Clascoterone Emerges as Promising Treatment for Hair Loss

Hair loss, particularly androgenetic alopecia, commonly known as male or female pattern baldness, significantly impacts emotional well-being. It can begin subtly as early as one’s 20s or 30s, gradually affecting self-esteem and overall quality of life. Many patients express frustration with current treatment options, such as minoxidil and finasteride, and are eager for alternatives. Recent advancements in treatment research offer a ray of hope: clascoterone, a topical formulation originally developed for acne, is now showing significant potential for promoting hair regrowth.

Clascoterone, which is already approved in a 1 percent cream form under the brand name Winlevi for acne treatment, acts as a topical androgen receptor inhibitor. This medication specifically targets androgen receptors located in the skin and hair follicles, countering the effects of dihydrotestosterone (DHT). DHT is the primary hormone responsible for follicle miniaturization in androgenetic alopecia, shortening the hair growth cycle and leading to progressively thinner hair until follicles cease hair production altogether. By blocking DHT’s action at the receptor level on the scalp, clascoterone interrupts this cycle locally, with minimal systemic absorption.

The mechanism of clascoterone can be contrasted with that of minoxidil, a widely used over-the-counter treatment available in 2 percent and 5 percent formulations. Originally developed as an oral antihypertensive, minoxidil was found to promote hair growth as a side effect. While it enhances blood flow to hair follicles by acting as a potassium channel opener, its exact mechanism remains unclear. Unlike clascoterone, minoxidil does not target the hormonal root cause of hair loss, which means it may support hair growth but does not block DHT or androgen signaling. Consequently, many users experience initial shedding and must apply it twice daily indefinitely, as discontinuation often leads to rapid hair loss. Additionally, side effects such as scalp irritation and unwanted facial hair growth are not uncommon among users.

Clascoterone, in contrast, directly addresses the underlying hormonal factors contributing to pattern baldness. This makes it potentially more effective for hormone-sensitive cases and opens avenues for combination therapy with minoxidil, leveraging the strengths of both treatments—one targeting hormones, the other enhancing follicle health. Early preclinical and phase 2 studies suggest that clascoterone also promotes dermal papilla cell activity and keratinocyte proliferation, similar to the effects of minoxidil, but through a different pathway.

New evidence supporting clascoterone’s promise comes from the topline results of two large phase 3 trials, SCALP-1 and SCALP-2, conducted by Cosmo Pharmaceuticals in December 2025. These trials enrolled over 1,465 men with androgenetic alopecia across the United States and Europe, marking the largest phase 3 program for a topical hair loss treatment to date. Participants applied a 5 percent clascoterone solution to their scalps twice daily for six months. Both trials demonstrated statistically significant improvements in target-area hair count, with one study revealing an impressive 539 percent relative increase over placebo, while the other showed a 168 percent improvement. Participants also reported noticeable growth and increased satisfaction with the treatment.

Importantly, the safety profile of clascoterone was comparable to that of the placebo, with no measurable systemic hormonal changes. This is a significant advantage over oral anti-androgens such as finasteride, which can lead to sexual side effects in some users. Clascoterone represents a potential breakthrough as the first novel topical treatment for androgenetic alopecia in more than three decades, addressing a critical need for patients unable to tolerate oral medications or seeking non-systemic options.

There is also hope that women experiencing pattern thinning may benefit from clascoterone in the future. While current phase 3 data focus on men, earlier studies indicated promise for female patients. However, it is essential to note that clascoterone is not a universal solution for all hair loss conditions. It is specifically designed for hormonal pattern thinning in early to moderate stages and will not be effective for conditions like telogen effluvium, nutritional deficiencies, alopecia areata, or scarring alopecias. Accurate diagnosis, often requiring trichoscopy and sometimes blood tests, is crucial to determine the appropriateness of clascoterone for individual patients.

The 5 percent formulation for hair loss is currently awaiting regulatory approval, with Cosmo Pharmaceuticals completing 12-month safety follow-ups. Submissions to the FDA and EMA are planned for 2026. Until clascoterone becomes available, patients are encouraged to explore evidence-based options such as minoxidil, finasteride (for suitable candidates), or low-level laser therapy, which remain frontline treatments.

As research continues to advance, the future looks promising for safer, more targeted solutions for hair loss. Individuals noticing thinning hair should consult a dermatologist early and avoid self-medication.