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.

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
Alzheimer Disease	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 Clinical Trials Update, Market Analysis and Generic/Biosimilar Exclusivity Outlook (2026)

Last updated: July 27, 2026

What is perphenazine and what clinical trials are active in 2026?

Perphenazine is a first-generation (typical) antipsychotic in the phenothiazine class. It is marketed in multiple countries as an oral agent (tablets) and, in some markets, as an injectable product. In the US, perphenazine products are largely mature and compete in a generic-heavy environment.

Clinical-trials visibility in 2026 Public registries typically show perphenazine trials as limited and uneven in US-centric volume, often focused on:

• schizophrenia symptom control comparisons vs. other antipsychotics
• short-course studies (tolerability, dose finding) in adult populations
• supportive care and antiemetic off-label evaluations

Featured snippet answer: In 2026, perphenazine clinical-trials activity is generally low versus newer antipsychotics, with studies that are more likely to be comparative or formulation/tolerability oriented than new mechanism development.

Which study types drive recent perphenazine trials?

• Comparative efficacy/safety against other typical antipsychotics
• Dose-ranging or switching studies for tolerability and adherence
• Anti-emetic/off-label trials (where sponsors run dedicated assessments)
• Formulation work (bioavailability or excipient/strength changes)

Where are trials typically run and who sponsors them?

Perphenazine trials are usually sponsored by:

• generic or formulation developers (bioequivalence style)
• academic groups conducting real-world comparative research
• regionally based clinical networks in countries where perphenazine remains standard of care for selected indications

Is perphenazine approved in the US and what is its FDA regulatory status?

US status: Perphenazine is an FDA-regulated drug with listed products that are largely generic. The clinical usefulness has been maintained by long-standing prescribing in psychiatry and off-label use in some settings.

Featured snippet answer: Perphenazine is an FDA-approved antipsychotic with an Orange Book footprint dominated by generics rather than ongoing brand exclusivities.

What do Orange Book listings typically show for perphenazine?

Perphenazine entries, where present, usually include:

• multiple applicant holders for tablets and possibly injectable forms
• patent listings that are historical and frequently expired for older products
• limited remaining regulatory exclusivity given the drug’s age

When does perphenazine lose exclusivity and what patent expirations matter?

Because perphenazine is an established, off-patent small molecule, the practical exclusivity question is less about brand-managed extension and more about whether any specific marketed product configuration still has protection (formulation, method-of-manufacture, or a “newer” branded label in a particular geography).

Featured snippet answer: For perphenazine broadly, exclusivity is effectively long expired in most jurisdictions; remaining IP risk is mostly product-specific and formulation-specific, not platform-typical.

How to think about “loss of exclusivity” for perphenazine

• If a particular applicant’s product has older patents already expired, generics can launch with minimal patent friction.
• If a product has late-expiring formulation or method patents (rare for this class in current years), a generic entry can be delayed pending clearance.

How many patents cover perphenazine and what is the strength of the patent estate?

For an established typical antipsychotic like perphenazine, the patent estate is usually:

• fragmented across older composition-of-matter and formulation families
• dominated by expirations across priority dates from decades past
• not concentrated in a single active “core” family for the active ingredient itself

Featured snippet answer: Patent coverage for perphenazine is mostly legacy and limited in practical strength today for blocking oral generic competition.

What patent types remain relevant in 2026?

• Formulation patents tied to specific excipient systems or controlled dissolution profiles
• Manufacturing process patents tied to specific steps or impurity controls
• Method-of-use patents for a narrow labeled use are less common for this drug class today

What patent litigation affects perphenazine generic entry risk?

In late-stage “risk mapping,” perphenazine typically shows:

• few high-profile modern disputes relative to current blockbuster molecules
• any litigation that does occur tends to be product-specific and tied to an individual applicant’s patents rather than a broad active-ingredient lockout

Featured snippet answer: Generic entry risk for perphenazine is generally low at the active-ingredient level due to long-off-patent status; any risk is localized to specific listed patents for a particular marketed product.

What is the Paragraph IV challenge landscape for perphenazine?

Given the long history and small molecule generics ecosystem, Paragraph IV filings are usually not a major feature for perphenazine in the same way they are for late-life branded biologics and newer small molecules.

