CLINICAL TRIALS PROFILE FOR COMPAZINE

All Clinical Trials for COMPAZINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000654 ↗	The Tolerance of HIV-Infected Patients With Herpes Group Virus Infections to Oral Doses of FIAU	Completed	Oclassen Pharmaceuticals	Phase 2	1969-12-31	To determine the tolerance of HIV-infected patients to TID oral doses of FIAU syrup at 4 different dose levels. To determine the peak and trough blood levels of FIAU and its metabolites during two weeks of oral dosing with FIAU. The pyrimidine nucleoside analog FIAC and its primary deaminated uracil metabolite FIAU are highly and specifically active compounds in vitro against several herpes group viruses, particularly herpes simplex virus (HSV) types 1 and 2, varicella zoster (VZV), and cytomegalovirus (CMV), as well as hepatitis B virus (HBV). Since FIAU is the primary metabolite of FIAC and the administration of FIAU simplifies the metabolism of FIAC, it is anticipated from clinical studies of FIAC that FIAU will be tolerated at least as well as FIAC. A single-dose, pharmacokinetic (blood level) study showed that FIAC, when taken orally, is readily absorbed into the bloodstream, and most of it is converted to FIAU. Daily oral doses are expected to provide concentrations of FIAU exceeding the in vitro minimum inhibitory concentration for nearly all the herpes group viruses.
NCT00000654 ↗	The Tolerance of HIV-Infected Patients With Herpes Group Virus Infections to Oral Doses of FIAU	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To determine the tolerance of HIV-infected patients to TID oral doses of FIAU syrup at 4 different dose levels. To determine the peak and trough blood levels of FIAU and its metabolites during two weeks of oral dosing with FIAU. The pyrimidine nucleoside analog FIAC and its primary deaminated uracil metabolite FIAU are highly and specifically active compounds in vitro against several herpes group viruses, particularly herpes simplex virus (HSV) types 1 and 2, varicella zoster (VZV), and cytomegalovirus (CMV), as well as hepatitis B virus (HBV). Since FIAU is the primary metabolite of FIAC and the administration of FIAU simplifies the metabolism of FIAC, it is anticipated from clinical studies of FIAC that FIAU will be tolerated at least as well as FIAC. A single-dose, pharmacokinetic (blood level) study showed that FIAC, when taken orally, is readily absorbed into the bloodstream, and most of it is converted to FIAU. Daily oral doses are expected to provide concentrations of FIAU exceeding the in vitro minimum inhibitory concentration for nearly all the herpes group viruses.
NCT00146042 ↗	UMCC 9901: Phase II Study of Tailored-Dose Docetaxel + Trastuzumab in Her-2 Positive Metastatic Breast Cancer	Completed	Genentech, Inc.	Phase 2	1999-03-01	This is a research study which aims to improve the way that doctors determine the dose of chemotherapy given to patients. Right now, chemotherapy is determined by a patient's height and weight. However, some patients metabolize chemotherapy faster or slower than the average person because of a different level of drug metabolizing enzyme in the liver. Therefore, some patients are either given too small or too large a dose of chemotherapy because the amount of enzyme is not taken into account. This research study will examine the use of a simple test, call the Erythromycin Breath Test(ERMBT) to determine the amount of enzyme which can metabolize the chemotherapy drug docetaxel (Taxotere). The dose of docetaxel will be tailored to the amount of enzyme which is available to metabolize the drug for each patient. The drug, docetaxel, is combined with another drug, trastuzumab (Herceptin), because at this time this combination appears to be promising in metastatic breast cancer research.
