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Imiquimod 5% Topical Cream
Imiquimod is a toll-like receptor 7 (TLR7) agonist that activates innate immune responses to enhance local antiviral and antitumor immunity.
Imiquimod is a toll-like receptor 7 (TLR7) agonist that activates innate immune responses to enhance local antiviral and antitumor immunity. Used for Actinic keratosis, Basal cell carcinoma, Genital warts (external).
At a glance
| Generic name | Imiquimod 5% Topical Cream |
|---|---|
| Also known as | Aldara |
| Sponsor | University of Michigan |
| Drug class | Toll-like receptor 7 (TLR7) agonist |
| Target | TLR7 |
| Modality | Small molecule |
| Therapeutic area | Dermatology/Oncology |
| Phase | FDA-approved |
Mechanism of action
Imiquimod binds to TLR7 on immune cells, triggering the production of interferon-alpha and other pro-inflammatory cytokines. This activation enhances both innate and adaptive immune responses at the site of application, making it effective for treating viral infections and certain skin cancers by promoting immune-mediated clearance of abnormal cells.
Approved indications
- Actinic keratosis
- Basal cell carcinoma
- Genital warts (external)
- Superficial cutaneous lymphoma
Common side effects
- Local skin irritation (erythema, edema)
- Pruritus
- Erosion or ulceration
- Flu-like symptoms
- Lymphadenopathy
Key clinical trials
- Topical Imiquimod Treatment of Oral Dysplasia (PHASE1, PHASE2)
- Basal Cell Carcinoma Chemoprevention Trial (PHASE3)
- Cemiplimab Plus Imiquimod and Laser Therapy As Neoadjuvant Treatment In Cutaneous Basal Cell Carcinoma (PHASE1, PHASE2)
- A MultIceNTER Phase I Peptide VaCcine Trial for the Treatment of H3-Mutated Gliomas (PHASE1)
- Intralesional 5-Fluorouracil (5FU), Topical Calcipotriene Treatment for SCC (PHASE1)
- Investigating the Effect of Topical Imiquimod on Sebaceous Hyperplasia (PHASE4)
- Safety and Efficacy Study of SL-701, a Glioma-Associated Antigen Vaccine To Treat Recurrent Glioblastoma Multiforme (PHASE1, PHASE2)
- Neoadjuvant Imiquimod Immunotherapy for Oral Cancer (EARLY_PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Imiquimod 5% Topical Cream CI brief — competitive landscape report
- Imiquimod 5% Topical Cream updates RSS · CI watch RSS
- University of Michigan portfolio CI