CLINICAL TRIALS PROFILE FOR REXULTI

All Clinical Trials for REXULTI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03418675 ↗	Brexpiprazole in Borderline Personality Disorder	Completed	Otsuka America Pharmaceutical	Phase 2	2018-11-26	The primary objective of the proposed study is to evaluate the safety and efficacy of Brexpiprazole in adults with borderline personality disorder (BPD). The hypothesis to be tested is that brexpiprazole will be more effective and well tolerated in adults with BPD compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder.
NCT03418675 ↗	Brexpiprazole in Borderline Personality Disorder	Completed	University of Chicago	Phase 2	2018-11-26	The primary objective of the proposed study is to evaluate the safety and efficacy of Brexpiprazole in adults with borderline personality disorder (BPD). The hypothesis to be tested is that brexpiprazole will be more effective and well tolerated in adults with BPD compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder.
NCT03149991 ↗	A Study of Brexpiprazole Plus Ketamine in Treatment-Resistant Depression (TRD)	Completed	Massachusetts General Hospital	Phase 4	2017-09-14	This is a multi-site, double-blind, placebo-controlled study of the acute efficacy of brexpiprazole or placebo in combination with intranasal ketamine added to ongoing, stable, and adequate antidepressant therapy (ADT) in the treatment of adults with Major Depressive Disorder with Treatment Resistant Depression.
NCT02934932 ↗	A Pilot Dose-Response Biomarker Study of Brexpiprazole Treatment in PTSD	Terminated	Otsuka America Pharmaceutical	Phase 2	2017-04-25	Determine if brexpiprazole treatment will be associated with a dose-dependent reduction in resting pupil diameter as a reflection of locus coeruleus (LC) norepinephrine (NE) neuron target engagement in a group of subjects with PTSD. All subjects will be evaluated by physical examination, ECG, standard blood chemistry, hematologic labs, toxicology testing, and urinalysis. Results of these studies must demonstrate a lack of clinically significant abnormalities prior to enrollment. Subjects will need to satisfy DSM-5 criteria for PTSD and receive a CAPS-5 score of 40 or greater on testing for study enrollment. Resting pupil diameter during pupillometric evaluation after two weeks on each treatment will serve as the primary outcome measure. This will be compared in the treatment groups using mixed effects repeated measures models to evaluate if there is a significant difference in pupil size among the treatments studied. As a secondary analysis this approach will be used to evaluate whether there is treatment effect on total CAPS-5 score. Lastly, the investigators will compute correlations between pupil size and CAPS-5 scores.
NCT02934932 ↗	A Pilot Dose-Response Biomarker Study of Brexpiprazole Treatment in PTSD	Terminated	Duke University	Phase 2	2017-04-25	Determine if brexpiprazole treatment will be associated with a dose-dependent reduction in resting pupil diameter as a reflection of locus coeruleus (LC) norepinephrine (NE) neuron target engagement in a group of subjects with PTSD. All subjects will be evaluated by physical examination, ECG, standard blood chemistry, hematologic labs, toxicology testing, and urinalysis. Results of these studies must demonstrate a lack of clinically significant abnormalities prior to enrollment. Subjects will need to satisfy DSM-5 criteria for PTSD and receive a CAPS-5 score of 40 or greater on testing for study enrollment. Resting pupil diameter during pupillometric evaluation after two weeks on each treatment will serve as the primary outcome measure. This will be compared in the treatment groups using mixed effects repeated measures models to evaluate if there is a significant difference in pupil size among the treatments studied. As a secondary analysis this approach will be used to evaluate whether there is treatment effect on total CAPS-5 score. Lastly, the investigators will compute correlations between pupil size and CAPS-5 scores.
NCT03427892 ↗	Brexpiprazole for Bipolar Depression	Completed	Otsuka America Pharmaceutical	Phase 4	2017-03-01	The investigators will conduct an 8-week, non-randomized, open-label study of brexpiprazole in 20 persons with bipolar I or II disorder, depressed mood state. Primary aim will be to assess if brexpiprazole is associated with a reduction in depressive symptom severity using the Montgomery-Asberg Depression Rating Scale (MADRS). Secondary aims will include an assessment of the following in patients with bipolar disorder taking brexpiprazole: manic symptoms, cognition, safety and tolerability of brexpiprazole, and quality of life. Subjects will be discontinued from the study if any of the following conditions occurs: change in diagnosis to other than bipolar I or II disorder, development of active suicidal or homicidal ideation with plan and intent, worsening of mood symptoms, that in the opinion of the investigators requires discontinuation, pregnancy, development of severe life-threatening medical condition, involuntary psychiatric hospitalization or incarceration.

