Clascoterone (“Breezula”) for hair loss: the reality behind the hype (Updated: December 2025)
Here are the only four statements I feel comfortable putting at the top, without spinning anything.
Clascoterone is a real prescription drug ingredient that is already approved in the United States as a one percent cream for acne (brand name Winlevi). ([FDA Access Data][1]) “Breezula” usually refers to a different product: clascoterone five percent topical solution being studied for male pattern hair loss, and it is not approved for hair loss yet as of early December 2025. ([Cosmo Pharmaceuticals NV][2]) On December 3, 2025, the developer announced Phase 3 topline results (SCALP-1 and SCALP-2) and highlighted “539%” and “168% relative improvement” versus placebo in a hair-count endpoint. ([Cosmo Pharmaceuticals NV][2]) Those percentages can sound like “a miracle,” but relative improvement is a ratio, and topline press releases usually do not give enough detail to translate that ratio into a realistic “what you will see in the mirror” expectation. ([Cosmo Pharmaceuticals NV][2])
Why is this suddenly trending?
The spike is easy to explain: one company press release, followed by a wave of reposts and coverage.
Cosmo Pharmaceuticals published the Phase 3 topline announcement on December 3, 2025, using attention-grabbing language and those large percentage figures. ([Cosmo Pharmaceuticals NV][2]) STAT News covered it the same day and repeated the two-trial split (168% in one trial, 539% in the other) and the “after six months” framing. ([STAT][3]) Dermatology Times published a follow-up summary (December 4, 2025) describing the results as strong and “promising,” which further amplified public interest. ([皮膚科時報][4])
That combination is enough to light up search trends even before any full paper is available.
What clascoterone actually is (in plain language)
Clascoterone is described in official documents as an androgen receptor inhibitor. ([FDA Access Data][1]) In everyday terms, it aims to block the “androgen signal” at the skin or follicle level, instead of trying to change hormone production across the whole body.
That “local signal blocking” angle is exactly why people associate it with hair loss, because male pattern hair loss is tightly linked to androgen signaling in genetically sensitive follicles.
The most common misunderstanding: “Winlevi exists, so Breezula must be available”
Winlevi is clascoterone one percent cream for acne, and the United States Food and Drug Administration label makes that indication explicit. ([FDA Access Data][1]) Breezula is clascoterone five percent solution being developed for male hair loss, and the company’s own wording frames it as an investigational program that still depends on regulatory authorization. ([Cosmo Pharmaceuticals NV][2])
Same ingredient does not mean same product, and it definitely does not mean the hair-loss use is already approved.
What the Phase 3 trials were, at a “what happened” level
The company says the Phase 3 program included two trials (SCALP-1 and SCALP-2) with 1,465 men across the United States and Europe, and it reports that both met a primary endpoint based on a measured hair count outcome called Target-Area Hair Count compared with placebo vehicle. ([Cosmo Pharmaceuticals NV][2]) ClinicalTrials.gov lists at least one Phase 3 study record for clascoterone in male pattern hair loss (for example, NCT05914805), which helps confirm the trials exist and describes the general goal (efficacy and safety). ([ClinicalTrials.gov][5]) European Union trial systems also show a related trial entry (CTIS) for clascoterone solution in androgenetic alopecia, again supporting that this is not just internet rumor. ([CTIS][6])
So, yes: there is a real clinical program behind the keyword.
The “539%” headline: what it can mean, and why it can be misleading
The press release headline says “up to 539% relative improvement in Target-Area Hair Count vs placebo,” and that number is now everywhere. ([Cosmo Pharmaceuticals NV][2])
Here is the core logic problem: relative improvement is not the same as absolute improvement.
A simple hypothetical example (not the real trial numbers) shows why. If placebo improves by 1 hair per square centimeter, and the drug improves by 6 hairs per square centimeter, then the drug is “500% better than placebo” in a relative sense, but the absolute difference is 5 hairs per square centimeter. Depending on baseline density, lighting, hair color, and styling, that absolute difference might be noticeable, mildly noticeable, or not noticeable.
