Clascoterone is a new topical treatment showing strong potential for androgenetic alopecia by locally blocking DHT at the hair follicle without systemic side effects linked to oral drugs. Developed as a 5% solution, it works as an androgen receptor antagonist that can improve hair count and density in mild-to-moderate male pattern baldness. Large Phase 3 trials reported significant gains versus placebo with a safety profile similar to the vehicle. Applied twice daily, it may be used alone or with minoxidil or finasteride. Regulatory submissions are in progress, positioning it as a promising future option for targeted hair loss treatment.
Long Version
Clascoterone: Revolutionizing Treatment for Androgenetic Alopecia
Androgenetic alopecia (AGA), commonly known as male pattern baldness, is the most prevalent form of hair loss affecting an estimated 1.2 to 2 billion men worldwide. This progressive condition, characterized by gradual thinning and receding hairlines, stems from androgen-dependent skin disorders where dihydrotestosterone (DHT) binds to androgen receptors in hair follicles, leading to miniaturization and reduced hair growth. While alopecia impacts self-esteem, emotional well-being, and quality of life, current options like minoxidil and finasteride have limitations, including potential systemic effects, inconsistent efficacy, and the need for lifelong use. Enter clascoterone, a topical anti-androgen offering hope as a non-oral option for hair regrowth, representing the first novel mechanism of action in over 30 years for male hair loss.
Understanding Androgenetic Alopecia and the Need for Innovation
AGA, or male pattern baldness, typically begins in the temples or crown, progressing through stages defined by the Norwood scale. It arises from a genetic predisposition combined with hormonal influences, where DHT—a potent form of testosterone—triggers follicle shrinkage and inhibits the hair growth cycle. This androgen blocker deficiency in existing treatments highlights the demand for targeted therapies that address the root cause without broad hormonal interference. Dermatologists often recommend scalp application of topical treatments to stimulate hair growth, but many patients seek alternatives with minimal systemic exposure to avoid side effects like sexual dysfunction, mood changes, or cardiovascular risks associated with oral DHT blockers.
Clascoterone emerges as a promising androgen receptor inhibitor, addressing these gaps by focusing on competitive binding at the follicle level without widespread hormonal disruption. As the first topical androgen receptor antagonist specifically designed for this purpose, it could reshape how clinicians approach androgen-dependent skin disorders, potentially expanding confidence in treatment regimens.
What Is Clascoterone?
Clascoterone, chemically known as cortexolone 17α-propionate, is a topical treatment developed by Cosmo Pharmaceuticals. Already marketed as Winlevi at a 1% concentration for acne vulgaris, it targets androgen receptor antagonists in the skin to manage androgen-related conditions. For hair loss, it’s formulated as a 5% topical solution under the investigational name Breezula. This higher dose aims to combat AGA by blocking DHT locally, promoting hair regrowth without the risks of systemic anti-androgens.
Unlike traditional therapies, clascoterone provides a scalp-specific approach, making it ideal for those preferring non-oral options. Its development underscores Cosmo Pharmaceuticals’ focus on androgen-dependent conditions, building on prior approvals like Winlevi to pioneer innovations in dermatology.
Mechanism of Action: How Clascoterone Combats Hair Loss
At its core, clascoterone functions as an androgen receptor antagonist, inhibiting DHT’s ability to bind and activate receptors in hair follicles. This topical anti-androgen prevents the androgenic signaling that leads to follicle miniaturization, allowing for improved hair count, density, and overall scalp health. By delivering competitive binding directly via scalp application—typically twice daily—it achieves efficacy with minimal systemic exposure, as blood levels remain low, reducing risks of broader hormonal imbalances.
This localized DHT blocker strategy contrasts sharply with oral medications, which can affect the entire endocrine system. While it doesn’t create new follicles, it revitalizes existing ones by extending the anagen (growth) phase and reducing the telogen (resting) phase, fostering significant hair regrowth in affected areas. Preclinical studies have shown its selective action on skin tissues, minimizing off-target effects and positioning it as a safer option for long-term management of androgenetic alopecia.
Clinical Trials: Evidence from Phase 3 Studies
Clascoterone’s journey through clinical trials has been rigorous, culminating in the largest Phase 3 program ever conducted for a topical treatment in male AGA. The two identically designed pivotal studies, SCALP-1 (NCT05910450) and SCALP-2 (NCT05914805), enrolled a total of 1,465 men with mild-to-moderate AGA across sites in the United States and Europe. Participants applied the 5% solution twice daily for six months in these randomized, double-blind, placebo-controlled trials.
In SCALP-1, participants demonstrated a remarkable 539% relative improvement in Target Area Hair Count (TAHC) compared to placebo, equivalent to 5.39 times the improvement. SCALP-2 showed a 168% relative improvement, or 1.68 times that of placebo. Both studies met their primary endpoint of TAHC with statistical significance (p
