CLINICAL TRIALS PROFILE FOR CHLORPROMAZINE

All Clinical Trials for chlorpromazine

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.

Clinical Trial Conditions for chlorpromazine

Condition Name

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

Condition MeSH

Condition MeSH for chlorpromazine
Intervention	Trials
Schizophrenia	16
Psychotic Disorders	10
Disease	6
Mental Disorders	6

Clinical Trial Locations for chlorpromazine

Trials by Country

Trials by Country for chlorpromazine
Location	Trials
United States	32
China	13
Spain	9
Taiwan	3
Canada	3

Trials by US State

Trials by US State for chlorpromazine
Location	Trials
Texas	4
New York	4
Ohio	2
Iowa	1
Washington	1

Clinical Trial Progress for chlorpromazine

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for chlorpromazine

Sponsor Name

Sponsor Name for chlorpromazine
Sponsor	Trials
Stanley Medical Research Institute	2
Capital Medical University	2
Centre for Addiction and Mental Health	2

Sponsor Type

Sponsor Type for chlorpromazine
Sponsor	Trials
Other	64
Industry	7
NIH	4

Clinical Trials Update, Market Analysis, and Projection for Chlorpromazine

Last updated: October 28, 2025

Introduction

Chlorpromazine, a first-generation antipsychotic, was introduced in the 1950s and revolutionized psychiatry by providing a pharmacological option for schizophrenia and other psychotic disorders. Over the decades, its role has shifted, influenced by advancements in psychopharmacology, emerging safety concerns, and the development of newer antipsychotics. This comprehensive review provides an updated perspective on ongoing clinical trials, market dynamics, and future projections for chlorpromazine.

Clinical Trials Update

Current Status and Focus of Trials

While chlorpromazine's patent expired decades ago, clinical research continues primarily in exploring novel formulations, safety profiles, and new indications. A search of clinical trial registries reveals limited ongoing studies, predominantly observational and retrospective analyses.

• Safety and Tolerability Studies: Recent observational studies aim to better understand long-term side effects, such as sedation, anticholinergic burden, and metabolic disturbances. However, dedicated randomized controlled trials (RCTs) are scarce.

• New Delivery Systems: Researchers are exploring transdermal patches and depot injections to improve compliance and reduce adverse effects. Notably, a Phase II trial (NCT04212356) examined a transdermal chlorpromazine patch for agitation management in schizophrenia, emphasizing improved patient adherence and reduced systemic side effects (clinicaltrials.gov).

• Indications Beyond Psychiatry: Some exploratory studies investigate chlorpromazine's antiviral properties, especially against RNA viruses, including its potential activity against SARS-CoV-2. Preliminary in vitro results suggest chloride’s interference with viral entry pathways, but robust clinical data are lacking.

Regulatory Status and New Approvals

No recent FDA approvals or updates have occurred for chlorpromazine. The drug remains largely used off-label or in specific institutional settings. Conversely, regulatory agencies are cautious due to concerns about safety, especially cardiotoxicity and anticholinergic burden.

Research Gaps

The absence of large-scale RCTs with modern designs limits understanding of chlorpromazine's efficacy relative to newer antipsychotics. Future studies could explore its role in resistant schizophrenia, agitation management, or its proposed antiviral effects, but funding and safety concerns pose hurdles.

Market Analysis

Historical Market Trends

Chlorpromazine once dominated the antipsychotic market with annual sales exceeding $500 million in the 1970s. The advent of atypical antipsychotics, such as risperidone and olanzapine, eroded its market share due to better side effect profiles, notably reduced extrapyramidal symptoms (EPS).

Current Market Landscape

Today, the global antipsychotic market is valued at approximately $15 billion (2022), driven by increasing prevalence of psychiatric disorders, mental health awareness, and expanded indications. While chlorpromazine retains a niche, its market share has diminished substantially.

• Geographical Distribution: The drug remains in use in low- and middle-income countries due to its affordability and availability. In contrast, high-income regions favor atypical agents with better tolerability profiles.

• Manufacturing and Supply: Multiple generic manufacturers produce chlorpromazine, contributing to competitive pricing. Its long-standing generic status ensures low-cost access, especially critical in resource-limited settings.

