After decades of limited options for male-pattern baldness, a new topical drug has delivered encouraging results in late-stage clinical trials, which showed significant hair regrowth with a safety profile similar to placebo.
Dublin-based Cosmo Pharmaceuticals has released topline results from two large phase 3 trials of a new topical drug for male-pattern hair loss, officially called androgenetic alopecia, reports Business Standard.
The twin studies – named SCALP-1 and SCALP-2 – enrolled 1 465 men across the United States and Europe, making it the largest phase 3 programme ever for any topical hair-loss treatment: the drug showed statistically significant and clinically meaningful hair regrowth within six months, said the scientists.
One study showed a 539% relative improvement in hair count compared with placebo. The second showed a 168% improvement. Both crossed the strict scientific threshold of significance.
How does this drug work, and what makes its mechanism different?
The drug in focus is clascoterone 5% solution. While most hair-loss medicines either work weakly at the scalp or block hormones system-wide through oral pills, clascoterone blocks dihydrotestosterone (DHT) locally at the hair follicle – where baldness begins – without significant absorption into the bloodstream.
DHT is a key driver behind male-pattern baldness. Existing drugs reduce it throughout the body, which is why side effects such as sexual dysfunction often discourage use. This one targets the follicle directly.
It is also the first new molecular mechanism in hair-loss treatment in more than 30 years.
How safe were the trial results, and should men worry about side effects?
The company said that across both trials, treatment-related adverse events were similar to placebo. Most side effects were mild and not linked to the drug. No meaningful hormonal disturbances were seen.
The trials measured patient-reported outcomes, including perceived coverage and satisfaction. One trial met strict significance on its own. The other showed a strong positive trend. When both were analysed together, the patient experience data matched the hair-count gains.
In other words, men saw and felt a visible difference.
Senior dermatologists believe it could be the biggest hair-loss breakthrough in three decades.
Dr Maria Hordinsky from the University of Minnesota said: “For decades, patients have had to choose between available treatment options with limited efficacy or safety issues due to systemic hormonal exposure, often resulting in patients not treating their hair loss at all.
“These findings show the potential for clascoterone 5% topical solution to change that equation by delivering real, measurable regrowth with negligible systemic exposure. These data have the potential to redefine how dermatologists treat androgenetic alopecia worldwide.”
Cosmo’s CEO Giovanni Di Napoli called male-pattern baldness a condition that affects confidence, identity and emotional well-being, not just appearance. He said this is the first time in 30 years that the treatment model itself may change.
It is important to note, however, that the detailed breakdown of the results is still awaited in peer-reviewed journals. Also, while the relative improvement numbers sound positive, absolute hair counts and long-term maintenance matter just as much.
Cosmo is now completing the mandatory 12-month safety follow-up, expected by spring 2026.
After that, the company plans parallel regulatory submissions to both the US Food and Drug Administration and the European Medicines Agency.
If approvals come through on schedule, the treatment could reach pharmacies by 2027.
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