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Imiquimod

Alternative Names: imiquimod, aldara, zyclara, tmx-101
Latest Update: 2024-07-02
Latest Update Note: News Article

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

Map of Global Clinical Trials for Imiquimod

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

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