Drug updated on 5/17/2024

Dosage FormCream (topical; 1%)
Drug ClassAndrogen receptor inhibitors
Ongoing and
Completed Studies


  • Indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

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  • Clascoterone (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older, showing significant efficacy in improving acne severity and reducing non-inflammatory lesions.
  • The information was derived from a study that focused on the safety and effectiveness of clascoterone compared to placebo.
  • In terms of efficacy, clascoterone significantly increased rates of treatment success compared to placebo with a risk ratio (RR) being 2.87; it also showed substantial reductions in Noninflammatory Lesion Counts but did not show a statistically significant impact on Inflammatory Lesion Counts.
  • Regarding safety, there were no significant differences in the incidence of Treatment-emergent Adverse Events between the clascoterone and placebo groups, suggesting that this drug does not increase the risk of adverse events when compared to placebo.
  • The incidence rate for nasopharyngitis was lower among those treated with clascoterone, indicating a potential protective effect against this condition, which may distinguish it from other treatments for acne vulgaris.
  • The study's indication suggests applicability across both adolescent and adult populations suffering from acne vulgaris, although specific data on population types or subgroups was not explicitly mentioned.

Product Monograph / Prescribing Information

Document TitleYearSource
Winlevi (clascoterone) Prescribing Information.2021Sun Pharmaceutical Industries, Inc. Cranbury, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
Guidelines of care for the management of acne vulgaris.2024Journal of the American Academy of Dermatology