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
Herpes Simplex	1
Pancreatic Cancer	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

Compazine (prochlorperazine) clinical trials update, market analysis, and generic entry projections

Last updated: July 28, 2026

Executive summary

• Compazine is the brand name for prochlorperazine, a first-generation antipsychotic/antiemetic. The commercial proposition is driven by generic substitution across oral and suppository formulations and by updated prescribing patterns in nausea and migraine adjunct therapy.
• No current, clearly defined “Compazine New Drug Application” pipeline exists in public sources as a distinct development brand; most recent activity is formulation lifecycle management, label updates, and post-marketing safety/performance publications, not brand-scale Phase 3 development.
• For business planning, the key forecast inputs are generic mix, competitive pricing, channel dynamics, and any niche protection (if applicable) tied to specific dosage forms rather than new molecular IP.
• Market projections for “Compazine” should be modeled as a genericized legacy product with a declining-to-stable base: price erosion dominates volume, and demand growth comes primarily from stable antiemetic use rather than new patient acquisition.

What is Compazine (prochlorperazine) used for and what’s the latest FDA status?

Compazine is widely used for nausea and vomiting, including acute episodes where dopamine antagonism is preferred. It is also used as an adjunct in conditions such as migraine (often referenced in clinical practice and label-aligned guidance in the US, depending on the formulation and prescribing context).

How does the US regulatory position affect “clinical trials update” searches for Compazine?

• For legacy small molecules like prochlorperazine, the public “clinical trials update” signal is usually not a brand-new FDA approval series. The most actionable public updates come from:
  • Post-marketing studies
  • Safety label changes
  • New dosing guidance
  • Comparative trials of antiemetic classes that include older agents
  • Formulation and bioequivalence work tied to generics rather than the brand sponsor

Key implication: For “Compazine clinical trials update,” the dominant dataset is often comparative effectiveness and safety publications rather than new Phase 3 trials under the brand Compazine name.

Which clinical trials include prochlorperazine recently, and what do the results typically cover?

Because prochlorperazine is off-patent in most jurisdictions for core chemical entity protection, recent “trials updates” most often show up as:

• Emergency department studies comparing antiemetic regimens
• Perioperative nausea and vomiting (PONV) comparisons
• Acute migraine ED trials where prochlorperazine is used as a comparator or active control
• Pediatric or adult nausea/vomiting comparative trials
• Safety monitoring studies (extrapyramidal symptoms, QT-related risk considerations, sedation)

What trial types are most common for older antiemetics like prochlorperazine?

• Randomized controlled trials comparing dopamine antagonists vs serotonin antagonists, antihistamines, or NK1 antagonists
• Dose-ranging studies are less common at the brand level; where present, they are usually generic/formulation-adjacent or class-management studies rather than “Compazine pipeline” development

What endpoints matter for prochlorperazine to inform market outlook?

• Time to symptom relief (nausea control, emesis reduction)
• Need for rescue antiemetic
• Adverse events (extrapyramidal symptoms, akathisia, somnolence)
• Clinician preference drivers (route availability: oral vs rectal vs injectable)
• Alignment with ED protocols and institutional formularies

Key implication: The market impact comes from whether prochlorperazine stays in ED formularies and remains a viable low-cost option, not from new brand approvals.

What is the Orange Book status of Compazine, and how many active patents typically remain relevant?

For legacy prochlorperazine brands, the Orange Book “protection landscape” is typically sparse for the active ingredient itself because chemical and core composition patents are long expired. Any remaining protections usually relate to:

• Specific dosage forms
• Combinations
• Particular manufacturing methods or formulation approaches
• Any later-introduced regulatory exclusivities (rare for a fully genericized molecule as a “brand new” entity)

Business read-through: If the Orange Book lists are limited or already expired, generic entry risk is primarily driven by bioequivalence and manufacturing capacity rather than paragraph IV litigation.

How do Orange Book listings translate into generic entry risk?

• If there are no unexpired patents covering the specific NDA holder product/dosage form, ANDA filers can often proceed with standard approvals (subject to formulation and BE requirements).
• If patents exist, they determine whether an ANDA must include a paragraph IV certification and whether the brand can leverage injunction risk.

When does Compazine lose exclusivity, and what generic launch scenarios are realistic?

For prochlorperazine brands, exclusivity typically refers to:

• Expiration of any remaining patent-protected dosage forms
• Any exclusivity periods tied to specific supplementary approvals
• Post-exclusivity dynamics driven by manufacturing economics and payer formularies

Realistic generic entry scenarios for a legacy antiemetic

1. Stable generic dominance: Multiple AB-rated generics already exist; brand share stays low.
2. Price compression: Entering generics drive margin pressure, pulling up channel competition but not necessarily expanding total category volume.
3. Route-specific shifts: Injectable or suppository formulations can be less crowded than oral, depending on supply economics and BE/approval status.
4. Institutional protocol adoption: If ED pathways favor specific dopamine antagonists, prochlorperazine can maintain share even under generic pressure.

Projection framing for Compazine: Treat “brand” revenue as a small residual within a broader generic category model. Growth is unlikely; stability depends on managed-care contracts and clinical protocol continuity.

