Breezula® (Clascoterone solution) is a novel androgen receptor inhibitor that targets androgen receptors in the scalp and is currently being studied for the treatment of androgenetic alopecia (AGA).
Clascoterone is a topical androgen receptor inhibitor. Breezula® is believed to address AGA by directly inhibiting testosterone and Dihydrotestosterone (DHT) binding to local hair follicle androgen receptors. If approved by the FDA, Breezula® has the potential to be the only topical androgen receptor inhibitor for AGA and the first drug with a new mechanism of action for the treatment of AGA in over two decades.
Breezula® is quickly metabolized to cortexolone, a metabolite with a known safety profile. Due to its rapid metabolism and local activity, there appears to be limited systemic exposure to Breezula® and therefore potential systemic side effects are likely minimized.
Following a successful phase IIa POC trial, a phase II Dose Ranging Study was conducted in males and results were announced in 2019. In the dose ranging trial, a total of 404 subjects were enrolled in six sites in Germany. This double-blind trial evaluated the efficacy and safety of four different doses of Breezula® compared to vehicle in male subjects 18−55 years of age with mild to moderate androgenetic alopecia in temple and vertex region, with a history of ongoing hair loss.
All subjects applied Breezula® or vehicle to the balding areas of the scalp twice daily for a total of twelve months. The results indicate that Breezula® stops the loss of hair, promotes the growth of new hair, and has a safety profile similar to vehicle for both adverse events and local skin reactions, even after 12 months treatment. Based on these results, we have selected the 75 mg BID dose for the phase III studies, and reported the first patient in the trials in June 2023. The phase III trials will evaluate and assess the use of clascoterone topical solution in males for the treatment of androgenetic alopecia (AGA). AGA is the most common form of hair loss and a substantial market with high unmet needs. It is an extremely common disorder that affects roughly 50% of men, Clascoterone topical solution is a potential first new mechanism of action in AGA in nearly three decades.
For more details on the trials and study design see full press release.