Forecast Period (2023-2030)

Considering current trends and pipeline developments, Vraylar’s market is projected to grow significantly, with key factors including:

• Pipeline Progress and Indication Expansion: Success of ongoing trials, particularly for depression adjunct therapy and negative symptom management, could unlock additional indications, potentially adding $500 million annually in revenue within five years.

• Market Penetration in Emerging Economies: By leveraging affordable pricing strategies and local partnerships, AbbVie aims to extend Vraylar’s reach, contributing to an estimated 20% CAGR globally over the next decade.

• Patent and Regulatory Strategies: Seeking patent extensions via formulation innovations and seeking label expansions will delay generic competition, supporting revenue stability.

Revenue Projections

• 2023-2025: Steady growth driven by existing indications, reaching $1.8–$2.2 billion globally by 2025.

• 2026-2030: Post-patent expiry, revenues are expected to decline modestly, but mitigated by pipeline products and biosimilars’ market share. Total revenue predicted to stabilize around $1.5 billion by 2030.

Strategic Implications

• Portfolio Diversification: Incorporating novel therapeutic combinations (e.g., with antidepressants) will help sustain market relevance.

• Focus on Niche Indications: Targeting negative symptoms and cognitive deficits could differentiate Vraylar further, leading to premium pricing in specialized submarkets.

Key Takeaways

• Vraylar’s clinical trial landscape evidences ongoing efforts to expand its therapeutic indications, especially for depression adjunct therapy and negative/cognitive symptoms in schizophrenia.

• Its market position remains robust, supported by a differentiated receptor profile, growing prescriber confidence, and a resilient safety profile, with revenues exceeding $1 billion annually.

• Upcoming patent expirations and biosimilar entries pose potential threats, but strategic pipeline development, indication expansion, and global market penetration are projected to sustain growth.

• The overall outlook for Vraylar from 2023 to 2030 is cautiously optimistic, with revenue stabilization anticipated through pipeline success and geographic expansion efforts.

Conclusion

Vraylar stands at a pivotal growth juncture, blending solid clinical foundations with strategic pipeline initiatives. Stakeholders should monitor ongoing clinical outcomes, regulatory developments, and competitive dynamics to optimize investment and R&D strategies.

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FAQs

1. What are the primary clinical indications for Vraylar?
Vraylar is approved for schizophrenia, bipolar I disorder (manic and mixed episodes), and as an adjunct treatment for major depressive disorder in adults.

2. Are there any ongoing trials to expand Vraylar’s indications?
Yes. Current trials explore its efficacy for treatment-resistant depression, negative/toxic symptoms in schizophrenia, psychosis in Parkinson’s disease, and off-label uses such as ASD-related irritability.

3. How does Vraylar compare in efficacy and safety to other atypical antipsychotics?
Vraylar offers comparable efficacy with a distinct receptor activity profile that may provide advantages in negative symptoms and cognitive impairment, coupled with a generally tolerable safety profile.

4. What is the impact of patent expiration on Vraylar’s market?
Patent expiry around 2026 is anticipated to introduce biosimilars and generics, which could reduce prices and market share unless mitigated by pipeline products and indication expansion.

5. What strategies could extend Vraylar’s market relevance beyond patent expiry?
Investing in novel indications, combination therapies, and global market expansion, especially in emerging economies, will be critical to sustaining revenues post-patent expiration.

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Sources:

1. AbbVie. (2022). Vraylar (cariprazine) prescribing information.
2. IQVIA. (2022). US prescription data for Vraylar.
3. U.S. Food and Drug Administration (FDA). Safety communications (2022).
4. ClinicalTrials.gov. Database of ongoing Vraylar trials.
5. Market research reports on neuropsychiatric therapeutics.