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.

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
Mexico	2
Israel	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 Market Analysis and Financial Projection

Last updated: April 28, 2026

Perphenazine: Clinical Trial Update, Market Analysis, and 5-Year Projection

Perphenazine is a first-generation (typical) antipsychotic with long-established use and no clear pattern of late-stage, sponsor-driven global expansion that would support a near-term “major pipeline rerating” thesis. Current clinical activity is largely consistent with repurposing/adjunct studies, bioequivalence work, and small-to-midsize academic or regional trials rather than global Phase 3 programs typical of “blockbuster” launches. In markets, perphenazine is constrained by aging patent status and competition from newer antipsychotics, but it retains niche demand in chronic schizophrenia and off-label uses, including nausea-related indications and psychiatric symptom management in settings where cost and formulary coverage dominate.

What clinical trials are active or recently reported for perphenazine?

Public trial reporting for perphenazine is fragmented and often occurs as: (1) smaller academic studies, (2) regional recruitment that does not translate into global Phase 3 headlines, and (3) formulation and exposure studies (bioequivalence, pharmacokinetics) rather than disease-modifying efficacy trials.

Clinical development signal (practical view for investors)

• No dominant, late-stage global Phase 3 signal that typically precedes major label expansion.
• Ongoing activity tends to be incremental (protocol refinements, adjunct comparisons, dosing strategies, and formulation-related work).
• Repurposing and supportive care appear more common than a full-scale new indication pathway in major registries.

What this means for near-term R&D value

• Without credible Phase 3 or registrational-comparable endpoints in major registries, the drug’s incremental clinical upside is more likely tied to label maintenance, optimized dosing, and generics lifecycle than to new-market creation.

How is perphenazine positioned in the global antipsychotic market?

Perphenazine’s market position is best framed as a cost-and-availability incumbent rather than an innovation-led franchise.

Market context

• Typical antipsychotics face headwinds versus second-generation agents due to tolerability, prescribing preferences, and guideline evolution.
• Perphenazine remains used where:
  • generic price pressure and formulary constraints are decisive
  • clinicians prefer older agents for efficacy/tolerability trade-offs
  • health systems require low-cost maintenance options for chronic psychosis
• Demand is also influenced by local supply, reimbursement rules, and generics switching dynamics.

Competitive structure (how perphenazine is actually competed)

• Second-generation antipsychotics dominate commercial growth historically, but they are priced at a level that makes payor-driven substitution plausible.
• Generic typical antipsychotics compete on price and availability, including chlorpromazine-like options and other older agents.
• Perphenazine competes as a “box” drug for chronic schizophrenia rather than a differentiated therapy.

IP and commercial constraint

• Perphenazine is off-patent in major markets.
• Growth, if any, comes from:
  • generics penetration (volume)
  • formulation differentiation (e.g., depot considerations are less relevant for perphenazine than for specific other agents)
  • local brand/generic arrangements
  • substitution within formularies

Where does perphenazine still have clinical and commercial pull?

Perphenazine demand persists due to three factors that are consistent with typical antipsychotic economics.

1. Chronic schizophrenia treatment needs

   • Maintenance use creates stable baseline volume in many countries.
   • Even with guideline shifts, real-world practice still includes older typical antipsychotics for some patient subgroups and payor settings.

2. Cost and formulary inclusion

   • In constrained reimbursement environments, perphenazine-like generics retain share through lower total therapy cost.

3. Supportive and off-label uses

   • Perphenazine is used in some settings for nausea or symptom control where clinicians accept the risk-benefit profile.

What is the 5-year market projection for perphenazine?

Given the drug’s mature status and the absence of a clear new-label, late-stage inflection, the most defensible projection framework is volume stability or modest decline offset by pricing-to-generic dynamics.

Projection framework used for planning

• Base case: stable-to-slightly declining volumes due to generics crowding and gradual substitution toward second-generation agents.
• Pricing effect: continued downward price pressure and margin compression in regions with intensified generics competition.
• Net effect: modest revenue erosion with potential pockets of resilience driven by formularies.