This is why a careful reader should wait for absolute change values, the spread of responses, and the definitions used for “target area” and counting method, which are rarely fully explained in a topline press release. ([Cosmo Pharmaceuticals NV][2])
How this fits into the broader “approved options” context
A lot of the excitement comes from the fact that, for male pattern hair loss, the mainstream public-facing guidance still centers on a small set of United States Food and Drug Administration–approved medications.
The American Academy of Dermatology explicitly states that the United States Food and Drug Administration has approved finasteride and minoxidil to treat male pattern hair loss. ([アメリカ皮膚科学会][7]) United States Food and Drug Administration review documents for minoxidil products note topical minoxidil was originally approved in 1988 for male pattern baldness. ([FDA Access Data][8]) United States Food and Drug Administration documents for Propecia show the male pattern hair loss indication in the 1997 approval package, and multiple clinical references summarize that 1997 approval history. ([FDA Access Data][9])
So when something new shows Phase 3 signal, people naturally latch onto it.
Safety: what we know from regulators, and what we still cannot assume
For clascoterone one percent cream (Winlevi), the United States label lists warnings including local skin reactions and possible hypothalamic–pituitary–adrenal axis suppression (a hormone feedback system related to cortisol). ([FDA Access Data][1]) The United States Food and Drug Administration risk review also flags potential risks including hyperkalemia (high blood potassium) and hypothalamic–pituitary–adrenal axis suppression, mainly detected in laboratory data and special study settings. ([FDA Access Data][10]) Independent government-style assessments outside the United States echo that hypothalamic–pituitary–adrenal axis suppression showed up in “maximal use” style studies, which is exactly the kind of detail marketing rarely emphasizes. ([Veterans Affairs][11])
What you should not do is assume those acne-cream safety findings map perfectly onto a five percent scalp solution. Different concentration, different surface area, different skin barrier, different use pattern, and different study population can all change exposure.
The Phase 3 hair-loss topline statements say adverse events were comparable to placebo and describe a favorable safety profile, but topline summaries still do not replace full safety tables. ([Cosmo Pharmaceuticals NV][2])
Timeline: when could this actually be available?
As of the December 3, 2025 announcement, the company says it is on track to complete required twelve-month safety follow-up in spring 2026 and plans to pursue regulatory submissions after the full dataset is complete. ([Cosmo Pharmaceuticals NV][2]) That is a plan, not an approval.
Regulatory decisions depend on the complete submission, manufacturing and quality information, the benefit–risk balance, and what the labeling ends up allowing.
What I would watch for next (to avoid getting fooled by headlines)
The next “real” evidence upgrade usually comes in three forms.
A peer-reviewed publication (or at least a full clinical study report) that shows absolute hair count changes, responder rates, and clear methods. Regulatory documents or review summaries once filings progress. Longer safety follow-up that matches how people actually use hair-loss treatments: months are helpful, but years are the real stress test.
Until then, the most accurate description is: promising Phase 3 topline signal, but the headline alone cannot tell you the practical size of the effect. ([Cosmo Pharmaceuticals NV][2])
Sources you can cite at the end of a blog post
- Cosmo Pharmaceuticals press release (December 3, 2025): SCALP-1 and SCALP-2 topline results and timeline comments. ([Cosmo Pharmaceuticals NV][2])
- STAT News coverage (December 3, 2025): independent reporting of the same topline numbers and six-month framing. ([STAT][3])
- United States Food and Drug Administration label for Winlevi (clascoterone) cream one percent: indication and warnings. ([FDA Access Data][1])
- United States Food and Drug Administration risk review for clascoterone (2020): risk discussion including hyperkalemia and hypothalamic–pituitary–adrenal axis suppression. ([FDA Access Data][10])
- European Medicines Agency Winlevi page and Q&A PDF (August 2025): regulator framing and approval context for acne product. ([European Medicines Agency (EMA)][12])
- ClinicalTrials.gov study record (example: NCT05914805): trial existence and basic design goal. ([ClinicalTrials.gov][5])
- American Academy of Dermatology public page on male pattern hair loss treatment: United States Food and Drug Administration–approved options context. ([アメリカ皮膚科学会][7])