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Aldara (IMIQUIMOD)
Aldara works by activating the immune system to recognize and attack abnormal cells.
Aldara (Imiquimod) is a small molecule drug in the imiquimod class, originally developed by MEDICIS and currently owned by Bausch. It targets 7,8-dihydro-8-oxoguanine triphosphatase and was FDA approved in 1997 for the treatment of actinic keratosis, condyloma acuminatum, superficial basal cell carcinoma, and verruca. As an off-patent medication, Aldara is available from multiple generic manufacturers. Key safety considerations include local skin reactions and potential systemic effects. Aldara is a topical immunomodulator that works by stimulating the body's immune response to fight off viral and cancerous cells.
At a glance
| Generic name | IMIQUIMOD |
|---|---|
| Sponsor | Bausch Health |
| Drug class | imiquimod |
| Target | 7,8-dihydro-8-oxoguanine triphosphatase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1997 |
Mechanism of action
The mechanism of action of imiquimod cream in treating AK lesions is unknown.
Approved indications
- Actinic keratosis
- Condyloma acuminatum
- Superficial basal cell carcinoma
- Verruca
Common side effects
- Application Site Reaction
- Upper Respiratory Tract Infection
- Sinusitis
- Headache
- Carcinoma Squamous
- Diarrhea
- Eczema
- Back Pain
- Fatigue
- Fibrillation Atrial
- Infection Viral
- Dizziness
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)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 8236816 | 2029-12-11 | Method of Use |
| 8222270 | 2029-12-11 | Method of Use |
| 10238645 | 2029-08-18 | Method of Use |
| 8299109 | 2029-12-11 | Method of Use |
| 8598196 | 2029-08-18 | Method of Use |
| 11318130 | 2029-12-11 | Method of Use |
| 11202752 | 2030-04-30 | Method of Use |
| 10238644 | 2029-12-11 | Method of Use |
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Aldara CI brief — competitive landscape report
- Aldara updates RSS · CI watch RSS
- Bausch Health portfolio CI