What is Clascoterone? A New Hair Loss Treatment
If you have been researching hair loss treatments, you are likely familiar with the two most common medical therapies: Minoxidil and Finasteride. For over three decades, these have been the standard options for managing male pattern baldness. While effective at slowing hair loss, they are not perfect for everyone. Many patients hesitate to use oral medications due to the inconvenience of daily pills or concerns about systemic side effects.
However, the landscape of hair restoration continues to evolve. Recent clinical trials have revealed highly encouraging results for a new type of medication: Clascoterone 5% topical solution. If approved by the FDA, it will represent the first new mechanism for managing hair loss in over 30 years. Here is a look at the science behind this upcoming treatment option.
Why is Clascoterone Important?
To understand why Clascoterone is an important development, it helps to understand what causes hair loss. Male pattern baldness (Androgenetic Alopecia) is primarily driven by a hormone called DHT. Over time, DHT binds to hair follicles, causing them to shrink, weaken, and eventually stop producing hair.
Currently, the most effective way to stop DHT is by taking oral medications like Finasteride. However, because it is an oral pill, it affects hormones throughout the entire body—not just the scalp. This systemic exposure is a primary reason some men choose to avoid medical therapy.
How it Takes a Different Approach
Clascoterone takes a completely different approach. Instead of altering hormones throughout your bloodstream, it is applied directly to the scalp as a topical solution.
It functions as a local androgen receptor inhibitor. In simple terms, it acts like a localized shield right at the follicle, blocking DHT from attaching to the hair root. Because the medication is quickly broken down by the body once it absorbs into the skin, it does its job locally without causing meaningful changes to your systemic hormones.
Note: While Clascoterone shows great promise as an effective management tool, it is important to understand that it is not a permanent cure for alopecia. Like Minoxidil and Finasteride, it must be used continuously to maintain results.
What Were the Phase 3 Results for Clascoterone?
The anticipation surrounding Clascoterone is backed by significant clinical data. Cosmo Pharmaceuticals recently concluded two large-scale Phase 3 clinical trials (known as SCALP 1 and SCALP 2) across the US and Europe, involving nearly 1,500 men.
The results demonstrated strong efficacy for hair retention and growth:
Significant Growth: In one of the trials, patients using Clascoterone saw a 539% relative improvement in their target-area hair count compared to those using a placebo vehicle.
Noticeable Changes: Patient-reported outcomes showed that the men actually perceived the visual improvement in their hair growth, a crucial factor for overall treatment satisfaction.
High Safety Profile: The side effects reported were minimal and similar to those experienced by patients who only used the placebo, reinforcing its safety as a localized, non-systemic treatment.
When Will Clascoterone Be Available?
The medication is currently finishing its final 12-month safety follow-ups. Cosmo Pharmaceuticals is expected to submit the drug to the FDA and European regulatory agencies this spring (2026). If approved, it will become the first topical androgen receptor inhibitor ever indicated for the management of hair loss.
Exploring Your Hair Restoration Options
At Advanced Hair Restoration, we are dedicated to providing our patients with the most effective, scientifically proven options available. While the medical community awaits the final FDA approval of Clascoterone, we currently offer comprehensive solutions to permanently address hair loss, including cutting-edge Advanced FUE hair transplants and customized hairline restoration procedures.