Featured snippet answer: Paragraph IV activity is not typically a defining commercial driver for perphenazine.

What formulations and dosage forms of perphenazine are marketed and protected?

Commonly marketed forms include:

• Oral tablets in multiple strengths
• Oral formulations vary by country and manufacturer
• Injectable forms can exist depending on market history and supply contracts

Protection, where it exists, is usually tied to:

• excipient systems
• tablet compression/manufacturing processes
• specific strength/package configurations

How does perphenazine compare with other typical antipsychotics for market positioning?

Perphenazine competes primarily with other typical antipsychotics such as:

• chlorpromazine
• trifluoperazine
• fluphenazine
• haloperidol (often stronger modern uptake in some clinical workflows)

Featured snippet answer: In procurement and formularies, perphenazine’s market share is driven by cost, hospital formulary history, and clinician familiarity rather than differentiation from a protected IP position.

Key differentiators influencing uptake

• side-effect profile tolerability and prescriber preference
• dosing convenience and tablet strength availability
• supply continuity and wholesaler pricing
• local guideline familiarity

Perphenazine market size, regional demand drivers and revenue exposure (2020–2026)

Perphenazine’s commercial footprint is best modeled as a mature generic category with:

• fragmented suppliers
• pricing compression over time
• dependence on institutional purchasing and off-label prescribing patterns

Featured snippet answer: Market revenue is mainly a function of low-cost volume and institutional substitution within typical antipsychotic classes, not premium pricing.

Demand drivers

• psychiatric inpatient formularies
• short-term acute stabilization use in systems where typicals are standard
• affordability and stock availability in cost-constrained settings
• country-specific reimbursement policies

Revenue exposure by stakeholder type

• Generic manufacturers: exposure is high to price competition and tender wins
• Wholesalers/distributors: exposure is high to supply chain stability and low margin spread
• API holders: exposure ties to volume stability rather than patent protection

Commercial projection: how will perphenazine evolve through 2030?

A realistic projection for perphenazine category economics to 2030 is:

• continued price pressure
• incremental volume growth where prescribing persists in public systems
• limited upside from new IP-linked premium launches

Featured snippet answer: Through 2030, perphenazine is projected to remain a low-to-mid single digit growth generic basket at best, with revenue broadly capped by generic pricing dynamics.

Base case projection structure

• Volume: modest growth if reimbursement and formulary access remain stable
• Price: likely downward or flat in competitive tenders
• Supplier churn: consolidation pressures for higher-cost manufacturing routes

Bull and bear cases

• Bull case: stable procurement for typical antipsychotics in inpatient care plus supply continuity
• Bear case: formulary substitution toward atypicals and haloperidol reduces typical usage in some geographies

What generic entry risks exist for perphenazine tablets and injectable products?

For mature generics, entry risks concentrate on:

• quality/inspection outcomes
• manufacturing scale-up and process validation
• localized patent listings that may remain in force for specific product configurations

Featured snippet answer: The active-ingredient level risk is low; the dominant risks are regulatory and manufacturing, not patent exclusivity.

Manufacturing and regulatory barriers that matter commercially

• FDA facility compliance history and batch consistency
• impurity control and stability profiles for specific strengths
• bioequivalence study burden where required

Key takeaways

• Perphenazine is a mature typical antipsychotic with limited modern clinical-trials visibility and a generic-dominated commercial structure.
• US exclusivity is effectively historical at the active-ingredient level; any IP friction is product-specific and typically formulation or manufacturing based.
• Patent litigation and Paragraph IV risk are not usually major determinants for perphenazine entry compared with newer branded drugs.
• Commercial outlook through 2030 is constrained by generic price compression, with upside tied mainly to institutional procurement continuity and volume stability rather than premium IP.

FAQs

1. Is perphenazine used as an antiemetic and does that drive clinical trials?
2. How does perphenazine’s side-effect profile compare with haloperidol for inpatient use?
3. Do Orange Book patents typically block perphenazine generics, or are they mostly expired?
4. What manufacturing quality factors most often affect generic launches for older antipsychotics?
5. Which countries still prescribe perphenazine heavily versus atypical antipsychotics?

References

1. U.S. Food and Drug Administration (FDA). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
2. U.S. National Library of Medicine. ClinicalTrials.gov. https://clinicaltrials.gov/