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Aldara (Imiquimod)
Aldara (Imiquimod) is a TLR7 agonist Small molecule drug developed by MEDA Pharma GmbH & Co. KG. It is currently in Phase 3 development for Genital warts (external), Actinic keratosis, Superficial basal cell carcinoma.
Imiquimod is a toll-like receptor 7 (TLR7) agonist that activates innate immune responses to treat viral infections and skin cancers.
Imiquimod is a toll-like receptor 7 (TLR7) agonist that activates innate immune responses to treat viral infections and skin cancers. Used for Genital warts (external), Actinic keratosis, Superficial basal cell carcinoma.
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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 | Aldara (Imiquimod) |
|---|---|
| Sponsor | MEDA Pharma GmbH & Co. KG |
| Drug class | TLR7 agonist |
| Target | TLR7 (Toll-like receptor 7) |
| Modality | Small molecule |
| Therapeutic area | Dermatology, Oncology, Immunology |
| Phase | Phase 3 |
Mechanism of action
Imiquimod binds to TLR7 on immune cells, triggering production of interferon-alpha and other cytokines that enhance antiviral and anti-tumor immunity. This immune activation helps the body's own defenses clear human papillomavirus (HPV) infections and eliminate abnormal skin cells. The drug is applied topically, concentrating immune stimulation at the site of lesions.
Approved indications
- Genital warts (external)
- Actinic keratosis
- Superficial basal cell carcinoma
Common side effects
- Local skin irritation (erythema, erosion)
- Pruritus
- Burning sensation
- Scabbing/crusting
- Flu-like symptoms
- Lymphadenopathy
Key clinical trials
- Imiquimod and Pembrolizumab in Treating Patients With Stage IIIB-IV Melanoma (EARLY_PHASE1)
- A Window of Opportunity Phase I Study of UGN-201 in Patients With Bladder Cancer Undergoing Radical Cystectomy Protocol #: 2021-0630 (PHASE1)
- Topical Imiquimod Treatment of Oral Dysplasia (PHASE1, PHASE2)
- Immunotherapy for Recurrent Ependymomas in Children Using Tumor Antigen Peptides With Imiquimod (PHASE1)
- Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer (PHASE1)
- Basal Cell Carcinoma Chemoprevention Trial (PHASE3)
- A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC) (PHASE1)
- A Study to Evaluate Neoadjuvant Sonidegib Followed by Surgery or Imiquimod in the Management of Basal Cell Carcinoma (PHASE2)
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) CI brief — competitive landscape report
- Aldara (Imiquimod) updates RSS · CI watch RSS
- MEDA Pharma GmbH & Co. KG portfolio CI
Frequently asked questions about Aldara (Imiquimod)
What is Aldara (Imiquimod)?
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Related
- Drug class: All TLR7 agonist drugs
- Target: All drugs targeting TLR7 (Toll-like receptor 7)
- Manufacturer: MEDA Pharma GmbH & Co. KG — full pipeline
- Therapeutic area: All drugs in Dermatology, Oncology, Immunology
- Indication: Drugs for Genital warts (external)
- Indication: Drugs for Actinic keratosis
- Indication: Drugs for Superficial basal cell carcinoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing