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Last Updated: March 16, 2025

CLINICAL TRIALS PROFILE FOR QUETIAPINE FUMARATE


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All Clinical Trials for QUETIAPINE FUMARATE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00090311 ↗ Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Children & Adolescents With Bipolar I Mania Completed AstraZeneca Phase 3 2004-07-01 The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of children and adolescent patients with Bipolar I mania.
NCT00083954 ↗ Controlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar Depression Completed AstraZeneca Phase 3 2004-06-01 The purpose of this study is to determine the efficacy of quetiapine compared to placebo in the treatment for a major depressive episode in patients with bipolar disorder after receiving treatment for up to 8 weeks.
NCT00085891 ↗ Efficacy & Safety of Quetiapine Fumarate (SEROQUEL) & Placebo in the Treatment of Acutely Ill Patients With Schizophrenia Completed AstraZeneca Phase 3 2004-06-01 The purpose of this study is to demonstrate superior efficacy of sustained release quetiapine compared to placebo in patients with schizophrenia after receiving treatment for up to 6 weeks.
NCT00081380 ↗ Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder Completed AstraZeneca Phase 3 2004-03-01 The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
NCT00060489 ↗ Safety and Efficacy Trial of the Use of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Patients With Bipolar Depression Completed AstraZeneca Phase 3 2002-09-01 The purpose of this study is to evaluate the efficacy and safety of quetiapine in the treatment of a major depressive episode in patients with bipolar disorder.
NCT00034775 ↗ A Study to Assess Safety and Tolerabiltiy Associated With a Switch From Oral Antipsychotic Medications to Long-acting Injectable Risperidone in Patients With Schizophrenia. Completed Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 3 2001-08-01 The primary purpose of the study is to assess the safety and tolerability of a long-acting injectable formulation of risperidone when switching from an oral antipsychotic in patients with schizophrenia.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 6 of 6 entries

Clinical Trial Conditions for QUETIAPINE FUMARATE

Condition Name

23121160-2024681012141618202224SchizophreniaBipolar DisorderMajor Depressive DisorderBipolar Depression[disabled in preview]
Condition Name for QUETIAPINE FUMARATE
Intervention Trials
Schizophrenia 23
Bipolar Disorder 12
Major Depressive Disorder 11
Bipolar Depression 6
[disabled in preview] 0
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Condition MeSH

292625240051015202530DiseaseDepressionSchizophreniaDepressive Disorder[disabled in preview]
Condition MeSH for QUETIAPINE FUMARATE
Intervention Trials
Disease 29
Depression 26
Schizophrenia 25
Depressive Disorder 24
[disabled in preview] 0
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Clinical Trial Locations for QUETIAPINE FUMARATE

Trials by Country

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Trials by Country for QUETIAPINE FUMARATE
Location Trials
United States 588
Canada 66
China 43
Korea, Republic of 21
Germany 20
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Trials by US State

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Trials by US State for QUETIAPINE FUMARATE
Location Trials
Texas 29
Florida 27
New York 26
California 26
Pennsylvania 24
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Clinical Trial Progress for QUETIAPINE FUMARATE

Clinical Trial Phase

22.7%52.6%7.2%17.5%0510152025303540455055Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for QUETIAPINE FUMARATE
Clinical Trial Phase Trials
Phase 4 22
Phase 3 51
Phase 2 7
[disabled in preview] 17
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Clinical Trial Status

86.6%6.2%00102030405060708090CompletedTerminatedUnknown status[disabled in preview]
Clinical Trial Status for QUETIAPINE FUMARATE
Clinical Trial Phase Trials
Completed 84
Terminated 6
Unknown status 4
[disabled in preview] 3
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Clinical Trial Sponsors for QUETIAPINE FUMARATE

Sponsor Name

trials010203040506070AstraZenecaRoxane LaboratoriesTorrent Pharmaceuticals Limited[disabled in preview]
Sponsor Name for QUETIAPINE FUMARATE
Sponsor Trials
AstraZeneca 68
Roxane Laboratories 3
Torrent Pharmaceuticals Limited 3
[disabled in preview] 6
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Sponsor Type

69.0%24.1%001020304050607080IndustryOtherNIH[disabled in preview]
Sponsor Type for QUETIAPINE FUMARATE
Sponsor Trials
Industry 80
Other 28
NIH 4
[disabled in preview] 4
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Quetiapine Fumarate: Clinical Trials, Market Analysis, and Projections

Introduction

Quetiapine fumarate, a widely used antipsychotic medication, has been a cornerstone in the treatment of various mental health disorders, including schizophrenia, bipolar disorder, and major depressive disorder (MDD). This article delves into recent clinical trials, market analysis, and future projections for quetiapine fumarate.

Clinical Trials and Efficacy

Adjunctive Therapy in Major Depressive Disorder

A significant clinical trial published in the International Journal of Neuropsychopharmacology evaluated the efficacy of once-daily extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in patients with MDD who had an inadequate response to ongoing antidepressant treatment. The study, conducted over 8 weeks, involved 446 patients randomized to receive quetiapine XR 150 mg/day, 300 mg/day, or placebo. The primary endpoint was the change in Montgomery–Åsberg Depression Rating Scale (MADRS) total score from randomization to week 6.

  • The results showed that quetiapine XR 300 mg/day significantly improved MADRS total scores compared to placebo, with a mean change of -14.7 vs. -11.7 (p < 0.01)[1].
  • Additionally, quetiapine XR 300 mg/day demonstrated significant improvements in MADRS response and remission rates, as well as in Hamilton Depression Rating Scale (HAMD) and Clinical Global Impression – Severity of illness (CGI-S) scores[1].

