Clascoterone: New Drug Shows Promise in Hair Regrowth – Study Results

A new potential treatment for male pattern baldness is showing promising results. A Phase 3 study, involving nearly 1500 men across the United States and Europe, revealed that participants experienced a 168 to 539 percent increase in hair count compared to those receiving a placebo. The study, conducted by the Irish pharmaceutical company Cosmo Pharmaceuticals, indicates a “significant, clinically relevant improvement” in hair growth.

Understanding the Science Behind Hair Loss

The treatment, centered around the active ingredient Clascoterone, targets a key factor in androgenetic alopecia – commonly known as male pattern baldness. According to Markus Zeitlinger, a clinical pharmacologist at the Medical University of Vienna, this type of hair loss occurs when hair follicles become overly sensitive to androgens, such as testosterone. Less frequently, a very high level of androgens can also contribute.

Did You Know? A Phase 3 study is the final stage of clinical trials before a drug can be submitted for regulatory approval.

How Clascoterone Works

Clascoterone is applied to the scalp as a solution or cream and works by blocking androgen receptors in the skin. This action is believed to reduce sebum production and inhibit inflammation. Inflammation is particularly relevant, as it can cause hair follicles to shrink and eventually stop producing hair. Zeitlinger explains that once this process reaches a certain point, it becomes irreversible.

The potential treatment appears most effective when used before hair loss becomes too advanced. “If there is a completely smooth scalp, it is definitely too late,” Zeitlinger stated. The most significant effects are expected in areas where follicles haven’t completely disappeared.

From Acne Treatment to Hair Growth

Interestingly, Clascoterone is already approved for use in treating acne, sold under the brand name Winlevi. It received approval from the European Medicines Agency (EMA) in October of last year, and from the US in 2020. During the development of Winlevi, researchers observed increased hair growth in many participants, prompting further investigation into its potential as a hair loss treatment. The dosage used for hair loss trials is five times higher than that used for acne.

Expert Insight: The fact that Clascoterone is already approved for another condition suggests a degree of established safety, which could expedite the regulatory process for a hair loss treatment. However, higher dosages, as used in the hair loss study, may introduce different risk profiles.

Potential Side Effects

The Phase 3 study did not report any side effects. However, individuals using Winlevi for acne have experienced local skin irritation, hormonal changes, and hyperkaliemia – a condition involving abnormally high potassium levels in the blood, which can lead to heart rhythm disturbances. Zeitlinger cautions that side effects observed at lower doses are likely to occur at higher doses as well. He emphasizes that all medications have potential side effects.

What’s Next?

While the results are encouraging, Zeitlinger doesn’t consider Clascoterone a “gamechanger” or “miracle cure.” He points out that the study data presented by the pharmaceutical company focuses on percentage increases, which can be misleading without absolute numbers. A 100 percent increase from a very small number of hairs may not be visually significant.

The study assessed hair growth based on two factors: the increase in hairs per square centimeter and subjective/objective evaluations of hair growth. Significant improvements in both assessments were seen in participants with nearly a 500 percent increase in hair growth, but less so in those with around a 170 percent increase. Zeitlinger finds this “suspicious,” suggesting the actual effects may be modest.

If approved, the treatment would likely require twice-daily application for an indefinite period, as stopping use would likely reverse any gains. The treatment is not a cure for hereditary hair loss.

Zeitlinger anticipates a potential launch in 2026, following further study details and a formal application to the EMA. Given the observed positive effects and relatively minor side effects, approval is considered likely.

Cost Considerations

The cost of treatment could be substantial. A 60-gram tube of Winlevi, the acne treatment, currently costs around 550 Euros. A dedicated hair loss medication is expected to be similarly priced, potentially costing several hundred Euros per month.

Existing Treatments

Currently, two main treatments are available: Minoxidil, a solution applied to the scalp that also has blood pressure-lowering effects, and Finasterid, a tablet that blocks the conversion of testosterone to dihydrotestosterone (DHT). Finasterid is also used to treat prostate enlargement, but can cause side effects such as erectile dysfunction. These existing treatments are considerably cheaper than Winlevi.

Using Winlevi at a high dose could potentially have an effect, but may not be cost-effective compared to Minoxidil and Finasterid.

Frequently Asked Questions

What causes androgenetic alopecia?

Androgenetic alopecia, or male pattern baldness, occurs when hair follicles become overly sensitive to androgens like testosterone, or in rarer cases, when androgen levels are very high.

How is Clascoterone administered?

Clascoterone is applied to the scalp as a solution or cream, and would likely require twice-daily application if approved.

Are there any known side effects of Clascoterone?

While the Phase 3 study reported no side effects, those taking Winlevi for acne have experienced local skin irritation, hormonal changes, and hyperkaliemia (high potassium levels).

What factors might influence whether this treatment is right for you?