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 a topical small molecule treatment for actinic keratosis (AK), a skin condition involving rough, scaly lesions caused by sun damage. It is applied to the skin. Sol-Gel Technologies Ltd. is developing its own 5-FU cream referencing Efudex as the comparator product in a bioequivalence study.
Efudex is the reference 5-fluorouracil (5-FU) cream that Sol-Gel Technologies Ltd. (ticker: SLGL) used as the comparator in its Phase 3 bioequivalence study of the company's own 5-FU cream candidate for actinic keratosis. Sol-Gel Technologies is the developer of the candidate studied against Efudex.
Efudex is an established reference product, and the Sol-Gel Technologies 5-FU cream evaluated against it was studied in a Phase 3 trial. That Phase 3 bioequivalence study, NCT03727074, is completed. The trial enrolled 462 participants and was randomized, double-blind, and placebo-controlled.
Efudex was the comparator in one completed Phase 3 trial, NCT03727074, titled a bioequivalence study comparing Sol-Gel Technologies' 5-FU cream with Efudex (5-FU) cream. The trial enrolled 462 participants aged 18 years and older in the United States and studied actinic keratosis. It was randomized, double-blind, and placebo-controlled.
Yes. Efudex and Efudex® refer to the same product, a 5-fluorouracil (5-FU) cream. The registered trademark symbol is simply a notation of the brand name, so searches for either form point to the same topical 5-FU treatment used as the comparator in Sol-Gel Technologies' Phase 3 bioequivalence study.
Efudex is a branded topical 5-fluorouracil (5-FU) cream, a small molecule therapy in dermatology. It is used for actinic keratosis (AK). In Sol-Gel Technologies Ltd.'s Phase 3 program, Efudex served as the reference comparator in a completed bioequivalence study of the company's own 5-FU cream candidate.