New Phase III Data for Breezula® (Clascoterone) Shows Strong Hair-Count Gains and Robust Safety in Androgenetic Alopecia Trials

FOR IMMEDIATE RELEASE

December 4, 2025

HEADLINE

New Phase III Data for Breezula® (Clascoterone) Shows Strong Hair-Count Gains and Robust Safety in Androgenetic Alopecia Trials

SUMMARY

Topical androgen receptor inhibitor Breezula® (clascoterone 5% solution) has met its co-primary endpoints in two Phase III trials, showing substantial improvements in scalp hair count over vehicle — raising hopes for a new non-systemic therapy for pattern hair loss. New York hair-loss specialist Dr. Dennis Porto comments on the promising data and what it could mean for patients.

BACKGROUND: ANDROGENETIC ALOPECIA AND LIMITATIONS OF CURRENT THERAPIES

Androgenetic alopecia (pattern hair loss) affects millions of men and women, and current approved treatments—topical minoxidil and oral finasteride—often yield incomplete results or require long-term use with variable patient tolerance. Many patients seek safer, more effective, and non-systemic options to preserve hair without systemic side effects or adherence issues.

NEW DEVELOPMENT: WHAT IS BREEZULA AND WHAT DID PHASE III SHOW

Breezula® (clascoterone, CB-03-01) is a topical androgen receptor antagonist designed to block dihydrotestosterone (DHT) from binding to scalp hair-follicle receptors, thereby preventing follicular miniaturization.

Cosmo Pharmaceuticals today announced that two six-month Phase III studies in men with androgenetic alopecia showed statistically significant gains in Target-Area Hair Count (TAHC) compared with vehicle. One trial showed a relative increase of 539% over vehicle, the other 168%, with a pooled analysis showing over 252% improvement (p < 0.05).

The safety profile was described as favorable, with low rates of treatment-emergent adverse events comparable to placebo, minimal local scalp reactions, and no evidence of systemic androgen-related effects.

Breezula remains investigational and is not yet FDA approved for hair loss, but these topline results represent a major milestone toward potential regulatory submission.

EXPERT COMMENTARY

“As a dermatologist who treats hair-loss every day, I’ve seen the limitations of topical minoxidil and compounded topical finasteride—both in efficacy and tolerability. The new data on Breezula are very encouraging because this agent appears to perform better than those treatments in scalp hair count gains while maintaining a strong safety profile. If these results hold through long-term follow-up, Breezula could represent a meaningful advance in how we manage androgenetic alopecia for many patients,” said Dr. Dennis Porto, MD, MPH, FAAD, clinical assistant professor of dermatology, Mount Sinai, New York City.

CLINICAL SIGNIFICANCE AND NEXT STEPS

If full 12-month data and safety follow-up remain favorable, Breezula may become the first FDA-approved topical androgen receptor inhibitor for hair loss in decades. For patients seeking a non-systemic, DHT-targeted option, it could offer a new standard of care.

Dermatologists should remain aware that absolute hair-count figures were not yet released, and direct head-to-head comparisons with topical minoxidil or oral finasteride are not yet available. Long-term efficacy, durability, dosing optimization, and real-world safety will determine how broadly the therapy is adopted once approved.

ABOUT DR. DENNIS PORTO

Dr. Dennis Porto, MD, MPH, FAAD, is a double board-certified Mohs micrographic surgeon and dermatologist practicing in New York City. He completed medical school at the University of Iowa, followed by a dermatology research fellowship at Harvard and advanced surgical training. Dr. Porto is a clinical assistant professor of dermatology at Mount Sinai, with extensive publication record in hair-loss research, cosmetic dermatology, and skin-cancer surgery. His practice emphasizes evidence-based, patient-centered care and thoughtful integration of emerging therapies.