TheraRadar
Data updated: May 26, 2026

PROLIXIN DECANOATE (fluphenazine decanoate)

Trial Activity: Declining
CNS Approved 1972-06-20
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)
1
Indication
--
Phase 3 Trials
53
Years on Market

Details

Status
Discontinued
First Approved
1972-06-20
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Bristol-Myers Squibb
Active Ingredient: FLUPHENAZINE DECANOATE

PROLIXIN DECANOATE Approval History

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Original
New Indication
New Form
Label Update
42 FDA actions from 1972 to 2009
Mar 2009 SUPPL
Label · Labeling
Oct 2002 SUPPL
Mfg · Manufacturing (CMC)
Sep 2001 SUPPL
Mfg · Manufacturing (CMC)

What PROLIXIN DECANOATE Treats

1 FDA approvals

Originally approved for its first indication in 1972 .

  • Other (1)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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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.

PROLIXIN DECANOATE FDA Label Details

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Data Sources

FDA Approval: NDA016727 → Patents: FDA Orange Book → 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