Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
S5G4T-1 · 2 trials · 1 indication
Percentage of participants in each treatment group achieving an acne severity IGA score of "clear (score=0)" or "almost clear (score=1)". Please note, the Percentage of Participants multiplied by the Overall Number of Participants Analyzed does not equal a whole number because missing efficacy data was based on estimation using the method of Markov Chain Monte Carlo (MCMC) imputation.
Inflammatory lesions were characterized as papules and pustules. A papule was defined as a solid, elevated inflammatory lesion equal to or less than 5 mm in diameter. A pustule was defined as an elevated inflammatory lesion equal to or less than 5 mm in diameter and contains pus (yellow-white exudate). Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment, analysis center and treatment by analysis center interaction and the Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
| Arm | Type | Description |
|---|---|---|
| S5G4T-1 | EXPERIMENTAL | Participants will topically apply S5G4T-1 cream, once daily to face for 12 weeks. |
| S5G4T-2 Vehicle Cream | PLACEBO_COMPARATOR | Participants will topically apply S5G4T-2 vehicle cream, once daily to face for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| S5G4T-1 | DRUG | Once a day topical cream |
| S5G4T-2 | DRUG | Once a day topical cream |
Inclusion Criteria: 1. Participants must sign an Institutional Review Board (IRB) approved written informed consent for this study. 2. Male and female 18 years of age and older. 3. Participants must have clinical diagnosis of moderate to severe rosacea. 4. Have a minimum total of 15 and a maximum o...
S5G4T-1 is an investigational small molecule being developed for the treatment of papulopustular rosacea, a dermatologic condition characterized by redness and pustules on the face. It is currently in Phase 3 clinical development and has not been approved by the FDA.
S5G4T-1 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.
S5G4T-1 is in Phase 3 clinical development for papulopustular rosacea. Two Phase 3 trials have been completed, but the drug remains investigational and has not received FDA approval.
S5G4T-1 has been studied in two completed Phase 3 trials: NCT03448939, which enrolled 361 participants, and NCT03564119, which enrolled 372 participants. Both trials were randomized, double-blind, placebo-controlled studies conducted in the United States.
No alternative names for S5G4T-1 have been disclosed. The drug is identified solely by its code name S5G4T-1 in clinical trial registrations and by the developer Sol-Gel Technologies.