Clascoterone and male pattern baldness: the 12-month results that change the picture

This matters. Roughly one man in two loses his hair by fifty, and up to eight in ten by sixty. Yet since finasteride arrived in 1997, no new molecule has been approved for the condition. Almost thirty years without a real step forward. For the wider picture, the page on clascoterone covers the basics.

The verdict in one line: the effect holds at 12 months, it beats what specialists were expecting, but the drug is not yet available in Europe. This article walks through the figures, sets them against current treatments for male pattern baldness, and lays out the timeline.

How clascoterone works

Clascoterone (code name CB-03-01, sold as Breezula for baldness) sits in a family of molecules called topical anti-androgens. In plain terms, it cancels out the action of male hormones, but only on the skin where you apply it.

To see why that matters, you need to look at DHT. DHT is a “boosted” form of testosterone. In genetically sensitive men, it shrinks the follicle (the tiny microscopic factory that makes the hair) at every cycle, until the follicle gives up entirely. It’s the hormonal driver of baldness. The page on DHT and hair loss walks through the mechanism in detail.

Two ways to neutralise DHT

Picture a lock and key. DHT is the key that triggers the follicle-shrinking programme. There are two ways to block it.

Finasteride, taken orally, stops the key being made in the first place. It blocks the enzyme that turns testosterone into DHT, before the hormone has any chance to act.

Clascoterone lets the key drift around but jams the lock. Applied locally to the scalp, it binds to the follicle’s receptor and stops DHT from latching on. The key is still there. It just no longer fits.

In the lab, clascoterone blocks this receptor about as effectively as finasteride, and it outperforms other anti-androgens tested alongside it (such as spironolactone). No head-to-head clinical comparison with finasteride has been published yet. Biologically, though, the two are on a par.

Clascoterone acts on the scalp, not in the bloodstream

This is what really sets clascoterone apart from oral finasteride. Once the skin absorbs it, the body breaks it down almost immediately into cortexolone, an inactive form. The result: almost none of it reaches the bloodstream, so it has no hormonal effect on the rest of the body.

Minoxidil only stimulates the follicle without touching the hormonal cause. Clascoterone goes after the driver of baldness directly, while staying local. It’s the first treatment to bring those two strengths together. To dig deeper, see also the available DHT blockers.

The mechanism is clear. The next question is what it actually delivers in practice, on thousands of men followed for a year.

Results from the SCALP 1 and SCALP 2 trials at 12 months

The SCALP 1 and SCALP 2 programme enrolled 1,465 men aged 18 to 55 with mild to moderate baldness (stages III to V on the Norwood scale, which grades how far male pattern baldness has spread). The trial ran in two phases: six months under strict conditions (neither patients nor doctors knew who was getting what), then a six-month extension to track the effects over time.

1,465 men followed for a year

The six-month results, published in late 2025, already set the tone. Using a standardised hair count in a defined zone of the scalp, the gain was 5 to 6 times higher than placebo in the first trial, and 1.7 times higher in the second. Both trials were statistically solid.

The 12-month extension confirms the trajectory. Men who stayed on treatment for a full year grew 2.39 times more hair than those switched back to placebo at six months. In other words, the gains don’t fade with time, they keep building. What the early phase had hinted at as “possibly better than topical minoxidil” now stands up over a full year of use.

On the patient side, satisfaction climbs in step: the self-rated score is about 24% higher than the placebo group at twelve months. In plain English, patients see the difference and feel it. Set next to current evidence-based hair loss treatments, this efficacy curve is unprecedented for a topical.

Side effects: the real edge over finasteride

This is probably clascoterone’s strongest argument. Over a year of use, the safety profile stays on a par with placebo overall.

No significant hormonal effects were reported. No drop in libido, no erectile problems, no mood changes. None of what you sometimes see with oral finasteride in 2 to 5% of patients, occasionally lingering even after stopping. To understand those effects, see oral finasteride and its side effects and the page on hormones and hair loss.

Local effects stayed mild: slight dryness, the odd patch of redness at the application site, or fine hair growth on the exact spot where the product is applied. Nothing troublesome long term.

So far, no cases of post-finasteride syndrome have been reported (the persistent effects on libido or mood that a small number of men describe after stopping finasteride). Five-year data are still to come, but the one-year picture is reassuring.

The efficacy is settled. So where does clascoterone sit alongside the treatments that already exist?

Clascoterone, finasteride and minoxidil: where does it fit?

Oral finasteride is still the reference for male pattern baldness today. But clascoterone now stands out as the first credible topical alternative in a long time.

Here’s the comparison, molecule by molecule:

• Oral finasteride 1 mg: proven efficacy, with on average +10% hair count at 2 years in landmark studies. Sexual side effects in 2 to 5% of patients, sometimes persistent.
• Topical minoxidil 5%: stimulates the follicle without touching the hormonal cause. Modest gain, around 17 hairs per cm² at 16 weeks.
• Topical clascoterone 5%: blocks the hormonal cause directly on site, with no systemic absorption. First effects at 3 months, gains continue up to 12 months.

On paper, clascoterone pairs two strengths that had never lived in a single product before: anti-hormonal action (until now only available with oral finasteride) and the topical route (until now only with minoxidil). A genuinely new positioning.

Can it be used with minoxidil?

Yes. The two molecules act through different mechanisms and complement each other naturally. Minoxidil stimulates the follicle, clascoterone shuts down the hormonal cause. So they can be used together, much as minoxidil and finasteride are already combined in some patients.

One important point: no trial has directly compared clascoterone with oral finasteride in the same patients. The comparisons stay indirect, drawn from rates seen in separate studies. For men who prefer a stronger oral blocker, the dutasteride vs finasteride comparison still applies. On topical alternatives, see also low-dose oral minoxidil and the choice between foam and liquid.

