Clascoterone (also known as Breezula® or CB-03-01) is a new topical androgen receptor inhibitor which was originally approved in August 2020 as Winlevi® cream 1% for acne in young patients aged 12 and above. Studies have shown that a higher dosage of 2.5% to 5% can help combat male pattern hair loss.
If You're Looking For A Hair Loss Solution, We Have You Covered
Breezula isn't currently available for sale. XYON offers the best solutions available now for hair loss. Find out which one is right for you.
How Does Breezula® Work for Hair Loss?
Compared to other medications used to treat pattern hair loss such as finasteride and dutasteride, Breezula (clascoterone) works a bit differently. Finasteride and dutasteride are DHT-blockers that prevent the conversion of testosterone to DHT. This lowers DHT levels, which can be helpful in delaying the process of follicular miniaturization (shrinking) in men who have a genetic predisposition for hair loss.
Instead of reducing DHT production, it is believed that Breezula “competes” with DHT for binding to the androgen receptor (AR), thereby allowing less DHT to bind to this receptor in the hair follicle and activating processes like follicular miniaturization. Additionally, clascoterone may also inhibit sebum or oil production, which could have an indirect effect on miniaturization (Draelos et al., 2025).
Does Breezula® Regrow Hair?
Based on available early clinical study data, Breezula does show promise in being able to help hair loss patients regrow hair. The latest data is based on two Phase 3 clinical trials conducted by Cosmo Pharmaceuticals (Ireland). Phase 3 clinical trials are an important milestone for new drugs because this is when their efficacy and safety are evaluated on a large scale.
The clinical trials, called SCALP 1 and SCALP 2, enrolled 1465 patients (male, aged >18) from the US and Europe. Study participants applied either a 5% topical clascoterone solution or placebo for a total of 12 months. The studies measured target area hair count (TAHC) and patient-reported outcomes (PROs). TAHC is the number of hairs present in a specific scalp area (usually 1 cm2), while PROs capture patients’ subjective assessments of treatment efficacy.
The first study reported a 539% relative increase in TAHC, while the second study reported a 168% relative increase in TAHC. For both studies, PRO data was positive, and patients’ perceptions of their improvement in hair loss usually matched the clinician assessors’ evaluations (Dermatology Times, 2025). In other words, patients and clinicians generally agreed that Breezula had a positive impact on hair growth and were satisfied with the treatment.
At this time, there is limited data available on whether these results are applicable to female pattern hair loss patients. Since male and female pattern hair loss share some similarities, it is possible that Breezula or clascoterone may be helpful in delaying hair loss in women as well. Some studies show that clascoterone's effects might be promising for women under 30, which if confirmed in larger controlled trials, would be great news for young women facing hair loss. However, there is still uncertainty around whether it would be safe for pregnant or breastfeeding women to use.
Is Breezula® Better Than Finasteride or Minoxidil?
The short answer is that we don’t have enough information at this time to directly compare Breezula to finasteride or minoxidil. The type of study that would be needed is something called a “head-to-head" trial. Given that the results from the Phase 3 trials were positive, it is possible that we may see future trials that directly compare these medications to each other.
It’s important to understand that Breezula or clascoterone treats hair loss in a different way compared to finasteride and minoxidil. Depending on the primary mechanism or cause of a patient’s hair loss, there may be variability in treatment response to these agents. In other words, what works for one person might not be the best option for another.
In cases where a patient may have already tried finasteride or minoxidil with minimal results or side effects, clascoterone could be a potential solution. It is the first new type of hair loss medication to emerge in more than three decades, which is part of the reason why it is so exciting.
What Are the Side Effects of Breezula®?
Since Breezula (clascoterone) is applied topically, many reported side effects are skin-related. These include local skin reactions, redness, scaling or dryness, itching, stretch marks, edema, or telangiectasia (appearance of blood vessels on the skin). In some patients, clascoterone affected the HPA axis, the body’s response system to stress. When the body breaks down clascoterone, one of the byproducts is a glucocorticoid called cortexolone. Glucocorticoids are steroid hormones that can affect this stress response. So far, these steroid effects have only been observed in patients who were exposed to 3x the recommended daily dose and were observed to be reversible in patients who stopped taking clascoterone.
In the Scalp 1 and Scalp 2 hair loss trials, side effects were similar between active treatment and placebo groups (5.1% in the clascoterone group and 6.1% in the placebo group). The side effects that were reported were not related to using clascoterone.
Although additional studies are needed, investigators noted that clascoterone did not seem to impact systemic DHT levels significantly (Dermatology Times, 2025). This is a potentially big deal, given that many pattern hair loss patients express concerns about the hormonal side effects of drugs such as finasteride.
Can Winlevi® Be Used for Hair Loss?
No, Winlevi refers to a 1% topical clascoterone cream that has only been approved for the treatment of acne in patients 12 or older. Other forms of clascoterone, such as the topical 5% solution used in the Scalp 1 and Scalp 2 trials, are currently undergoing clinical trials that could lead to approval by the FDA for treatment for male pattern hair loss.
When Will Breezula® Be FDA Approved?
Breezula is still in clinical trials, but phase 3 trial results have been positive. Drug manufacturers have stated that all of the study participants will complete their 12-month safety follow-up in the spring of 2026. If there are no safety warning signals, Cosmo Pharmaceuticals will start regulatory submissions in the US and Europe.
How Breezula® Compares to Other Topical Hair Loss Treatments
Breezula or clascoterone is the first topical androgen receptor inhibitor being tested to combat hair loss. Other topicals such as minoxidil work differently, by stimulating the follicle to improve blood flow, but have no effect on DHT levels.
