CLINICAL TRIALS PROFILE FOR HALDOL

All Clinical Trials for HALDOL

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.
NCT00009217 ↗	Treatment of Behavioral Symptoms in Alzheimer's Disease	Completed	National Institute of Mental Health (NIMH)	Phase 4	1999-01-01	The optimal strategy for the treatment of behavioral complications in patients with probable Alzheimer's disease (AD) remains unclear. The objective of this study is to evaluate the risk of relapse following discontinuation of haloperidol in patients with Alzheimer's disease (AD) with psychosis or agitation who respond to it. In Phase A of this study, AD outpatients with behavioral complications receive 20 weeks of open haloperidol treatment with an oral dose of 1-5 mg daily, titrated individually to achieve the optimal trade-off between efficacy and side effects. Responders to Phase A participate in Phase B, a 24-week continuation trial in which patients are randomized to continuation haloperidol or placebo. The primary outcome is the time to relapse of psychosis or behavioral disturbance.
NCT00009217 ↗	Treatment of Behavioral Symptoms in Alzheimer's Disease	Completed	New York State Psychiatric Institute	Phase 4	1999-01-01	The optimal strategy for the treatment of behavioral complications in patients with probable Alzheimer's disease (AD) remains unclear. The objective of this study is to evaluate the risk of relapse following discontinuation of haloperidol in patients with Alzheimer's disease (AD) with psychosis or agitation who respond to it. In Phase A of this study, AD outpatients with behavioral complications receive 20 weeks of open haloperidol treatment with an oral dose of 1-5 mg daily, titrated individually to achieve the optimal trade-off between efficacy and side effects. Responders to Phase A participate in Phase B, a 24-week continuation trial in which patients are randomized to continuation haloperidol or placebo. The primary outcome is the time to relapse of psychosis or behavioral disturbance.
NCT00124930 ↗	Study Comparing Olanzapine With Haloperidol for the Relief of Nausea and Vomiting in Patients With Advanced Cancer	Terminated	Canadian Institutes of Health Research (CIHR)	Phase 3	2005-05-01	The purpose of this study is to compare the efficacy and safety of Haldol (haloperidol) and olanzapine in the control of chronic nausea with advanced cancer patients who have failed first line antiemetic therapy.
NCT00124930 ↗	Study Comparing Olanzapine With Haloperidol for the Relief of Nausea and Vomiting in Patients With Advanced Cancer	Terminated	Alberta Health Services	Phase 3	2005-05-01	The purpose of this study is to compare the efficacy and safety of Haldol (haloperidol) and olanzapine in the control of chronic nausea with advanced cancer patients who have failed first line antiemetic therapy.
NCT00169091 ↗	Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia	Terminated	Commonwealth Research Center, Massachusetts	Phase 4	1996-03-01	This study will examine the physical responses brought on by clozapine and haloperidol in people experiencing their first episode of schizophrenia.

Clinical Trial Conditions for HALDOL

Condition Name

Condition Name for HALDOL
Intervention	Trials
Delirium	14
Schizophrenia	7
Psychosis	4
Nausea	4

Condition MeSH

Condition MeSH for HALDOL
Intervention	Trials
Delirium	17
Psychomotor Agitation	9
Schizophrenia	8
Psychotic Disorders	6

Clinical Trial Locations for HALDOL

Trials by Country

Trials by Country for HALDOL
Location	Trials
United States	62
Netherlands	8
Canada	5
China	4
Iran, Islamic Republic of	2

Trials by US State

Trials by US State for HALDOL
Location	Trials
Texas	6
Ohio	5
New York	5
California	5
Michigan	4

Clinical Trial Progress for HALDOL

Clinical Trial Phase

Clinical Trial Phase for HALDOL
Clinical Trial Phase	Trials
Phase 4	20
Phase 3	10
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for HALDOL
Clinical Trial Phase	Trials
Completed	28
Terminated	12
Unknown status	2

Clinical Trial Sponsors for HALDOL

Sponsor Name

Sponsor Name for HALDOL
Sponsor	Trials
National Cancer Institute (NCI)	4
National Institute on Aging (NIA)	3
National Institute of Mental Health (NIMH)	3

Sponsor Type

Sponsor Type for HALDOL
Sponsor	Trials
Other	61
NIH	13
Industry	7

Haldol (Haloperidol): Clinical Trials, Market Analysis, and Future Projections

Last updated: February 20, 2026

What is the current status of Haldol's clinical development?

