Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Efudex · 1 trial · 1 indication
Proportion of subjects, in the Per-Protocol (PP) population, with treatment success, defined as complete clearing (100% clearance of all AK lesions within the designated treatment area) at the End of Study visit
| Arm | Type | Description |
|---|---|---|
| 5-FU Cream | EXPERIMENTAL | topical cream |
| Efudex® | ACTIVE_COMPARATOR | topical cream |
| Vehicle | PLACEBO_COMPARATOR | topical cream |
| Name | Type | Description |
|---|---|---|
| 5-FU Cream | DRUG | topical cream twice a day |
| Efudex® | DRUG | topical cream twice a day |
| Vehicle | DRUG | topical cream twice a day |
Inclusion Criteria: 1. Male and female 18 years of age and older. 2. Subject is able to understand and willing to sign Institutional Review Board (IRB) approved written informed consent for this study. 3. Subject must be generally healthy, based on medical records, and free from any clinically sign...
Efudex is used for the treatment of Actinic Keratosis (AK), a skin condition characterized by rough, scaly patches caused by sun damage. It is a topical cream being developed for this dermatological indication. The drug is currently in Phase 3 clinical development and is being studied in patients aged 18 years and older.
Efudex is being developed by Sol-Gel Technologies Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SLGL. The company is conducting clinical trials for this drug in the United States. Sol-Gel Technologies is focused on developing topical dermatological products.
Efudex is in Phase 3 clinical development for the treatment of Actinic Keratosis (AK). It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug is being evaluated for bioequivalence to a reference product.
Efudex has one completed Phase 3 clinical trial registered under NCT03727074. This was a randomized, double-blind, placebo-controlled bioequivalence study comparing Sol-Gel Technologies' 5-FU cream with Efudex (5-FU) cream in 462 participants with Actinic Keratosis. The trial was conducted in the United States.
Efudex is a 5-FU (fluorouracil) cream, and the clinical trial NCT03727074 was designed to compare Sol-Gel Technologies' 5-FU cream with Efudex (5-FU) cream for bioequivalence. This indicates that Efudex is a reference product containing 5-FU, and the investigational product is a generic version.