Product Description
Imiquimod is an immune response modifier commercially available as a 3.75 and 5% cream. Topical imiquimod stimulates the innate and adaptive immune responses and induces cytokine production. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/27387373/)
Mechanisms of Action: Immunomodulator,TLR7 Agonist,TLR8 Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Topical
FDA Designation: None *
Approval Status: Approved
Approved Countries: Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Basal Cell Carcinoma | Oncology Unspecified | Warts | Warts
Known Adverse Events: Headache | Erythema | Skin Ulcer | Edema | Pain Unspecified | Pruritus | Influenza, Human
Company: Graceway
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: France, Puerto Rico, United States
Active Clinical Trial Count: 8
Highest Development Phases
Phase 3: HIV Infections|Squamous Intraepithelial Lesions of the Cervix|Vulvar Cancer
Phase 2: Basal Cell Carcinoma|Hepatitis B|Inflammation|Keratosis, Actinic
Phase 1: Glioma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 2020PI198 | P2 |
Not yet recruiting |
Hepatitis B |
2026-08-07 |
|
| Phase I Trial | P1 |
Recruiting |
Glioma |
2025-09-15 |
27% |
| AMC-088 | P3 |
Completed |
HIV Infections|Squamous Intraepithelial Lesions of the Cervix |
2023-12-05 |
|
| 2021-005429-26 | P2 |
Completed |
Inflammation |
2022-03-25 |