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Last Updated: March 23, 2025

CLINICAL TRIALS PROFILE FOR FLUVOXAMINE MALEATE


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All Clinical Trials for FLUVOXAMINE MALEATE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT02194075 ↗ Methylphenidate Hydrochloride Controlled-Release Tablets Augmentation Strategy for Patients With Obsessive Compulsive Disorder Completed Guangdong General Hospital Phase 4 2013-10-01 Explore the efficacy of methylphenidate hydrochloride controlled-release tablets add-on pharmacotherapy on clinical symptomatology and cognitive functioning in a sample of patients with obsessive-compulsive disorder (OCD) receiving fluvoxamine maleate. To test the hypothesis that methylphenidate hydrochloride controlled-release tablets augmentation of fluvoxamine treatment is well tolerated and may be proposed as an effective therapeutic strategy to improve outcome in OCD.
NCT01933919 ↗ A Phase 3 Study of Fluvoxamine (SME3110) in Pediatric/Adolescent Patients With Obsessive Compulsive Disorder Completed Meiji Seika Pharma Co., Ltd. Phase 3 2013-08-14 The objective of the first phase of this study is to evaluate the efficacy of fluvoxamine compared to placebo on change in total score of Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) 10-item from baseline to the last observation visit (10 weeks) in pediatric/adolescent participants with obsessive compulsive disorder (OCD). The objective of the second phase of the study is to evaluate the long-term safety and efficacy of fluvoxamine in pediatric/adolescent patients with OCD.
NCT01933919 ↗ A Phase 3 Study of Fluvoxamine (SME3110) in Pediatric/Adolescent Patients With Obsessive Compulsive Disorder Completed AbbVie Phase 3 2013-08-14 The objective of the first phase of this study is to evaluate the efficacy of fluvoxamine compared to placebo on change in total score of Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) 10-item from baseline to the last observation visit (10 weeks) in pediatric/adolescent participants with obsessive compulsive disorder (OCD). The objective of the second phase of the study is to evaluate the long-term safety and efficacy of fluvoxamine in pediatric/adolescent patients with OCD.
NCT00353028 ↗ Fluvoxamine Maleate in the Treatment of Depression/Depressive State : A Post-marketing Clinical Study in Children and Adolescents Completed Solvay Pharmaceuticals Phase 4 2006-10-01 This study is to verify the efficacy of fluvoxamine maleate given for 8 weeks in the treatment of children and adolescents with depression or depressive state
NCT00352768 ↗ Fluvoxamine Maleate in the Treatment of Obsessive-Compulsive Disorder: A Post-marketing Clinical Study in Children and Adolescents Terminated Solvay Pharmaceuticals Phase 4 2006-08-01 This study is to verify the efficacy of fluvoxamine maleate given for 10 weeks in treatment of children and adolescents with obsessive-compulsive disorder
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 5 of 5 entries

Clinical Trial Conditions for FLUVOXAMINE MALEATE

Condition Name

3111000.511.522.53Obsessive Compulsive DisorderMajor Depressive DisorderMetastatic Cancer[disabled in preview]
Condition Name for FLUVOXAMINE MALEATE
Intervention Trials
Obsessive Compulsive Disorder 3
Major Depressive Disorder 1
Metastatic Cancer 1
Social Anxiety Disorder 1
[disabled in preview] 0
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Condition MeSH

3333000.511.522.53Obsessive-Compulsive DisorderDiseaseCompulsive Personality DisorderCompulsive Behavior[disabled in preview]
Condition MeSH for FLUVOXAMINE MALEATE
Intervention Trials
Obsessive-Compulsive Disorder 3
Disease 3
Compulsive Personality Disorder 3
Compulsive Behavior 3
[disabled in preview] 0
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Clinical Trial Locations for FLUVOXAMINE MALEATE

Trials by Country

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Trials by Country for FLUVOXAMINE MALEATE
Location Trials
Japan 3
China 2
United States 1
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Trials by US State

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Trials by US State for FLUVOXAMINE MALEATE
Location Trials
New York 1
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Clinical Trial Progress for FLUVOXAMINE MALEATE

