Men concerned about future hair loss may have additional prescription options to combat male androgenetic alopecia, commonly known as male pattern baldness, Gizmodo reported.
Cosmo Pharmaceuticals unveiled on Wednesday the outcomes of two phase III clinical studies evaluating the topical medication clascoterone for androgenetic alopecia, according to Gizmodo. Participants using clascoterone demonstrated substantially greater hair restoration than those receiving a placebo – one study reported approximately 500% greater hair regrowth. These findings will facilitate potential Food and Drug Administration authorization in 2026, potentially establishing clascoterone as the first genuinely innovative pattern baldness therapy introduced in multiple decades.
The primary driver of male pattern baldness is genetic factors that render an individual's hair follicles overly sensitive to androgens, particularly dihydrotestosterone.
Effective treatments for androgenetic alopecia exist, including minoxidil (Rogaine's active component) and finasteride, alongside alternative procedures such as hair transplantation, according to Gizmodo. However, these options carry various potential limitations, including financial considerations, or may prove ineffective for certain individuals, Gizmodo noted.
Cosmo anticipates that clascoterone will establish a new category of hair-loss pharmaceuticals, Gizmodo reported. The topical medication functions as an androgen receptor inhibitor, directly targeting the hormones responsible for hair-follicle deterioration in androgenetic alopecia, according to Gizmodo. The Dublin-headquartered corporation maintains that clascoterone is not systemically absorbed, thereby reducing potential adverse effects.
The company's two pivotal studies enrolled nearly 1,500 male participants diagnosed with androgenetic alopecia, Gizmodo reported. Participants received random assignment to either placebo or topical clascoterone 5% solution applied to affected scalp regions, according to Gizmodo. Both investigations achieved their primary objectives – one demonstrated that clascoterone recipients experienced a 539% improvement in hair growth volume relative to placebo, while the other showed a 168% improvement, Gizmodo noted. The corporation stated, however, that absolute regrown hair quantities observed during trials remained comparable between both treatment cohorts, according to Gizmodo. Clascoterone demonstrated safety and tolerability, with most recorded adverse events during studies unrelated to the medication itself, Gizmodo reported.
"With strong efficacy across the two largest Phase III studies, and a favorable safety profile, clascoterone 5% topical solution opens the door to a fundamentally better treatment paradigm for patients," stated Giovanni Di Napoli, Cosmo chief executive officer, according to Gizmodo.
Should clascoterone receive approval for male pattern baldness, it would constitute the first innovative treatment introduced in approximately three decades – though this wouldn't represent clascoterone's inaugural success, Gizmodo reported. During 2020, Cassiopea, currently a Cosmo subsidiary, secured FDA authorization for the medication as a topical acne treatment, according to Gizmodo.
The corporation remains positioned to complete a mandatory 12-month follow-up safety investigation by spring 2026, subsequently planning to submit approval applications in both the US and the European Union, Gizmodo reported. Should authorization be granted, a substantial potential patient population exists, according to Gizmodo. Estimates indicate up to 50% of men will experience some pattern baldness by age 50, Gizmodo noted.
