Credit: Adobe Stock
Men confronting a receding hairline traditionally have had few choices. Minoxidil and finasteride, the stalwarts of hair-loss treatment, arrived in the 1980s and 1990s. Since then, little has changed. But new data from Cosmo Pharmaceuticals suggest that could soon shift.
In two large late-stage clinical trials, the company’s experimental drug clascoterone triggered significant hair regrowth in men with male-pattern baldness, marking what could be the first truly new treatment for the condition in a generation.
A New Hair Loss Breakthrough
Male-pattern hair loss, or androgenetic alopecia (AGA), affects as many as two billion men worldwide. The condition arises when hair follicles become overly sensitive to dihydrotestosterone (DHT), a potent derivative of testosterone that gradually shrinks the follicles until they stop producing visible hair.
Cosmo’s new topical therapy tackles the problem at its hormonal roots. Clascoterone is an androgen receptor inhibitor, designed to block DHT directly at the follicle without being absorbed into the bloodstream.
Across two identically designed Phase III studies—Scalp 1 and Scalp 2—the company enrolled 1,465 men in the United States and Europe. Participants applied either a 5% clascoterone solution or a placebo to thinning areas of their scalp.
In one trial, hair counts improved by 539% relative to placebo. In the other, the increase reached 168%, according to Cosmo’s announcement. Both outcomes were statistically significant. “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,” said Giovanni Di Napoli, Cosmo’s chief executive officer.
Bloomberg reported that the results sent Cosmo’s shares soaring by 24%, their biggest surge in 17 years.
First-in-Class Approach
While hair loss can have a profound emotional impact. Studies have shown the strong links between hair loss and lower self-esteem. “Androgenetic alopecia is far more than a cosmetic issue—it affects confidence, identity, and emotional well-being,” said Di Napoli. “For the first time in more than thirty years, we have a completely new mechanism with the potential to truly change that reality.”
Indeed, the search for new hair-loss therapies has been a long one. Scientists have experimented with stem cell transplants, growth factors, and even 3D-printed follicles, yet few have reached late-stage clinical testing.
Clascoterone’s progress could signal a broader shift in how researchers approach hormonal conditions. Instead of altering hormones throughout the body, the focus is turning to precision treatments that act locally, reducing unwanted effects elsewhere.
If approved, clascoterone would join only two other FDA-approved medications for male-pattern hair loss: minoxidil and finasteride. Both can help slow or reverse thinning, but neither works for everyone, and both require continuous use to maintain results.
By directly targeting the androgen receptor in scalp tissue, Cosmo’s drug represents a “first-in-class” approach. The company also points out that its proprietary formulation prevents systemic absorption, a key differentiator from oral medications.
Cautious Optimism
Despite the excitement, experts urge restraint. The company has not yet released full peer-reviewed data or absolute numbers of new hairs grown—only relative improvements compared to placebo. And while “539%” sounds dramatic, the actual difference may depend on the size of the target area and the baseline hair density.
Still, the consistency of results across two large trials, combined with favorable safety data, has dermatologists intrigued. If approved, clascoterone could finally expand the sparse toolkit for men struggling with baldness.
For now, the company’s next milestone will be regulatory review. Cosmo expects to submit its application next year. If the FDA agrees, the drug could reach the market by 2027, becoming the first major new treatment for hair loss since the Clinton administration.