TheraRadar
Data updated: May 26, 2026

VISTARIL (hydroxyzine pamoate)

Trial Activity: Mature 1 active trials
CNS Approved 1957-09-18
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

University of Washington conducting 1 trials (17%)
15 indications explored (Broad Platform)
→ dental caries in children (1 trials)
→ pediatric dental sedation (1 trials)
→ meperidine (1 trials)
3
Indications
--
Phase 3 Trials
68
Years on Market

Details

Status
Discontinued
First Approved
1957-09-18
Routes
ORAL, INJECTION
Dosage Forms
CAPSULE, INJECTABLE, SUSPENSION

Companies

Pfizer
Active Ingredient: HYDROXYZINE PAMOATE

VISTARIL Approval History

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Original
New Indication
New Form
Label Update
55 FDA actions from 1957 to 2016
Nov 2016 SUPPL
Label · Labeling
FDA Letter Label
Feb 2016 SUPPL
Label · Labeling
FDA Letter Label
Jun 2014 SUPPL
Label · Labeling
FDA Letter Label

What VISTARIL Treats

3 FDA approvals

Originally approved for its first indication in 1957 . Covers 3 distinct patient populations.

  • Other (3)
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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.

VISTARIL FDA Label Details

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Data Sources

FDA Approval: NDA011459 → 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