EMA is re-examining Winlevi (clascoterone at lower concentration) Treatment 7/1/2025
Clascoterone in Winlevi, a topical AR antagonist, is being re-examined due to concerns about HPA axis suppression in adolescents, but it's unlikely to be banned for adult use in androgenetic alopecia (AGA). The European Medicines Agency recommended refusing Winlevi for acne vulgaris, but this may not affect Breezula's approval for AGA.
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The conversation discusses the progress of Clascoterone (Breezula) for hair loss treatment, noting that COVID-19 delayed female trials by three months but Phase III trials for males are proceeding with a Special Protocol Assessment filed with the FDA. Users express hope for Breezula as an alternative to existing treatments like finasteride and minoxidil, despite concerns about its potential high cost.
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research Topical Antiandrogen Therapies for Androgenetic Alopecia and Acne Vulgaris
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