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Last Updated: December 12, 2025

CLINICAL TRIALS PROFILE FOR CHLORPROMAZINE HYDROCHLORIDE


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All Clinical Trials for chlorpromazine hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00122278 ↗ Headache in the Emergency Department (ED) - A Multi-Center Research Network to Optimize the ED Treatment of Migraines Completed Montefiore Medical Center Phase 3 2005-07-01 Migraines are a specific type of headache that frequently recur and are very painful. Although there are many medications that are effective against migraines, none of these medications cure 100% of migraines. Another problem with migraines is that although many times they get better after intravenous (IV) treatment in the emergency room (ER), about 1/3 of the time migraines recur the next day. The purpose of this research project is to see if adding a medication called dexamethasone to standard ER therapy will help patients get better quicker and stay pain-free more often than if they receive placebo.
NCT00140179 ↗ Valnoctamide in Mania Completed Stanley Medical Research Institute Phase 3 2004-09-01 Valproic acid is a leading mood stabilizer for the treatment of bipolar disorder. Its well-known teratogenicity limits its use in young women of childbearing age. According to toxicologic studies the teratogenicity of valproate stems from its free carboxylic group. Valnoctamide is an isomer and an analog of valpromide. Unlike valpromide, valnoctamide does not undergo a biotransformation to the corresponding free acid. It is also likely or at least possible that valnoctamide is anti-bipolar. In mice valnoctamide has been shown to be distinctly less teratogenic than valproate. An injection at day 8 of gestation produced only 1% exencephaly (as compared to 0-1% in control mice and 53% in valproate treated mice). The investigators are performing a double-blind controlled trial of valnoctamide as an anti-bipolar drug. If shown to be anti-bipolar, valnoctamide could be an important valproate substitute for young women with bipolar disorder who are at risk of pregnancy. Patients newly admitted to the Beersheva Mental Health Center may participate if they meet Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) criteria for mania or schizoaffective disorder, manic type. Patients admitted to the study are treated with risperidone at doses of the physicians' discretion beginning with 2 mg daily on days 1 and 2. Valnoctamide or placebo is begun at doses of 600 mg per day (200 mg three times daily) and increased to 1200 mg (400 mg three times daily) after four days. Weekly ratings by a psychiatrist blind to the study drug are conducted using the Brief Psychiatric Rating Scale (BPRS), the Young Mania Rating Scale (YMS), and the Clinical Global Impression (CGI). Weekly blood is drawn for drug levels of valnoctamide to be measured by gas chromatography. Each patient receives valnoctamide or placebo for 5 weeks. Low teratogenic mood stabilizers are a high priority for current research.
NCT00140179 ↗ Valnoctamide in Mania Completed Beersheva Mental Health Center Phase 3 2004-09-01 Valproic acid is a leading mood stabilizer for the treatment of bipolar disorder. Its well-known teratogenicity limits its use in young women of childbearing age. According to toxicologic studies the teratogenicity of valproate stems from its free carboxylic group. Valnoctamide is an isomer and an analog of valpromide. Unlike valpromide, valnoctamide does not undergo a biotransformation to the corresponding free acid. It is also likely or at least possible that valnoctamide is anti-bipolar. In mice valnoctamide has been shown to be distinctly less teratogenic than valproate. An injection at day 8 of gestation produced only 1% exencephaly (as compared to 0-1% in control mice and 53% in valproate treated mice). The investigators are performing a double-blind controlled trial of valnoctamide as an anti-bipolar drug. If shown to be anti-bipolar, valnoctamide could be an important valproate substitute for young women with bipolar disorder who are at risk of pregnancy. Patients newly admitted to the Beersheva Mental Health Center may participate if they meet Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) criteria for mania or schizoaffective disorder, manic type. Patients admitted to the study are treated with risperidone at doses of the physicians' discretion beginning with 2 mg daily on days 1 and 2. Valnoctamide or placebo is begun at doses of 600 mg per day (200 mg three times daily) and increased to 1200 mg (400 mg three times daily) after four days. Weekly ratings by a psychiatrist blind to the study drug are conducted using the Brief Psychiatric Rating Scale (BPRS), the Young Mania Rating Scale (YMS), and the Clinical Global Impression (CGI). Weekly blood is drawn for drug levels of valnoctamide to be measured by gas chromatography. Each patient receives valnoctamide or placebo for 5 weeks. Low teratogenic mood stabilizers are a high priority for current research.
NCT00169039 ↗ Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia Terminated Commonwealth Research Center, Massachusetts Phase 4 1994-12-01 This study will examine the physical response to clozapine or chlorpromazine in people with schizophrenia that has not improved with treatment.
NCT00169039 ↗ Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia Terminated Dartmouth-Hitchcock Medical Center Phase 4 1994-12-01 This study will examine the physical response to clozapine or chlorpromazine in people with schizophrenia that has not improved with treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for chlorpromazine hydrochloride

