Mode of action

IN-VITRO PROPOSED MOA OF WINLEVI®

WINLEVI® is a novel androgen receptor inhibitor that when applied topically appears to target androgen receptors in the pilosebaceous unit.1,2,13

Proposed mode of action

The exact mechanism of action of clascoterone for the topical treatment of acne vulgaris is not fully characterised. In vitro findings may not accurately reflect in vivo phenomena.

Compete

Within the skin, clascoterone binds to androgen receptors, competing with the binding of androgens such as DHT.1

Inhibit

In-vitro studies suggest this inhibits the action of androgen receptors on cells in the sebaceous gland.1

Reduce

This allows to reduce sebum production and inflammation.1

 

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Indication

WINLEVI® (clascoterone) 10 mg/g cream is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.3

Adverse event reporting

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Glenmark Pharmaceuticals Europe Ltd medical_information@glenmarkpharma.com or call 0800 458 0383.

References

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See yellowcard.mhra.gov.uk for how to report side effects.

 

  1. Kurokawa I, et al. Dermatol Ther (Heidelb). 2021;11(4):1129-1139.
  2. Tuchayi S, et al. Acne vulgaris. Nat Rev Dis Primers. 2015; 1:15029.
  3. WINLEVI® SPC
  4. Piszczatoski CR, Powell J. Clin Ther. 2021;43(10):1638-1644.
  5. Rosette C, et al. J Drugs Dermatol. 2019;18(5):412-418.
  6. Eichenfield LF, et al. J Drugs Dermatol. 2024;23(1):1278-1283.
  7. Purdy S, DeBerker D. BMJ Clin Evid. 2008;1714.
  8. Zouboulis CC, Bettoli V. Br J Dermatol. 2015;Suppl 1:27-36.
  9. ONS. Estimates of the population for the UK, England, Wales, Scotland and Northern Ireland. Accessed 27 June 2024. https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/datasets/populationestimatesforukenglandandwalesscotlandandnorthernireland.
  10. Primary Care Dermatology Society. Acne: acne vulgaris. Accessed 27 June 2024. https://www.pcds.org.uk/clinical-guidance/acne-vulgaris.
  11. Dawson AL, et al. BMJ. 2013;346:f2634.
  12. Layton AM, Thiboutot D, Tan J. Br J Dermatol. 2021;184(2):219-225.
  13. Morshed ASM, et al. Sci Rep. 2023; 13: 21084.
  14. Baldwin, H et al. J Drugs Dermatol. 2023;22(6):582-587.
  15. Del Rosso JQ, Kircik L. J Dermatolog Treat. 2024;35(1):2298878.
  16. Kim HJ, et al. Int J Mol Sci. 2024;25(10):5302.
  17. Hebert A, et al. J Drugs Dermatol. 2023;22(2):174-181.
  18. Hebert A, et al. JAMA Dermatology. 2020;156(6):621–630
  19. Abelson MB, Fink K. (2003). Controlling for the Placebo Effect. Review of Ophthalmology. Accessed 17 October 2024. https://www.reviewofophthalmology.com/article/controlling-for-the-placebo-effect.
  20. Hebert A, et al. JAMA Dermatology. 2020;156(6):621–630 (Supplement 1).
  21. Shergill M, et al. Dermatol Ther (Heidelb). 2024;14:1093–1102.
  22. Eichenfield L, et al. J Am Acad Dermatol. 2020;83(2):477-485.
  23. Mazzetti A, et al. J Drugs Dermatol. 2019;18(6):563.
  24. NICE Clinical Knowledge Summary WINLEVI®

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