IMIQUIMOD
Details
- Status
- Prescription
- First Approved
- 2010-02-25
- Routes
- TOPICAL
- Dosage Forms
- CREAM
IMIQUIMOD Approval History
What IMIQUIMOD Treats
4 indicationsIMIQUIMOD is approved for 4 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Actinic Keratosis
- Basal Cell Carcinoma
- External Genital Warts
- Perianal Warts
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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.
IMIQUIMOD FDA Label Details
ProIndications & Usage
Imiquimod Cream is indicated for the topical treatment of: • Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AK) on the face or scalp in immunocompetent adults. • Biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults with a maximum tumor diameter of 2.0 cm on trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured. • External genital and perianal warts (EGW) in immunocompetent patients 12 years of a...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.