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New remedy for hair loss before approval: A game changer? – DiePresse.com

Hope on the Horizon: New Drug Clascoterone Shows Dramatic Hair Growth in Clinical Trials – Is This the Breakthrough Millions Have Been Waiting For?

Vienna, Austria – In a potentially game-changing development for the millions suffering from hair loss, a new drug called clascoterone has demonstrated remarkable results in a phase 3 clinical trial. Published by Irish pharmaceutical company Cosmo Pharmaceuticals, the study, involving nearly 1,500 men across the US and Europe, revealed a staggering 168 to 539 percent increase in hair growth compared to a placebo. This is breaking news for anyone affected by androgenetic alopecia, commonly known as male pattern baldness.

How Does Clascoterone Work? Targeting the Root Cause of Hair Loss

According to clinical pharmacologist Markus Zeitlinger of the Medical University of Vienna, understanding the underlying cause of hair loss is key. “Alopecia often occurs when hair follicles become overly sensitive to androgens – male sex hormones like testosterone,” explains Zeitlinger. Clascoterone tackles this issue directly by blocking androgen receptors in the skin. This action is believed to reduce sebum production and, crucially, inhibit inflammation, a process that leads to follicle shrinkage and eventual hair loss. “Once the follicle dies, that’s it. The process isn’t reversible at that late stage,” Zeitlinger cautions.

Early Intervention is Crucial: When Can Clascoterone Help?

The study suggests clascoterone is most effective when used before hair loss becomes severe. Zeitlinger is blunt: “If you have a mirror-smooth bald head, it’s definitely too late.” The greatest impact is expected in areas where follicles are still active, showing transitional hair loss. This isn’t a cure, but a potential way to slow or halt the progression of hair loss.

From Acne Treatment to Hair Growth: A Serendipitous Discovery

Interestingly, clascoterone isn’t a new drug. It’s already approved under the brand name Winlevi as a topical treatment for acne, having received the green light from the European Medicines Agency (EMA) in October and the US FDA in 2020. Stronger hair growth was observed as a “side effect” during acne trials, prompting Cosmo Pharmaceuticals to investigate its potential as a hair loss treatment, using a five-times higher dose. Currently, Winlevi is available online, offering a glimpse into potential accessibility should the hair loss treatment gain approval.

Potential Side Effects and Cost: What You Need to Know

While the phase 3 study reported no side effects specifically related to the hair loss application, Zeitlinger points out that Winlevi (for acne) has been linked to local irritation, hormonal changes, and hyperkalemia – a potentially dangerous electrolyte imbalance that can cause heart arrhythmias. “If these side effects occur at low doses, it’s reasonable to assume they could occur at higher doses too,” he states. He emphasizes that all medications carry risks, but also potential benefits.

The cost is also a significant factor. A 60-gram tube of Winlevi currently sells for around €550. Zeitlinger anticipates a hair loss treatment based on clascoterone would likely be similarly priced, translating to several hundred euros per month. This positions it as a potentially premium option compared to existing treatments.

Clascoterone vs. Existing Treatments: How Does it Stack Up?

Currently, two main treatments are widely used for hair loss: minoxidil, a topical solution, and finasteride, an oral medication. Minoxidil promotes circulation to the scalp, while finasteride blocks the conversion of testosterone to DHT, a hormone linked to hair loss. Finasteride, while significantly cheaper, carries potential side effects like erectile dysfunction. Zeitlinger suggests that while a high dose of Winlevi might offer some benefit, it’s unlikely to compete with minoxidil and finasteride on a cost-benefit basis.

What’s Next? Approval Timeline and Future Outlook

Zeitlinger predicts a potential EMA application in 2026, following the release of more detailed study data in the coming months. Given the positive results and relatively few reported side effects, approval seems likely. However, he tempers expectations: “Clascoterone is not a miracle cure, but a potentially valuable addition to the arsenal against hair loss.” The need for twice-daily application and lifelong use are also important considerations.

The development of clascoterone represents a significant step forward in the ongoing quest to combat hair loss. While not a panacea, it offers a new avenue of hope for those seeking to preserve and restore their hair, and underscores the importance of continued research in this often-overlooked area of health and well-being. Stay tuned to archyde.com for further updates on this developing story and expert analysis on the latest advancements in medical science.

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