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
HER-2 Positive Metastatic Breast Cancer	1
Opioid Dependence	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
Terminated	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

Last updated: April 28, 2026

Compazine (prochlorperazine): Clinical-trials update, market analysis and projections

What is Compazine and how is it used?

Compazine is the brand name for prochlorperazine, a typical antipsychotic (phenothiazine class) used across multiple indications. In current practice it is used mainly for:

• Nausea and vomiting (including chemotherapy-induced and acute episodes)
• Migraine and other severe headache-related nausea
• Schizophrenia/psychotic disorders (where it remains a treatment option in some settings)

Compazine is an older, off-patent product in most jurisdictions, which strongly shapes the clinical-trials pipeline and the commercial forecast (generic competition dominates pricing and unit economics).

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What does the clinical-trials landscape look like for Compazine/prochlorperazine?

No meaningful late-stage (Phase 3) or registrational trials for Compazine-specific prochlorperazine indications are evident in the major public trial registries in a way that would support a clean, brand-specific “near-term approval catalyst” thesis. Public activity is largely consistent with:

• Supportive or comparative studies
• Formulation and dosing work
• Use-in-practice observational studies

For a brand like Compazine, the practical clinical signal tends to be driven more by new compositions/formulations or by newer drug combinations rather than by fresh prochlorperazine registrational programs.

Key implication for business planning: the clinical strategy for Compazine is typically not built around brand-new efficacy approvals; it is built around market access, competitive differentiation via supply and dosage form, and lifecycle management.

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What is the market structure for prochlorperazine/Compazine?

How supply and pricing typically behave

Compazine/prochlorperazine is subject to:

• Widespread generics (multiple manufacturers in most markets)
• Price compression after loss of effective exclusivity
• Tender-driven procurement in many countries
• Formulary preference based on logistics, availability, and cost

That structure lowers the upside from new clinical reads and makes forecast accuracy more dependent on market share, distribution, and tender dynamics than on trial results.

Where revenue tends to be concentrated

Demand clusters around:

• Hospitals and acute-care settings for antiemetic use
• Emergency departments for acute nausea and headache-related symptoms
• Oncology supportive care where antiemetics are used in protocols

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Market size and revenue projection framework

Because Compazine is a branded reference product in a largely generic market, a robust projection has to be framed as:

• Global prochlorperazine/prochlorperazine-ed product spend trend
• Share of branded vs generic
• Share by dosage form and route (oral, injectable)
• Geographic access and tender patterns
• Erosion from generic competition

Projection logic used here (business-grade):

1. Start with generic-dominant baseline demand for prochlorperazine as an antiemetic across acute care and oncology supportive care.
2. Model brand Compazine as a small, stable share relative to generics.
3. Assume low growth or modest decline in unit demand with periodic spikes from oncology volumes and acute-care capacity.
4. Apply inflation in unit prices only to the extent tender pricing does not reset faster than inflation.

This approach yields a forecast that typically looks like:

• Units: flat to low single-digit decline (aging usage patterns and generic switching effects)
• Brand revenue: flat to low single-digit decline (brand share retention is harder as generics remain cheaper)

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What is the near-term outlook (next 24 to 36 months)?

Clinical catalysts

• No clear Phase 3 or registrational milestone specific to Compazine/prochlorperazine is apparent as a near-term driver.
• Any clinical activity is unlikely to change market access rapidly for a mature generic-dominant product.

Commercial catalysts

The near-term drivers are:

• Supply continuity (injectables are especially sensitive)
• Tender wins and formulary renewals
• Price resets by competitors
• Route mix (injectable vs oral)

Net:

• Brand-like commercial upside is limited.
• The most realistic outcome is defensive revenue stability with gradual erosion.

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Projections: Base, downside, and upside scenarios (brand Compazine)

Important framing: Brand Compazine is forecast as a commercially mature product with generic competition as the dominant variable.

Scenario design

• Base case: stable branded share with modest pricing pressure
• Downside: branded share erodes faster due to tender shifts and supply substitution
• Upside: improved access for particular dosage forms and tender wins in select regions

Projected annual brand revenue direction

• Base case: low single-digit decline annually
• Downside: mid single-digit decline annually
• Upside: low single-digit growth or near-flat

This is consistent with how off-patent, generic-dominated antiemetics typically behave when no registrational efficacy expansion exists.

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Competitive landscape: what likely drives share losses

Compazine faces competition on:

• Cost (generics and biosimilar-like substitution dynamics are not applicable; it is generics)
• Formulary preference for alternative antiemetics (other phenothiazines, dopamine antagonists, 5-HT3 antagonists, NK1 antagonists, and newer regimen preferences)
• Route and dose convenience (OTC-like oral availability vs inpatient injectable demand)
• Safety and regimen protocols that shift practice patterns away from older agents in some protocols

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Key risks to the forecast

• Protocol shifts in oncology supportive care that reduce reliance on older dopamine antagonists
• Injectable supply disruptions or manufacturing reallocations
• Regional tender resets that accelerate brand share erosion
• Clinician substitution to cheaper alternatives within the same class or to non-class agents

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Key Takeaways

• Compazine (prochlorperazine) is a mature, generic-dominated product, so late-stage clinical catalysts are not a credible near-term growth lever.
• The clinical-trial picture is consistent with non-registrational or supportive activity, which does not typically change market access for branded supply.
• The market outlook is driven by tender procurement, formulary renewals, supply reliability, and route mix, not by new approvals.
• Forecast behavior for brand Compazine is most consistent with defensive revenue stability transitioning to low single-digit decline in the absence of a new registrational cycle.

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FAQs

1) Is Compazine expected to have a major Phase 3 approval catalyst?

No clear Phase 3 registrational path appears to be driving a near-term brand-specific approval catalyst, based on the mature, off-patent status and the lack of evident registrational milestones.

2) What is the main revenue driver for a mature off-patent antiemetic like Compazine?

It is primarily access and procurement: hospital formularies, emergency and oncology supportive care protocols, and injectable supply continuity.

3) What commercial variable matters most versus clinical outcomes?

Branded share versus generics under tender pricing and regional formulary dynamics.

4) Which indication category tends to hold demand most reliably?

Acute nausea and vomiting use in acute care and supportive care in oncology settings tends to maintain baseline utilization.

5) What would change the forecast materially?

A new validated formulation with improved differentiation that wins tenders or a new regulatory indication that changes procurement behavior. Without that, pricing and share erosion dominate.

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References

[1] ClinicalTrials.gov. Prochlorperazine (search results and trial records). National Library of Medicine. https://clinicaltrials.gov/
[2] EMA. Prochlorperazine product information and associated references (where available for approved uses). European Medicines Agency. https://www.ema.europa.eu/
[3] FDA. Prochlorperazine drug information and labeling resources. U.S. Food and Drug Administration. https://www.fda.gov/
[4] PubChem. Prochlorperazine (compound summary). National Center for Biotechnology Information. https://pubchem.ncbi.nlm.nih.gov/