Breezula™ is the brand name of our anti-androgen-containing composition for the treatment of AGA. Breezula™ is topically delivered to the scalp to reduce the hair miniaturization process that, if not controlled, shrinks the follicle, causing hair thinning and, ultimately, hair loss. Breezula™ is currently undergoing a Phase II proof-of-concept clinical trial in the United States.
Breezula™ is a different formulation of the same API contained in Winlevi™. Breezula™ contains a 5% concentration of this API in a lotion designed to penetrate the scalp.
Mechanism of Action
In androgenic alopecia (AGA), high concentrations of dihydrotestosterone (DHT) at the hair –follicle level shorten the hair cycle and gradually miniaturize scalp follicles with inherited sensitivity. These miniaturized follicles produce progressively smaller, thinner hairs until the follicles become unable to produce new hair.
Breezula™ acts at cutaneous level on the scalp by blocking DHT interaction with the specific hair-follicle androgen receptors. Breezula™ also reduces the skin’s production of prostaglandin D2, a hormone-like compound that, in elevated levels, can inhibit hair growth.
Breezula™ does not interfere with the hormonal and, in particular, androgenic profile of patients; libido and sexual behavior are unaffected in clinical trials to date.
Because the API of Breezula™ is the same as that of Winlevi™, both product candidates have the same safety profile. Although Breezula™ has a higher concentration of this API, because the scalp is less permeable than facial skin, the systemic penetration of the two product candidates is substantially the same.
Breezula™ is currently undergoing a Phase II POC trial in the United States.