Topical finasteride, a compounded medication, treats pattern hair loss by targeting and blocking DHT production to lower DHT levels and delay its hair follicle-shrinking effects. As mentioned, since there have not yet been head-to-head trials, it is not possible at this time to compare safety or efficacy of clascoterone to these other agents.
Breezula® vs. Other Antiandrogens: What’s Different?
If approved, Breezula would be the first topical anti-androgen indicated for the treatment of male pattern hair loss. There have been some clinical studies of compounded topical formulations, including topical spironolactone (a different anti-androgen) that have been investigated for the treatment of pattern hair loss, but again, none of these have been formally approved.
One of the significant differences between topical clascoterone and other anti-androgens is that the topical delivery method may result in lower systemic absorption of the drug. In other trials comparing oral and topical medications, topicals typically are associated with lower blood concentrations of active ingredients, which has been linked to a reduced risk of side effects.
Where Is Breezula® Available Right Now?
Breezula® is not yet available anywhere and is still being tested before it can be evaluated for FDA approval.
Should You Wait for Breezula® or Try Other Hair Loss Treatments?
It is generally recommended that pattern hair loss be treated sooner, rather than later for the best chances of treatment success. It is hard to say how much longer it could take before Breezula or clascoterone is approved. The decision to wait is entirely up to the patient but depending on the severity of your hair loss or the speed at which it progresses, you may wish to consider other medications.
Currently, the FDA has approved options such as oral finasteride (1 mg) and topical minoxidil (2% solution and 5% foam) for male and female pattern hair loss. Dutasteride may also be prescribed off label in oral or topical form (it is a similar medication to finasteride).
If your primary motivation for wanting to wait until Breezula is approved is to reduce the potential risk of side effects, topical formulations containing the ingredients mentioned above — finasteride, dutasteride, minoxidil — may be helpful.
XYON offers compounded forms of topical finasteride, topical finasteride with minoxidil, and topical dutasteride, with a unique delivery system, known as SiloxysSystemTM, designed for optimized scalp delivery with lower systemic drug absorption. We recommend consulting with a physician if you’re interested in any of these options.
Final Thoughts: Will Breezula® Be a Gamechanger for Hair Loss?
Breezula® is an exciting prospect and would be a great addition to current hair loss medications available if it passes FDA approval and has strong efficacy and safety data. Right now, the impact it has is entirely speculative with promising results so far in phase 3 clinical trials.
Resources
1. Han, S. H., Byun, J. W., Lee, W. S., Kang, H., Kye, Y. C., Kim, K. H., & Kim, M. B. (2021). Clascoterone: First Approval. Annals of Dermatology, 33(1), 10–15. https://pubmed.ncbi.nlm.nih.gov/33030710/
2. Jimenez‐Cauhe, J., Saceda‐Corralo, D., Rodrigues‐Barata, R., Hermosa‐Gelbard, A., & Fernandez‐Nieto, D. (2019). Cortexolone 17α-Propionate (Clascoterone) is an Androgen Receptor Antagonist in Dermal Papilla Cells In Vitro. Journal of the American Academy of Dermatology, 81(2), 556–566. https://pubmed.ncbi.nlm.nih.gov/30811143/
3. Siah, T. W., & Sinclair, R. (2023). Androgenetic Alopecia: Therapy Update. BMJ, 380, e072732. https://pmc.ncbi.nlm.nih.gov/articles/PMC10173235/
4. Chang, M. R., et al. (2024). Hypothalamic-Pituitary-Adrenal Axis Response in Patients With Acne Vulgaris Treated With Clascoterone: A systematic review and meta-analysis. Journal of the European Academy of Dermatology and Venereology. Published online 2024. https://pubmed.ncbi.nlm.nih.gov/38834220/
5. Hervik, A. K., & Mørk, C. (2020). Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials. BMC Dermatology, 20, 1–7. https://pubmed.ncbi.nlm.nih.gov/32320027/
6. Saleh, D., Alsmadi, M., Abdelrahman, R., et al. (2024). Recent Advances in Drug Development for Hair Loss, 17(7), 18–25. https://pmc.ncbi.nlm.nih.gov/articles/PMC12026576/
7. Siah, T. W., & Sinclair, R. (2020). Clascoterone as a novel treatment for androgenetic alopecia, 13, 527–534. https://pubmed.ncbi.nlm.nih.gov/32421862/
8. Clascoterone for acne. (2024). Australian Prescriber, 47(5), 160–161. https://doi.org/10.18773/austprescr.2024.040
9. Cosmo announces breakthrough phase III topline results from Scalp 1 and Scalp 2 for clascoterone 5% solution in male hair loss, showing up to 539% relative improvement in target-area hair count vs placebo; US and EU submissions are underway. News release. Cosmo Pharmaceuticals. Published December 3, 2025. Accessed December 4, 2025. https://www.cosmopharma.com/news/cosmo-announces-breakthrough-phase-iii-topline-results-from-scalp-1-and-scalp-2-for-clascoterone-5-solution-in-male-hair-loss-showing-up-to-539-relative-improvement-in-target-area-hair-count-vs-place
10. Draelos, Z. D., Kyeremateng, K., & Squittieri, N. (2025). Reduction in Facial Sebum Production Following Treatment with Clascoterone Cream 1% in Patients with Acne Vulgaris: 12-Week Interim Analysis. Dermatology and Therapy, 15(9), 2657–2666. https://doi.org/10.1007/s13555-025-01495-y
