Medically reviewed by Kristin Hall, FNP
Written by Our Editorial Team
Last updated 12/07/2020
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 even your self esteem.
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.
Unfortunately, when it comes to Breezula®, you’ll have to wait a while. This topical treatment isn’t yet available for sale, and it will likely be at least a few years.
In the meantime, however, read up on how this new drug will reportedly work, and perhaps explore hair loss solutions that are available and backed by an effective and reputable track record.
Breezula is a brand name for the drug clascoterone, manufactured by Italian drug maker, Cassiopea. It is currently undergoing clinical trials and is not yet available to purchase.
According to the pharmaceutical company Cassiopea, the drug is a topical solution that’s applied to the scalp in the treatment of androgenetic alopecia.
Breezula is said to inhibit the actions of androgens (male hormones) that can cause hair loss.
If approved, it would be the first topical anti-androgen for hair loss in both men and women.
Androgenetic or androgenic alopecia is the most common type of hair loss. It is sometimes referred to as male pattern baldness in men, or female pattern hair loss in women.
Typically, hair loss in androgenetic alopecia happens in a pattern, first receding above the temples and thinning at the crown, with these bald or thin spots ultimately converging.
Male pattern hair loss is related to androgens, or male hormones, and one hormone specifically: dihydrotestosterone, or DHT.
Increased DHT activity or sensitivity to DHT is associated with hair loss.
DHT binds to androgen receptors in hair follicles, which ultimately shortens the hair cycle and contributes to miniaturization of the follicles.
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.
Whether or not this not-yet-available drug can stop hair loss and promote new hair growth safely remains to be seen.
“I tried several different options before but Hims combined approach of all four methods by far created the best results.”
“Hims has been the greatest confidence boost, no more bald jokes! I look and feel so much younger!”
“When I show my barber my progress, he is always in disbelief. I have to recommend Hims to any guy who’s experiencing thinning.”
“Cost effective and affordable. My hair keeps growing thicker, fuller, and at a fast rate.”
“I noticed a huge change in the overall health and fullness of my hairline.”
“Now after 5 months I’m able to style waves first time in 10 years!”
“I decided to jump right in and I'm so glad I did. I definitely feel ten years younger!”
“In just as little over two and half months, I can really see the difference in thickness and in color.”
“4-months strong and my confidence boosted back up to 100% using Hims, future me really does thank me.”
“I’m a 34 year old father of two and have been using Hims for over a year now. My hair is back to what it was in my mid twenties.”
As the drug has moved through phase II clinical trials, Cassiopea has documented the so-far positive results through a series of press releases.
The latest and largest analyses of the drug’s effectiveness involved 400 subjects in Germany and lasted 12 months.
The phase II trial participants, each with mild to moderate androgenetic alopecia, used four different dosages of clascoterone.
All groups saw an increase in target hair counts and hair widths during the study period, and positive changes in their hair growth assessment (HGA, a questionnaire for study participants).
The placebo group, on the other hand, saw worsening of their hair loss when left untreated.
According to the research: “these data confirm that clascoterone stops the loss of hair and grows new hair.”
As for safety, the manufacturer says there have been no “treatment-related serious adverse events” among patients in the clinical trials, declaring their drug as safe and free of side effects.
If you’re interested is piqued, take it down a few — you’ll have to wait a while to try Breezula.
The drug is not currently available for use in the U.S., as it’s still undergoing clinical trials.
According to the manufacturer, phase III trials are up next in men. If and when this stage is completed, the drug can move on to the FDA approval stage.
As of September, 2020, Cassiopea anticipates beginning phase III trials in the first half of 2021, but they have been previously delayed by factors related to the COVID-19 pandemic, and could be delayed again.
The drug maker expects beginning sales of the drug in 2024, though it isn’t clear if they’ll release it in European markets first, or globally (including the United States) all at once.
In the company’s annual report, they claim the hope is Breezula will be “at least as effective as Propecia,” a drug currently available and proven effective in treating male pattern hair loss.
Breezula is a new name-brand drug for clascoterone, a topical solution in development that may be used to treat androgenetic alopecia.
While the clinical trials for Breezula seem promising so far, we’re still a while away from phase III trials, let alone the rigorous FDA approval process.
Which means: while things look promising, it seems like Breezula is a few years away from the American market.
Luckily, there are viable alternatives — clinically proven, FDA-approved medications that you can learn more about right now.