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.

How it works: Targeting hair loss

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.

Phase III trials show strong results

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.

Why it matters

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:

  • Real hair regrowth, not just slowing loss

  • Safer, easier topical use

  • A new alternative to ineffective oils, creams, and supplements

Who could benefit

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.

Caution: What we still don’t know

  • Absolute gains may vary: Percent improvements can exaggerate visual impact

  • Long-term effects are unknown: Trials lasted six months with limited extensions

  • Regulatory approval is pending: Higher-dose use for hair loss remains experimental

  • Not all hair-loss types respond: Clascoterone targets androgen-driven baldness, not autoimmune or scarring-related hair loss

A promising future

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.

What’s next

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.