CB-03-01 (Breezula) : An experimental drug for male balding.

Do we really need more anti-androgen drugs for male balding?

There is no doubt that antiandrogens are among the most effective treatments for male balding (androgenetic alopecia, AGA) in the present year. Antiandrogens like finasteride and dutasteride stop hair loss in a high proportion of users and even improve density in a good proportion as well. However they don't help everyone and side effects (sexual dysfunction, depression, etc) limit their wide spread use.  Safer anti androgens, if they worked well, would be a great addition to the treatments we currently use. 

We've seen an increasing interest in topical anti androgens in recent years, including agents such as topical finasteride, topical Fluridil, topical RU 54481 and others. 

To date there is no topical anti androgen approved by the FDA for use in male AGA. In theory a good topical anti androgen should have potent activity that is confined to the skin, have no systemic side effects and have good tolerability.


What is CB-03-01 ?

CB-03-01 is a topical anti-androgen compound patented by Cosmo and investigated under the name Breezula. It is an androgen receptor antagonist rather than an inhibitor of 5 alpha reductase. It has good penetration through the skin.  Studies are underway to determine if the drug has benefit in male pattern balding or not.  In fact, a 26 week study by Intreprid is now underway to compare 5 % CB-03-01 to 5 % minoxidil and placebo. It will be interesting to see if CB-03-01 has any benefit and if so, how it compares to topical minoxidil.  

To date, there are only two published studies in the medical literature about CB-03-01. So we have limited information on the drug. It appears that CB-03-01 is rapidly metabolized to cortexolone which does not have any anti androgen activity.  Second, it appears that CB-03-01 has an anti-inflammatory effect which could be important in treating AGA which is known to be associated with inflammation in many cases.  Studies in rats and rabbits showed that it is not mutagenic. Studies in humans have not shown any significant adverse events. 


Final Comment

Stay tuned for the outcome of trials on CB-03-01. 



Dr. Jeff Donovan is a Canadian and US board certified dermatologist specializing exclusively in hair loss. To schedule a consultation, please call the Whistler office at 604.283.1887

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