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Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-.
CASRN: 19608-29-8
Drug Levels and Effects
Summary of Use during Lactation
No information is available on the clinical use of clascoterone during breastfeeding. However, because it is poorly absorbed from the skin and 84% to 89% protein bound, amounts in breastmilk are probably low and would not be expected to cause any adverse effects in breastfed infants. Avoid application to the nipple area and ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated.
Drug Levels
Maternal Levels. Relevant published information was not found as of the revision date.
Infant Levels. Relevant published information was not found as of the revision date.
Effects in Breastfed Infants
Relevant published information was not found as of the revision date.
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
Substance Identification
Substance Name
Clascoterone
CAS Registry Number
19608-29-8
Drug Class
Breast Feeding
Lactation
Milk, Human
Androgen Antagonists
Androgen Receptor Antagonists
Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.
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- Pharmacokinetic Profile, Safety, and Tolerability of Clascoterone (Cortexolone 17-alpha propionate, CB-03-01) Topical Cream, 1% in Subjects With Acne Vulgaris: An Open-Label Phase 2a Study.[J Drugs Dermatol. 2019]Pharmacokinetic Profile, Safety, and Tolerability of Clascoterone (Cortexolone 17-alpha propionate, CB-03-01) Topical Cream, 1% in Subjects With Acne Vulgaris: An Open-Label Phase 2a Study.Mazzetti A, Moro L, Gerloni M, Cartwright M. J Drugs Dermatol. 2019 Jun 1; 18(6):563.
- Evaluation of in vitro Skin Permeation of Clascoterone From Clascoterone Topical Cream, 1% (w/w).[AAPS PharmSciTech. 2024]Evaluation of in vitro Skin Permeation of Clascoterone From Clascoterone Topical Cream, 1% (w/w).Yang Y, Wang J, Wanasathop A, Niu M, Ghosh P, Zidan A, Gu J, Hunt R, Faustino P, Ashraf M, et al. AAPS PharmSciTech. 2024 Aug 13; 25(6):186. Epub 2024 Aug 13.
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- A Phase 1 Study to Investigate the Effects of Cortexolone 17α-Propionate, Also Known as Clascoterone, on the QT Interval Using the Meal Effect to Demonstrate ECG Assay Sensitivity.[Clin Pharmacol Drug Dev. 2021]A Phase 1 Study to Investigate the Effects of Cortexolone 17α-Propionate, Also Known as Clascoterone, on the QT Interval Using the Meal Effect to Demonstrate ECG Assay Sensitivity.Täubel J, Mazzetti A, Ferber G, Burch W, Fernandes S, Patel A, Spencer CS, Freier A, Graff C, Kanters JK, et al. Clin Pharmacol Drug Dev. 2021 Jun; 10(6):572-581. Epub 2021 May 3.
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