NCT00146042 ↗	UMCC 9901: Phase II Study of Tailored-Dose Docetaxel + Trastuzumab in Her-2 Positive Metastatic Breast Cancer	Completed	University of Michigan Cancer Center	Phase 2	1999-03-01	This is a research study which aims to improve the way that doctors determine the dose of chemotherapy given to patients. Right now, chemotherapy is determined by a patient's height and weight. However, some patients metabolize chemotherapy faster or slower than the average person because of a different level of drug metabolizing enzyme in the liver. Therefore, some patients are either given too small or too large a dose of chemotherapy because the amount of enzyme is not taken into account. This research study will examine the use of a simple test, call the Erythromycin Breath Test(ERMBT) to determine the amount of enzyme which can metabolize the chemotherapy drug docetaxel (Taxotere). The dose of docetaxel will be tailored to the amount of enzyme which is available to metabolize the drug for each patient. The drug, docetaxel, is combined with another drug, trastuzumab (Herceptin), because at this time this combination appears to be promising in metastatic breast cancer research.
NCT00146042 ↗	UMCC 9901: Phase II Study of Tailored-Dose Docetaxel + Trastuzumab in Her-2 Positive Metastatic Breast Cancer	Completed	University of Michigan Rogel Cancer Center	Phase 2	1999-03-01	This is a research study which aims to improve the way that doctors determine the dose of chemotherapy given to patients. Right now, chemotherapy is determined by a patient's height and weight. However, some patients metabolize chemotherapy faster or slower than the average person because of a different level of drug metabolizing enzyme in the liver. Therefore, some patients are either given too small or too large a dose of chemotherapy because the amount of enzyme is not taken into account. This research study will examine the use of a simple test, call the Erythromycin Breath Test(ERMBT) to determine the amount of enzyme which can metabolize the chemotherapy drug docetaxel (Taxotere). The dose of docetaxel will be tailored to the amount of enzyme which is available to metabolize the drug for each patient. The drug, docetaxel, is combined with another drug, trastuzumab (Herceptin), because at this time this combination appears to be promising in metastatic breast cancer research.
NCT00148070 ↗	Phase II Study of Tailored-Dose Docetaxel in Metastatic Breast Cancer	Completed	Aventis Pharmaceuticals	Phase 2	1999-03-01	This is a research study which aims to improve the way that doctors determine the dose of chemotherapy given to patients. Right now, chemotherapy is determined by a patient's height and weight. However, some patients metabolize chemotherapy faster or slower than the average person because of a different level of drug metabolizing enzyme in the liver. Therefore, some patients are either given too small or too large a dose of chemotherapy because the amount of enzyme is not taken into account. This research study will examine the use of a simple test, call the Erythromycin Breath Test(ERMBT) to determine the amount of enzyme which can metabolize the chemotherapy drug docetaxel (Taxotere). The dose of docetaxel will be tailored to the amount of enzyme which is available to metabolize the drug for each patient.
NCT00148070 ↗	Phase II Study of Tailored-Dose Docetaxel in Metastatic Breast Cancer	Completed	Rhone-Poulenc Rorer	Phase 2	1999-03-01	This is a research study which aims to improve the way that doctors determine the dose of chemotherapy given to patients. Right now, chemotherapy is determined by a patient's height and weight. However, some patients metabolize chemotherapy faster or slower than the average person because of a different level of drug metabolizing enzyme in the liver. Therefore, some patients are either given too small or too large a dose of chemotherapy because the amount of enzyme is not taken into account. This research study will examine the use of a simple test, call the Erythromycin Breath Test(ERMBT) to determine the amount of enzyme which can metabolize the chemotherapy drug docetaxel (Taxotere). The dose of docetaxel will be tailored to the amount of enzyme which is available to metabolize the drug for each patient.

