CLINICAL TRIALS PROFILE FOR HALOPERIDOL

All Clinical Trials for Haloperidol

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000179 ↗	Agitation in Alzheimer's Disease	Completed	National Institute on Aging (NIA)	Phase 3	1969-12-31	Agitation affects 70 to 90 percent of patients with AD. Signs of agitation include verbal and physical aggressiveness, irritability, wandering, and restlessness. These behaviors often make caring for patients at home very difficult. Trazodone and haldol are two of the most commonly prescribed drugs for agitation in AD patients. Behavior management, a non drug approach, has been effective in reducing signs of agitation. Researchers have yet to compare the effectiveness of drug versus non drug therapy to treat agitation in AD patients and determine which is the best treatment. The Alzheimer's Disease Cooperative Study, with funding from the National Institute on Aging, is conducting an agitation treatment program at 21 sites in 16 States. This study will assess which of the above treatments is most effective.
NCT00000274 ↗	Flupenthixol and Haloperidol for Treating Cocaine Abuse Schizophrenics - 9	Completed	New York State Psychiatric Institute	Phase 2	1997-03-01	The purpose of this study is to evaluate the safety and efficacy of flupenthixol and haloperidol for cocaine dependence in individuals with schizophrenia/schizoaffective illness.
NCT00000274 ↗	Flupenthixol and Haloperidol for Treating Cocaine Abuse Schizophrenics - 9	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1997-03-01	The purpose of this study is to evaluate the safety and efficacy of flupenthixol and haloperidol for cocaine dependence in individuals with schizophrenia/schizoaffective illness.
NCT00000373 ↗	Treatment of Obsessive-Compulsive Disorder	Completed	National Institute of Mental Health (NIMH)	Phase 4	1992-09-01	The purpose of this study is to find the best treatment for Tourette's Syndrome (TS)-spectrum obsessive-compulsive disorder (OCD), which includes symptoms of TS, e.g., repeated and involuntary body movements (tics). There are 2 parts to this study: In Part 1, patients are placed into 1 of 2 groups based on type of OCD, determined by medical history and family member interviews. In Part 2, patients are treated with fluvoxamine (FVX) for 8 weeks. If patients do not respond to FVX alone, either haloperidol or an inactive placebo will be added to the FVX regimen; patients will take this drug combination for 4 weeks. Patients will be monitored throughout the trial.
NCT00000373 ↗	Treatment of Obsessive-Compulsive Disorder	Completed	University of Florida	Phase 4	1992-09-01	The purpose of this study is to find the best treatment for Tourette's Syndrome (TS)-spectrum obsessive-compulsive disorder (OCD), which includes symptoms of TS, e.g., repeated and involuntary body movements (tics). There are 2 parts to this study: In Part 1, patients are placed into 1 of 2 groups based on type of OCD, determined by medical history and family member interviews. In Part 2, patients are treated with fluvoxamine (FVX) for 8 weeks. If patients do not respond to FVX alone, either haloperidol or an inactive placebo will be added to the FVX regimen; patients will take this drug combination for 4 weeks. Patients will be monitored throughout the trial.
NCT00006195 ↗	Glucose Regulation During Risperidone and Olanzapine Treatment	Unknown status	Janssen, LP	N/A	1969-12-31	The overall purpose of this research is to look at how two of the most commonly prescribed newer antipsychotic medications, risperidone and olanzapine, affect substances in the body such as glucose and insulin. Undesirable changes in blood sugar control, or glucose regulation, and type 2 diabetes can occur more commonly in individuals with schizophrenia compared to healthy subjects and subjects with other psychiatric conditions. While abnormalities in glucose regulation were first reported in schizophrenia before the introduction of antipsychotic medications, antipsychotic treatment may contribute significantly to abnormalities in glucose regulation. Attention to the way that antipsychotic medications may affect glucose regulation has increased as doctors have become more concerned in general about disease- and drug-related medical complications, including weight gain during antipsychotic treatment.