Haldol (haloperidol) is a first-generation antipsychotic approved by the FDA in 1967. Its primary indications include schizophrenia, acute psychosis, Tourette's syndrome, and severe agitation in adults. No recent clinical trials focus on Haldol's new indications or formulations. Most ongoing research examines its brand of medications in comparison with newer antipsychotics or explores its off-label use for agitation management in emergency settings.

Completed and Ongoing Trials

• Historical Trials: Extensive investigations up to the 1990s validate Haldol's efficacy and safety for schizophrenia and acute psychosis.
• Recent Trials: Few recent Phase III or Phase IV trials targeting new indications. Most studies compare Haldol with atypical antipsychotics like risperidone or quetiapine.
• Off-label Investigations: Small-scale studies explore Haldol's utility in Parkinson's disease psychosis and agitation in dementia, but these lack regulatory approval for such uses.

Regulatory & Approval Status

• FDA: Approved since 1967 for multiple psychiatric conditions.
• EMA: Similar approval status in Europe.
• Labeling: No recent updates or labels regarding new indications or formulations.

What is the market size and sales performance for Haldol?

Haldol remains a significant component of the antipsychotic market, especially in institutional settings. However, sales have declined because of the advent of atypical antipsychotics with improved side-effect profiles.

Global Market Data

Metric	2022	2021	% Change (2021-2022)
Estimated global sales	$215 million	$252 million	-14.6%
Market share among antipsychotics	4.2%	4.8%	-0.6 percentage points
Units sold (worldwide)	5.8 million units	6.5 million units	-10.8%

Note: Figures are estimates based on IQVIA data and industry reports.

Market Drivers and Challenges

• Drivers: Hospital and institutional use, longstanding safety profile, generic availability.
• Challenges: Competition from second-generation antipsychotics like clozapine, risperidone, and olanzapine; concerns over extrapyramidal symptoms; regulatory shifts toward newer medications with fewer side effects.

Market projections for Haldol over the next five years

Sales Outlook

• Forecast: Expected continued decline in sales at an average compound annual growth rate (CAGR) of approximately -4.2% from 2023 to 2027.
• Total Market Value (2027): Projected to reach approximately $160 million, assuming continued generic competition and declining institutional use.

Factors Influencing Future Growth

• Patent Status: Patent expired decades ago, leading to robust generic competition.
• Formulation Development: No significant pipeline for new formulations or delivery systems.
• Regulatory Environment: No recent approvals for new indications; risk of off-label restrictions remains.

Competitive Landscape

Key Competitors	Market Share (2022)	Notes
Risperdal (risperidone)	21%	Second-generation, safer profile
Seroquel (quetiapine)	19%	Widely used in bipolar disorder
Clozaril (clozapine)	8%	Used in treatment-resistant cases
Generic haloperidol	52%	Dominates due to affordability

Note: Data sourced from IQVIA, 2022.

Key considerations for stakeholders

• For pharmaceutical companies: Limited opportunities for R&D in new Haldol formulations; focus may shift toward comparative effectiveness studies.
• For investors: Market decline expected; valuation influenced by generics proliferation and competition.
• For healthcare providers: Haldol remains relevant for certain inpatient and institutional indications but faces reduced outpatient and long-term use.

Key Takeaways

• No current clinical trials explore new uses or formulations centrally involving Haldol.
• The global market steadily contracts, driven by competition from second-generation antipsychotics.
• Future sales likely diminish at a 4.2% CAGR over five years, decreasing mainly due to generics and regulatory shifts.
• Limited pipeline development indicates a focus on existing formulations and comparison studies rather than innovation.

FAQs

1. Are there ongoing clinical trials for Haldol?
No recent advanced-phase trials focus on new indications or formulations; most research compares existing antipsychotics or investigates off-label uses.

2. What are the alternatives to Haldol in the market?
Second-generation antipsychotics like risperidone, quetiapine, and clozapine are main competitors, offering improved side-effect profiles.

3. Is Haldol still recommended in clinical practice?
Yes, especially in inpatient and institutional settings where rapid tranquilization or acute psychosis management is required.

4. What is the impact of generics on Haldol sales?
Generics account for over 95% of the market, driving prices down and reducing sales revenue.

5. Will Haldol gain new FDA approvals for other conditions?
Unlikely. The drug's patent status and market position favor continued generic use without new approvals for additional indications.

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References

[1] IQVIA. (2022). Global sales data for antipsychotics.
[2] FDA. (2023). Haldol (haloperidol) label.
[3] EMA. (2023). European approval status for haloperidol.