Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
S6G5T-3 · 4 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)" and achieving an acne severity IGA score of at least 2 grades less than Baseline.
Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.
Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA at Week 12
Absolute change from Baseline in lesion count on the face at Week 12 (separately for inflammatory and non-inflammatory lesions)
The degree of systemic exposure of S6G5T-3 compared to the Reference Listed Drug (RLD) when applied topically once daily for 14 days, under maximal use conditions in subjects with acne vulgaris. Cmax = Maximum plasma concentration will be calculated
| Arm | Type | Description |
|---|---|---|
| S6G5T-3 | EXPERIMENTAL | Participants will topically apply S6G5T-3 cream, once daily to face for 12 weeks. |
| S6G5T-8 Vehicle Cream | PLACEBO_COMPARATOR | Participants will topically apply S6G5T-8 vehicle cream, once daily to face for 12 weeks. |
| S6G5T-1 | EXPERIMENTAL | topical cream |
| S6G5T-5 | ACTIVE_COMPARATOR | topical cream |
| S6G5T-7 | ACTIVE_COMPARATOR | topical cream |
| S6G5T-6 | ACTIVE_COMPARATOR | topical cream |
| S6G5T-8 | PLACEBO_COMPARATOR | topical cream |
| Retin-A® 0.1% Cream | ACTIVE_COMPARATOR | topical cream |
| Name | Type | Description |
|---|---|---|
| S6G5T-3 | DRUG | Once a day topical cream |
| S6G5T-8 | DRUG | Once a day topical cream |
| S6G5T-1 | DRUG | once a day topical cream |
| S6G5T-5 | DRUG | once a day topical cream |
| S6G5T-6 | DRUG | once a day topical cream |
| S6G5T-7 | DRUG | once a day topical cream |
| Retin-A® 0.1% Cream | DRUG | once daily |
Inclusion Criteria: 1. Participant must sign an Institutional Review Board (IRB) approved written informed consent for this study. 2. Male and female 9 years of age and older. 3. Have 2 or fewer cysts or nodules. Exclusion Criteria: 1. More than 2 acne nodules or cysts (defined as an inflammatory...
S6G5T-3 is an investigational small molecule being developed for the treatment of acne vulgaris. It is a topical dermatology product studied in patients aged 9 years and older. The drug is currently in Phase 3 clinical development and is not yet approved by the FDA.
S6G5T-3 is being developed by Sol-Gel Technologies Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker SLGL. The company is conducting clinical trials for this dermatology asset in the United States.
S6G5T-3 is in Phase 3 clinical development for acne vulgaris. It has completed two Phase 3 trials, one Phase 2 trial, and one Phase 1 trial. The drug remains investigational and has not received FDA approval.
S6G5T-3 has completed four clinical trials in the United States. These include NCT02661958 (Phase 2, 726 patients), NCT03761784 (Phase 3, 424 patients), NCT03761810 (Phase 3, 434 patients), and NCT04059523 (Phase 1, 62 patients). All trials studied the drug in acne vulgaris.
No, S6G5T-3 is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for acne vulgaris. The drug has completed clinical trials but has not yet received regulatory approval for marketing.
S6G5T-3 is a small molecule developed for topical treatment of acne vulgaris. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being evaluated for efficacy, safety, and tolerability in patients aged 9 years and older.