Last Updated: May 23, 2026

CLINICAL TRIALS PROFILE FOR TRILAFON


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All Clinical Trials for TRILAFON

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

Clinical Trial Conditions for TRILAFON

Condition Name

Condition Name for TRILAFON
Intervention Trials
Schizophrenia 2
Healthy 1
Hepatitis B 1
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Condition MeSH

Condition MeSH for TRILAFON
Intervention Trials
Schizophrenia 2
Herpes Simplex 1
Psychotic Disorders 1
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Clinical Trial Locations for TRILAFON

Trials by Country

Trials by Country for TRILAFON
Location Trials
United States 16
Sweden 1
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Trials by US State

Trials by US State for TRILAFON
Location Trials
Texas 2
Maryland 2
California 2
North Carolina 1
New York 1
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Clinical Trial Progress for TRILAFON

Clinical Trial Phase

Clinical Trial Phase for TRILAFON
Clinical Trial Phase Trials
Phase 4 2
Phase 2 1
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for TRILAFON
Clinical Trial Phase Trials
Completed 4
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Clinical Trial Sponsors for TRILAFON

Sponsor Name

Sponsor Name for TRILAFON
Sponsor Trials
University of Texas Southwestern Medical Center 1
Oclassen Pharmaceuticals 1
National Institute of Allergy and Infectious Diseases (NIAID) 1
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Sponsor Type

Sponsor Type for TRILAFON
Sponsor Trials
Industry 3
NIH 2
Other 1
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TRILAFON (Perphenazine): Clinical Trials Update, Market Analysis, and Projection

Last updated: May 6, 2026

What is TRILAFON and what is the current clinical-trials footprint?

TRILAFON is the brand name for perphenazine, a first-generation antipsychotic (typical antipsychotic). Perphenazine is used for psychiatric indications including schizophrenia and other psychotic disorders (labeling varies by jurisdiction and product version).

Clinical trials update (current, actionable): No complete, up-to-date, brand-specific clinical-trials program for TRILAFON perphenazine (new Phase 2/3 registrations or large-scale interventional studies) is identified from the material available in the cited sources. The publicly indexed trial landscape for perphenazine in recent years is dominated by older studies, comparator work, and limited observational or secondary analyses rather than new late-stage development tied to TRILAFON as a brand. (Sources: ClinicalTrials.gov search results and trial listings for “perphenazine” and “TRILAFON” are the primary check points, with FDA labeling as the product reference.)

Regulatory status anchor: The product is marketed as a conventional antipsychotic; clinical development intensity for the active ingredient has not shown the pattern typical of a late-stage, brand-driven program in the public registry record.

Market-relevant implication

Because TRILAFON/perphenazine is an established, off-patent molecule in most major markets, the near-term clinical-trials pipeline is usually not the dominant driver of growth. The market tends to be driven by:

  • Formulary access and contracting (generic substitution and payer policies)
  • Safety/tolerability positioning versus second-generation antipsychotics
  • Supply continuity and manufacturing economics for older formulations

What does the market look like for perphenazine/TRILAFON?

Perphenazine is widely available as a generic antipsychotic in many jurisdictions. As a result, brand-level dynamics typically diverge from molecule-level dynamics:

  • Molecule demand is supported by long-running use of first-generation antipsychotics where cost and formulary rules favor them.
  • Brand revenue is constrained by generic availability and tends to remain steady or decline unless there is payer- or system-level friction against generics (rare in mainstream settings).

Competitive structure

Direct competitive set for TRILAFON is not a single class entrant. It is a portfolio of:

  • Other first-generation antipsychotics (e.g., typicals used for cost-sensitive patients or specific payer pathways)
  • Second-generation antipsychotics (SGAs) where prescribers and payers favor lower EPS risk profiles

Demand driver vs substitution

The key market feature for perphenazine is substitution pressure:

  • When generics are on formulary, TRILAFON competes on availability, dosing convenience, and clinician familiarity, not on exclusivity.
  • Growth is more likely to come from limited switching windows (hospital protocols, psychiatric practice habits) than from switching at scale.

What is the revenue outlook for TRILAFON in 3 to 7 years?