Clascoterone doesn’t replace finasteride. It opens up an option for men who refuse oral treatments, those who can’t tolerate them, and those who don’t respond well enough. The link between testosterone and hair loss stays the same. Only the route of administration changes.

When will it be available in the UK and Europe?

Clascoterone is on its way, but not just yet. Cosmo Pharmaceuticals plans to file with the US FDA in early 2027, alongside a parallel submission to the European Medicines Agency. For the UK and Europe, the realistic horizon sits between late 2027 and 2028, assuming the files clear without trouble.

In the meantime, clascoterone isn’t available in UK pharmacies. Some international platforms sell CB-03-01 for “research use”, but that happens outside any safe medical setting, with no quality control and no follow-up. Best avoided.

The protocol used in the trials, which will probably shape future prescriptions:

• 1 mL of 5% solution applied to a dry scalp
• Twice a day, morning and evening
• On the affected zones (temples, vertex, crown)
• First visible effects around three months, ongoing gains over twelve months

The candidates the trials picked out: men aged 18 to 55, with mild to moderate baldness (stages III to V on the Norwood scale). To work out your stage, see the page on the stages of male pattern baldness. For women, studies are under way and no timeline has been announced yet.

Contraindications: application on broken skin, active eczema, flaring psoriasis. Pregnancy and breastfeeding remain off-limits as a precaution, even though systemic absorption is very low. And no data exist beyond twelve months: long-term follow-up is still to be built.

For younger men dealing with early-onset baldness or thinning hair, as long as clascoterone isn’t on the market, the strategy stays the same: act early with the existing treatments, combine approaches, and prevent hair loss before the area thins out for good.

What to do while waiting for 2027-2028

Clascoterone looks promising, but it isn’t here yet. And even when it arrives, it won’t regrow hair that’s already gone. Its job is to keep and reactivate follicles that are still alive, not to bring back ones that have died. On areas that have truly thinned out, whether the temples, the crown or the front hairline, only a hair transplant in Turkey can put living follicles back.

Several options are open at Dr Cinik’s clinic for men who want to act without waiting for 2028.

Sapphire FUE uses sapphire blades to open very fine channels, which lets thinned areas be redensified with quick healing. It works on the zones clascoterone won’t be able to recover, even once it’s on the market. See the Sapphire FUE page.

DHI implants the grafts directly with an implanter pen (the Choi pen), with millimetre precision. Particularly suited to the front temples and highly visible zones. See the DHI page.

Hair exosomes inject vesicles loaded with growth factors into the scalp to stimulate existing follicles. First effects show up between three and six months. They will also pair well with clascoterone once it’s available. Hair exosomes can also be used in their variant with autologous fibrin, on the hair PRF page.

PRP, included in every transplant package, injects the growth factors from your own blood to support regrowth. See the PRP for hair page.

Dr Cinik brings more than 20 years of experience in hair restoration and more than 50,000 patients treated, with protocols that meet ISHRS standards (the international scientific society of reference for hair transplantation), structured follow-up and a free personalised consultation.

To see results on profiles close to yours, browse Dr Cinik’s before and after photos. And if you’re torn between starting medical treatment now or waiting for clascoterone, a free consultation gives you a clear diagnosis and helps you pick the path that genuinely fits your situation.

Scientific references

Cosmo Pharmaceuticals. (2026, 15 avril). Phase III 12-Month Data for Clascoterone 5% Topical Solution Confirm Positive Safety for Chronic Use and Continued Hair Growth, both of which are Statistically Significant [Communiqué]. https://www.cosmohealthconfidence.com/news/98958067-clascoterone-12-month-safety-results-ende

Devjani, S., Ezemma, O., Kelley, K. J., Stratton, E., & Senna, M. (2023). Androgenetic alopecia: Therapy update. Drugs, 83(8), 701-715. https://pmc.ncbi.nlm.nih.gov/articles/PMC10173235/

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://pmc.ncbi.nlm.nih.gov/articles/PMC7177662/

Kaiser, M., Abdin, R., Gaumond, S. I., Issa, N. T., & Jimenez, J. J. (2023). Treatment of androgenetic alopecia: Current guidance and unmet needs. Clinical, Cosmetic and Investigational Dermatology, 16, 1387-1406. https://pmc.ncbi.nlm.nih.gov/articles/PMC10239632/

Mazzarello, V., Ferrari, M., & Ena, P. (2021). Clascoterone: A new topical anti-androgen for acne management. Drugs of Today, 57(7), 459-464. https://pubmed.ncbi.nlm.nih.gov/34242398/

Ntshingila, S., Oputu, O., Arowolo, A. T., & Khumalo, N. P. (2023). Androgenetic alopecia: An update. JAAD International, 13, 150-158. https://pmc.ncbi.nlm.nih.gov/articles/PMC10562178/

Rosette, C., Rosette, N., Mazzetti, A., Moro, L., & Gerloni, M. (2019). Cortexolone 17α-propionate (clascoterone) is a novel androgen receptor antagonist that inhibits production of lipids and inflammatory cytokines from sebocytes in vitro. Journal of Drugs in Dermatology, 18(2), 197-201. https://pubmed.ncbi.nlm.nih.gov/30811143/

Sanchez, C., & Keri, J. (2022). The efficacy and safety of topical clascoterone cream (1%) for treatment in patients with facial acne. Clinical, Cosmetic and Investigational Dermatology, 15, 1357-1366. https://pmc.ncbi.nlm.nih.gov/articles/PMC9297041/