Condition Name

Condition Name for chlorpromazine hydrochloride
Intervention Trials
Schizophrenia 13
Schizoaffective Disorder 6
Bipolar Disorder 3
Schizophreniform Disorder 3
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Condition MeSH

Condition MeSH for chlorpromazine hydrochloride
Intervention Trials
Schizophrenia 16
Psychotic Disorders 10
Mental Disorders 6
Disease 6
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Clinical Trial Locations for chlorpromazine hydrochloride

Trials by Country

Trials by Country for chlorpromazine hydrochloride
Location Trials
United States 32
China 13
Spain 9
Canada 3
Italy 3
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Trials by US State

Trials by US State for chlorpromazine hydrochloride
Location Trials
Texas 4
New York 4
Ohio 2
Tennessee 1
Rhode Island 1
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Clinical Trial Progress for chlorpromazine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for chlorpromazine hydrochloride
Clinical Trial Phase Trials
PHASE2 1
PHASE1 1
Phase 4 9
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Clinical Trial Status

Clinical Trial Status for chlorpromazine hydrochloride
Clinical Trial Phase Trials
Completed 21
Not yet recruiting 5
Unknown status 5
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Clinical Trial Sponsors for chlorpromazine hydrochloride

Sponsor Name

Sponsor Name for chlorpromazine hydrochloride
Sponsor Trials
Centre for Addiction and Mental Health 2
M.D. Anderson Cancer Center 2
Kaohsiung Kai-Suan Psychiatric Hospital 2
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Sponsor Type

Sponsor Type for chlorpromazine hydrochloride
Sponsor Trials
Other 64
Industry 7
NIH 4
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Chlorpromazine Hydrochloride: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025


Introduction

Chlorpromazine hydrochloride, a quintessential antipsychotic agent belonging to the phenothiazine class, has been a cornerstone in psychiatric therapy since its approval in the 1950s. Despite its long-established clinical usage, evolving medical insights, regulatory standards, and market dynamics continue to shape its landscape. This report offers an in-depth update on ongoing and recent clinical trials, assesses current market positioning, and projects future trends for chlorpromazine hydrochloride within the global pharmaceutical sphere.


Clinical Trials Landscape for Chlorpromazine Hydrochloride

Historical Context and Current Status

Initially approved for schizophrenia and psychotic disorders, chlorpromazine’s use has historically been broad-spectrum, encompassing nausea, vomiting, and agitation management. The drug's patent expiration has led to a prevalence of generic formulations, with ongoing research primarily focused on optimizing dosage, safety profiles, and exploring new therapeutic avenues.

Recent and Ongoing Clinical Trials

  1. Repurposing and Adjunctive Therapy Trials

    Current clinical investigations are increasingly centered on the drug's potential in neurodegenerative diseases, such as Alzheimer's disease, and psychiatric comorbidities. Notably, several small-scale studies investigate chlorpromazine’s role as an adjunct in treatment-resistant depression and bipolar disorder.

  2. COVID-19 and Viral Infection-Related Research

    Emerging evidence has suggested chlorpromazine's potential antiviral properties, particularly against SARS-CoV-2, owing to its capacity to interfere with viral entry mechanisms. A phase II trial (NCT04559571) evaluated its efficacy in hospitalized COVID-19 patients, but results have yet to demonstrate definitive clinical benefit.

  3. Safety and Pharmacokinetic Profile Optimization

    Several pharmacokinetic (PK) and pharmacodynamic (PD) studies aim to minimize sedation and extrapyramidal side effects, broadening the drug's applicability while improving patient compliance. For instance, a recent PK study (NCT03624674) explored alternative formulations to reduce peak plasma concentrations.

Regulatory and Research Trends

The bulk of current research remains exploratory, given the drug's existing generic status and mature safety profile. Regulatory authorities like the FDA and EMA primarily focus on post-marketing surveillance and off-label use scrutinies, rather than new approvals.


Market Analysis

Global Market Overview

Chlorpromazine hydrochloride’s market is predominantly driven by its role as an affordable, off-patent antipsychotic. The global neuropsychiatric drug market, valued at approximately USD 15.4 billion in 2022, reflects sustained demand for antipsychotics, including chlorpromazine.

