Is Clascoterone approved by the FDA?

Yes, clascoterone (Winlevi) is an FDA-approved topical cream for the treatment of acne vulgaris in patients aged 12 and older. Approved on August 26, 2020, it offers a novel mechanism of action by inhibiting androgen receptors in the skin, reducing oil production and inflammation associated with acne.

What is Clascoterone?

Clascoterone is a topical medication used for the treatment of acne vulgaris in individuals aged 12 and older. It is part of the drug class of topical acne agents and is applied directly to the skin in the form of a 1% cream.

How Clascoterone Works

Clascoterone works by blocking the effects of androgens (male hormones) on the skin's sebaceous (oil) glands. Androgens can increase oil production and inflammation, leading to acne. By inhibiting these hormones, clascoterone helps reduce acne lesions.

Administration and Dosage

Clascoterone is intended for topical use only and should not be ingested. The typical dosage involves applying a thin, uniform layer of the cream to the affected areas twice a day, once in the morning and once in the evening. It is important to follow the prescribed instructions carefully:

Wash your hands before and after applying the cream.
Clean the affected area with mild soap and water, then dry thoroughly.
Apply a small amount of the cream, rubbing it in gently.
Do not cover the treated skin with a bandage unless instructed by your doctor.

Potential Side Effects

Clascoterone can cause a range of side effects, from common to serious:

Common Side Effects:

Redness
Itching
Stinging or burning sensation
Swelling of treated skin
Dry or scaly skin

Serious Side Effects:

Severe itching, burning, peeling, or redness
High blood potassium levels (hyperkalemia)
Decreased adrenal gland hormones

If you experience any serious side effects, you should contact your doctor immediately.

Warnings and Precautions

Pregnancy and Breastfeeding: Consult your doctor if you are pregnant or breastfeeding.
Eczema or Skin Problems: Inform your doctor if you have a history of eczema or other skin conditions.
Avoidance: Do not apply clascoterone to open wounds, eczema-affected areas, or sunburned skin. Avoid getting the cream in your eyes, mouth, nose, vagina, or rectum.

How to obtain the latest development progress of all drugs?

In the Synapse database, you can stay updated on the latest research and development advances of all drugs. This service is accessible anytime and anywhere, with updates available daily or weekly. Use the "Set Alert" function to stay informed. Click on the image below to embark on a brand new journey of drug discovery!