Clascoterone 5% Achieves Promising Part 3 Hair Progress Outcomes

Cosmo Prescribed drugs has reported encouraging topline findings from 2 massive, identically designed section 3 trials evaluating clascoterone 5% topical answer for male androgenetic alopecia (AGA). If in the end authorized, the drug might symbolize the primary new therapeutic mechanism for AGA in over 30 years—a notable growth for a situation with excessive prevalence and restricted therapy choices.¹

Addressing an Outdated Downside With a New Mechanism

Male AGA impacts an estimated 1.2–2 billion males worldwide and is characterised by progressive miniaturization of hair follicles pushed by dihydrotestosterone (DHT). Present therapies, together with oral 5-α reductase inhibitors and topical minoxidil, have demonstrated profit however are related to both systemic publicity, variable efficacy, or points with long-term adherence.²

Clascoterone 5% topical answer employs a special method: native androgen receptor inhibition on the follicular degree, designed to cut back DHT signaling with out significant systemic absorption. This mechanism could enchantment to sufferers who keep away from oral therapies attributable to considerations about hormonal results or different systemic hostile occasions.

Examine Design and Inhabitants

The two section 3 trials—the SCALP 1 (NCT05910450) and SCALP 2 research (NCT05914805)—have been multicenter, randomized, double-blind, vehicle-controlled trials carried out throughout america and Europe. A complete of 1,465 males aged over 18 have been enrolled. Every research included a 6-month double-blind therapy section adopted by a 6-month single-blind extension.

Co-primary endpoints have been:

• Goal Space Hair Rely (TAHC)
• Affected person-Reported Outcomes (PROs) assessing perceived enchancment in hair development

Efficacy Outcomes

Each trials demonstrated statistically important enhancements in hair development in contrast with automobile. In a single research, clascoterone produced a 5.39-fold (539%) relative enchancment in TAHC, whereas the second trial confirmed a 1.68-fold (168%) relative enchancment. The magnitude of distinction between the two research isn’t uncommon for hair-growth analysis, which frequently reveals variability primarily based on baseline illness severity, regional demographics, or site-level variations in evaluation method.

Importantly, PRO information strengthened the target findings. One research met its PRO endpoint whereas the opposite demonstrated a constructive development; mixed evaluation throughout each trials achieved statistical significance. Alignment between affected person notion and investigator-assessed enchancment is clinically related, significantly in a situation the place self-image and therapy satisfaction play a central position in adherence.

Security and Tolerability

Therapy-emergent hostile occasions (TEAEs) have been related between lively therapy and automobile teams. Most TEAEs weren’t thought of drug-related. The absence of significant systemic androgen blockade—supported by the recognized security profile of clascoterone in its authorized pimples formulation—could differentiate this therapy from oral choices.

Maria Hordinsky, MD, professor of dermatology on the College of Minnesota, emphasised the medical relevance of those findings. “For many years, sufferers have had to decide on between out there therapy choices with restricted efficacy or issues of safety attributable to systemic hormonal publicity,” she famous. “These findings present the potential for clascoterone 5% topical answer to vary that equation by delivering actual, measurable regrowth with negligible systemic publicity.”

Implications for Scientific Apply

If in the end authorized by regulatory companies, clascoterone 5% answer might develop therapy selections for AGA by offering a mechanistically distinct choice that targets the androgen receptor immediately within the follicle. This method could also be significantly enticing for sufferers unwilling to make use of oral 5-α reductase inhibitors or those that haven’t responded to present therapies.

Cosmo Prescribed drugs’ CEO Giovanni Di Napoli underscored the potential affect, stating: “For the primary time in additional than thirty years, we have now a totally new mechanism with the potential to really change that actuality.” Whereas enthusiasm have to be tempered till full datasets and regulatory choices can be found, the early information recommend the remedy could meaningfully tackle a longstanding hole within the dermatologic armamentarium.

Subsequent Steps

Cosmo plans to finish the required 12-month security follow-up by spring 2026, after which parallel FDA and EMA submissions are anticipated. If authorized, clascoterone 5% answer would change into the primary topical androgen receptor inhibitor indicated for AGA.

Clinicians ought to look ahead to forthcoming detailed analyses, together with subgroup evaluations, long-term security information, and steering on use alongside present therapies—areas that can assist contextualize how this product is likely to be built-in into routine observe.

References

1. Cosmo proclaims breakthrough pphase III topline outcomes from Scalp 1 and Scalp 2 for clascoterone 5% answer in male hair loss, displaying as much as 539% relative enchancment in target-area hair rely vs placebo; US and EU submissions are underway. Information launch. Cosmo Prescribed drugs. Revealed December 3, 2025. Accessed December 4, 2025. https://www.cosmopharma.com/information/cosmo-announces-breakthrough-phase-iii-topline-results-from-scalp-1-and-scalp-2-for-clascoterone-5-solution-in-male-hair-loss-showing-up-to-539-relative-improvement-in-target-area-hair-count-vs-place
2. Chen S, Li L, Ding W, Zhu Y, Zhou N. Androgenetic alopecia: An replace on pathogenesis and pharmacological therapy. Drug Des Devel Ther. 2025 Aug 25;19:7349-7363. doi: 10.2147/DDDT.S542000.