Clascoterone (Winlevi®)

Pregnancy

The use of clascoterone is best avoided during pregnancy because there is no evidence from human studies that have investigated whether clascoterone use is safe during pregnancy or not.

Category: Not assigned yet

Category A

Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

Category B

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Category C

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category D

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category X

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Breastfeeding

Excreted into human milk: No data

There are no adequate studies that have tested the risk of topical clascoterone use during breastfeeding.

There is no data regarding the presence of clascoterone or clascoterone metabolites in human milk, nor the data about clascoterone effects on milk production. 

To prevent the potential risk of clascoterone on infant during breastfeeding, it is not advised to use clascoterone during this period until more data is available.