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Zyclara®
Zyclara is an imiquimod cream that activates toll-like receptors (TLR7 and TLR8) on immune cells to stimulate local and systemic immune responses against skin lesions.
Zyclara is an imiquimod cream that activates toll-like receptors (TLR7 and TLR8) on immune cells to stimulate local and systemic immune responses against skin lesions. Used for Actinic keratosis, Basal cell carcinoma (superficial and nodular), Cutaneous melanoma metastases.
At a glance
| Generic name | Zyclara® |
|---|---|
| Also known as | Imiquimod Cream (generic name) |
| Sponsor | Actavis Inc. |
| Drug class | Toll-like receptor agonist |
| Target | TLR7, TLR8 |
| Modality | Small molecule |
| Therapeutic area | Dermatology/Oncology |
| Phase | FDA-approved |
Mechanism of action
Imiquimod is a synthetic toll-like receptor agonist that enhances innate and adaptive immune responses by activating dendritic cells and other immune cells in the skin. This leads to increased production of interferon-alpha and other cytokines, promoting clearance of abnormal skin cells and viral infections. The topical formulation allows direct application to affected skin areas.
Approved indications
- Actinic keratosis
- Basal cell carcinoma (superficial and nodular)
- Cutaneous melanoma metastases
Common side effects
- Local skin irritation (erythema, erosion, flaking)
- Pruritus
- Burning sensation
- Scabbing/crusting
- Flu-like symptoms (systemic)
Key clinical trials
- A MultIceNTER Phase I Peptide VaCcine Trial for the Treatment of H3-Mutated Gliomas (PHASE1)
- Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5% (PHASE4)
- Deep Phenotyping of Cutaneous Lupus Erythematosus (NA)
- iVAC-CLL01: Patient-individualized Peptide Vaccination After First Line Therapy of CLL (PHASE2)
- Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses (LEIDA 2) (PHASE4)
- Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses (PHASE4)
- Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis (PHASE3)
- Cyclophosphamide, TAPA-Pulsed Dendritic Cell Therapy and Imiquimod in Progressive and/or Refractory Solid Malignancies (PHASE1, 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:
- Zyclara® CI brief — competitive landscape report
- Zyclara® updates RSS · CI watch RSS
- Actavis Inc. portfolio CI