Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Clascoterone
Clascoterone 1% · 2 trials · 1 indication
Percentage of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)" and at least a two-point reduction in IGA compared to Baseline.
Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.
Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.
Time to maximum plasma concentration
Maximum plasma concentration
Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration
Maximum plasma concentration at steady state
Minimum plasma concentration at steady state
| Arm | Type | Description |
|---|---|---|
| Clascoterone Cream 1% | EXPERIMENTAL | Clascoterone Cream 1% (Winlevi) |
| Vehicle cream | PLACEBO_COMPARATOR | Vehicle cream manufactured to mimic look and feel of Clascoterone Cream 1% but without the active ingredient. |
| Name | Type | Description |
|---|---|---|
| Clascoterone | DRUG | Clascoterone Cream 1% (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. |
| Vehicle cream | DRUG | Vehicle cream manufactured to mimic look and feel of Clascoterone Cream 1% but without the active ingredient. |
| Clascoterone Cream 1% | DRUG | Clascoterone Cream 1% (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. |
Inclusion Criteria: * Diagnosed with facial acne vulgaris (which includes the nose) from moderate to severe, has an Investigator's Global Assessment (IGA) score of 3 or 4; with at least 30 to a maximum of 75 inflammatory lesions (papules, pustules, and nodules) and 30 to a maximum of 100 non-inflam...
Clascoterone 1% is an investigational small molecule being developed for the treatment of acne vulgaris. It is applied as a cream and is currently in Phase 3 clinical development for this dermatological condition.
Clascoterone 1% is being developed by Sunshine Biopharma Inc., a company traded under the ticker SBFM. The drug is in Phase 3 clinical trials for acne vulgaris.
Clascoterone 1% is in Phase 3 clinical development for acne vulgaris. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study has been completed, and a Phase 3 trial is currently recruiting participants.
Clascoterone 1% is being studied in two clinical trials. NCT06403501 is a Phase 3, randomized, double-blind, placebo-controlled trial in 692 patients with facial acne vulgaris in China. NCT06454708 is a completed Phase 1 pharmacokinetics study in 12 healthy Chinese adults.
Yes, Clascoterone 1% is also known as Clascoterone. The 1% refers to the concentration of the active ingredient in the cream formulation being studied for acne vulgaris.