Clinical Trial Phase

66.7%16.7%16.7%000.511.522.533.54Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for FLUVOXAMINE MALEATE
Clinical Trial Phase Trials
Phase 4 4
Phase 3 1
Phase 2 1
[disabled in preview] 0
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Clinical Trial Status

50.0%16.7%16.7%16.7%00.811.21.41.61.822.22.42.62.833.2CompletedUnknown statusNot yet recruiting[disabled in preview]
Clinical Trial Status for FLUVOXAMINE MALEATE
Clinical Trial Phase Trials
Completed 3
Unknown status 1
Not yet recruiting 1
[disabled in preview] 1
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Clinical Trial Sponsors for FLUVOXAMINE MALEATE

Sponsor Name

trials000111112222Solvay PharmaceuticalsAbbVieAlphacait, LLC[disabled in preview]
Sponsor Name for FLUVOXAMINE MALEATE
Sponsor Trials
Solvay Pharmaceuticals 2
AbbVie 2
Alphacait, LLC 1
[disabled in preview] 2
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Sponsor Type

50.0%50.0%0-0.500.511.522.533.544.555.5IndustryOther[disabled in preview]
Sponsor Type for FLUVOXAMINE MALEATE
Sponsor Trials
Industry 5
Other 5
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Fluvoxamine Maleate: Clinical Trials, Market Analysis, and Projections

Introduction to Fluvoxamine Maleate

Fluvoxamine maleate, a selective serotonin reuptake inhibitor (SSRI), is widely recognized for its use in treating mental health disorders such as obsessive-compulsive disorder (OCD), depression, and post-traumatic stress disorder (PTSD). Recently, it has also been investigated for its potential in treating COVID-19 due to its anti-inflammatory properties.

Clinical Trials Update

COVID-19 Treatment

The use of fluvoxamine as a treatment for COVID-19 has garnered significant attention. A notable study conducted at the Golden Gate Fields horse racing track in Berkeley, California, involved workers who were infected with COVID-19. Those who opted to take fluvoxamine showed no worsening of symptoms, and their symptoms cleared within two weeks. In contrast, 12.5% of those who did not take the drug were hospitalized, with two requiring ventilators and one fatality[1].

A randomized trial supported by the COVID-19 Early Treatment Fund, led by tech entrepreneur Steve Kirsch, also showed promising results. None of the 80 patients assigned to fluvoxamine became seriously ill, whereas 8.3% of the 72 patients on placebo required hospitalization[1].

However, these findings need verification from larger, randomized clinical trials. Ongoing trials, including one at Washington University School of Medicine in St. Louis and others in Korea, Brazil, and Hungary, are investigating fluvoxamine's efficacy in treating mild to moderate COVID-19[1][4].

Other Clinical Trials

In addition to COVID-19, fluvoxamine continues to be studied for its primary indications. Clinical trials and observational studies have consistently shown its effectiveness in managing OCD, depression, and PTSD. The drug's mechanism of increasing serotonin levels in the brain makes it a valuable treatment option for these conditions[3].

Market Analysis

Current Market Status

The fluvoxamine maleate market is experiencing robust growth driven by several factors:

  • Increasing Prevalence of Mental Health Disorders: The rising prevalence of OCD, depression, and other mental health conditions globally is a major driver. As awareness and diagnosis rates increase, so does the demand for effective treatments like fluvoxamine maleate[2][3].
  • Advances in Pharmaceutical Formulations: The availability of generic versions and improvements in drug formulations have expanded the market. Pharmaceutical companies' focus on research and development to enhance drug efficacy and safety also contributes to market growth[2][3].
  • Healthcare Infrastructure Expansion: The expansion of healthcare infrastructure in emerging economies and the increasing availability of fluvoxamine maleate tablets across various regions are further fueling market growth[2].

Market Size and Forecast

The global fluvoxamine maleate market is projected to grow significantly:

  • The market is expected to reach USD 8.65 billion by 2024 and USD 20.24 billion by 2031, with a compound annual growth rate (CAGR) of 12.91% from 2024 to 2031[2].
  • Another forecast indicates that the fluvoxamine market will grow at a CAGR of 4% from 2022 to 2029[3].

