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Last Updated: December 16, 2025

CLINICAL TRIALS PROFILE FOR PERPHENAZINE


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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PERPHENAZINE

Condition Name

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

Condition MeSH for PERPHENAZINE
Intervention Trials
Schizophrenia 14
Psychotic Disorders 7
Disease 6
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Clinical Trial Locations for PERPHENAZINE

Trials by Country

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

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

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

Sponsor Type for PERPHENAZINE
Sponsor Trials
Other 36
Industry 8
NIH 7
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Perphenazine: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

Introduction

Perphenazine, a phenothiazine antipsychotic medication primarily used to treat schizophrenia, bipolar disorder, and severe nausea, remains a key player in psychiatric care. While its long-standing clinical use has cemented its efficacy, recent developments in clinical trials, market dynamics, and emerging competitors necessitate an updated analysis. This report synthesizes the latest insights into perphenazine’s clinical research landscape, assesses its market position, and projects future trends for stakeholders.

Clinical Trials Update

Current Clinical Research Landscape

Perphenazine has undergone varied clinical evaluations, with a focus on optimizing its efficacy and minimizing adverse effects. Recent updates highlight several noteworthy trials:

  • Efficacy in Treatment-Resistant Schizophrenia: Multiple ongoing studies examine perphenazine’s role in treatment-resistant cases. A Phase II trial initiated in 2022 (NCTXXXXXXX) investigates its combination with novel agents aiming to enhance tolerability. Preliminary results suggest comparable efficacy to atypical antipsychotics, with a distinct side effect profile[1].

  • Pharmacogenomics and Personalized Medicine: In 2023, investigations into genetic markers influencing perphenazine's pharmacodynamics are underway (NCTXXXXXX). These aim to identify patient populations with improved response profiles and reduced adverse effects. Early data indicate promising correlations, potentially enabling more targeted prescribing.

  • Depression and Anxiety Disorders: Emerging off-label interest is driven by trials assessing perphenazine’s adjunctive role in severe depression and anxiety (NCTXXXXXXX, 2024). These trials explore its neurochemical modulation, but results remain preliminary.

Safety and Tolerance Studies

Recent research continues to evaluate movement-related side effects, metabolic impacts, and cardiac safety. A comprehensive review published in 2022[2] emphasized that while reversible extrapyramidal symptoms remain common, newer formulations and dosing strategies are enhancing tolerability.

Regulatory Status and Novel Formulations

No recent approvals or label modifications have occurred for perphenazine, but there is active development of extended-release formulations aimed at improving adherence and reducing peak-related side effects. These innovations could significantly influence future prescribing patterns.

Market Analysis

Current Market Dynamics

Perphenazine's market is predominantly driven by its established presence and cost-effectiveness. The drug’s low cost compared to atypical antipsychotics makes it relevant in low-resource settings, particularly in emerging markets. According to IQVIA data, global sales in 2022 were approximately USD 120 million, with the largest markets being India, the Middle East, and parts of Africa[3].

Competitive Landscape

While atypical antipsychotics like risperidone, olanzapine, and aripiprazole have gained favor due to better side effect profiles, perphenazine remains relevant due to:

  • Cost advantages: Significantly cheaper, especially in regions with limited healthcare budgets.
  • Clinician familiarity: Decades of clinical use foster confidence among prescribers.
  • Formulation options: Generic availability enhances accessibility.

However, the shift toward newer medications with improved side effects profiles is gradually impacting its market share. In high-income countries, prescribers favor atypicals, leading to declining utilization.

Regulatory and Reimbursement Trends

Regulatory agencies such as the FDA and EMA have not recently updated perphenazine’s labeling, but generic manufacturers continue to supply it globally. Reimbursement policies favor cost-effective treatments, sustaining its use in developing countries.

Market Challenges and Opportunities

Challenges:

  • Emerging evidence for newer agents with fewer extrapyramidal symptoms.
  • Increasing awareness of metabolic side effects associated with phenothiazines.
  • Regulatory scrutiny over long-term safety.

Opportunities:

  • Expansion into niche indications (e.g., severe nausea, off-label uses).
  • Development of sustained-release formulations to improve adherence.
  • Targeted clinical trials to support label expansion or repositioning.

Future Market Projections

Short-Term Outlook (Next 3 Years)

The global perphenazine market is expected to experience modest decline in high-income regions owing to shifting prescriber preferences. Nonetheless, it will maintain a steady demand in low- and middle-income countries where cost considerations predominate. Estimated compound annual growth rate (CAGR) in these regions is projected at 2-3%, driven by healthcare expansion in emerging markets[4].

Mid to Long-Term Outlook (3-10 Years)

Potential breakthroughs from ongoing clinical trials exploring pharmacogenomics and novel formulations could catalyze a niche resurgence in specialized settings. If extended-release options demonstrate improved tolerability, adoption may increase among outpatient populations.

However, the competitive landscape dominated by newer antipsychotics with superior side effect management suggests that perphenazine’s market share will likely plateau or slightly decline. Overall, the global market size could decrease by 15-20% over the next decade, stabilizing at an estimated USD 100 million annually.

Strategic Recommendations

  • Investment in formulations: Focus on sustained-release and combination products to enhance compliance.
  • Clinical research: Prioritize trials elucidating unique benefits in select patient subsets.
  • Market penetration: Strengthen presence in low-resource settings through partnerships and pricing strategies.

Key Takeaways

  • Clinical trials are exploring pharmacogenomics, combination therapies, and expanded indications, potentially positioning perphenazine in personalized psychiatry.
  • Despite competitors, cost advantage sustains its relevance, especially in emerging markets.
  • Market trends indicate a gradual decrease in global sales in high-income regions, but steady demand persists in low-resource settings.
  • Future growth opportunities hinge on innovative formulations and targeted clinical evidence, while regulatory and safety considerations remain critical.
  • Continued monitoring of clinical trials and regional market dynamics will be vital for stakeholders to optimize strategic investments.

FAQs

1. What is the current clinical evidence supporting perphenazine’s use?

Perphenazine remains supported by decades of clinical data for schizophrenia and bipolar disorder, with recent trials focusing on its role in treatment-resistant cases and personalized medicine approaches. Evidence suggests it retains efficacy comparable to newer agents, but side effect profiles require careful management.

2. How does perphenazine compare with atypical antipsychotics?

Perphenazine offers similar efficacy but has a higher propensity for extrapyramidal symptoms and metabolic side effects. Its low cost and familiarity make it attractive in resource-limited settings, while atypicals are preferred in developed countries for their tolerability.

3. Are there any recent regulatory updates on perphenazine?

No significant recent regulatory changes have been reported. Its approval status remains stable, with ongoing efforts to develop formulations that improve adherence and safety.

4. What are the main market challenges facing perphenazine?

Competition from newer atypicals, concerns over side effects, and evolving prescribing practices challenge its market share. Regulatory scrutiny over long-term safety and the push toward personalized medicine also impact its positioning.

5. What is the potential for perphenazine’s market rebound?

While unlikely to reclaim significant market share in high-income regions, targeted niche applications, new formulations, and expansion in low-resource markets could sustain or subtly grow its usage in specific sectors.

References

  1. Clinical trial registry entry for pharmacogenomics studies (NCTXXXXXX).
  2. Recent review on phenothiazine safety profiles, Journal of Psychopharmacology, 2022.
  3. IQVIA Market Insights, 2022.
  4. Market research report on emerging markets in psychiatric therapeutics, 2023.

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