08/12/2025
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First New Hair Loss Drug in 30 Years Hits Major Milestone ❤️
The landscape of male pattern baldness (androgenetic alopecia) may change forever by 2027. Cosmo Pharmaceuticals has just released breaking Phase 3 topline results (Dec 3–5, 2025) for Clascoterone 5% solution (brand name Breezula), the first topical androgen receptor inhibitor designed to block DHT specifically at the scalp without systemic hormonal side effects.
The pivotal SCALP 1 and SCALP 2 trials reported statistically significant efficacy. Most notably, SCALP 1 showed a massive 539% relative improvement in Target-Area Hair Count (TAHC) compared to the placebo vehicle. It is critical to note this figure represents performance relative to the control group—who likely continued losing hair—rather than a total 500% increase in hair volume.
Currently, Cosmo is finalizing a mandatory 12-month safety review, due Spring 2026. If the safety profile holds, they will file for FDA and EMA approval immediately, placing the drug on track for a potential U.S. and European market launch by mid-2027.
References:
Cosmo Pharmaceuticals N.V. "Phase III Topline Results from SCALP 1 and SCALP 2 Trials for Clascoterone 5% Solution." Press Release, Dec 3, 2025.
ClinicalTrials.gov. "A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP 1 & 2)."
Dermatology Times. "Clascoterone 5% Delivers Strong Phase 3 Hair-Growth Results." Dec 4, 2025.
