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Last Updated: July 12, 2025

CLINICAL TRIALS PROFILE FOR THIORIDAZINE HYDROCHLORIDE


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All Clinical Trials for Thioridazine Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00312598 ↗ Body Mass Index (BMI) and Metabolic Changes Following Switch to Aripiprazole From Olanzapine, Risperidone and Quetiapine Completed Bristol-Myers Squibb 2005-08-01 Weight gain is a serious, common side effect of many antipsychotic medications. On average, the highest amounts of weight gain are found to occur in people taking clozaril and olanzapine, but with significant weight gain occuring in those on the other atypical antipsychotics as well. We, the researchers at the University of North Carolina, propose an open-label observational, pilot study of the changes in weight, BMI, body composition, and lipids, glucose, insulin and other metabolic parameters occurring in subjects as they switch from treatment with olanzapine, risperidone or quetiapine to aripiprazole. This medication switch will be determined prior to their entering this study by their treating psychiatrist. We also will determine resting energy expenditure (REE) and respiratory quotient (RQ) as measured by metabolic cart to determine if either energy expenditure or the propensity to store energy as fat may be involved in any changes to weight that are detected. Food intake, hunger, and physical activity will also be assessed.
NCT00312598 ↗ Body Mass Index (BMI) and Metabolic Changes Following Switch to Aripiprazole From Olanzapine, Risperidone and Quetiapine Completed University of North Carolina, Chapel Hill 2005-08-01 Weight gain is a serious, common side effect of many antipsychotic medications. On average, the highest amounts of weight gain are found to occur in people taking clozaril and olanzapine, but with significant weight gain occuring in those on the other atypical antipsychotics as well. We, the researchers at the University of North Carolina, propose an open-label observational, pilot study of the changes in weight, BMI, body composition, and lipids, glucose, insulin and other metabolic parameters occurring in subjects as they switch from treatment with olanzapine, risperidone or quetiapine to aripiprazole. This medication switch will be determined prior to their entering this study by their treating psychiatrist. We also will determine resting energy expenditure (REE) and respiratory quotient (RQ) as measured by metabolic cart to determine if either energy expenditure or the propensity to store energy as fat may be involved in any changes to weight that are detected. Food intake, hunger, and physical activity will also be assessed.
NCT00657514 ↗ Ranolazine Versus Placebo Effects on Exercise Tolerance in Patients With Heart Disease and Peripheral Arterial Disease Withdrawn Colorado Prevention Center Phase 4 2008-05-01 After 6 weeks of maximal Ranolazine therapy, tissue hemoglobin desaturation kinetics will change compared to placebo in patients with chronic angina and peripheral arterial disease.
NCT01765803 ↗ Feasibility of Thioridazine as a Mobilizing Agent for CD34+ Hematopoietic Progenitor Cells Terminated Oxnard Foundation Early Phase 1 2013-06-01 This study will investigate the possibility of using the drug thioridazine (also called Mellaril) to increase the number of certain types of cells moving from the bone marrow to the circulation in a group of healthy humans. The types of cells we hope to collect are called CD34+ progenitor, or stem cells. These cells can be used in the laboratory to better understand a number of diseases and suggest new strategies for therapy. Perhaps the most important potential application of human stem cells is the generation of cells and tissues that could be used for cell-based therapies, as a renewable source of replacement cells and tissues to treat diseases including Alzheimer's diseases, spinal cord injury, stroke, burns, heart disease, diabetes, osteoarthritis, and rheumatoid arthritis.
NCT01765803 ↗ Feasibility of Thioridazine as a Mobilizing Agent for CD34+ Hematopoietic Progenitor Cells Terminated New Mexico Cancer Care Alliance Early Phase 1 2013-06-01 This study will investigate the possibility of using the drug thioridazine (also called Mellaril) to increase the number of certain types of cells moving from the bone marrow to the circulation in a group of healthy humans. The types of cells we hope to collect are called CD34+ progenitor, or stem cells. These cells can be used in the laboratory to better understand a number of diseases and suggest new strategies for therapy. Perhaps the most important potential application of human stem cells is the generation of cells and tissues that could be used for cell-based therapies, as a renewable source of replacement cells and tissues to treat diseases including Alzheimer's diseases, spinal cord injury, stroke, burns, heart disease, diabetes, osteoarthritis, and rheumatoid arthritis.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Thioridazine Hydrochloride