5-Year projection (directional revenue outlook)

Because perphenazine is generic in most jurisdictions, a “revenue” forecast is best interpreted as net sales in branded-equivalent and generics-inclusive terms under a typical commercial planning lens.

Period	Volume trend	Price trend	Net market value trend
2026	Slight decline	Down	Low single-digit decline
2027	Flat to slight decline	Down	Low single-digit decline
2028	Slight decline	Down	Mid single-digit decline
2029	Flat to slight decline	Down	Low-to-mid single-digit decline
2030	Slight decline	Down	Low single-digit decline

Projection interpretation for investors

• The upside case requires a structural trigger (regulatory expansion, payer-level preferences shifting back to typical antipsychotics, or a major supply disruption affecting competitors).
• Without such triggers, expected performance looks like a mature-generic asset: stable demand, declining unit economics.

What market scenarios should be modeled for investors and R&D operators?

Base case (most likely)

• Continued competition from second-generation antipsychotics.
• Perphenazine retains share in formularies with generic preference and in clinician practice pockets.
• Revenue growth stays negative or flat.

Bear case

• Faster substitution toward second-generation agents in guideline-following markets.
• Generic pricing compresses more aggressively.
• Supply interruptions reduce continuity in smaller markets.

Bull case

• Payor formularies tighten on cost and older typicals regain share.
• Niche label reinforcement or local regulatory actions expand allowable use for a supportive indication.
• Stable supply and efficient tendering improve availability and uptake.

What are the key strategic R&D angles that remain realistic for perphenazine?

With perphenazine itself largely mature, R&D value creation tends to concentrate in:

• Formulation work: improved dosing convenience, stability, and patient adherence.
• Comparative tolerability strategies: dose optimization and protocolized management of extrapyramidal symptoms.
• Niche clinical development: small trials supporting off-label or supportive uses where endpoints are pragmatic rather than blockbuster-style.

These paths typically generate limited high-multiple repricing unless they lead to a regulatory label expansion with a clear market-size impact.

How should businesses underwrite perphenazine exposure now?

If you are underwriting a generic or distributor business

• Model volume stability with pricing decay.
• Underwrite tender and supply chain continuity as primary risk drivers.
• Treat new clinical trials as secondary signals unless they map to reimbursement changes.

If you are underwriting a “pipeline” investor thesis

• Avoid late-stage blockbuster expectations.
• Price the asset as mature competitive positioning, unless a credible regulatory pathway appears in registries for a new indication.

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Key Takeaways

• Perphenazine’s clinical activity is consistent with incremental and smaller-scale studies rather than a clear global late-stage pivot to new registrational value.
• Commercially, perphenazine is positioned as a cost-and-availability incumbent in chronic psychosis management, constrained by typical antipsychotic market headwinds versus second-generation agents.
• A realistic 5-year view is stable-to-slightly declining volumes with continued price erosion, producing low-to-mid single-digit market value decline annually in the base case.

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FAQs

1) Is perphenazine currently seeing meaningful Phase 3 trials that could expand indications?
Clinical activity appears more consistent with incremental studies than with a dominant global Phase 3 expansion pattern.

2) What drives perphenazine sales if it is off-patent?
Formulary inclusion, generic availability, tender-driven pricing, and stable maintenance demand in chronic schizophrenia.

3) How does the market for perphenazine compare with second-generation antipsychotics?
Second-generation drugs tend to dominate growth due to guideline and tolerability preferences, pushing perphenazine into niche and cost-led share retention.

4) What is the most likely risk to perphenazine market value over the next 5 years?
Further generics price compression and continued substitution away from typical antipsychotics in payor-guided settings.

5) What R&D outcomes would change the investment outlook most?
A regulatory label expansion with sizable payer relevance or a clear new clinical endpoint pathway that supports broader adoption beyond existing niche use.

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References

[1] ClinicalTrials.gov. “Perphenazine” results (accessed 2026-04-28).
[2] FDA Orange Book (Drug Products and Therapeutic Equivalence Evaluations). Perphenazine listings (accessed 2026-04-28).
[3] WHO ATC/DDD Index. Perphenazine ATC information (accessed 2026-04-28).