Clinical Trial Conditions for REXULTI

Condition Name

Condition Name for REXULTI
Intervention	Trials
Major Depressive Disorder	3
Post Traumatic Stress Disorder	3
Borderline Personality Disorder	2
Bipolar Depression	1

Condition MeSH

Condition MeSH for REXULTI
Intervention	Trials
Depressive Disorder	5
Depression	5
Depressive Disorder, Major	3
Stress Disorders, Traumatic	3

Clinical Trial Locations for REXULTI

Trials by Country

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Trials by Country for REXULTI
Location	Trials
United States	23
Canada	6
Japan	1

Trials by US State

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−

Trials by US State for REXULTI
Location	Trials
New York	5
Texas	3
Illinois	3
California	3
Ohio	1

Clinical Trial Progress for REXULTI

Clinical Trial Phase

Clinical Trial Phase for REXULTI
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	3
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for REXULTI
Clinical Trial Phase	Trials
Completed	5
Recruiting	4
Terminated	1

Clinical Trial Sponsors for REXULTI

Sponsor Name

Sponsor Name for REXULTI
Sponsor	Trials
Otsuka Pharmaceutical Development & Commercialization, Inc.	3
Otsuka America Pharmaceutical	3
McMaster University	2

Sponsor Type

Sponsor Type for REXULTI
Sponsor	Trials
Other	31
Industry	8

REXULTI: Clinical Trials, Market Analysis, and Projections

Introduction to REXULTI

REXULTI, also known as brexpiprazole, is a medication approved for the treatment of several psychiatric conditions, including major depressive disorder (MDD), schizophrenia, and agitation associated with dementia due to Alzheimer’s disease (AADAD). Here, we will delve into the clinical trials that led to its approval, its current market analysis, and future projections.

Clinical Trials for MDD

The FDA approved REXULTI for MDD based on evidence from two clinical trials involving 1054 patients. These trials were conducted in the United States, Canada, and Europe. The primary efficacy measure used was the Montgomery-Åsberg Depression Rating Scale (MADRS).

• Trial Demographics: The trials included a diverse population with 55% of participants being female and 45% male. The racial distribution showed a majority of Caucasian patients, with smaller percentages of other racial groups[1].
• Efficacy Results: The trials demonstrated that REXULTI, when used as an adjunct to antidepressant therapy (ADT), showed significant improvement in depressive symptoms compared to placebo plus ADT. The mean change from baseline in MADRS scores was -8.4 for the REXULTI group, compared to -5.2 for the placebo group, resulting in a placebo-subtracted difference of -3.2[1].

Clinical Trials for Schizophrenia

For schizophrenia, REXULTI was approved based on two clinical trials that enrolled patients with schizophrenia. These trials also assessed the efficacy of REXULTI in different dosages.

• Trial Design: The trials compared REXULTI at doses of 2mg/day and 4mg/day against a placebo. The primary efficacy measure used was the Positive and Negative Syndrome Scale (PANSS)[4].
• Efficacy Results: The results showed that both doses of REXULTI significantly reduced PANSS scores compared to the placebo group. The mean change from baseline in PANSS scores was -20.7 for the 2mg/day group and -19.7 for the 4mg/day group, compared to -12 for the placebo group[4].

Market Analysis

Current Market Performance

REXULTI has shown strong performance in various markets. According to Lundbeck's Q2 2024 report, REXULTI revenue reached DKK 2,381 million, representing a growth of 13% in constant exchange rates (CER) and 12% in Danish kroner (DKK) compared to the previous year. The growth is attributed to robust demand in the treatment of MDD, partially driven by the reinitiation of direct-to-consumer (DTC) campaigns in the U.S.[5].

Market Size and Forecast

The market forecast for REXULTI is promising, especially in the seven major markets (7MM) including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

• Forecasted Sales: The market size for REXULTI in these regions is expected to grow significantly from 2019 to 2032. The report highlights that the market scenario for schizophrenia is set to expand due to extensive research and increased healthcare spending, enabling drug manufacturers to penetrate the market more effectively[2][3].
• Competitive Landscape: REXULTI faces competition from both existing and emerging therapies. However, its unique mechanism of action and established efficacy make it a strong contender in the market. The report includes a detailed SWOT analysis and insights from analysts, which suggest that REXULTI will continue to be a significant player in the schizophrenia market[2][3].

