Table of Contents
- Clascoterone, a Game Changer for Hair Loss Treatment in 30 Years
- Basic Ingredients and Mechanism of Action of Clascoterone
- Development Process and Relationship with Winlevi
- Introduction of Cosmo Pharmaceuticals and Stock Analysis
- Relationship with Hyundai Pharmaceuticals and Position in the Korean Market
- Outlook on the Hair Loss Treatment Market and Conclusion
- Frequently Asked Questions (FAQ)
Clascoterone, a Game Changer for Hair Loss Treatment in 30 Years
A new hair loss treatment for men, ‘Clascoterone (Clascoterone) 5% solution,’ is gaining attention for its excellent hair growth effects shown in Phase 3 clinical trials. It is evaluated as an innovative hair loss drug candidate that has emerged for the first time in 30 years.
In global Phase 3 clinical trials SCALP 1·2, this medication showed that the number of hairs in the target area increased by up to 5.39 times compared to placebo after 6 months of use. Another study also recorded a 1.68-fold increase in hair count.
This achievement brings new hope for hair loss treatment and is expected to be good news for those suffering from androgenetic alopecia.
In a situation where there have been no notable new drugs for decades aside from minoxidil and finasteride, a new drug has recently gained attention. This new drug demonstrates significant hair growth effects through topical application while showing safety comparable to a placebo, hinting at a major change in the hair loss treatment market.
Driven by such expectations, Cosmo Pharmaceuticals’ stock surged more than 20% in a day following the announcement of clinical results, marking the largest increase in 17 years. This can be viewed as a testament to substantial interest in the market.
Basic Ingredients and Mechanism of Action of Clascoterone
Clascoterone is the world's first developed topical androgen receptor (AR) blocker. The primary cause of male pattern hair loss, or androgenetic alopecia, is DHT (dihydrotestosterone), which binds to androgen receptors in hair follicles, thinning hair and shortening the growth cycle.
The 5% solution of this product, when applied to the scalp, allows DHT to compete with the androgen receptors surrounding the hair follicles. By blocking DHT's signaling, it suppresses the miniaturization process of hair follicles.
The systemic absorption of Clascoterone is very low, and even if a small amount is absorbed into the blood, it is rapidly converted into inactive metabolites, leading to negligible effects on the overall hormonal system. Thanks to these characteristics, users can expect relatively safe hair loss treatment effects.
Unlike existing hormonal hair loss medications, Clascoterone has the advantage of avoiding systemic side effects like decreased sexual function or depression. This drug acts locally on the scalp and has minimal systemic side effects.
Moreover, several studies have shown that Clascoterone helps lower the levels of inflammatory factors PGD₂ and IL-6, which induce inflammation in the areas where hair loss occurs. As a result, the activity of sebaceous glands is regulated, and the scalp environment is improved. Additionally, activation of dermal papilla cells and proliferation of keratinocytes in hair follicles have also been observed.
Clascoterone exhibits a dual action of blocking the cause through DHT inhibition and improving the scalp environment. This goes beyond a simple hair growth agent and is likely to be even more effective when used together with minoxidil or oral finasteride in the future.
Development Process and Relationship with Winlevi
The development code of Clascoterone is CB-03-01, and its brand name is ‘Breezula,’ known as a hair loss treatment. A brief overview of the development history of this product is as follows.
In the mid-2010s, Cassiopea, an Italian dermatology-focused biotech company, discovered Clascoterone, a topical anti-androgen substance based on steroid derivatives.
In 2019, it demonstrated significant hair growth effects and safety compared to a placebo in a 12-month Phase 2 clinical trial involving patients with male pattern baldness, showing its potential as a hair loss treatment.
In 2020, Winlevi, an acne treatment developed in a 1% cream formulation with the same ingredient, received approval from the US FDA. This is a new topical acne treatment with a novel mechanism after about 40 years and is currently sold in North America, Europe, Asia, etc.
In 2021, Cosmo Pharmaceuticals, listed in Switzerland, acquired Cassiopea, securing worldwide development and commercialization rights related to Clascoterone.
Between 2023 and 2025, Phase 3 clinical trials SCALP 1·2 will be conducted for the indication of male pattern baldness, involving a total of 1,465 patients. The topline results over 6 months are scheduled to be released on December 3, 2025, with both trials expected to meet the primary endpoint of increased hair count and report safety comparable to the placebo group.
Future plans include the completion of a long-term safety follow-up over 12 months in spring 2026, followed by simultaneous applications for approval to the US FDA and European EMA. The industry predicts that if the process proceeds smoothly, it is likely to be launched in the market around 2027.
It is noteworthy that Winlevi and Breezula share the same active ingredient, Clascoterone.