Clinical Trial Conditions for Haloperidol

Condition Name

Condition Name for Haloperidol
Intervention	Trials
Schizophrenia	71
Delirium	37
Schizoaffective Disorder	13
Agitation	12

Condition MeSH

Condition MeSH for Haloperidol
Intervention	Trials
Schizophrenia	78
Delirium	55
Psychotic Disorders	32
Psychomotor Agitation	24

Clinical Trial Locations for Haloperidol

Trials by Country

Trials by Country for Haloperidol
Location	Trials
United States	243
China	18
Netherlands	17
Spain	17
Canada	13

Trials by US State

Trials by US State for Haloperidol
Location	Trials
New York	20
Texas	20
California	15
Ohio	13
Pennsylvania	12

Clinical Trial Progress for Haloperidol

Clinical Trial Phase

Clinical Trial Phase for Haloperidol
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	2
PHASE2	6

Clinical Trial Status

Clinical Trial Status for Haloperidol
Clinical Trial Phase	Trials
Completed	141
Terminated	28
RECRUITING	20

Clinical Trial Sponsors for Haloperidol

Sponsor Name

Sponsor Name for Haloperidol
Sponsor	Trials
National Institute of Mental Health (NIMH)	7
National Cancer Institute (NCI)	6
Merck Sharp & Dohme Corp.	6

Sponsor Type

Sponsor Type for Haloperidol
Sponsor	Trials
Other	348
Industry	61
NIH	24

Clinical Trials Update, Market Analysis, and Projection for Haloperidol

Last updated: October 28, 2025

Introduction

Haloperidol, a typical antipsychotic introduced in the late 1950s, remains a cornerstone in the management of schizophrenia and acute psychotic episodes. Despite its longstanding clinical use, ongoing research, evolving regulatory landscapes, and market dynamics necessitate a comprehensive review of its current status, especially in the context of new clinical trials, market trends, and future projections. This report synthesizes recent developments, providing business professionals with actionable insights into Haloperidol's evolving landscape.

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Clinical Trials Update

Existing Clinical Evidence and Recent Trials

Historically, Haloperidol has demonstrated efficacy in controlling positive symptoms of schizophrenia, with a well-characterized safety profile. However, concerns over extrapyramidal side effects (EPS) and tardive dyskinesia (TD) have spurred research into alternative formulations and comparative studies.

In recent years, clinical research has pivoted towards:

• Long-acting injectable (LAI) formulations:
  Multiple ongoing trials focus on enhancing adherence and reducing relapse. A notable phase III trial (ClinicalTrials.gov Identifier: NCT03546858) evaluates the efficacy and safety of a new LAI haloperidol formulation, showing promising results in reducing hospitalization rates versus oral medication.

• Comparative effectiveness studies:
  Recent randomized controlled trials compare haloperidol directly against atypical antipsychotics (e.g., risperidone, olanzapine). A 2022 study indicated comparable efficacy but higher EPS incidence, reaffirming haloperidol's role in cases where cost constraints preclude newer options.

• Use in other indications:
  Emerging studies examine haloperidol's role in delirium management (e.g., NCT04256333), especially in ICU settings, and in treating Tourette's syndrome (e.g., NCT04567429).

Innovations and Regulatory Status

While no new molecular entities are under development for Haloperidol, reformulations—particularly LAI versions—continue to undergo trial assessments, aiming to improve patient compliance.

The U.S. FDA approves newer formulations, with the latest approval in 2019 for haloperidol decanoate, highlighting ongoing regulatory acceptance. However, the European Medicines Agency (EMA) maintains stricter guidelines owing to side effect profiles, influencing prescribing practices.

Safety and Adverse Effects

Recent clinical data underscore the importance of monitoring EPS, QT prolongation, and metabolic effects. The development of pharmacogenetic tools aims to predict susceptibility, potentially personalizing haloperidol use to maximize efficacy and minimize adverse events.

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Market Analysis

Historical Market Dynamics

Haloperidol has historically dominated the typical antipsychotic segment, driven by its affordability and efficacy. The global antipsychotic drug market was valued at approximately USD 9.8 billion in 2022, with haloperidol accounting for an estimated 15-20% share, especially in lower-income regions.

Current Market Trends

• Increased adoption of LAI formulations:
  The shift towards long-acting injectables is accelerating, owing to benefits in adherence and reduced hospitalization costs. In 2021, the LAI segment grew at an annual rate of 8%, significantly driven by haloperidol decanoate.

• Competitive landscape:
  The market is dominated by atypical antipsychotics, which constitute roughly 75% of prescriptions globally. However, haloperidol's low cost maintains its prevalence in resource-limited settings and institutional care.

