Breezula (topical clascoterone): a new treatment for androgenetic alopecia?

Cosmo Pharmaceuticals published new results on Breezula (topical clascoterone 5%), a drug in development that could become a new option for the treatment of androgenetic alopecia.

The announcement has generated excitement in both specialized media and financial markets, but what's really behind this data? Does Breezula represent a paradigm shift in hair loss?

Let's analyze it with medical criteria, focusing on its mechanism of action, real effectiveness, limitations, and its possible future role in the management of alopecia.

What is Breezula (clascoterone) and how does it work?

Breezula, whose active ingredient is clascoterone, is a topical antiandrogen designed to block the male hormone receptor (androgen receptor) directly in the scalp.

Mechanism of action

Unlike classic drugs such as:

• finasteride or dutasteride, which reduce the production of dihydrotestosterone (DHT),

• or minoxidil, which stimulates hair growth,

  
  

Clascoterone does not reduce systemic hormones, but rather:

• locally blocks the androgen receptor,

• It is rapidly metabolized in the skin,

• It barely passes into the bloodstream,

This reduces the risk of systemic side effects, one of the main fears of many patients.

This pathway is particularly interesting, since there are no approved treatments in men that directly block the androgen receptor locally.

SCALP-1 and SCALP-2 clinical trials: what the data really say

Cosmo Pharmaceuticals has reported results from two clinical trials:

• SCALP-1

• SCALP-2

With a total of approximately 145 patients, evaluating the efficacy of topical clascoterone 5% versus placebo.

Primary variable: hair count (THC)

The main variable was the Target Hair Count (THC), that is, the number of hairs in a specific area of the scalp previously marked.

Important: the measurement is not taken at the entrances, but in a central area more favorable to the response, something common in clinical trials, but which must be taken into account when interpreting the results.

Results: striking percentages, but few absolute data

According to the press release:

• In SCALP-1 , a relative improvement of 539% compared to placebo is reported.

• In SCALP-2 , the improvement is much smaller: 168% versus placebo .

  
  

Why does this data raise doubts?

1. Absolute data (actual number of hairs gained) is not published.

2. The comparison is against a placebo, which in androgenetic alopecia usually worsens or does not improve.

3. Small absolute differences can translate into very high percentages.

4. The enormous variability between the two trials (539% vs 168%) raises methodological questions.

   
   

Although the percentages are impressive, they do not allow us to assess the real clinical relevance.

Safety and regulatory approval: realistic timelines

Regarding security:

• No serious adverse effects have been reported.

• Local itching is described, similar to topical minoxidil.

  
  

However:

• There is no long-term (12 months) safety data yet.

• Cosmo has indicated that it will not seek approval from the FDA or EMA until it has this data.

  
  

If development continues without setbacks, Breezula would not be approved before 2027, and that's in the best-case scenario.

Is Breezula more effective than finasteride or minoxidil?

According to previous studies:

• It will not change the treatment of moderate or advanced alopecia.

• Yes, it could have a role in mild alopecia, initial stages or maintenance.

  
  

In which patients might Breezula make sense?

From a clinical point of view, Breezula could be useful in:

• patients with mild androgenetic alopecia,

• maintenance phases, reducing doses of oral drugs,

• patients who do not tolerate finasteride,

• combined topical regimens (minoxidil + antiandrogen).

  
  

Key findings on Breezula and androgenetic alopecia

1. There will be no approval in the short term (probably 2027 or later).

2. Current communication is primarily aimed at investors, not patients.

3. It will not replace current treatments, but it can be a complement.

4. It provides a new therapeutic approach: local androgen receptor blockade.

5. It is positive that the industry continues to invest in new treatments for alopecia, a field with few real advances in recent years.

Final reflection

Breezula represents an interesting advance from a pharmacological perspective, but it's important to maintain a critical and realistic view. In hair restoration medicine, sensational headlines don't always translate into significant clinical improvements. Comprehensive evidence, with absolute data and long-term follow-up, will be key to assessing its true impact.