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Topical Imiquimod
Topical Imiquimod is a TLR7 agonist Small molecule drug developed by Medical University of Vienna. It is currently in Phase 3 development for Actinic keratosis, Basal cell carcinoma, Genital warts. Also known as: Aldara®.
Imiquimod is a toll-like receptor 7 (TLR7) agonist that activates innate immune responses to enhance local antiviral and antitumor immunity.
Imiquimod is a small molecule that acts as a Toll-like receptor 7 agonist, classified as an agonist drug. It has been studied for various conditions, including photoaging, warts, basal cell carcinoma, and skin cancer, through clinical trials.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Topical Imiquimod |
|---|---|
| Also known as | Aldara® |
| Sponsor | Medical University of Vienna |
| Drug class | TLR7 agonist |
| Target | TLR7 (Toll-like receptor 7) |
| Modality | Small molecule |
| Therapeutic area | Dermatology/Oncology |
| Phase | Phase 3 |
Mechanism of action
Imiquimod binds to TLR7 on immune cells, triggering production of interferon-alpha and other pro-inflammatory cytokines. This stimulates both innate and adaptive immune responses, making it effective for treating viral skin lesions and certain skin cancers when applied topically. The local immune activation helps the body recognize and eliminate abnormal cells or viral pathogens.
Approved indications
- Actinic keratosis
- Basal cell carcinoma
- Genital warts
- Superficial skin lesions
Common side effects
- Local skin irritation (erythema, edema)
- Pruritus
- Erosion or ulceration at application site
- Systemic flu-like symptoms
Key clinical trials
- Topical Imiquimod Treatment of Oral Dysplasia (PHASE1, PHASE2)
- Basal Cell Carcinoma Chemoprevention Trial (PHASE3)
- A Study to Evaluate Neoadjuvant Sonidegib Followed by Surgery or Imiquimod in the Management of Basal Cell Carcinoma (PHASE2)
- Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects (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)
- Imiquimod, Fluorouracil, or Observation in Treating HIV-Positive Patients With High-Grade Anal Squamous Skin Lesions (PHASE3)
- Intralesional 5-Fluorouracil (5FU), Topical Calcipotriene Treatment for SCC (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:
- Topical Imiquimod CI brief — competitive landscape report
- Topical Imiquimod updates RSS · CI watch RSS
- Medical University of Vienna portfolio CI
Frequently asked questions about Topical Imiquimod
What is Topical Imiquimod?
How does Topical Imiquimod work?
What is Topical Imiquimod used for?
Who makes Topical Imiquimod?
Is Topical Imiquimod also known as anything else?
What drug class is Topical Imiquimod in?
What development phase is Topical Imiquimod in?
What are the side effects of Topical Imiquimod?
What does Topical Imiquimod target?
Related
- Drug class: All TLR7 agonist drugs
- Target: All drugs targeting TLR7 (Toll-like receptor 7)
- Manufacturer: Medical University of Vienna — full pipeline
- Therapeutic area: All drugs in Dermatology/Oncology
- Indication: Drugs for Actinic keratosis
- Indication: Drugs for Basal cell carcinoma
- Indication: Drugs for Genital warts
- Also known as: Aldara®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing