TheraRadar
Data updated: Jul 17, 2026

FLUPHENAZINE (fluphenazine decanoate) · QUAD PHARMS

Trial Activity: Declining
CNS

FLUPHENAZINE is FDA-approved to treat 1 condition (same as FLUPHENAZINE DECANOATE).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Technical University of Munich conducting 1 trials (25%)
9 indications explored (Moderate)
→ schizophrenia (2 trials)
→ schizophrenia and disorders with psychotic features (1 trials)
→ schizoaffective disorders (1 trials)

Details

Status
Discontinued
First Approved
N/A
Routes
Injection
Dosage Forms
Injectable

Companies

QUAD PHARMS
Active Ingredient: FLUPHENAZINE DECANOATE

FLUPHENAZINE Approval History

No approval records found

What FLUPHENAZINE Treats

1 indications

FLUPHENAZINE is approved for 1 conditions . These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as FLUPHENAZINE DECANOATE (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

4 trials
Trial Sponsor ID Phase Status Title
NCT02307396 1723/1-1 2013-000338-37, DO 1723/1-1 Ph 4 completed Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients
NCT02374567 GAP GAP-2014 Ph 3 terminated Pharmacovigilance in Gerontopsychiatric Patients
NCT00929578 FP-CL2 results posted FP-CL2 Ph 2 completed Fluphenazine Hydrochloride for Psoriasis
NCT02203786 HFDEX results posted 232-2009 Ph 2 completed D1 and D2 Dopamine Receptors in Gambling and Amphetamine Reinforcement
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

FLUPHENAZINE FDA Label Details

Indications & Usage

FLUPHENAZINE is FDA-approved to treat 1 condition — same approved indications as FLUPHENAZINE DECANOATE.

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Data Sources

FDA Approval: ANDA070762 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment