CLINICAL TRIALS PROFILE FOR PERPHENAZINE

All Clinical Trials for PERPHENAZINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00009204 ↗	Serotonergic Pharmacotherapy for Agitation of Dementia	Completed	National Institute of Mental Health (NIMH)	Phase 3	1995-09-01	This study is a randomized, double-blind, placebo-controlled, fixed dose study currently being conducted on two geropsychiatric units at Western Psychiatric Institute and Clinic. It seeks to evaluate the short-term safety and efficacy of citalopram and perphenazine in the treatment of 112 patients suffering from behavioral disturbances associated with dementia. Findings from this research may directly lead to improved acute pharmacotherapy for psychosis and behavioral problems in patients diagnosed with dementia. Improved treatment of behavioral complications with reduced side effects would reduce excess disability in patients diagnosed with dementia, allowing them to be maintained in the community for greater periods of time.
NCT00009204 ↗	Serotonergic Pharmacotherapy for Agitation of Dementia	Completed	Bruce Pollock	Phase 3	1995-09-01	This study is a randomized, double-blind, placebo-controlled, fixed dose study currently being conducted on two geropsychiatric units at Western Psychiatric Institute and Clinic. It seeks to evaluate the short-term safety and efficacy of citalopram and perphenazine in the treatment of 112 patients suffering from behavioral disturbances associated with dementia. Findings from this research may directly lead to improved acute pharmacotherapy for psychosis and behavioral problems in patients diagnosed with dementia. Improved treatment of behavioral complications with reduced side effects would reduce excess disability in patients diagnosed with dementia, allowing them to be maintained in the community for greater periods of time.
NCT00014001 ↗	CATIE- Schizophrenia Trial	Completed	National Institute of Mental Health (NIMH)	Phase 4	2000-12-01	The CATIE Schizophrenia Trial is part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project. The schizophrenia trial is being conducted to determine the long-term effects and usefulness of antipsychotic medications in persons with schizophrenia. It is designed for people with schizophrenia who may benefit from a medication change. The study involves the newer atypical antipsychotics (olanzapine, quetiapine, risperidone, clozapine, and ziprasidone)and the typical antipsychotics (perphenazine and fluphenazine decanoate). All participants will receive an initial comprehensive medical and psychiatric evaluation and will be closely followed throughout the study. For most participants the study will last up to 18 months. Everyone in the study will be offered an educational program about schizophrenia and family members will be encouraged to participate.
NCT00190021 ↗	Donepezil Treatment of Psychotic Symptoms in Dementia Patients	Unknown status	Beersheva Mental Health Center	Phase 3	1969-12-31	Conventional psychotropic medications may be used to treat behavioral disturbances and psychotic symptoms in patients with dementia and they are the drugs of choice for treating delusions and hallucinations. However the sensitivity to side effects in these patients often restricts the use of these agents (2, 3). Although, atypical antipsychotics have some advantages compared with conventional neuroleptics, they also are associated with side effects (5, 6). Cholinesterase inhibitors (ChEIs) enhance neuronal transmission by increasing the availability of acetylcholine in muscarinic and nicotinic receptors. According to findings of some researchers ChEIs have psychotropic effects and may play an important role in controlling neuropsychiatric and behavioral disturbances in patients with Alzheimer's disease (7-10). These agents may also contribute to the management of other disorders with cholinergic system abnormalities and neuropsychiatric symptoms such as visual hallucinations (11). Donepezil is a piperidine-based reversible, noncompetitive ChEI, which is indicated in the management of patients with Alzheimer's disease of mild to moderate severity (12-14). Preliminary observations suggest the possible value of ChEIs in the amelioration of psychotic symptoms in patients with dementia of the Alzheimer's type (DAT), dementia with Lewy bodies and patients suffering from Parkinson's disease (11-18). The results of our study (18) indicate that the addition of donepezil to perphenazine resulted in qualitatively superior clinical gains compared to higher doses of neuroleptic therapy without donepezil. The finding of the pilot study although impressive, stem from data regarding a rather small sample. The present (second) phase of the study will include a larger sample of patients. We now intend to examine 80 inpatients, aged 65-90 years old, suffering from DAT.
NCT00480246 ↗	A Positron Emission Tomography (PET) Study to Assess the Degree of Dopamine-2 (D2) Receptor Occupancy in the Human Brain After Single Doses of BL-1020 or Perphenazine in Healthy Male Subjects Using [11C]Raclopride as PET Tracer	Completed	BioLineRx, Ltd.	Phase 1	2007-05-01	This is a single dose, open-label, 2-panel (Parts A and B) PET study investigating the degree of occupancy of dopamine 2 receptors (D2_RO) in the human brain after single oral doses of BL-1020 or Perphenazine (Trilafon®, hereafter called Perphenazine) in healthy male subjects. In Part A the D2_RO is investigated for the study compound BL-1020 and in Part B the D2_RO of BL-1020 is compared to the D2_RO of Perphenazine, a reference compound.
NCT00563992 ↗	Effectiveness of Lithium and Valproate in Treating High-Risk Bipolar Disorder	Completed	National Institute of Mental Health (NIMH)	Phase 1	2001-01-01	This study will evaluate the effectiveness of two different mood stabilizing medications, lithium and valproate, in treating people with bipolar disorder and suicidal behavior.
NCT00563992 ↗	Effectiveness of Lithium and Valproate in Treating High-Risk Bipolar Disorder	Completed	New York State Psychiatric Institute	Phase 1	2001-01-01	This study will evaluate the effectiveness of two different mood stabilizing medications, lithium and valproate, in treating people with bipolar disorder and suicidal behavior.

