Clascoterone: A Topical Anti-Androgen For Hair Loss?
Clascoterone: A Topical Anti-Androgen for Hair Loss (2025 Update)
Last updated December 2025. This page will be revised as new data and regulatory decisions are released.
Clascoterone (also known as CB-03-01, and under development as Breezula for hair loss) is a topical anti-androgen that blocks the effect of dihydrotestosterone (DHT) directly at the hair follicle. In 2020,
clascoterone cream 1 percent was approved by the FDA as Winlevi for acne treatment in patients 12 and older, based on favorable safety and efficacy data in large phase 3 trials [Dhillon, 2020; Hebert, 2020]. Today, a higher strength 5 percent solution is in late stage development for androgenetic alopecia (pattern hair loss).
At Bauman Medical, we are closely following the science and clinical data around clascoterone. This page is designed to give patients a balanced, up to date overview of what we know, what we do not yet know, and how this emerging treatment may fit into a personalized hair restoration plan in the future.
What is clascoterone?
Clascoterone is a non steroidal topical androgen receptor inhibitor. Instead of lowering hormone levels throughout the body, it is designed to sit in the skin and block DHT where it binds to androgen receptors in hair follicles and sebaceous glands [Dhillon, 2020; Kalabalik-Hoganson, 2021]. This local action is what makes it so interesting for hair loss. The goal is to protect vulnerable follicles from DHT without exposing the rest of the body to significant hormonal effects.
The 1 percent cream formulation is already approved for acne. In those studies, side effects were mostly mild and localized to the skin such as redness, dryness, or irritation (phase 3 randomized clinical trials in JAMA Dermatology) [Hebert, 2020]. Long term acne data up to 12 months also suggest a favorable safety profile with very low rates of systemic side effects, including no clear signal for problematic changes in blood potassium (Del Rosso, 2023).
For hair loss, a stronger 5 percent topical solution has been developed specifically for androgenetic alopecia (AGA), which is the most common cause of hair loss in both men and women. You can read more about AGA on our pages for male pattern baldness and female pattern hair loss.
How does clascoterone work for hair loss?
In androgenetic alopecia, genetically susceptible hair follicles shrink over time under the influence of DHT. This process, called miniaturization, leads to thinner, shorter, and less pigmented hairs and eventually to visible thinning or baldness.
Preclinical work in human scalp cells has shown that clascoterone acts as an androgen receptor antagonist in dermal papilla cells in vitro, blocking DHT driven signaling and reducing inflammatory cytokines [Rosette, 2019]. Clinically, clascoterone is designed to:
- Bind to androgen receptors in scalp hair follicles
- Compete with DHT at those receptors
- Reduce DHT driven signaling that triggers miniaturization
Because clascoterone acts at the receptor level in the skin, it provides a completely different approach than oral finasteride or dutasteride, which reduce systemic DHT production. This new mechanism is part of why clascoterone is considered one of the most promising emerging treatments in the hair loss pipeline [Kim, 2025; Sun & Sebaratnam, 2020].
2025 Phase 3 trial update for clascoterone 5 percent solution
In December 2025,
Cosmo Pharmaceuticals announced topline results from two large phase 3 trials, called SCALP 1 and SCALP 2, in men with male pattern hair loss [Cosmo Pharmaceuticals, 2025].
Study design at a glance
- Two identically designed phase 3 studies: SCALP 1 (NCT05910450) and SCALP 2 (NCT05914805)
(SCALP 1,
SCALP 2) [ClinicalTrials.gov, 2024] - 1,465 adult men with androgenetic alopecia randomized across both trials
- 6 month, multicenter, randomized, double blind, vehicle controlled design
- Twice daily application of clascoterone 5 percent topical solution versus vehicle (placebo) solution
- Co primary endpoints: change in Target Area Hair Count (TAHC) and patient reported outcomes related to hair growth and satisfaction
- Each trial followed by a planned 6 month single blind extension for longer term safety
Main efficacy findings
According to the company’s announcement, both phase 3 studies met their primary hair count endpoint [Cosmo Pharmaceuticals, 2025]:
- One trial showed a 5.39 fold (539 percent) relative improvement in Target Area Hair Count compared with vehicle
- The second trial showed a 1.68 fold (168 percent) relative improvement versus vehicle
- A pooled analysis across both trials showed a statistically significant and clinically meaningful benefit
An independent analyst review noted that the pooled data represented roughly a 252 percent relative improvement versus placebo and described the results as positive but emphasized the need for full data to judge absolute effect size
(Carey, 2025).
Patient reported outcomes (how patients felt and perceived their own hair) were also generally consistent with the objective hair count data, with combined analyses reaching statistical significance [Cosmo Pharmaceuticals, 2025; Carey, 2025].
Safety and tolerability
Topline safety data from the phase 3 studies indicate that:
- Treatment emergent adverse events were similar in the clascoterone and vehicle (placebo) groups
- Most reported side effects were mild and not related to the study drug
- The overall safety profile appeared comparable to vehicle over the first 6 months of treatment [Cosmo Pharmaceuticals, 2025]
This is consistent with the earlier acne program, where clascoterone cream 1 percent showed a primarily local, skin related side effect profile and minimal systemic absorption [Dhillon, 2020; Hebert, 2020; Del Rosso, 2023].
What we still do not know
It is very important to recognize that these are topline results released by the sponsor. At this time:
- Full phase 3 data have not yet been published in a peer reviewed journal
- Detailed information about response by age, degree of hair loss, and scalp region is not yet available
- Only adult men were included in these phase 3 trials, so data for women with androgenetic alopecia are still limited
- The required 12 month safety follow up is ongoing, with completion anticipated in 2026 [Cosmo Pharmaceuticals, 2025]
Cosmo has stated that it plans parallel regulatory submissions to the FDA and EMA after the 12 month safety dataset is complete. Regulatory timing and final label details will depend on the full data package and agency review. No approvals for hair loss have been granted yet.
What this means for patients right now
For patients, the clascoterone phase 3 results are encouraging, but clascoterone 5 percent solution for hair loss is still an investigational therapy. That means:
- It is not yet FDA approved for androgenetic alopecia
- It is not commercially available as a standardized, on label hair loss treatment
- Any current use for hair loss would be considered experimental or off label and may not match the exact 5 percent solution or application schedule used in the clinical trials
At Bauman Medical, we view clascoterone as a promising potential addition to the treatment toolbox, especially for:
- Men who are hesitant to use or cannot tolerate oral finasteride or dutasteride
- Patients who prefer a topical, scalp focused approach to androgen control
- Individuals already on multi therapy regimens who may benefit from another mechanism targeting DHT at the follicle level
Until a formal approval and detailed prescribing information are available, the best approach is to continue using proven, evidence based therapies while we track new data and regulatory updates.
How clascoterone may fit into a Bauman Medical treatment plan in the future
Dr. Bauman has long advocated a multi therapy, personalized approach to hair restoration that addresses the full biology of hair loss. This often includes a combination of:
- Topical and oral medications such as minoxidil and finasteride
- Medical grade low level laser light therapy with devices like the Bauman Turbo LaserCap
- Regenerative treatments including PRP, exosomes, TED, and PDOgro
- Advanced nutritional and supplement strategies
- Hair follicle stem cell banking and other regenerative options for the future
- FUE hair transplantation when needed for permanent redistribution of hair
You can learn more about some of these options here: