Cosmo Pharmaceuticals N.V., a global leader in AI-powered healthcare and specialty pharma, today announced compelling topline results from its two pivotal Phase III trials of clascoterone 5% topical solution for male androgenetic alopecia (AGA, also known as male-pattern hair loss), marking a potential first major therapeutic breakthrough in hair-loss treatment in more than three decades.
– 1,465 patients were randomized into the two identical-in-design clinical studies Scalp 1 (NCT05910450) and Scalp 2 (NCT05914805)
– Both studies reached statistically significant endpoints in TAHC (Target-Area Hair Count), with one reaching 539% relative improvement to placebo and the second study reaching 168% relative improvement to placebo
– Positive safety profile demonstrated across both studies
– Largest Phase III program ever conducted for a Topical Treatment for Male Androgenetic Alopecia (AGA)
– First novel mechanism of action and first potential innovation in over 30 years in male hair loss
– Preparations are underway for parallel regulatory submissions in the United States and Europe