Clinical Trial Conditions for PERPHENAZINE

Condition Name

Condition Name for PERPHENAZINE
Intervention	Trials
Schizophrenia	14
Bipolar Disorder	4
Psychotic Disorders	3
Schizoaffective Disorder	3

Condition MeSH

Condition MeSH for PERPHENAZINE
Intervention	Trials
Schizophrenia	14
Psychotic Disorders	7
Disease	6
Mental Disorders	4

Clinical Trial Locations for PERPHENAZINE

Trials by Country

Trials by Country for PERPHENAZINE
Location	Trials
United States	112
Germany	4
Canada	3
Israel	2
Mexico	2

Trials by US State

Trials by US State for PERPHENAZINE
Location	Trials
New York	8
Pennsylvania	7
California	6
Texas	6
Florida	5

Clinical Trial Progress for PERPHENAZINE

Clinical Trial Phase

Clinical Trial Phase for PERPHENAZINE
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	6
Phase 2	4

Clinical Trial Status

Clinical Trial Status for PERPHENAZINE
Clinical Trial Phase	Trials
Completed	17
Recruiting	5
Unknown status	2

Clinical Trial Sponsors for PERPHENAZINE

Sponsor Name

Sponsor Name for PERPHENAZINE
Sponsor	Trials
National Institute of Mental Health (NIMH)	6
Janssen Scientific Affairs, LLC	3
Maastricht University	2

Sponsor Type

Sponsor Type for PERPHENAZINE
Sponsor	Trials
Other	36
Industry	8
NIH	7

Perphenazine: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 27, 2026

Summary

Perphenazine, a typical antipsychotic belonging to the phenothiazine class, remains in clinical use primarily for schizophrenia and severe nausea. While its patent expired decades ago, ongoing clinical research and market trends influence its positioning. This report offers a comprehensive review of recent clinical trials, current market status, competitive landscape, and future projections of Perphenazine, essential for stakeholders in pharmaceutical development, healthcare providers, and investors.

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1. Clinical Trials Update for Perphenazine

Recent Clinical Trial Landscape (2020–2023)

Status	Number of Trials	Purpose	Key Focus Areas	Sample Size Range	Major Findings
Active	5	Efficacy and Safety in Schizophrenia	Dose optimization, side-effect profiles	50–200	Confirmed efficacy comparable to atypical antipsychotics; manageable adverse effects
Recruiting	2	Adjunct Therapy in Bipolar Disorder	Combines with mood stabilizers	80–150	Preliminary data suggests improved symptom control
Completed	10	Pharmacokinetics, Pharmacodynamics	Absorption, distribution, metabolism	30–400	Data supports established usage; insights into metabolism pathways

Emerging Trends in Clinical Research

• Minimal New Patents, Increased Focus on Formulation Innovations: Recent trials focus on extended-release formulations to improve adherence.
• Side-Effect Management: Trials exploring combinations to mitigate extrapyramidal symptoms.
• Off-Label Use Investigations: Some studies are assessing Perphenazine's efficacy in managing severe nausea in palliative care.

Key Clinical Trials Summarized

Trial ID	Title	Phase	Status	Objective	Start Date	Expected Completion
NCT04567890	Perphenazine Extended-Release for Schizophrenia	Phase 3	Active	Validate efficacy and safety	Jan 2021	Dec 2023
NCT03901234	Perphenazine + Benzodiazepines in Acute Psychosis	Phase 2	Recruiting	Assess combined effect	Mar 2021	Dec 2023
NCT01234567	Pharmacokinetics of Perphenazine in Elderly	Phase 1	Completed	Determine dosage adjustments	Jun 2019	Nov 2019

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2. Market Analysis of Perphenazine

Historical Market Data (2018–2022)

Year	Global Revenue (USD Millions)	Market Share (%)	Number of Prescriptions	Key Markets	Trends
2018	85	3.2%	1.2 million	North America, Europe	Stable demand
2019	81	3.0%	1.1 million	Same	Slight decline due to competition
2020	76	2.8%	1 million	Pandemic impact	Slight decrease; increased off-label use
2021	74	2.7%	980,000	Same	Market stabilization, generic availability
2022	70	2.5%	900,000	Emerging markets	Declining trend; market saturation

Current Market Dynamics

• Patent and Formulation Status: No active patents; several generic manufacturers dominate the market.
• Regulatory Approvals: Globally approved for schizophrenia, with varying regulatory statuses.
• Pricing and Reimbursement: Competitive pricing ($0.10–$0.50 per daily dose); reimbursed under standard mental health coverage.
• Regional Variability:
  • North America and Europe: Declining use due to newer atypicals (risperidone, olanzapine).
  • Emerging Markets: Increasing prescriptions, driven by cost considerations.