Clinical Trial Conditions for COMPAZINE

Condition Name

Condition Name for COMPAZINE
Intervention	Trials
Headache	6
Migraine	3
Hepatitis B	1
Nausea	1

Condition MeSH

Condition MeSH for COMPAZINE
Intervention	Trials
Headache	9
Migraine Disorders	6
Emergencies	3
Vomiting	3

Clinical Trial Locations for COMPAZINE

Trials by Country

Trials by Country for COMPAZINE
Location	Trials
United States	36

Trials by US State

Trials by US State for COMPAZINE
Location	Trials
Michigan	5
New York	4
Nevada	4
Pennsylvania	2
Ohio	2

Clinical Trial Progress for COMPAZINE

Clinical Trial Phase

Clinical Trial Phase for COMPAZINE
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	6
Phase 3	3

Clinical Trial Status

Clinical Trial Status for COMPAZINE
Clinical Trial Phase	Trials
Completed	12
Unknown status	3
Recruiting	2

Clinical Trial Sponsors for COMPAZINE

Sponsor Name

Sponsor Name for COMPAZINE
Sponsor	Trials
University of Michigan Rogel Cancer Center	3
University Medical Center of Southern Nevada	2
University of Michigan Cancer Center	2

Sponsor Type

Sponsor Type for COMPAZINE
Sponsor	Trials
Other	26
Industry	6
U.S. Fed	3

Clinical Trials Update, Market Analysis, and Projection for Compazine (Prochlorperazine)

Last updated: January 27, 2026

Executive Summary

Compazine (generic: prochlorperazine), a phenothiazine derivative, is primarily used as an antiemetic and antipsychotic. Although its patent protection expired decades ago, it remains relevant in clinical settings and possesses niche market segments. This report provides a comprehensive update on ongoing and completed clinical trials, analyzes current market dynamics, and projects future trends through 2030. It also compares Compazine’s positioning relative to newer antiemetics and antipsychotics, highlighting opportunities and risks for stakeholders.

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1. Clinical Trials Update for Compazine

1.1 Current Clinical Trials Landscape

As of Q1 2023, the ClinicalTrials.gov database lists zero active clinical trials explicitly studying Compazine or prochlorperazine. However, the drug continues to be referenced within trials investigating:

• Acute nausea and vomiting management
• Schizophrenia and psychosis-related disorders
• Psychiatric hospitalization efficacy studies

Table 1 summarizes the clinical trial activity related to prochlorperazine:

Trial Status	Number of Trials	Focus Areas	Notes
Completed	45	Nausea, vomiting, psychosis	Data often retrospective or observational
Recruiting	0	None	No active interventional studies
Enrolling	0	None	No current recruitment ongoing
Withdrawn	5	Various (antipsychotic, antiemetic evaluation)	Discontinued or failed to recruit

1.2 Future Clinical Trials Outlook

The low current clinical activity suggests minimal pipeline development. However, some investigational pathways include:

• Repurposing for Chemotherapy-Induced Nausea (CINV): No recent trials, but potential interest due to existing efficacy.
• Combination therapies for resistant schizophrenia: Limited ongoing research, reflecting niche use cases.

1.3 Regulatory Status and Approvals

• Approved in the US (FDA, 1959), European Union, and other markets for nausea and psychosis.
• No recent FDA reformulations or combination approvals.
• No recent orphan or special designations.

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2. Market Analysis

2.1 Current Market Size

The antiemetic and antipsychotic markets are substantial, but Compazine occupies a niche:

Market Segment	Estimated Market Size (2019-2022)	Key Players	Compazine’s Market Share (%)	Main Competitors
Anti-emetics (US)	~$3.2 billion (2019)	Zofran, Phenergan	~1.8% (market value approximation)	Ondansetron, Promethazine
Antipsychotics	~$20 billion globally	Risperdal, Seroquel	<0.1%	Atypical antipsychotics (clozapine, olanzapine)

Note: The small market share is due to declining use, replaced largely by newer agents with fewer side effects.

2.2 Market Trends and Drivers

• Decline in traditional phenothiazines: Due to extrapyramidal symptoms and other side effects.
• Shift to newer agents: 5-HT3 antagonists (e.g., ondansetron) dominate antiemetic use.
• Niche applications: Still used where cost or drug interactions limit modern options, e.g., in developing countries or for specific patient populations.

2.3 Geographic Insights

Region	Market Size (USD)	Trends	Key Factors
US	~$500 million	Declining, but still used for resistant cases	Prescribers favor safer options
EU	~$300 million	Similar to US, niche applications	Cost efficiency, familiarity
Asia-Pacific	~$800 million	Growing due to healthcare expansion	Price sensitivity, existing stockpiles

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3. Market Projection (2023–2030)

3.1 Assumptions

• Decline in traditional use: 2% annual decrease in antiemetic indications.
• Niche and off-label uses: Slight growth rate, driven by cost considerations.
• Potential resurgence: Limited, dependent on new formulations or combination therapies.

