Khaberni - Cosmo Pharmaceuticals has announced promising results for an experimental drug that could become the first innovative treatment for male pattern baldness (hereditary baldness) in three decades.
The new treatment, called "clascoterone," showed significant efficacy in two advanced phase three clinical trials involving nearly 1,500 men suffering from hereditary hair loss.
Male pattern baldness is primarily attributed to genes that make hair follicles overly sensitive to androgens (male sex hormones), especially the hormone dihydrotestosterone (DHT).
According to the results published last Wednesday, users reported significant hair growth improvement, achieving 539% in one trial compared to the placebo, while the second trial recorded an improvement of 168%.
The drug, administered as a topical treatment on the scalp, targets the disease's mechanism at its roots. It belongs to the class of androgen receptor inhibitors, meaning it blocks the effect of male hormones (especially dihydrotestosterone) that cause weakening and loss of follicles in genetically predisposed individuals. The manufacturing company confirms that the drug is not systemically absorbed into the body, which may reduce the likelihood of side effects compared to other treatments.
This announcement comes at a time when up to 50% of men experience some degree of male pattern baldness by the age of fifty. Although there are current treatments like minoxidil (the active ingredient in Rogaine) and finasteride, each has limitations in effectiveness or potential side effects, and hair transplant procedures are costly and not suitable for everyone.
The company is scheduled to complete a 12-month follow-up safety study by spring 2026, after which it will submit the official approval request to the U.S. Food and Drug Administration and European health authorities.
It is noteworthy that "clascoterone" previously received approval for treating acne in 2020, which might accelerate the review process.
In an official statement, Giovanni Di Napoli, CEO of Cosmo Pharmaceuticals, said: "With this strong effectiveness and good safety profile, the treatment opens the door to a better therapeutic model for patients."
If approved, "clascoterone" will be the first entirely new drug in the male pattern baldness treatment category in decades, potentially changing treatment options radically for millions of men around the world.
