HYDROXYZINE PAMOATE
Hydroxyzine pamoate is indicated for the symptomatic relief of anxiety and tension associated with psychoneurosis or as an adjunct in organic disease states where anxiety manifests. It is also indicated for the management of pruritus due to allergic conditions, including chronic urticaria, atopic and contact dermatoses, and histamine-mediated pruritus. Additionally, it is used as a sedative for premedication and following general anesthesia. The effectiveness of hydroxyzine for long-term use (exceeding 4 months) has not been systematically evaluated; therefore, its usefulness should be reassessed periodically for individual patients.
How HYDROXYZINE PAMOATE Works
Hydroxyzine is a first-generation antihistamine that acts as a potent H1-receptor inverse agonist. Its anxiolytic and sedative properties are attributed to its activity in the subcortical regions of the central nervous system, specifically the limbic system and reticular formation, rather than the cerebral cortex. Unlike many other anxiolytics, it does not possess affinity for GABA receptors. Additionally, hydroxyzine exhibits antagonistic effects at 5-HT2A, D2, and α1-adrenergic receptors, which may contribute to its clinical profile. It also possesses anticholinergic and antiemetic properties.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1981-12-14
- Routes
- ORAL
- Dosage Forms
- CAPSULE
Companies
HYDROXYZINE PAMOATE Approval History
What HYDROXYZINE PAMOATE Treats
6 indicationsHYDROXYZINE PAMOATE is approved for 6 conditions since its original approval in 1981. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anxiety
- Psychoneurosis
- Pruritus
- Urticaria
- Atopic Dermatitis
- Contact Dermatitis
HYDROXYZINE PAMOATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in HYDROXYZINE PAMOATE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications HYDROXYZINE PAMOATE treats. First-in-class if their pivotal trials read out positive.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
HYDROXYZINE PAMOATE FDA Label Details
Indications & Usage
HYDROXYZINE PAMOATE is indicated for the treatment of Anxiety; Psychoneurosis; Pruritus; Urticaria; Atopic Dermatitis; Contact Dermatitis.
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VISTARIL
Full clinical data, patents, trials, and competitive landscape for hydroxyzine pamoate.
Data Sources
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