Breezula for Hair Loss: How It Works & Side Effects

Could the answer to male pattern baldness be a medication that’s currently approved for something else entirely? Enter Breezula®, a possible treatment for androgenetic alopecia.

Breezula, which is manufactured by the Italian drug maker Cassiopea,  is the brand name for a topical treatment whose generic version is called clascoterone. It’s currently undergoing clinical trials for the treatment of hair loss and is not yet available to purchase for this purpose. But once it is, studies thus far suggest it may be a gamechanger when it comes to treating hair loss.

Below, we’ve explained how this new drug will reportedly work, whether Breezula hair loss results look promising, and what side effects we know about.

Breezula works by inhibiting the actions of androgens (male hormones), which can cause conditions like acne and hair loss. Pharmaceutical company Cassiopea explains that the topical solution is effective in the treatment of androgenetic alopecia when applied to the scalp (more on the data to back that up in a moment).

For now, just know that Breezula is fairly far along in the testing process — and some versions of it are already FDA-approved. You may even already know someone taking this medication for acne in another form since clascoterone goes by several names, including:

• Breezula

• Clascoterone

• Cortexolone 17α-propionate

• Winlevi

The active ingredient in Breezula is clascoterone, an antiandrogen medication sold under the name Winlevi, which is FDA-approved for acne vulgaris in adolescents and adults. And it may soon gain FDA approval for hair loss under the brand name Breezula.

Can Breezula stop male pattern balding and regrow hair that’s already been lost?

Things look promising for conditions like androgenetic alopecia, or androgenic alopecia, which is the most common type of hair loss.

Male pattern hair loss is related to androgens, or male hormones, and one hormone specifically: dihydrotestosterone (DHT). Increased DHT activity and sensitivity to DHT are both associated with hair loss. When DHT binds to androgen receptors in hair follicles, it causes miniaturization of the follicles and, eventually, hair loss. 

According to Breezula’s makers, the drug is an antiandrogen, meaning it inhibits the ability of DHT to bind with androgen receptors in the scalp. This action reportedly reduces hair miniaturization, or hair thinning and loss. 

In this regard, it works similarly to finasteride, an FDA-approved and widely accepted hair loss treatment. Both finasteride and Breezula are blockers of the formation of DHT.

As Breezula has moved through phase II clinical trials, Cassiopea has documented the so-far positive results through a series of press releases. This has included a study that involved 400 subjects in Germany and lasted 12 months. 

In the phase II trial, participants with mild to moderate androgenetic alopecia saw an increase in target hair counts and hair widths during the study period and reported positive changes in their hair growth assessments (a questionnaire for study participants). The placebo group, on the other hand, saw a worsening of their hair loss.  According to the research, “these data confirm that clascoterone stops the loss of hair and grows new hair.”

Now, we’ll be the first to say that a pharmaceutical company’s own data is not the same as independent study data. But assuming that these results are replicated by FDA testing, it certainly seems that Breezula could be effective.

Unfortunately, side effects of Breezula are not widely known yet. The manufacturer says there have been no “treatment-related serious adverse events” among patients in the clinical trials, thus declaring their drug safe and free of side effects.

However, there have been some anecdotal studies of Breezula and the other versions of the drug in which users reported skin irritation and other issues common to topical hair regrowth medications. However, one 2020 study of the acne-fighting format clascoterone solution found side effects to be generally mild.

Dermatology issues aside, it will be some time before an FDA-approved formulation’s official side effect list is approved — and until then, we’re going to be a little short on data.

Below, you’ll find answers to some common questions about Breezula.

Is Breezula available in the U.S.?

While the acne-fighting version of clascoterone called Winlevi is now available in the United States, Breezula for hair loss has yet to receive FDA approval, which means it’s not yet available in the United States. 

Right now, Breezula is undergoing phase III trials. If and when this stage is completed, the drug can move on to the FDA approval stage, after which it would become available in the U.S.

When will Breezula be available?

According to some estimates, the drug maker continues to expect to begin sales of the drug in the U.S. somewhere between 2024 and 2026, though it may appear in European markets first. 

However, as of March 2024, Cosmo Pharmaceuticals, (the developer of Breezula) has indicated that recruiting for the trials is on schedule but at the time had only 348 out of a planned 726 patients recruited for one study and 507 of 726 for the second.

Should it win approval, Breezula will be the only topical androgen receptor inhibitor for androgenetic alopecia (AGA), and it will also become the first drug with a new mechanism of action for AGA in more than 20 years.

Is Breezula for men and women?

Yes, Breezula can be used by both men and women. Right now, it’s approved for the treatment of acne vulgaris in adolescents and adults. If it’s approved by the FDA for hair loss, it would be the first topical anti-androgen for hair loss in both men and women.

Breezula may be the hair health hero and baldness beater that everyone wants, but in all likelihood, it will just be another tool in the toolbox for fighting hair loss.  Before we can tell you how effective it will be with any certainty, the FDA needs to look into it — and that’s still an ongoing process. 

Here’s what to remember:

• Breezula is a new, name-brand version of the generic clascoterone. It is a topical solution in development that may be used to treat androgenetic alopecia. 

• While the clinical trials for Breezula seem promising so far, it’s likely a year or more away from the American market, thanks to the rigorous FDA approval process it will have to go through after it phase III trials are complete.

• Whether this not-yet-available drug can stop hair loss and promote new hair growth safely remains to be seen, though early trials seem promising.

• Luckily, there are viable alternatives to treat hair loss while waiting for Breezula to hit the market. Already, there are two FDA-approved hair growth products on the market: finasteride and minoxidil.

Until potential FDA approval of Breezula, our blog has great tips for hair growth for guys who want to harness some science to fight male pattern baldness and other types of hair loss.

You can also consider already FDA-approved options like finasteride (the active ingredient in Propecia®) and minoxidil (the active ingredient in Rogaine®). We offer both, with options including minoxidil foam, minoxidil solution, and a combo topical finasteride & minoxidil spray.