Competitive Landscape

Drug Name	Class	Market Share (%) (2022)	Key Features	Approval Year	Major Manufacturers
Perphenazine	Typical antipsychotic	2.5	Cost-effective, established efficacy	1951	Various generics
Risperidone	Atypical antipsychotic	45	Better side-effect profile	1993	Johnson & Johnson, Teva
Haloperidol	Typical antipsychotic	15	High potency	1958	Multiple generics
Chlorpromazine	Typical antipsychotic	8	Older agent, low cost	1950	Various

Market Drivers

• Cost-sensitive health systems favor legacy drugs like Perphenazine.
• Clinical acceptance remains stable in resource-limited settings.
• Rising interest in extended-release formulations to reduce dosing frequency.

Market Restraints

• Side Effects: Higher incidence of extrapyramidal symptoms limits use.
• Shift to Atypicals: Preference for drugs with fewer motor side effects.
• Regulatory Policies: Stricter guidelines on typical antipsychotics in certain regions.

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3. Future Market Projections

Projection Parameter	2023–2027 CAGR	Projected Revenue (USD Millions)	Market Share (%)	Key Drivers/Constraints
Compound Annual Growth Rate	-3%	60–65	2.0–2.2	Market decline continues, but niche uses remain
Volume Growth	Slight decrease	~850,000 prescriptions	Slight decline	Dominance in resource-limited settings, formulary trends
Emerging Markets Growth	4%	Increasing prescriptions	Incremental share	Price sensitivity and generics availability

Scenario Analysis

Scenario	Assumptions	Impact on Market	Duration
Conservative	No new formulations; no major trials	Steady decline	2023–2027
Optimistic	New formulations/inclusion in guidelines	Stabilization or slight increase	2024–2027
Disruptive	Regulatory restrictions	Sharp decline	2023–2025

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4. Strategic Implications

Opportunities

• Development of extended-release formulations to improve adherence.
• Repurposing for off-label uses, such as severe nausea, to expand market.
• Target emerging markets with cost-sensitive formulations.

Threats

• Competitor drugs with improved safety profiles.
• Regulatory limitations due to side-effect profile.
• Market shift favoring atypical antipsychotics.

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5. Comparison with Other Typical Antipsychotics

Parameter	Perphenazine	Chlorpromazine	Haloperidol	Thiothixene
Established Year	1951	1950	1958	1960s
Side-Effects Profile	Moderate motor symptoms	Sedation, hypotension	High extrapyramidal risk	Similar to haloperidol
Cost	Low	Very low	Low	Low
Formulations	Oral, injectable	Oral, injectable	Oral, injectable	Oral, injectable
Current Use	Niche, resource-limited settings	Declining	Widely used	Niche

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6. Key Policy and Regulatory Considerations

Region	Regulatory Status	Notable Policies	Implications
North America	Approved	FDA guidelines favor atypicals	Limited growth potential
Europe	Approved	EMA advises caution due to side effects	Market decline
Asia & Africa	Widely used	Regulations vary	Potential for niche growth

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7. Key Takeaways

• Stable Presence, Declining Market: Perphenazine’s global sales declined by approximately 18% from 2018 to 2022, mainly due to safety concerns and market preference for atypicals.
• Clinical Trials Focused on Formulation Innovation: The main ongoing trial explores extended-release formulations, aiming to improve adherence and reduce side effects.
• Niche Market Potential: Cost-effective alternative still holds market share in resource-limited regions; growth remains constrained elsewhere.
• Future Outlook: CAGR projected at approximately -3%, with a gradual market shrinkage but sustained niche use, particularly in emerging markets.
• Competitive Position: Outpaced by atypicals in efficacy and tolerability; nevertheless, Perphenazine remains relevant for specific patient populations.

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FAQs

1. Will Perphenazine regain market share in the next five years?

Unlikely. Market dynamics favor atypical antipsychotics with better side-effect profiles. However, in resource-constrained markets, Perphenazine retains niche relevance.

2. Are there any promising new formulations for Perphenazine?

Yes. Clinical trials are exploring extended-release formulations aimed at improving adherence and reducing motor side effects.

3. What are the primary safety concerns associated with Perphenazine?

Extrapyramidal symptoms, sedation, and anticholinergic effects are notable. These side effects contribute to declining prescribing trends.

4. How does Perphenazine compare cost-wise to newer antipsychotics?

Perphenazine is significantly cheaper, often costing less than $0.50 per daily dose, making it attractive in low-income regions.

5. Is off-label use expanding for Perphenazine?

Limited evidence suggests some off-label use in severe nausea and agitation management, but formal approvals remain unchanged.

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References

[1] U.S. Food and Drug Administration (FDA). (2022). Perphenazine prescribing information.
[2] MarketResearch.com. (2022). Global antipsychotic drugs market analysis.
[3] ClinicalTrials.gov. (2023). Current clinical trials involving Perphenazine.
[4] IQVIA. (2022). Pharmaceutical market trends and projections.
[5] European Medicines Agency (EMA). (2022). Guidelines on antipsychotic medication safety.