Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Imiquimod, 3.75% · 1 trial · 1 indication
The primary efficacy endpoint is the proportion of subjects with treatment success at Visit 5/Week 14 (8 weeks post-treatment). Treatment success is defined as 100% clearance of all AK lesions (baseline AK lesions and any new AK lesions) within the treatment area.
| Arm | Type | Description |
|---|---|---|
| Investigational Test Product | EXPERIMENTAL | Imiquimod Cream, 3.75% (Teva) |
| Reference Listed Drug | ACTIVE_COMPARATOR | Zyclara® (imiquimod Cream), 3.75% (Medicis) |
| Vehicle | PLACEBO_COMPARATOR | Vehicle of Test Product (Teva) |
| Name | Type | Description |
|---|---|---|
| Imiquimod Cream, 3.75% | DRUG | - |
| Zyclara® | DRUG | - |
| Vehicle of Test Product | OTHER | - |
Inclusion Criteria: * Willing and able to provide written informed consent for the study * At least 18 years of age. * Immunocompetent male or non-pregnant and non-lactating female. Each female subject of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at...
Imiquimod 3.75% is a small molecule used for the topical treatment of actinic keratosis, a skin condition characterized by rough, scaly patches caused by sun damage. It is applied directly to the affected areas of the skin. The drug is being developed by Teva Pharmaceutical Industries Limited and is currently in Phase 3 clinical development.
Imiquimod 3.75% is being developed by Teva Pharmaceutical Industries Limited, a company traded on the New York Stock Exchange under the ticker symbol TEVA. The drug is intended for the treatment of actinic keratosis and is currently in Phase 3 clinical development.
Imiquimod 3.75% is in Phase 3 clinical development for the treatment of actinic keratosis. It is an investigational drug and has not yet been approved by regulatory authorities. One Phase 3 clinical trial has been completed to evaluate its safety and efficacy.
Imiquimod 3.75% has been studied in one completed Phase 3 clinical trial, identified as NCT01686152. This randomized, double-blind, placebo-controlled study enrolled 589 participants with actinic keratosis in the United States. The trial compared Imiquimod 3.75% to Zyclara (imiquimod) cream 3.75% in the treatment of this condition.
Imiquimod 3.75% is being studied as a potential generic or alternative version of Zyclara (imiquimod) cream 3.75%. A Phase 3 clinical trial (NCT01686152) directly compared the two products in patients with actinic keratosis to assess their equivalence. The drug is not yet approved and remains investigational.