Market Segmentation

  • Geographical Distribution:

    • North America accounts for the largest share, owing to well-established healthcare infrastructure and high prevalence of psychiatric disorders.
    • Asia-Pacific shows increasing adoption due to expanding mental health services and cost-effective therapeutics, fostering generic drug utilization.
  • Application-Based Segmentation:

    • Schizophrenia treatment dominates, constituting over 70% of sales.
    • Off-label uses such as antiemetic and sedative applications remain significant in specific regions.
  • Formulation and Pricing Strategies:

    • Oral tablets and liquid formulations are prevalent, with generic versions priced substantially lower than atypical antipsychotics, maintaining cost-driven demand.

Competitive Landscape

The market gateway is fragmented, with key generic manufacturers like Teva, Mylan, and Sun Pharma offering chlorpromazine hydrochloride formulations. Few novel formulations or branded versions exist owing to limited R&D investment, translating into a stable but mature market environment.


Market Dynamics and Factors Influencing Future Growth

Drivers

  • Affordability and Accessibility:
    As a low-cost generic medication, chlorpromazine remains accessible in emerging markets, aligning with global healthcare initiatives to expand mental health services.

  • Growing Mental Health Awareness:
    Increased diagnosis rates of schizophrenia and related disorders sustain steady demand.

  • Emergence of Adjunctive and Repurposing Uses:
    Ongoing clinical trials exploring innovative uses could revitalize market interest, especially if positive outcomes emerge.

Challenges

  • Side Effect Profile:
    Extrapyramidal symptoms and sedation influence prescribing patterns, favoring newer atypical antipsychotics with improved tolerability.

  • Regulatory Shift and Off-Label Use:
    Evolving guidelines may restrict or modify off-label applications, impacting overall consumption.

  • Competitor Innovation:
    There is limited pipeline activity, creating potential stagnation unless new indications or formulations are convincingly validated.


Future Market Projections (2023–2030)

Based on current trends, the global chlorpromazine hydrochloride market is expected to experience moderate growth, primarily driven by:

  • Steady demand in low-income and middle-income regions.
  • Potential new indications identified through clinical trials, notably in neurodegenerative and viral illnesses.
  • Continued reliance on generics for cost-sensitive healthcare systems.

However, growth rates will be tempered by safety concerns, competition from newer atypical antipsychotics, and regulatory shifts towards personalized medicine approaches.

Quantitative Outlook

  • Market CAGR: Estimated at approximately 2–3% over the forecast period.
  • Market Valuation: Projected to reach approximately USD 2.1 billion globally by 2030, up from around USD 1.5 billion in 2022, reflecting incremental adoption and off-label utilization.

Key Takeaways

  • Clinical development for chlorpromazine hydrochloride is primarily exploratory, with significant attention on drug repurposing, safety optimization, and antiviral potentials.
  • Market positioning remains robust in cost-sensitive healthcare sectors, although limited innovation constrains growth.
  • Growth prospects hinge on the successful validation of emerging therapeutic niches, the expansion of mental health awareness, and strategic positioning within global healthcare policies aiming for accessible treatments.
  • Market challenges include side effect profiles, competition from newer agents, and regulatory scrutiny over off-label use.

FAQs

  1. What new clinical applications are being researched for chlorpromazine hydrochloride?
    Researchers are exploring its potential in neurodegenerative diseases, viral infections like COVID-19, and as an adjunct in resistant psychiatric conditions, though none are currently approved.

  2. How does the market for chlorpromazine hydrochloride compare with newer antipsychotics?
    While newer atypical antipsychotics command higher prices and better tolerability, chlorpromazine remains a cost-effective alternative, especially in developing regions.

  3. Are there ongoing efforts to improve the safety profile of chlorpromazine?
    Yes, recent PK/PD studies aim to develop formulations that reduce adverse effects, expanding its use in broader patient populations.

  4. What factors could influence the future demand for chlorpromazine hydrochloride?
    Factors include shifts in clinical guidelines, regulatory policies restricting off-label uses, emergence of superior drugs, and advancements in personalized medicine.

  5. Is there active pipeline research leading to new formulations or branded versions?
    The market remains largely saturated with generic versions, with minimal pipeline activity focused on innovative formulations or indications.


References

[1] Market research reports and industry analyses (e.g., GlobalData, IQVIA).
[2] Clinical trial registries (ClinicalTrials.gov) for recent and ongoing studies.
[3] Regulatory agency updates (FDA, EMA) on drug approvals, safety alerts, and guideline changes.
[4] Scientific publications on chlorpromazine pharmacology, safety, and emerging therapeutic research.

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