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The possibility of a long-awaited change in the treatment of male baldness has been raised by Cosmo Pharmaceuticals’ announcement of encouraging topline results from two sizable phase 3 clinical trials assessing clascoterone 5 per cent topical solution. If authorised, the medicine could address a condition that affects well over a billion men worldwide and be the first hair-loss treatment in over 30 years to act through a completely new biological channel.
Male androgenetic alopecia (AGA) is driven by the hormone dihydrotestosterone (DHT), which gradually shrinks hair follicles and shortens the growth cycle, leading to thinning and eventual hair loss. For years, treatment options have remained largely unchanged. Oral 5-α reductase inhibitors reduce DHT production systemically, while topical minoxidil works through a different, not fully understood mechanism to prolong hair growth. Although both can be effective, each comes with limitations related to side effects, inconsistent results, and long-term adherence.
Clascoterone 5 per cent topical solution is designed to tackle the problem from a different angle. Instead of altering hormone levels throughout the body, it acts locally at the hair follicles, blocking androgen receptors and dampening DHT signalling where it matters most. By keeping its action confined to the skin, the therapy aims to deliver regrowth benefits without the systemic hormonal exposure that causes some patients to avoid oral treatments.
Robust phase 3 trial design
The findings come from two identically designed phase 3 studies, SCALP 1 and SCALP 2, conducted across multiple centres in the United States and Europe. Together, the trials enrolled 1,465 men over the age of 18 with androgenetic alopecia. Participants were randomly assigned to receive either clascoterone 5 per cent solution or a vehicle control in a double-blind fashion for six months, followed by a six-month single-blind extension period.
The trials assessed efficacy using two co-primary endpoints: Target Area Hair Count (TAHC), an objective measure of hair density in a defined scalp area, and patient-reported outcomes evaluating participants’ own perception of hair growth and improvement.
Meaningful improvements in hair growth
Both studies met their primary objective of demonstrating statistically significant hair growth compared with the vehicle. In one trial, clascoterone delivered a 5.39-fold relative improvement in TAHC, while the second showed a 1.68-fold improvement. Variability of this nature is common in hair-loss research and may reflect differences in baseline severity, demographics, or assessment techniques across study sites.
Crucially, patient-reported outcomes (PRO) aligned with these findings. One trial met its PRO endpoint outright, while the other showed a positive trend. When data from both studies were analysed together, the improvement in patient perception reached statistical significance. This convergence between objective measurements and patient experience is particularly important in AGA, where satisfaction and self-image strongly influence whether patients continue treatment.
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Safety profile supports long-term use
The safety data were encouraging. Rates of treatment-emergent adverse events were comparable between the clascoterone and vehicle groups, and most events were not considered related to the drug. The lack of meaningful systemic androgen blockade is consistent with clascoterone’s established safety record in its approved topical use for acne, reinforcing the appeal of a locally acting therapy.
Dermatology specialists recognised the possible clinical importance of these results. Maria Hordinsky, MD, from the University of Minnesota, emphasised that patients have historically had to weigh modest effectiveness against worries about systemic impacts. She observed that the findings indicate clascoterone may provide quantifiable regrowth with limited systemic exposure, possibly altering clinicians’ treatment conversation approaches.
If regulatory approval is obtained, clascoterone 5 per cent solution would offer a novel mechanism in a therapeutic field that has experienced minimal innovation. It could be particularly appealing for individuals who prefer not to take oral medications, have suffered from side effects, or have noticed little improvement from current treatments. Its targeted action on follicles suggests the potential for combined use with existing treatment standards.
The management of Cosmo Pharmaceuticals has emphasised the data’s higher significance, portraying the medication as a potential breakthrough. Preliminary results suggest the medication may address a long-standing need in the treatment of male hair loss, even if complete datasets and regulatory evaluations are still pending.
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By spring 2026, the company hopes to complete the full 12-month safety follow-up. Following that, regulatory filings in the US and Europe are expected. The 5 per cent clascoterone solution would be the first topical androgen receptor blocker licensed especially for androgenetic alopecia if it were approved.
More thorough assessments, such as long-term safety data, subgroup outcomes, and suggestions on how the treatment could supplement current alternatives, will be sought throughout this period by both clinicians and patients. When taken as a whole, these discoveries will determine if clascoterone can indeed revolutionise the field of hair loss treatments.
