If you’ve been searching for the best hair loss products for men, you know the struggle: most treatments have been the same for over 30 years. Whether it’s oral pills or topical foams, the mechanism has largely remained unchanged.
But that is about to change.
New data from Cosmo Pharmaceuticals has just revealed groundbreaking Phase III results for a new topical treatment called Clascoterone 5% solution. The results are turning heads in the dermatology world—specifically, a massive 539% relative improvement in hair count compared to placebo.
Here is everything you need to know about this new development in androgenetic alopecia treatment and what it means for the future of your hair regrowth journey.
What is Clascoterone?
Clascoterone (specifically the 5% topical solution) is a new type of treatment known as a topical androgen receptor inhibitor.
Unlike oral medications that affect hormones throughout your entire body, Clascoterone is designed to work locally. It targets the biological root cause of male pattern hair loss—Dihydrotestosterone (DHT)—directly at the hair follicle level on your scalp.
Why is this a big deal?
For decades, men have had to choose between efficacy and potential systemic side effects. Because Clascoterone is applied directly to the scalp and rapidly metabolizes, it aims to block DHT without significantly impacting your body’s natural hormonal balance elsewhere.
The Phase III Trial Results: SCALP 1 & SCALP 2
Cosmo Pharmaceuticals recently released topline results from their two pivotal Phase III trials, SCALP 1 and SCALP 2, which included 1,465 male patients across the US and Europe. These are the largest Phase III studies ever conducted for a topical hair loss treatment.
Here are the key takeaways from the data:
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Massive Regrowth Numbers: In the SCALP 1 study, patients saw a 5.39x (539%) relative improvement in Target-Area Hair Count (TAHC) compared to those using a placebo. The SCALP 2 study showed a 168% relative improvement.
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Safety Profile: The safety profile was highly favorable. The rate of adverse events was similar to the vehicle (placebo) group, suggesting the drug is well-tolerated.
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Patient Satisfaction: It wasn’t just a numbers game; patient-reported outcomes showed that men actually perceived meaningful improvements in their hair coverage.
"For decades, patients have had to choose between available treatment options with limited efficacy or safety issues... These findings show the potential for clascoterone 5% topical solution to change that equation." > — Dr. Maria Hordinsky, Professor of Dermatology, University of Minnesota
How Does This Compare to Current Hair Loss Products?
If you are currently using products like Minoxidil or natural DHT blockers, you might be wondering where this fits in.
Current treatments generally fall into two categories:
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Stimulants: Like Minoxidil, which stimulate blood flow and prolong the hair growth phase.
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Systemic Blockers: Oral medications that reduce DHT production body-wide.
Clascoterone represents a third category: a local DHT blocker. It stops the hormone from damaging the follicle right at the source, without lowering DHT levels in the rest of your body. This makes it a potential game-changer for men who are hesitant to take oral medications due to side effects.
When Will It Be Available?
Cosmo Pharmaceuticals is currently completing a mandatory 12-month safety follow-up, which is expected to finish in Spring 2026. Following that, they plan to submit applications to the FDA (USA) and EMA (Europe).
While we wait for this prescription-grade treatment to hit the market, it is vital to maintain your current hair health regimen. Keeping your scalp healthy and follicles active is the best way to ensure you are a good candidate for future treatments.
What You Can Do Now
While science advances, consistency is key.
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Stick to your routine: Continued use of hair growth serums and scalp treatments helps maintain the hair you have.
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Scalp Health: a healthy scalp environment is necessary for any growth treatment to work. Look for shampoos that reduce inflammation and clear pore-blocking sebum. We've personally vetted and hand picked many of the best products like this, available for purchase here on Pelo!
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Stay Informed: We will keep updating our shop with the latest hair loss news so you never miss a breakthrough.
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