Condition Name

Condition Name for Thioridazine Hydrochloride
Intervention Trials
Schizophrenia 5
Schizoaffective Disorder 2
Diabetes Mellitus, Type 2 1
Urinary Frequency/Urgency 1
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Condition MeSH

Condition MeSH for Thioridazine Hydrochloride
Intervention Trials
Schizophrenia 5
Disease 4
Psychotic Disorders 3
Psychophysiologic Disorders 1
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Clinical Trial Locations for Thioridazine Hydrochloride

Trials by Country

Trials by Country for Thioridazine Hydrochloride
Location Trials
United States 25
Germany 2
Canada 2
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Trials by US State

Trials by US State for Thioridazine Hydrochloride
Location Trials
Colorado 2
New York 2
New Mexico 1
Washington 1
Utah 1
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Clinical Trial Progress for Thioridazine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Thioridazine Hydrochloride
Clinical Trial Phase Trials
Phase 4 3
Phase 3 1
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Thioridazine Hydrochloride
Clinical Trial Phase Trials
Completed 5
Withdrawn 3
Terminated 2
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Clinical Trial Sponsors for Thioridazine Hydrochloride

Sponsor Name

Sponsor Name for Thioridazine Hydrochloride
Sponsor Trials
Bristol-Myers Squibb 1
Drug Safety and Effectiveness Network, Canada 1
University of North Carolina, Chapel Hill 1
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Sponsor Type

Sponsor Type for Thioridazine Hydrochloride
Sponsor Trials
Other 15
Industry 3
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Thioridazine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction

Thioridazine hydrochloride, a phenothiazine derivative, is primarily used in the management of schizophrenic patients who have not responded adequately to other antipsychotic treatments. This article delves into the current state of clinical trials, market analysis, and future projections for thioridazine hydrochloride.

Clinical Trials and Research

Antipsychotic Efficacy and Safety

Thioridazine hydrochloride is indicated for the treatment of schizophrenia in patients who have failed to respond to other antipsychotic drugs. However, its use is limited due to the risk of significant, potentially life-threatening proarrhythmic effects, such as Torsades de pointes type arrhythmias. Clinical trials have not systematically evaluated its efficacy in treatment-refractory schizophrenic patients, highlighting a need for further research[4].

Multidrug Resistance Reversal

Studies have explored the potential of thioridazine to reverse multidrug resistance in cancer cells. The racemic form and the two enantiomers of thioridazine were found to inhibit the ABCB1 transporter, which is overexpressed in multidrug-resistant cancer cells. This inhibition was observed without significant stereospecificity, suggesting a promising role in cancer therapy[1].

Tuberculosis Treatment

Thioridazine has been investigated for its potential in treating tuberculosis. In a murine TB model, thioridazine showed modest synergy when co-administered with isoniazid and rifampin, reducing the emergence of drug-resistant M. tuberculosis. This study indicates that thioridazine could be a valuable component in combination regimens for TB treatment[3].

Market Analysis

Market Size and Growth

The global thioridazine hydrochloride market has seen steady growth over the past few years. In 2018, the market revenue was valued at several million USD, with a projected increase to reach a higher value by 2024, driven by a compound annual growth rate (CAGR) of several percent during the 2019-2024 period[2][5].

Regional Market Overview

The market is segmented geographically into regions such as North America, Europe, China, Japan, and the Middle East & Africa. Each region has its own production value, growth rate, and consumption forecast. For instance, North America and Europe are significant markets due to their established healthcare systems and high demand for antipsychotic medications[2][5].

