Balding? Acne drug offers breakthrough hair-loss results

A common acne medication may soon offer hope to millions of men struggling with hair loss. Ireland-based pharmaceuticals reported that clascoterone, a topical drug originally approved for acne, produced remarkable hair growth in two large Phase III trials.

Hair loss has long been a source of frustration, with treatments mostly limited to minoxidil or oral anti-androgens like finasteride. Lotions, oils, and supplements often promise results but rarely deliver real regrowth. Now, clascoterone—FDA-approved in 2020 for acne—is emerging as a promising topical solution for hair restoration.

According to Cosmo Pharmaceuticals, clascoterone blocks DHT, the hormone responsible for shrinking hair follicles, directly at the scalp. Unlike oral pills such as finasteride, it works locally, allowing men to avoid systemic side effects like sexual dysfunction.

The company adds that this targeted approach could mark the first major innovation in male hair-loss treatment in over 30 years.

Cosmo Pharmaceuticals conducted two Phase III trials involving 1,500 men with androgenetic alopecia (male pattern baldness):

Giovanni Di Napoli, CEO of Cosmo Pharmaceuticals, described the results as “a fundamentally better treatment paradigm” for patients. Experts say these results could make clascoterone the first major new treatment for male pattern baldness in 30 years.

Until now, options were limited to minoxidil or oral anti-androgens, both of which have limited effectiveness or potential side effects. Clascoterone could finally offer a safer, more effective alternative:

Men in the early to mid-stages of hair loss may see the most dramatic results. Male pattern baldness typically progresses in seven stages, from early thinning at the temples to widespread hair loss on the crown.

Experts caution that:

Clascoterone’s breakthrough offers hope to millions of men who have struggled with ineffective treatments for decades. With FDA approval expected next year, the drug may redefine male pattern baldness therapy, providing a safe, effective, and scientifically validated solution for hair regrowth.

Regulators are reviewing the drug for hair loss, and approval could come as early as next year. If cleared, clascoterone may transform the way male pattern baldness is treated, giving millions of men a safer and more effective solution.