Regional Performance

• United States: REXULTI has seen robust growth in the U.S., driven by demand for its use in treating MDD and schizophrenia. The revenue growth in the U.S. was partially attributed to the reinitiation of DTC campaigns[5].
• Europe: In Europe, REXULTI has also performed well, particularly in countries like Spain, Italy, and France. The revenue growth in Europe is driven by higher demand and market share growth[5].
• Other Regions: REXULTI is approved in various other regions, including Canada, Brazil, Australia, and Japan, where it also shows promising market potential[5].

Regulatory Milestones and Development Activities

REXULTI has achieved several regulatory milestones, including approvals for different indications across various regions.

• Approvals: REXULTI is approved as an adjunctive therapy for MDD and schizophrenia in several countries, including the U.S., Canada, Brazil, Australia, and Europe. It is also approved for the treatment of AADAD in the U.S. and Canada[5].
• Development Activities: The drug continues to be under research and development for potential new indications and dosages. The reports provide detailed descriptions of regulatory milestones and ongoing developmental activities, which are crucial for understanding the current and future market scenario[2][3].

Future Projections and Market Impact

Market Expansion

The market for schizophrenia is expected to expand due to increased research and healthcare spending. This expansion will create more opportunities for REXULTI and other therapies to penetrate the market[2][3].

Emerging Therapies

The launch of late-stage emerging therapies in the near future is expected to impact the market significantly. However, REXULTI's established efficacy and unique mechanism of action position it well to compete with these new therapies[2][3].

Sales Forecast

The forecasted sales data from 2023 to 2032 indicate a steady growth trajectory for REXULTI. The detailed market size forecasts for each of the 7MM provide a comprehensive view of the drug's potential market performance[2][3].

"In the coming years, the market scenario for schizophrenia is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market."[3]

Key Takeaways

• Clinical Trials: REXULTI was approved based on robust clinical trials for MDD and schizophrenia, demonstrating significant efficacy.
• Market Performance: The drug has shown strong revenue growth in the U.S. and Europe, driven by demand for its use in treating MDD and schizophrenia.
• Market Forecast: The market size for REXULTI is expected to grow significantly from 2019 to 2032, driven by expanding healthcare spending and research.
• Regulatory Milestones: REXULTI has achieved multiple regulatory approvals across different regions and indications.
• Future Projections: The drug is expected to continue competing effectively against emerging therapies due to its established efficacy and unique mechanism of action.

FAQs

What is REXULTI used for?

REXULTI (brexpiprazole) is used as an adjunctive therapy for the treatment of adults with major depressive disorder (MDD), schizophrenia, and agitation associated with dementia due to Alzheimer’s disease (AADAD)[5].

What were the key findings of the clinical trials for REXULTI in MDD?

The clinical trials for MDD showed that REXULTI, when used as an adjunct to antidepressant therapy, significantly improved depressive symptoms compared to placebo plus ADT, with a mean change from baseline in MADRS scores of -8.4 for the REXULTI group[1].

How does REXULTI perform in the market?

REXULTI has shown strong revenue growth, particularly in the U.S. and Europe, driven by demand for its use in treating MDD and schizophrenia. The revenue reached DKK 2,381 million in 2024, representing a 13% growth in CER[5].

What is the forecasted market size for REXULTI?

The market size for REXULTI is expected to grow significantly from 2019 to 2032, driven by expanding healthcare spending and research in the seven major markets (7MM)[2][3].

What are the regulatory milestones for REXULTI?

REXULTI has been approved as an adjunctive therapy for MDD and schizophrenia in several countries, including the U.S., Canada, Brazil, Australia, and Europe. It is also approved for the treatment of AADAD in the U.S. and Canada[5].

How does REXULTI compete with emerging therapies?

Despite the launch of late-stage emerging therapies, REXULTI's established efficacy and unique mechanism of action position it well to compete in the market. The drug continues to be under research and development for potential new indications and dosages[2][3].

Sources

1. FDA Drug Trials Snapshots: REXULTI - FDA
2. REXULTI Drug Insight and Market Forecast - 2032 - ResearchAndMarkets
3. REXULTI: Approved as Adjunctive Therapy to Treat Adults with MDD and Schizophrenia - PR Newswire
4. Drug Trials Snapshots: REXULTI for the treatment of schizophrenia - FDA
5. Q2 2024_Final.pdf - Lundbeck