Regional Analysis

  • North America: This region dominates the fluvoxamine market due to the presence of major key players, high disposable income, and well-developed healthcare infrastructure[3].
  • Asia-Pacific: This region is expected to grow rapidly due to increasing research and development activities and the rising prevalence of OCD and other mental health disorders[3].
  • Europe: Europe is another significant market, characterized by a mature market with well-established infrastructure and consumer preferences[2].
  • Latin America and Middle East & Africa: These regions present opportunities and challenges, with countries like Brazil, Mexico, and South Africa showing promising growth potential[2].

Market Drivers and Challenges

Drivers

  • Rising Prevalence of Mental Health Disorders: The increasing incidence of anxiety, depression, and OCD is a major driver for the expansion of the fluvoxamine market[3].
  • Growing Geriatric Population: The increasing geriatric population and rising healthcare expenditure also contribute to market growth[3].
  • Research and Development: Ongoing clinical trials and research activities provide beneficial opportunities for the fluvoxamine market[3].

Challenges

  • High Cost of the Drug: The high cost associated with fluvoxamine, despite the availability of generics, can hamper market growth[3].
  • Side Effects: Side effects such as diarrhea, headache, indigestion, and others can deter some patients from using the drug[3].
  • Lack of Awareness: Limited awareness about mental health issues and the benefits of fluvoxamine can further challenge market growth[3].

Market Strategies and Trends

Mergers and Acquisitions

The fluvoxamine maleate market is witnessing a wave of mergers and acquisitions as companies seek to consolidate their market positions, expand their product portfolios, and leverage synergies to drive growth and competitiveness[2].

Access to New Technologies

Acquisitions provide companies with access to new technologies, intellectual property, and talent, enabling them to innovate faster and stay ahead of market trends[2].

Sustainable Solutions

Growing environmental concerns and stringent regulations are fostering a shift towards sustainable alternatives, boosting the demand for eco-friendly fluvoxamine maleate products and services[2].

Key Takeaways

  • Fluvoxamine maleate shows promise in treating COVID-19, with ongoing clinical trials aiming to provide definitive evidence.
  • The market for fluvoxamine maleate is driven by the increasing prevalence of mental health disorders, advances in pharmaceutical formulations, and expanding healthcare infrastructure.
  • The global market is projected to grow significantly, with North America and Asia-Pacific being key regions.
  • Despite challenges such as high drug costs and side effects, the market is expected to continue its upward trajectory.

FAQs

What are the current scale and future growth prospects of the Fluvoxamine Maleate Tablets Market?

The Fluvoxamine Maleate Tablets Market is anticipated to witness a CAGR of 12.91% from 2024 to 2031, transitioning from a valuation of USD 8.65 Billion in 2024 to USD 20.24 billion by 2031[2].

What are the primary uses of Fluvoxamine Maleate?

Fluvoxamine maleate is primarily used to treat obsessive-compulsive disorder (OCD), depression, and post-traumatic stress disorder (PTSD)[3].

Has Fluvoxamine Maleate been tested for COVID-19 treatment?

Yes, fluvoxamine maleate has been investigated for its potential in treating COVID-19 due to its anti-inflammatory properties. Ongoing clinical trials are evaluating its efficacy in this context[1][4].

What are the major drivers of the Fluvoxamine Maleate market?

The major drivers include the rising prevalence of mental health disorders, advances in pharmaceutical formulations, and the expansion of healthcare infrastructure in emerging economies[2][3].

What are the challenges facing the Fluvoxamine Maleate market?

Challenges include the high cost of the drug, side effects associated with its use, and a lack of awareness about mental health issues and the benefits of fluvoxamine[3].

Which regions are expected to drive the growth of the Fluvoxamine Maleate market?

North America and Asia-Pacific are expected to be key drivers of market growth, with other regions such as Europe, Latin America, and the Middle East & Africa also contributing to the market expansion[2][3].

Sources

  1. Science News: "Antidepressant fluvoxamine could keep mild COVID-19 from worsening" - February 1, 2021
  2. OpenPR: "Fluvoxamine Maleate Tablets Market Size, Share and Forecast" - August 13, 2024
  3. Data Bridge Market Research: "Global Fluvoxamine Market - Industry Trends and Forecast to 2029"
  4. American Chemical Society: "Fluvoxamine" - September 6, 2021

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