If you've spent any time on Reddit or in hair loss groups over the past few months, you've likely come across the name: clascoterone. Headlines have called it "the first breakthrough in thirty years," citing figures like 539 percent more hair growth than a placebo. It sounds like the treatment everyone has been waiting for.
It’s not that simple. Clascoterone is indeed a new type of treatment, and the results so far are promising. However, that 539 percent means something different than you might think, and you cannot simply buy it anywhere yet. In this blog, you will read what clascoterone does, what the studies show, what you should be cautious about, and what you can do in the meantime.
What is clascoterone?
Clascoterone is an anti-androgen that you apply to the skin. The substance itself is not new. Under the brand name Winlevi, a 1 percent cream has been approved in the United States since 2020 for acne, and according to the manufacturer, Cosmo Pharmaceuticals, it has also been approved by the European Medicines Agency (EMA). For hair loss, Cosmo is developing a separate 5 percent solution that you apply to the scalp.
To understand why people are paying such close attention, you have to look back at the cause of hereditary hair loss. In men with a predisposition, hair follicles on the crown and at the temples are sensitive to DHT, a hormone derived from testosterone. DHT binds to the androgen receptor in the hair follicle. This triggers a process that causes the follicle to shrink, resulting in thinner, shorter hair regrowth. You can read more about this in DHT and hair loss.
How it differs from finasteride and minoxidil
The well-known treatments address the problem in a different way.
- Finasteride inhibits the enzyme that converts testosterone into DHT. As a result, DHT levels decrease throughout your entire body, not just on your head. This is the reason why some men experience side effects. More in finasteride explained honestly.
- Minoxidil does nothing with hormones at all. It extends the growth phase of the hair and increases blood flow around the hair follicle, but the underlying sensitivity to DHT remains.
- Clascoterone leaves your DHT levels as they are, but blocks the receptor in the hair follicle. The DHT is still there; it just can no longer bind.
The idea is that clascoterone is broken down quickly once it enters the bloodstream, so the rest of your body is barely affected. That is the main selling point: an approach that targets the root cause without altering your hormone balance. Whether that plays out that way for everyone in practice remains to be seen. But it is a different mechanism than anything currently available.
What the studies show so far
Cosmo conducted two large Phase 3 studies, SCALP 1 and SCALP 2. Together, 1,465 men with mild to moderate hair loss participated across 51 clinics in the US and Europe. Half received clascoterone, while the other half received a solution without an active ingredient. After six months, researchers counted the number of hairs in a fixed area of the scalp.
The results, as announced by Cosmo in December 2025 and April 2026:
- In one study, the hair count increased more than five times as much as with the placebo; in the other, about 1.7 times as much.
- Regarding how men rated their own hair growth, the results in one study were significantly better than the placebo. In the other, there was a positive trend, but no hard difference.
- Side effects occurred about as often as with the placebo.
- Men who continued applying the treatment after six months continued to see hair growth up to twelve months. Men who switched to the placebo saw their gains diminish.
The last point is perhaps the most instructive. Just like with finasteride and minoxidil, clascoterone only works as long as you use it. If you stop, the process simply continues.
Why that 539 percent says less than it seems
This is where most articles go wrong. The 539 percent is a relative number. It compares growth in the clascoterone group with growth in the placebo group.
Suppose the placebo group gains an average of 2 hairs per square centimeter and the clascoterone group gains 11. That is more than five times as much. It sounds spectacular, but it involves a difference of a few hairs on a small area. The smaller the gain in the placebo group, the larger such a percentage becomes.
The honest answer is that we do not yet fully know the absolute numbers from Phase 3. These have not yet appeared in a peer-reviewed scientific journal. Until that happens, no one outside the company knows exactly how much hair an average user will gain and how that compares to minoxidil or finasteride. The difference between the two studies (5 times vs 1.7 times) is also significant enough to be curious about the details.
Also, keep in mind that almost everything we know comes from press releases from the manufacturer. That does not make it untrue. It just means you should read it with a grain of salt until independent researchers have been able to review the full data.
When can you get it?
Not yet. Cosmo plans to submit the application to the US FDA in early 2027 and is preparing a European application. A review usually takes about a year. Do not count on being able to get it at a Dutch pharmacy before 2028, and even then, it remains to be seen how expensive it will be and whether you will need a prescription.
Can't you just use the acne cream?
On forums, you may read about men applying Winlevi to their scalps. This is understandable, but there are some good reasons not to do it:
- It is a 1 percent acne cream, not the 5 percent solution tested for the scalp. No one knows how much actually reaches your hair follicles.
- Applying a cream to your hair is messy and greasy in practice.