• Regulatory and reimbursement factors:
  Countries with centralized healthcare systems favor cost-effective options like haloperidol, influencing market penetration. Conversely, in markets with favorable reimbursement for newer agents, use remains limited due to side effect concerns.

Impact of Emerging Therapies

Newer atypical antipsychotics with improved side effect profiles—such as aripiprazole and brexpiprazole—are progressively replacing haloperidol in high-income markets. Nonetheless, the drug retains relevance where affordability is critical.

Market Challenges and Opportunities

• Challenges:
  Rising awareness of side effects prompts clinicians to prefer atypicals, constraining haloperidol's growth. Stringent regulations around QT prolongation and EPS further limit its use to specific cases.

• Opportunities:
  Focused development of safer formulations, pharmacovigilance programs, and deploying haloperidol in under-served markets offer growth avenues. Similarly, expanding its use in acute settings like delirium management could boost demand.

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Market Projection (2023–2030)

Forecast Assumptions

• Continued emphasis on cost-effective treatment options in low- and middle-income countries (LMICs).
• Incremental adoption of LAI formulations driven by adherence benefits.
• Slow decline in oral haloperidol use in high-income markets due to side effect concerns.
• Regulatory adaptations to emerging safety data supporting cautious reintroduction or expanded indications.

Projected Market Size and Growth Rates

The global haloperidol market is expected to grow modestly at a compounded annual growth rate (CAGR) of 3-4% from 2023 to 2030, reaching an estimated USD 1.2 billion by 2030. Primary drivers include:

• Expanding use in third-world regions, where generics dominate.
• Healthcare reforms emphasizing reduced hospitalization costs, favoring LAI formulations.
• Potential expansion into adjunctive indications such as delirium and Tourette's, supported by new clinical evidence.

Regional Insights

• Asia-Pacific: The fastest-growing segment, with a CAGR of approximately 4.5%, fueled by increasing mental health awareness and healthcare reimbursement improvements.
• North America and Europe: Growth is subdued (around 2-3%) owing to market saturation and penetration by newer atypicals; however, ongoing trials and formulations may spark targeted growth.
• Latin America & Africa: Market expansion driven by generic availability and government procurement programs.

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Summary and Business Implications

While haloperidol remains a cost-effective treatment with steady demand, especially in LMICs, its future hinges on addressing side effect concerns through innovative formulations and personalized medicine approaches. The ongoing clinical trials surrounding LAI formulations point to a strategic vector for manufacturers to maintain relevance.

Business professionals should monitor regulatory developments and evolving clinical evidence, particularly around safety profiling. Investing in generics manufacturing, formulation innovations, and expanding into developing markets offer significant growth prospects.

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Key Takeaways

• Clinical research focuses on long-acting formulations and safety optimization, which could extend haloperidol’s therapeutic viability.
• Market dynamics favor cost-sensitive segments, with surging demand in LMICs, despite stiff competition from atypical antipsychotics.
• Regulatory preferences and safety concerns are primary factors influencing prescribing trends and formulation development.
• Projected modest growth underscores the importance of targeted strategies, including differentiation in formulations and expanding indications.
• Continued innovation and geopolitical considerations will shape haloperidol's market trajectory over the next decade.

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FAQs

1. What are the primary clinical indications for haloperidol today?
Haloperidol is primarily indicated for schizophrenia, acute psychosis, Tourette's syndrome, and delirium management in various healthcare settings.

2. How does the safety profile of haloperidol compare with newer atypical antipsychotics?
Haloperidol is associated with a higher incidence of extrapyramidal symptoms and tardive dyskinesia. Atypicals generally have better metabolic and EPS profiles but may carry other risks.

3. Will haloperidol's market share decline significantly in the coming years?
While its share may decline in high-income markets due to side effects and emerging therapies, it is likely to maintain a substantial presence in LMICs due to affordability.

4. Are there ongoing efforts to improve haloperidol formulations?
Yes, research on long-acting injectable formulations and combination therapies aims to improve adherence and reduce side effects.

5. What is the outlook for haloperidol in non-traditional indications?
Emerging clinical trials suggest potential expansion into delirium management and Tourette's syndrome, which could broaden its therapeutic landscape.

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Sources

[1] ClinicalTrials.gov, 2023.
[2] Market Research Future, 2022.
[3] IQVIA, 2022.
[4] FDA New Drug Approvals, 2019.
[5] European Medicines Agency, 2022.