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Breezula for Hair Loss: How It Works & Side Effects

Kristin Hall, FNP

Reviewed by Kristin Hall, FNP

Written by Geoffrey Whittaker

Published 12/05/2020

Updated 09/01/2023

When you’re losing your hair, all options are on the table. Hair loss can be scary and even traumatic, as it may impact your self-image and your self-esteem. Most guys will agree that male pattern baldness is to be prevented at all costs — but could the answer be a medication currently approved for the treatment of acne?

Breezula, which is manufactured by the Italian drug maker Cassiopea,  is a brand-name for a topical treatment whose generic version is called clascoterone. It is currently undergoing clinical trials for the treatment of hair loss and is not yet available to purchase for this purpose. 

But when it’s available, studies thus far suggest it may be a game changer. Below, we’ve explained how this new drug will reportedly work, what side effects we know about and what to do in the meantime.

When a new “wonder drug” comes out, it’s normal to want to know everything you can about how it works and where you can get it. Breezula may one day be on that list of wonder drugs.

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

  • Breezula

  • Clascoterone

  • Cortexolone 17α-propionate

  • Winlevi

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

So what’s this “if” we keep referring to? And can Breezula stop male pattern balding and regrow hair that’s already been lost?

Things look promising. But first, some hair loss basics.

Androgenetic alopecia, or androgenic alopecia, is the most common type of hair loss. Typically, hair loss in androgenetic alopecia happens in a pattern — hair first recedes above the temples and thins at the crown, until these bald or thin spots ultimately converge. 

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. This happens when DHT binds to androgen receptors in hair follicles, which causes miniaturization of the follicles and, eventually, hair loss. 

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

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

As the drug has moved through phase II clinical trials, Cassiopea has documented the so-far positive results through a series of press releases, including 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 positive changes in their hair growth assessment (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. 

So, what about safety?

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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, declaring their drug safe and free of side effects.

There have been some anecdotal studies of Breezula and the other versions of it that reported skin irritation and other issues common to topical hair regrowth medications. But one 2020 study of the acne-fighting format clascoterone solution found side effects to be generally mild.

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

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If your interest is piqued in this potential hair loss treatment, take it down a few notches, bud. 

While the acne-fighting version of clascoterone called Winlevi is now available in the United States, Breezula for hair loss has yet to meet FDA approval.

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.

The drug maker continues to expect to begin sales of the drug in the U.S. in 2024, though it may appear in European markets first.

Should it win approval, Breezula will become 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.

But let’s not count our follicles before they hatch — for now, the wait continues. 

Hair loss treatments, delivered

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 drug version of the generic clascoterone, and 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.

  • Whether or not this not-yet-available drug can stop hair loss and promote new hair growth safely remains to be seen.

  • Luckily, there are viable alternatives — clinically proven, FDA-approved medications that you can learn more about right now.

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 FDA-approved hair growth products like finasteride and minoxidil. We offer both, including minoxidil foam, minoxidil solution and a combined topical finasteride & minoxidil spray.

6 Sources

  1. Cosmo announces the beginning of the phase III trials in ... - cosmo pharma. (n.d.-b). https://www.cosmopharma.com/news-and-media/news-releases/2023/290623.
  2. Kinter KJ, Anekar AA. Biochemistry, Dihydrotestosterone. [Updated 2023 Mar 6]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557634/.
  3. Ho CH, Sood T, Zito PM. Androgenetic Alopecia. [Updated 2022 Oct 16]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK430924/.
  4. Zito PM, Bistas KG, Syed K. Finasteride. [Updated 2022 Aug 25]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK513329/.
  5. Breezula® – Cosmo Pharmaceuticals NV. (n.d.-a). https://www.cosmopharma.com/pipeline/breezula.
  6. Hebert, A., Thiboutot, D., Stein Gold, L., Cartwright, M., Gerloni, M., Fragasso, E., & Mazzetti, A. (2020). Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials. JAMA dermatology, 156(6), 621–630. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7177662/.
Editorial Standards

Hims & Hers has strict sourcing guidelines to ensure our content is accurate and current. We rely on peer-reviewed studies, academic research institutions, and medical associations. We strive to use primary sources and refrain from using tertiary references. See a mistake? Let us know at [email protected]!

This article is for informational purposes only and does not constitute medical advice. The information contained herein is not a substitute for and should never be relied upon for professional medical advice. Always talk to your doctor about the risks and benefits of any treatment. Learn more about our editorial standards here.

Kristin Hall, FNP

Kristin Hall is a board-certified Family Nurse Practitioner with decades of experience in clinical practice and leadership. 

She has an extensive background in Family Medicine as both a front-line healthcare provider and clinical leader through her work as a primary care provider, retail health clinician and as Principal Investigator with the NIH

Certified through the American Nurses Credentialing Center, she brings her expertise in Family Medicine into your home by helping people improve their health and actively participate in their own healthcare. 

Kristin is a St. Louis native and earned her master’s degree in Nursing from St. Louis University, and is also a member of the American Academy of Nurse Practitioners. You can find Kristin on LinkedIn for more information.

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