Dopamine Receptor Occupancy

Another study focused on the dopamine receptor occupancy of quetiapine, comparing its effects when administered as extended-release (XR) and immediate-release (IR) formulations. The study found that quetiapine, similar to clozapine, may exhibit antipsychotic effects at lower D2 receptor occupancy levels[4].

Market Analysis

Global Market Size and Forecast

The global quetiapine market is projected to experience significant growth. As of 2023, the quetiapine market size was valued at USD 16.11 billion and is expected to reach USD 26.45 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.2% during the forecast period[3].

Regional Market Dynamics

The market is segmented geographically, with North America and Europe being key regions due to high prevalence rates of psychiatric disorders and well-established healthcare infrastructures. Europe, in particular, holds a significant market share, with about 92% of the quetiapine fumarate market[2].

Competitive Landscape

The quetiapine fumarate market is competitive, with several major players including TAPI, Accord, Hexal, Dr.Reddy's, Lupin, and Sun Pharmaceutical. These companies occupy a substantial market share, with the top three companies accounting for about 74% of the market[2].

Types and Applications

Quetiapine fumarate is available in two main types: immediate-release tablets and extended-release tablets. The primary applications include treatment for adult patients with schizophrenia, bipolar disorder, and major depressive disorder[5].

Market Drivers and Opportunities

Increasing Prevalence of Mental Health Disorders

The rising prevalence of mental health disorders globally, including schizophrenia, bipolar disorder, and depression, drives the demand for effective treatments like quetiapine fumarate[3].

Growing Awareness and Acceptance

Increased awareness and reduced stigma associated with mental health conditions have led more patients to seek treatment, boosting the market for antipsychotic medications[3].

Aging Population

The aging population contributes to an increase in age-related mental health issues, further increasing the demand for psychiatric medications[3].

Research and Development

Ongoing research and clinical trials exploring new therapeutic uses for quetiapine or combinations with other treatments can expand its application and market potential[3].

Market Challenges and Restraints

Generic Competition

The expiration of patents for branded versions of quetiapine has led to the entry of generic formulations, which can increase accessibility but also exert pressure on prices and profit margins for branded products[3].

Regulatory Challenges

Stricter regulations and longer approval times for new drug formulations or indications can impede market entry for new competitors or innovations[3].

Safety Concerns and Side Effects

Reports of side effects related to quetiapine, such as metabolic issues, sedation, and potential cardiovascular problems, can lead to reduced prescriptions and physician hesitance to recommend the drug[3].

Market Saturation

The antipsychotic market is highly competitive, with numerous alternatives available, which can limit the market potential for quetiapine fumarate[3].

Future Projections

Market Size and Growth

Despite the challenges, the quetiapine fumarate market is expected to grow, albeit at a slower rate in some segments. The global quetiapine fumarate market is projected to decline slightly from USD 155.9 million in 2024 to USD 136.4 million by 2030, at a CAGR of -2.2% during the forecast period[2].

Innovations and Advancements

Advancements in drug delivery systems and formulations may enhance the efficacy and safety profile of quetiapine, potentially driving its use in clinical practice. Health authorities’ approvals for new indications or formulations of quetiapine can significantly influence market dynamics, creating new opportunities[3].

Regional Growth

North America and Europe are expected to continue as major markets, driven by high prevalence rates of psychiatric disorders and favorable healthcare infrastructures. Emerging markets in Asia-Pacific and Latin America may also see growth due to increasing awareness and improving healthcare access[3].

Key Takeaways

  • Quetiapine fumarate has shown significant efficacy as an adjunctive therapy in MDD and other mental health disorders.
  • The global quetiapine market is projected to grow to USD 26.45 billion by 2031, driven by increasing prevalence of mental health disorders and growing awareness.
  • The market faces challenges from generic competition, regulatory hurdles, and safety concerns.
  • Innovations in drug delivery and new therapeutic uses are expected to expand the market potential.

FAQs

What is the current market size of quetiapine fumarate, and what is the projected growth?

The global quetiapine market was valued at USD 16.11 billion in 2023 and is projected to reach USD 26.45 billion by 2031, growing at a CAGR of 5.2%[3].

What are the primary applications of quetiapine fumarate?

The primary applications include treatment for adult patients with schizophrenia, bipolar disorder, and major depressive disorder[5].

What are the main drivers of the quetiapine fumarate market?

Key drivers include the increasing prevalence of mental health disorders, growing awareness and acceptance of mental health issues, and an aging population[3].

What challenges does the quetiapine fumarate market face?

The market faces challenges from generic competition, regulatory hurdles, safety concerns, and market saturation[3].

Which regions are expected to drive the growth of the quetiapine fumarate market?

North America and Europe are expected to continue as major markets, with emerging markets in Asia-Pacific and Latin America also showing potential growth[3].

Sources

  1. International Journal of Neuropsychopharmacology: "A multicentre, randomized, double-blind, placebo-controlled study of quetiapine as adjunctive therapy in patients with major depressive disorder with inadequate response to ongoing antidepressant treatment"[1].
  2. Valuates Reports: "Global Quetiapine Fumarate Market Insights, Forecast to 2030"[2].
  3. Verified Market Research: "Quetiapine Market Size, Share, Scope, Trends & Forecast"[3].
  4. International Journal of Neuropsychopharmacology: "Comparison of D2 dopamine receptor occupancy after oral administration of quetiapine extended-release and immediate-release formulations"[4].
  5. Cognitive Market Research: "Quetiapine Fumarate Market Report 2024 (Global Edition)"[5].

More… ↓

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