- The product information for the acne cream states that temporary suppression of adrenal function has sometimes been observed with intensive use on a large skin area. Your scalp is a large area.
- You would be using a medication off-label without medical supervision.
In short: waiting until the treatment for hair loss is available is the wiser choice.
What you can do now
Perhaps the biggest risk of clascoterone is not a side effect, but the risk of just waiting. Hereditary hair loss continues as long as you do nothing, and a hair follicle that has produced nothing for years cannot be brought back by any treatment. Not even by clascoterone. You can read more about why this is in when is hair loss still reversible.
What is available now:
- Minoxidil over-the-counter at a pharmacy or drugstore.
- Finasteride by prescription, as a pill or through a clinic as topical finasteride. Your GP is a logical first point of contact for this; see visiting the GP with hair loss.
- A non-medicated hair serum, if you do not want to use medication (yet).
For the latter group, we created the Hairborn Growth Serum, with Redensyl, Procapil, and Baicapil. It works differently than clascoterone and does not block the androgen receptor. It focuses on the scalp and the hair growth phase. Do not expect miracles, and give it three to six months. Some men combine it with a derma roller. If clascoterone comes to market later, the one does not exclude the other.
As far as we are concerned, clascoterone is good news. A treatment that targets the root cause while leaving your hormones alone is exactly what many men are looking for. But it is not a done deal yet, and it is certainly no reason to leave your hair to its fate for the next two years.
Frequently Asked Questions
Is clascoterone available in the Netherlands for hair loss?
No, clascoterone for hair loss is not approved anywhere yet. The manufacturer, Cosmo, plans to submit an application to the US FDA in early 2027 and is preparing a European application. A review usually takes about a year. So, do not count on the medication being available at a Dutch pharmacy before 2028. If you encounter anything online sold as clascoterone for your hair, it has not been approved for this use.
What is the difference between clascoterone and Breezula?
There is no difference in the active substance. Breezula is the name under which the 5 percent solution for hair loss was previously referred to in research; clascoterone is the substance itself. Whether the treatment will actually be called Breezula upon approval is not yet known. Winlevi is the same substance, but as a 1 percent cream for acne.
Does clascoterone work better than finasteride?
We don't know that yet. There is no study that directly compares the two. Clascoterone has only been tested against a placebo, and the absolute hair growth data from Phase 3 has not yet been published. Additionally, finasteride has decades of data behind it. The advantage of clascoterone lies primarily in its mechanism of action: it does not lower DHT throughout your entire body.
Does clascoterone have side effects?
In the Phase 3 studies, side effects occurred about as often as with the placebo, even after twelve months. That is hopeful, but the full data has not yet been reviewed by independent researchers. With the acne cream containing the same substance, temporary suppression of adrenal function was sometimes seen with intensive use on large skin areas. How this applies to daily use on the scalp will be determined by the official assessment.
Does clascoterone cause sexual side effects like finasteride?
As far as currently known, no more often than a placebo. The idea behind clascoterone is that it works locally and is broken down quickly once it enters your blood, so your hormone levels remain stable. The manufacturer reports no significant hormonal side effects in the studies. Until the full data is published, it is wise to view this as preliminary.
Do you have to use clascoterone for the rest of your life?
Yes, if you want to maintain the effect. In the study, men who switched to the placebo after six months saw their gains diminish, while men who continued to use it continued to gain hair. This is the same pattern as with finasteride and minoxidil. The treatment inhibits the process as long as you use it, but it does not remove the hereditary predisposition.
Is it better to wait for clascoterone instead of doing something now?
No, waiting is usually the worst choice. Hereditary hair loss continues, and hair follicles that have produced nothing for years will not come back with any treatment. Clascoterone is at least a few years away. If you start with an existing approach now, you will have more hair left to protect, regardless of what you choose in the future.
Can I combine clascoterone with minoxidil later?
Theoretically, that makes sense, as they work in different ways. Minoxidil stimulates the growth phase; clascoterone blocks the effect of DHT on the hair follicle. However, no research has been published on that combination. Once the treatment is on the market, it is best to discuss such a combination with a doctor or dermatologist.
Does clascoterone also work for women?
That has not yet been researched in large studies. SCALP 1 and SCALP 2 were only conducted with men with mild to moderate hereditary hair loss. Therefore, there is no reliable data on how it works for women. For women with hair loss, the existing options via a GP or dermatologist remain the route for now.
Does clascoterone also work if you are already bald?
Probably not. The studies only included men with mild to moderate hair loss. A treatment that blocks DHT can protect a hair follicle that is still alive and producing hair. If an area has been smooth and bald for years, the hair follicles there have usually shrunk to the point where there is little left to save. No treatment can do much about that.