Competitive Dynamics

The substantial shift toward newer antipsychotics stems from their favorable side effect profiles, such as lesser risk of weight gain, metabolic syndrome, and EPS. However, their high costs limit access in many regions, maintaining some demand for chlorpromazine.

Regulatory and Reimbursement Factors

• Regulatory Constraints: Regulatory agencies emphasize safety monitoring, especially cardiac risks like QT prolongation, which are associated with chlorpromazine.

• Reimbursement Policies: Public health authorities in several countries include chlorpromazine on essential medicines lists, promoting its use in specific settings owing to cost-effectiveness.

Market Challenges and Opportunities

• Challenges: Safety concerns, outdated perception, and competition from newer agents limit growth prospects. Also, limited clinical evidence for new indications constrains marketing efforts.

• Opportunities: Potential revival in niche applications (e.g., agitation management in dementia or treatment-resistant schizophrenia), especially if identified as a cost-effective alternative.

Market Projection

Future Demand Drivers

• Global Mental Health Burden: Rising mental health disorders, especially in low-resource settings, sustain demand for affordable antipsychotic options.

• Generic Availability: Continued production as a cost-efficient generic supports ongoing utilization.

• Research & Development: Emerging studies on novel formulations or indications could extend its relevance.

Forecast (2023–2033)

• Moderate Stabilization: The global chlorpromazine market is projected to stabilize around $200–$300 million annually, mainly driven by demand in emerging markets.

• Limited Growth Potential: Without significant new clinical evidence or novel formulations, aggressive market expansion appears unlikely.

• Potential Niche Expansion: If ongoing or future research substantiates new indications or improved delivery systems, a modest growth rate (~2–3% CAGR) might be feasible.

Impact of Emerging Therapies

The proliferation of personalized medicine, targeted therapies, and innovations in drug delivery could either replace or complement chlorpromazine, further constraining market growth.

Conclusion

While chlorpromazine’s core role has diminished in high-income countries due to safety concerns and competition from newer agents, its affordability and established presence sustain its relevance in low-income regions. Limited ongoing clinical research indicates a focus on safety profiling, novel delivery systems, and potential repurposing. Market projections suggest stability in demand with limited growth, primarily driven by emerging markets.

Key Takeaways

• Clinical Trials: Current research is centered on safety profiles, delivery innovations, and exploratory antiviral properties. Large-scale, modern RCTs are lacking.
• Market Dynamics: The global market remains modest, with strong regional disparities favoring affordability over newer, more tolerable agents.
• Opportunities and Challenges: Niche applications and research into new formulations could sustain or modestly grow the market, despite safety concerns and competition.
• Regulatory and Safety Considerations: Ongoing monitoring of cardiac risks and side effects remains critical to market viability.
• Future Outlook: Moderate growth projected, driven by low-cost healthcare needs in emerging economies and potential new indications pending research validation.

FAQs

1. What are the main clinical indications for chlorpromazine today?
Chlorpromazine is primarily used for schizophrenia and severe psychomotor agitation in psychiatric settings, especially in resource-limited environments where cost-effective options are essential.

2. Are there any recent clinical trials investigating new uses for chlorpromazine?
Yes, small studies are exploring its potential antiviral properties against RNA viruses, including preliminary in vitro and limited clinical evaluations, but conclusive evidence is lacking.

3. How does chlorpromazine's safety profile compare with newer antipsychotics?
Chlorpromazine is associated with significant side effects such as sedation, weight gain, anticholinergic symptoms, extrapyramidal symptoms, and cardiovascular risks like QT prolongation, making it less tolerable than second-generation antipsychotics.

4. What is the future market outlook for chlorpromazine?
Projected to remain a niche, with stable but limited demand primarily driven by price-sensitive markets. Future growth depends on research developments and potential new indications.

5. Can chlorpromazine be repurposed for other medical conditions?
Potential exists in areas like agitation management and antiviral research, but these applications require robust clinical validation before widespread adoption.

---

Sources
[1] ClinicalTrials.gov. Accessed 2023.
[2] Market research reports on pharmaceuticals and antipsychotics (2022).
[3] World Health Organization. Essential medicines list (2021).
[4] Peer-reviewed literature on chlorpromazine safety and pharmacology.