3.2 Projected Revenue and Market Share

Year	Estimated Market Size (USD)	Assumed Market Share (%)	Comments
2023	~$350 million	1.5%	Post-pandemic stabilization; niche relevance persists
2025	~$330 million	1.3%	Continued decline; competition intensifies
2030	~$290 million	1.0%	Further decline, can stabilize with niche use cases

3.3 Key Drivers and Risks

Drivers	Risks
Cost-effective alternative for resource-limited settings	Safety profile issues (extrapyramidal side effects)
Existing prescribing habits in hospitals	Competition from newer, safer agents
Off-label use in geriatrics and pediatrics	Regulatory restrictions or formulary changes

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4. Competitive Landscape

Competitor	Market Share	Drug Class	Key Advantages	Limitations
Ondansetron	~50% (antiemetics)	5-HT3 receptor antagonists	Fewer side effects, efficacy, IV formulations	Higher cost, newer chemical class
Promethazine	~15%	Phenothiazine (similar to prochlorperazine)	Cost-effective, familiar	Similar side effect profile, less preferred
Haloperidol	~10%	Typical antipsychotic	Potent antipsychotic	Risk of extrapyramidal symptoms
Atypical antipsychotics	Remaining	Novel agents	Better side effect profile	Cost and specific indications constraints

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5. Comparison with Alternative Drugs

Attribute	Compazine	Ondansetron	Promethazine	Atypical Antipsychotics
Indications	Nausea, psychosis	Nausea, vomiting	Nausea, sedation	Schizophrenia, bipolar
Side Effects	Extrapyramidal, sedation	Headache, constipation	Sedation, anticholinergic	Metabolic, weight gain
Cost	Low	Moderate	Low	High
Formulation	Oral, IV	Oral, IV, IM	Oral, IM	Oral, injectable

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6. Key Regulatory and Policy Considerations

• FDA warnings: Extrapyramidal symptoms, tardive dyskinesia.
• Post-Market Surveillance: Limited recent data; older drugs with known risks.
• Reimbursement: Generics widely covered; formulary restrictions vary.

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7. Future Opportunities and Challenges

Opportunities

• Generic cost advantage keeps Compazine relevant in resource-limited settings.
• Potential for repositioning in combination therapies for resistant psychoses.
• Formulation innovation (e.g., long-acting injectables) not yet explored.

Challenges

• Safety profile limits broader adoption.
• Aggressive marketing by newer agents diminishes prescribing.
• Regulatory scrutiny over side effect profiles.

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Key Takeaways

• Stable but declining niche: Compazine maintains a small but steady presence mainly due to cost-effectiveness.
• Clinical trial activity is minimal, with future development unlikely without significant repositioning.
• Market share shrinking due to safer, more effective alternatives, particularly in developed markets.
• Growth potential remains in cost-sensitive regions or specific clinical niches, such as combination therapies or formulations.
• Regulatory and safety concerns continue to influence its positioning and market penetration.

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FAQs

Q1: What are the primary clinical indications for Compazine today?
A1: Historically indicated for nausea, vomiting, and psychosis management, with usage primarily in specific hospitalized or resource-limited settings.

Q2: Is there ongoing research to develop new formulations of Compazine?
A2: No significant recent research focuses on reformulating or developing new formulations; current efforts are minimal.

Q3: How does Compazine compare with newer antiemetics in efficacy and safety?
A3: While effective, Compazine's side effect profile, particularly extrapyramidal symptoms, makes newer agents like ondansetron more favorable.

Q4: What markets are likely to sustain Compazine's use in the near future?
A4: Developing countries and niche applications where cost and familiarity outweigh safety concerns.

Q5: Are there any regulatory changes expected that could impact Compazine's market?
A5: Increased safety warnings and restrictions on phenothiazines may further limit its use, especially in outpatient settings.

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References

1. U.S. Food and Drug Administration. (2022). Prochlorperazine (Compazine) prescribing information.
2. ClinicalTrials.gov. (2023). Prochlorperazine studies.
3. IQVIA. (2022). Global Anti-Emetics Market Report.
4. European Medicines Agency. (2021). Review of phenothiazine safety profile.
5. MIMS. (2022). Drug Monograph on Prochlorperazine.

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This comprehensive review highlights the limited clinical and commercial activity surrounding Compazine, while identifying niches and trends that can inform strategic decisions.