Given generic competition and the lack of evidence for a brand-led late-stage program tied to TRILAFON/perphenazine in the public registry sources, projections must assume:

  • No new regulatory exclusivity from a brand-differentiating trial
  • Continued generic substitution pressure
  • Fragmented demand across reimbursement systems

Base-case directional forecast (non-binding, market-mechanics based):

  • Brand-level sales: low-growth to modest decline, with periodic stability depending on formulary placement and manufacturing/supply conditions.
  • Molecule-level demand: stable-to-slightly down in regions where SGAs dominate, but resilient in settings that retain typical antipsychotics for cost control.

Key scenario drivers

  1. Formulary tightening and generic penetration (most sensitive variable)
  2. Safety-positioning shifts in clinical practice (EPS burden vs SGA preference)
  3. Availability and supply continuity for older formulations (less predictable)

How do current safety and labeling constraints affect adoption?

Perphenazine carries the class-level safety profile of typical antipsychotics, including risks such as extrapyramidal symptoms and tardive dyskinesia. These risks influence clinician choice and payer pathway design, particularly in chronic psychiatric care.

Labeling reference point: TRILAFON prescribing information reflects the class’s safety framework and boxed warnings consistent with older antipsychotic labeling in jurisdictions that use consolidated warning language. (Source: FDA prescribing information for perphenazine brand labeling, where available in the cited record.)


What would change the projection materially?

The market projection would shift materially only if one of the following occurs:

  • A new, brand-linked regulatory event creates exclusivity (rare for an off-patent antipsychotic without a new indication, formulation breakthrough, or strategy that reaches regulatory thresholds)
  • A payer policy reverses typical antipsychotic substitution (uncommon given generic economics)
  • Clinical evidence supports a differentiated use-case that payers formalize into coverage criteria (would require modern trials with outcomes relevant to reimbursement)

Competitive benchmark: how TRILAFON typically performs versus SGAs

In practical payer dynamics:

  • SGAs often win for first-line coverage due to perceived tolerability.
  • Typical antipsychotics like perphenazine remain in pathways where cost is prioritized, or where prescribers accept EPS trade-offs with monitoring.

This means TRILAFON’s trajectory usually follows policy and cost more than it follows clinical breakthrough.


Business outlook

TRILAFON’s near-to-mid-term outlook is primarily a commercial and access story, not a clinical development story. Without a visible late-stage brand program in the public trial registry sources, the practical levers for brand performance are:

  • Contracting and formulary placement
  • Generic price compression and interchange rules
  • Inventory/supply reliability
  • Prescriber familiarity and institutional protocols

Key Takeaways

  • TRILAFON (perphenazine) is established and off-patent in most markets, which makes brand growth constrained by generic substitution.
  • Public clinical-trials registry visibility does not show a clear, brand-driven late-stage program tied to TRILAFON/perphenazine in the cited sources.
  • The 3 to 7 year outlook is most likely low-growth to modest decline at brand level, with stability possible where typical antipsychotics stay in formulary pathways.
  • Projection risk is dominated by payer policy, formulary access, and generic economics rather than by new clinical evidence.

FAQs

  1. Is TRILAFON currently in late-stage clinical development?
    Public trial registry records in the cited sources do not show a clear late-stage, brand-linked TRILAFON program.

  2. What drives TRILAFON demand more: clinical outcomes or reimbursement policy?
    For an established, generic-dominated antipsychotic, reimbursement and formulary access typically drive the commercial trajectory more than brand clinical differentiation.

  3. Does perphenazine face the same competition as other typical antipsychotics?
    Yes. It competes against both typical antipsychotics and SGAs, with payer pathways often determining which subgroup is covered preferentially.

  4. What safety factors most affect formulary preference?
    Class-level risks, especially EPS and tardive dyskinesia monitoring expectations, shape clinician and payer choice.

  5. What is the most realistic catalyst for a sales inflection?
    A regulatory exclusivity event tied to TRILAFON, or a payer pathway shift that formalizes typical antipsychotics as preferred options.


References

[1] ClinicalTrials.gov. (n.d.). Search results for perphenazine and TRILAFON. https://clinicaltrials.gov/
[2] U.S. Food and Drug Administration (FDA). (n.d.). Prescribing information and labeling references for perphenazine (TRILAFON brand where applicable). https://www.accessdata.fda.gov/

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