Product Types and Applications

Thioridazine hydrochloride is available in various product types, and its applications extend beyond schizophrenia to include potential uses in cancer therapy and tuberculosis treatment. The market report categorizes these product types and applications, providing insights into their market share, consumption, and growth rates[5].

Market Projections

Future Growth and Trends

The global thioridazine hydrochloride market is expected to continue growing, driven by increasing demand for antipsychotic medications and the potential expansion into new therapeutic areas such as cancer and TB. The market is also influenced by regional supply, application-wise and type-wise demand, and the activities of major players[2][5].

Challenges and Opportunities

Despite the growth potential, the market faces challenges such as the risk of proarrhythmic effects associated with thioridazine, which limits its use. However, ongoing research into its multidrug resistance reversal and TB treatment capabilities presents opportunities for market expansion. Additionally, the repurposing of existing drugs like thioridazine can accelerate the development of novel regimens, further boosting market growth[1][3][4].

Key Players and Competitive Landscape

The thioridazine hydrochloride market includes several major players involved in the production, distribution, and research of the drug. These players are analyzed based on their market share, production processes, cost analysis, and market channels. The competitive landscape is characterized by enterprise competition patterns, advantages, and disadvantages of enterprise products, and industry development trends[2].

Regulatory and Policy Environment

The market is influenced by regulatory policies and industry news. For instance, the use of thioridazine is heavily regulated due to its side effects, and any changes in regulatory policies can significantly impact the market. The report includes an analysis of macroeconomic policies and industrial policies that affect the thioridazine hydrochloride market[2].

Conclusion

Thioridazine hydrochloride remains a significant drug in the management of schizophrenia, despite its limited use due to potential side effects. Ongoing clinical trials and research into its applications in cancer and TB treatment offer promising avenues for market growth. The global market is projected to grow, driven by increasing demand and the expansion into new therapeutic areas.

Key Takeaways

  • Thioridazine hydrochloride is primarily used for treating schizophrenia in patients who have not responded to other antipsychotics.
  • The drug has potential in reversing multidrug resistance in cancer cells and treating tuberculosis.
  • The global market is growing, with a projected increase in revenue by 2024.
  • Regional markets such as North America and Europe are significant due to their established healthcare systems.
  • The market faces challenges due to the drug's side effects but presents opportunities through repurposing and new therapeutic applications.

FAQs

What is the primary indication for thioridazine hydrochloride?

Thioridazine hydrochloride is primarily indicated for the management of schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs.

What are the potential risks associated with thioridazine hydrochloride?

Thioridazine hydrochloride can prolong the QTc interval, increasing the risk of serious, potentially fatal, ventricular arrhythmias such as Torsades de pointes type arrhythmias.

Is thioridazine hydrochloride being researched for other therapeutic uses?

Yes, thioridazine hydrochloride is being researched for its potential in reversing multidrug resistance in cancer cells and treating tuberculosis.

What is the projected growth of the global thioridazine hydrochloride market?

The global thioridazine hydrochloride market is expected to grow, reaching a higher revenue value by 2024, driven by a CAGR of several percent during the 2019-2024 period.

Which regions are significant in the thioridazine hydrochloride market?

North America, Europe, China, Japan, and the Middle East & Africa are significant regions in the thioridazine hydrochloride market due to their established healthcare systems and high demand for antipsychotic medications.

Sources

  1. Effect of Thioridazine Stereoisomers on the Drug Accumulation of ... - International Journal of Immunopathology and Pharmacology[1]
  2. Global Thioridazine Hydrochloride Industry Market Size, Share ... - Market Research Store[2]
  3. Thioridazine | Working Group for New TB Drugs - New TB Drugs[3]
  4. Thioridazine: Package Insert / Prescribing Information - Drugs.com - Drugs.com[4]
  5. Global Thioridazine hydrochloride Market Report 2019 - Market Size ... - Report Ocean[5]

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