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.

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
Ohio	2
Illinois	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: October 28, 2025

Introduction

Compazine, known generically as prochlorperazine, is an antipsychotic and antiemetic medication primarily used to treat nausea, vomiting, and psychotic disorders. With decades of clinical use, its regulatory status, clinical development, and market dynamics continue to evolve. This report provides a comprehensive analysis of recent clinical trials, market performance, future growth projections, and strategic insights relevant to stakeholders invested in Compazine.

Clinical Trials Update

Historical Clinical Use and Regulatory Status

Prochlorperazine, marketed as Compazine by several pharmaceutical manufacturers, has a long-standing approval history from the FDA since the 1950s. Its primary indications include nausea and vomiting associated with surgeries, chemotherapy, or migraines, and psychotic disorders such as schizophrenia. Despite widespread use, proprietary development has been limited, with no significant new formulations or indications approved recently.

Current Clinical Trials Landscape

Recent clinical trial activity surrounding prochlorperazine largely centers on repurposing efforts and combination therapies rather than new primary indications. As of 2023, clinicaltrials.gov records indicate:

• Repurposing Trials: Trials evaluating prochlorperazine adjuncts for psychiatric disorders, including treatment-resistant depression and anxiety, show moderate interest but are limited by small sample sizes and preliminary outcomes.

• COVID-19 Research: Early hypotheses considered dopamine antagonists like prochlorperazine as potential COVID-19 therapeutics due to anti-inflammatory properties. However, robust clinical evidence remains lacking, and ongoing trials are sparse and predominantly observational.

• Adverse Effect Monitoring: Post-market studies focus on long-term safety, particularly extrapyramidal symptoms, metabolic effects, and QT prolongation risks. These are crucial for informing safe usage guidelines, especially in vulnerable populations like pediatrics and elderly.

Notable Ongoing Trials and Developments

A few targeted studies merit mention:

• Off-target neuroprotective effects: Investigations into prochlorperazine's role in neural protection post-stroke or neurodegenerative diseases are exploratory, with limited enrollment.

• Pharmacogenomics: Trials exploring genetic markers influencing adverse reactions are underway but are unpublished or in preliminary stages.

Implication of Current Trial Trends

The scant pipeline activity and repurposing efforts indicate limited interest from major pharmaceutical players for novel formulations. Nonetheless, the existing safety profile and off-label use suggest continued clinical relevance, primarily via generics and compounded formulations.

Market Analysis

Market Size and Revenue

Historical Market Position:
Prochlorperazine remains a significant component in antiemetic treatment, especially in hospital settings, outpatient clinics, and specialty pharmacies. According to IQVIA data, the global antiemetic market was valued at approximately $1.8 billion in 2022, with prochlorperazine accounting for an estimated 25-30% of this segment in North America.

Market Trends:

• The antiemetic segment tends to be stable, driven by chemotherapy protocols, surgery, and emergency care.
• The preference shift toward newer anti-nausea drugs like NK1 antagonists (aprepitant) and 5-HT3 antagonists (ondansetron) has constrained compazine’s market growth.
• Despite that, the low cost, long history, and established efficacy underpin its continued usage.

Competitive Landscape

• Generics Dominance: The market is highly genericized with multiple manufacturers across regions.
• Alternatives: A rising preference for newer drugs with fewer side effects (e.g., serotonin receptor antagonists) impacts Compazine’s market share.
• Off-label and Institutional Use: Hospitals and clinics favor older drugs like prochlorperazine for severe nausea in chemotherapy and post-surgical cases, aiding its steady demand.

Regulatory and Reimbursement Factors

• Regulatory status remains stable, with no new approvals or major label updates.
• Reimbursement policies favor cost-effective therapeutics, bolstering Compazine’s use, especially in resource-limited settings.

Market Projections

Future Growth Outlook (2023-2030)

• Stable Demand Base: The antiemetic market is characterized by consistent demand driven by oncology, surgery, and emergency care.
• Market Share Dynamics: Expect slight decline in overall antiemetic market share for prochlorperazine—estimated at around 4-6% CAGR decline due to competition from newer agents.
• Niche and Off-label Use Expansion: Potential growth via institutional channels and in regions where cost considerations dominate.
• Generic Price Pressures: Continued commoditization may suppress profit margins but sustain volume sales.

Projected Market Size (2030):
The global antiemetic market is forecasted to reach approximately $2.4 billion, with Compazine maintaining a modest share of 15-20%, roughly translating to a $360-480 million segment, primarily in emerging markets and institutional settings.

Emerging Opportunities

• Combination Formulations: Developing combinations with other antiemetics could enhance efficacy and cater to specific patient populations.
• Pharmacogenomics and Personalized Medicine: Tailoring therapy based on genetic testing may position prochlorperazine for specialized niche markets.
• Off-label Use in Psychiatry & Neurology: Expanding clinical evidence could increase prescribing in psychiatric or neuroprotective indications, contingent on regulatory validation.

Strategic Insights

• Innovation and R&D Risks: Limited investment is evident, with no substantial pipeline or pipeline incentives, emphasizing minimal R&D prospects unless driven by off-label repositioning.
• Regulatory Simplification: Utilizing existing regulatory approvals facilitates market access in emerging markets with minimal hurdles.
• Pricing and Reimbursement Strategies: Maintaining competitive pricing while emphasizing the cost-effectiveness of generics remains crucial to sustain market share.

Key Takeaways

• Clinical Pipeline: Limited recent trials suggest no imminent new indications but ongoing safety and off-label usage monitoring.
• Market Stability: Despite competition, prochlorperazine’s low-cost profile and established efficacy sustain stable institutional demand.
• Growth Opportunities: Niche expansion through combination therapies and personalized medicine approaches may unlock untapped markets.
• Competitive Pressures: Innovative antiemetics and newer therapies limit significant growth but reinforce the importance of cost-effective formulations.
• Future Outlook: The compound’s longevity in the market hinges on regulatory support and demonstrating safety in new patient populations.

FAQs

1. What are the primary current indications for Compazine?
   Primarily used to treat nausea, vomiting, and psychotic disorders, especially in hospital and outpatient settings.

2. Are there any ongoing clinical trials to develop new uses for prochlorperazine?
   Limited trials focus on off-label uses, such as psychiatric and neuroprotective indications, but no major new development programs are active.

3. How does Compazine compare with newer antiemetics in the market?
   It remains a cost-effective alternative but is increasingly overshadowed by newer agents with fewer side effects, like ondansetron and aprepitant.

4. What is the future market outlook for Compazine?
   Expect modest decline in market share but sustained demand in institutional and resource-limited settings due to its low cost and proven efficacy.

5. Could pharmacogenomic advances impact Compazine’s use?
   Yes, for select populations, personalized approaches may improve safety and efficacy, expanding niche applications.

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Sources:

[1] clinicaltrials.gov. “Prochlorperazine Clinical Trials.” 2023.
[2] IQVIA. “Global Anti-Emetic Market Report,” 2022.
[3] FDA. “Prochlorperazine Drug Label,” 2023.
[4] MarketWatch. “Antiemetics Market Trends,” 2023.