HEALTH

Clascoterone Breakthrough Boosts Hair Growth by Up to 539%, Offering New Hope Against Baldness

After decades of limited progress in male-pattern baldness treatment, new clinical data released this month have generated a wave of optimism in the dermatology and biotech communities. 

Clascoterone 5% topical solution, developed by Irish-based Cosmo Pharmaceuticals, has shown remarkably strong results in late-stage clinical trials, including up to a 539% relative improvement in hair count compared with placebo in one study. 

The results, drawn from two identically designed Phase III trials named SCALP-1 and SCALP-2, represent the largest late-stage clinical program ever conducted for a topical hair-loss treatment. Together, these studies enrolled 1,465 men across the United States and Europe with androgenetic alopecia, the most common form of hair loss worldwide. 

In SCALP-1, participants using clascoterone showed a 5.39-fold (539%) relative increase in target-area hair count compared with those receiving a placebo vehicle. The second trial demonstrated a 1.68-fold (168%) improvement over placebo. Both results met strict statistical significance thresholds. 

Why This Matters?

Male-pattern baldness, or androgenetic alopecia (AGA), affects a huge portion of the global population, with some estimates suggesting over 1 billion men are impacted. Current treatment options include oral medication like finasteride and topical minoxidil.

Clascoterone works differently. Instead of interfering with the hormone system-wide, it blocks dihydrotestosterone (DHT) locally at the hair follicle, the hormone widely understood to shrink hair roots and trigger thinning in genetically predisposed individuals. By acting directly on the scalp with minimal systemic absorption, clascoterone aims to reduce common side effect concerns associated with oral treatments. 

Early patient-reported outcomes also supported the objective findings, with many users noting visible regrowth and satisfaction, an encouraging sign that the statistical benefits translated into meaningful change for subjects in the trials. 

Safety and the Path Ahead

Safety data from the trials are promising. Incidences of treatment-emergent adverse events were comparable to placebo, indicating a favorable tolerability profile. 

Cosmo Pharmaceuticals is now completing an additional 12-month safety and durability study, expected by spring 2026, after which it plans parallel regulatory submissions to U.S. and European authorities. 

If approved, clascoterone could become the first novel topical hair-loss mechanism in over 30 years, a milestone many clinicians have long awaited. 

While not a guaranteed “cure,” these results may reshape the therapeutic landscape for millions struggling with hair loss and could launch a new era of effective, topical solutions.