PLIAGLIS
Details
- Status
- Prescription
- First Approved
- 2006-06-29
- Routes
- TOPICAL
- Dosage Forms
- CREAM
PLIAGLIS Approval History
What PLIAGLIS Treats
6 indicationsPLIAGLIS is approved for 6 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
- Soreness
- Burning
- Itching
- Hemorrhoids
- Anorectal Discomfort
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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.
PLIAGLIS FDA Label Details
ProIndications & Usage
FDA Label (PDF)For the temporary relief of pain, soreness, and burning. Helps relieve the local itching and discomfort associated with hemorrhoids. Temporarily shrinks hemorrhoidal tissue. Temporarily provides a coating for the relief of anorectal discomforts. Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.