New Baldness Drug Boosted Hair Growth by 539% in Trials

Are you a man worried about losing your hair as you get older? There might soon be more prescription treatments to help stem the tide of male androgenetic alopecia (AGA), aka male pattern baldness.

On Wednesday, Cosmo Pharmaceuticals announced the results of its two phase III trials testing out the topical drug clascoterone for AGA. Compared to placebo, people on clascoterone gained back significantly more hair—with one trial showing a roughly 500% improvement in hair restoration. The results will pave the way for a potential FDA approval next year, which could make clascoterone the first truly novel treatment for pattern baldness seen in decades.

First-in-class

Male pattern baldness is primarily caused by having genes that make a person’s hair follicles overly sensitive to androgens (male-related sex hormones), particularly the hormone dihydrotestosterone (DHT).

There are effective medications for AGA, such as minoxidil (the active ingredient in Rogaine) and finasteride, as well as other interventions like hair transplants. But these treatments have all their potential drawbacks (including cost) or may not work for everyone.

Cosmo is hoping that clascoterone can become the first of a new class of hair loss drugs. The topical drug is an androgen receptor inhibitor, meaning it directly targets the hormones that help cause the loss of hair follicles in AGA. The Dublin-based company also argues that clascoterone isn’t systemically absorbed by the body, minimizing the risk of potential side effects.

Its two pivotal trials involved nearly 1,500 male patients diagnosed with AGA. The volunteers were randomized to receive a placebo or a topical clascoterone 5% solution on affected parts of their scalp. Both trials met their primary goal. In one, clascoterone users experienced a 539% improvement in the amount of hair grown relative to placebo, while in the other, there was a 168% improvement. According to the company, however, the absolute amount of regrown hair seen during the trials was similar between the two treatment groups. Clascoterone also appeared to be safe and tolerable, the company said, with most adverse events recorded during the studies not related to the drug itself.

“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 CEO, in a statement from the company. 

The future of hair loss?

If clascoterone is approved for male pattern baldness, it would represent the first novel treatment seen in roughly 30 years—but this wouldn’t be the first success for clascoterone. In 2020, the company Cassiopea (now a subsidiary of Cosmo) won FDA approval for the drug as a topical acne medication.

The company is on track to finish a required 12-month follow-up safety study by spring next year, after which it plans to file for approval in both the U.S. and the European Union. And should it win approval, there’s certainly a large potential patient base. It’s estimated that up to 50% of men will experience some pattern baldness by age 50.