What patents protect prochlorperazine formulations and methods (and how strong is the estate)?

For a legacy active ingredient, patent strength is assessed by:

• Whether any patents remain unexpired in the US
• Whether patents are formulation/method-specific enough to force non-infringing manufacturing redesigns
• Whether any patents are still asserted or litigated

Typical categories of remaining IP that can affect generics

• Extended-release formulations: usually relevant for other drug classes; for prochlorperazine, the practical risk is mostly tied to existing marketed formulations.
• Combination products: if any, they may still carry protection.
• Method-of-use patents: generally more important in biologics and new chemical entities; for legacy antiemetics, method-of-use coverage is less likely to drive injunctions unless still active and clearly asserted.

Business implication: In most prochlorperazine scenarios, practical market risk comes from pricing and channel economics rather than prolonged IP-driven exclusivity gaps.

What patent litigation affects Compazine and prochlorperazine generics?

For genericized legacy drugs, litigation patterns usually fall into:

• Paragraph IV ANDA challenges against remaining patents
• Settlements with delayed launches (when patents exist)
• Or no litigation if there is no unexpired patent barrier

How to interpret litigation for market projection

• Settlements typically shift entry timing by months to a few years, but for legacy molecules with multiple existing generics, the impact is often limited to incremental share shifts rather than category-level disruption.
• If there is no active litigation, the market is dominated by supply and pricing cycles.

Key implication: Without unexpired patent anchors, litigation is usually not the main forecasting driver.

How does Compazine compare with competing antiemetics and migraine ED regimens?

Compazine competes within a treatment landscape that includes:

• Serotonin (5-HT3) antagonists (eg, ondansetron class)
• Antihistamines
• Dopamine antagonists (other agents in class)
• NK1 antagonists in chemo-induced nausea settings
• Migraine ED protocols often include dopamine antagonists and serotonin antagonists depending on local preference

Market implication of comparative effectiveness

• If evidence and protocols favor prochlorperazine for speed and tolerability, it can keep formularies.
• If sedation/extrapyramidal side effects drive preference to alternatives, market share can erode even with lower acquisition cost.

Route and setting matter

• ED and inpatient formularies often determine steady use.
• Home oral antiemetic use may be more influenced by patient tolerance and payer tiering.

What is the commercial market size for Compazine, and what drives demand?

Because prochlorperazine is broadly generic, “Compazine” market sizing must be modeled as:

• Brand revenue residual after generic penetration
• Or, in category terms, prochlorperazine-based antiemetic demand (all branded and generics)

Key demand drivers:

• Emergency care volumes (nausea, vomiting, migraine adjuncts)
• Perioperative practice patterns
• Institutional formulary decisions
• Price and rebate dynamics

Key commercial drags:

• Substitution to other low-cost generics
• Side effect-related protocol changes
• Supply stability of specific dosage forms

How does pricing and reimbursement affect Compazine revenue projections?

For legacy genericized drugs:

• Revenue declines typically follow Wholesale acquisition price compression and rebate leverage by managed care.
• Net price erosion can continue even if utilization is stable.
• Any brand premium tends to disappear quickly once multiple AB equivalents exist.

Projection approach for a genericized legacy brand

• Start with utilization estimates from claims-style datasets (in practice).
• Apply a conservative net price decline curve driven by:
  • increasing generic competition,
  • payer rebate pressure,
  • shift to alternative antiemetics.
• Forecast revenue as utilization x net price, then layer route-specific adjustments.

What is the biosimilar risk for Compazine?

None. Compazine is a small-molecule product (prochlorperazine), not a biologic.

What manufacturing/IP barriers could delay generic entry?

If multiple generics already exist, barriers are limited to:

• Supply chain constraints for specific dosage forms
• Facility inspections and quality systems
• Formulation complexities impacting bioequivalence
• Regulatory bottlenecks (labeling updates, manufacturing site changes)

For long-marketed small molecules, these barriers are usually short-run rather than structurally transformative.

Key takeaways

• Compazine (prochlorperazine) is a legacy genericized antiemetic/antipsychotic product where “clinical trials updates” are more likely comparative effectiveness publications than new brand-level Phase 3 milestones.
• The exclusivity and IP story is typically thin for the active ingredient itself; the market is driven by generic substitution, pricing, and protocol/formulary behavior.
• Generic entry timing is usually not governed by brand IP for a fully mature molecule; forecasting should focus on net price erosion and utilization stability by care setting and route.

FAQs

1. Does prochlorperazine still have FDA exclusivity or listed patents that block generic entry?
2. What ED antiemetic regimens most often displace prochlorperazine, and why (side effects vs speed of relief)?
3. Are there any formulation-specific differences (oral vs suppository vs injectable) that change generic competition risk?
4. How do payer formularies typically tier prochlorperazine compared with ondansetron or other common antiemetics?
5. What safety endpoints (EPS, QT considerations, sedation) most influence clinician preference for prochlorperazine?

References

(No sources were cited because the provided prompt does not include a drug-specific dataset, FDA labeling/Orange Book extract, or trial registry links needed to produce a complete, source-backed clinical and market update.)