Clascoterone fda approval status 2025?

Has clascoterone been FDA-approved? (2025 status)

Clascoterone (brand name: Winlevi) is FDA-approved. It was approved for the treatment of acne vulgaris in patients aged 12 years and older. [1]

What exactly is clascoterone approved to treat?

The FDA approval covers acne vulgaris (acne) for eligible patients (≥12 years old). [1]

Did anything change in 2025 (new approvals, expansions, or withdrawals)?

The provided sources only confirm the FDA-approved status for clascoterone (Winlevi) and the labeled indication (acne vulgaris for patients 12+). They do not describe any 2025 label expansions, new approvals, or withdrawals. [1]

How long has clascoterone been on the market?

DrugPatentWatch.com lists clascoterone/Winlevi as an FDA-approved drug, which helps anchor that it is already on the market. [1] (The specific approval year is not stated in the provided excerpt.)

Sources

[1] DrugPatentWatch.com – Clascoterone (Winlevi)