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Aldara (imiquimod) cream, 5%
Imiquimod is a toll-like receptor 7 (TLR7) agonist that activates innate immune responses to treat skin lesions and certain cancers.
Imiquimod is a toll-like receptor 7 (TLR7) agonist that activates innate immune responses to treat skin lesions and certain cancers. Used for Actinic keratosis, Basal cell carcinoma (superficial and nodular), Genital warts (external).
At a glance
| Generic name | Aldara (imiquimod) cream, 5% |
|---|---|
| Sponsor | Graceway Pharmaceuticals, LLC |
| Drug class | TLR7 agonist |
| Target | TLR7 (Toll-like receptor 7) |
| Modality | Small molecule |
| Therapeutic area | Oncology, Dermatology, Immunology |
| Phase | FDA-approved |
Mechanism of action
Imiquimod binds to TLR7 on immune cells, triggering the production of interferon-alpha and other cytokines that enhance local immune activation. This stimulates both innate and adaptive immune responses against abnormal cells, making it effective for treating actinic keratosis, basal cell carcinoma, and genital warts when applied topically.
Approved indications
- Actinic keratosis
- Basal cell carcinoma (superficial and nodular)
- Genital warts (external)
Common side effects
- Local skin irritation (erythema, erosion, excoriation)
- Pruritus
- Burning sensation
- Flaking/scaling
- Systemic flu-like symptoms
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)
- A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors (PHASE1)
- Intralesional 5-Fluorouracil (5FU), Topical Calcipotriene Treatment for SCC (PHASE1)
- Combination Therapy of Imiquimod 5%Cream and Cryotherapy vs Monotherapy for Common Warts:Randomized Comparative Trial.
- Investigating the Effect of Topical Imiquimod on Sebaceous Hyperplasia (PHASE4)
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:
- Aldara (imiquimod) cream, 5% CI brief — competitive landscape report
- Aldara (imiquimod) cream, 5% updates RSS · CI watch RSS
- Graceway Pharmaceuticals, LLC portfolio CI