Winlevi is used for acne treatment in a 1% cream form, while Breezula is suitable for treating male pattern baldness in a 5% solution.
In conclusion, applying a previously proven ingredient at a high concentration to the scalp is a significant step in establishing it as a new hair loss drug.
Introduction of Cosmo Pharmaceuticals and Stock Analysis
Cosmo Pharmaceuticals N.V. is a specialized pharmaceutical and medtech company listed on the Swiss exchange. This company addresses gastrointestinal diseases and dermatological issues and provides various healthcare solutions including AI-based endoscopy assistance system, GI Genius.
According to recently announced results, the estimated sales for 2024 are expected to be around €266 million, an increase of over 180% from the previous year.
Operating profits and EBITDA have also significantly improved, with cash and cash equivalents exceeding €170 million.
Additionally, the company maintains a debt-free structure, ensuring excellent financial health.
Following the announcement of Phase 3 results, the news of the success of the Clascoterone 5% solution led to a stock surge of over 20% in a short period. Recent valuation analysis sites have mentioned that the current stock price (around 70-80 CHF) is undervalued by about 20% compared to its intrinsic value (around 98 CHF).
This indicates that the market is considering the sales growth of the already commercialized Winlevi, the potential revenues from Clascoterone for hair loss indications (Breezula), and AI medtech businesses like GI Genius simultaneously. These factors make Cosmo a focused pharmaceutical company with distinct growth potential in the medium to long term.
Ultimately, the analysis of 12 months' worth of data reveals that the FDA and EMA approval processes, as well as competition from pipelines like PYRILUTAMIDE, could increase stock volatility, posing a risk that investors must be cautious of.
Relationship with Hyundai Pharmaceuticals and Position in the Korean Market
For domestic investors, a crucial factor is the relationship between Clascoterone and Hyundai Pharmaceuticals. The currently known official connection is limited to the acne treatment Winlevi. However, as of December 5, Hyundai Pharmaceutical's stock has surged as a company related to Cosmo's hair loss new drug.
In June 2023, Cosmo and Hyundai Pharmaceuticals signed a licensing agreement for exclusive rights to Winlevi 1% cream in Korea. Through this agreement, Hyundai Pharmaceuticals secured exclusive rights to the domestic approval and sale of Winlevi.
In October 2025, Winlevi received product approval from the Korean Ministry of Food and Drug Safety, and under this contract, Hyundai Pharmaceuticals acquired full authority for domestic registration and commercialization. Consequently, Cosmo will serve as the exclusive supplier. This trend will provide significant implications for future investors.
Expectations related to Breezula
Currently, an official licensing agreement for Breezula (Clascoterone 5% hair loss treatment) has not yet been announced in Korea. However, based on the fact that it shares the same active ingredient and a partnership has already been established with Winlevi, the market is hopeful that Hyundai Pharmaceuticals may introduce Breezula in the hair loss treatment field.
These expectations are based on possibilities, and the actual impact on Hyundai Pharmaceutical's performance and corporate value may vary depending on whether and under what conditions a contract is signed.
In summary, if Breezula is introduced, it seems likely that Cosmo will benefit directly. Additionally, Hyundai Pharmaceuticals is expected to receive secondary benefits as it has already introduced Winlevi. Furthermore, as it possesses the ‘Minoxidil’ lineup of the existing minoxidil ingredients, the dynamics of the Korean dermatology and hair loss treatment market could shift significantly depending on who secures the Breezula license in the future.
Hyundai Pharmaceuticals has the potential to develop new drugs with the same active ingredient for acne and hair loss.
This could yield positive results through synergy with existing over-the-counter and prescription drugs, and
represents a point where the company's image and premium value can be enhanced through overseas innovative drug introduction strategies.
Outlook on the Hair Loss Treatment Market and Conclusion
Clascoterone 5% solution has a unique mechanism that directly blocks DHT receptors. As a result, significant hair growth effects can be anticipated even with topical application. It is also noteworthy that it has safety similar to a placebo.
Based on the verified ingredient and formulation platform through the already commercialized Winlevi, it is gaining recognition as a new ‘game changer’ after 30 years. These four factors further highlight the innovativeness of Clascoterone.
From an investment perspective, Cosmo Pharmaceuticals is expected to benefit most as it directly conducts new drug development. Although the stock price increase resulting from the success of Phase 3 has largely already occurred, there are still positive prospects for further approvals, commercialization, and pipeline expansion.
Hyundai Pharmaceuticals, having secured exclusivity for Winlevi, could see significant changes in its dermatology-related portfolio depending on whether Breezula is introduced. However, as the relationship with the hair loss indication has not yet been formally confirmed, premature pricing could pose a risk.
Looking at the entire market, the global hair loss treatment market is already a multi-trillion won market. As new effective new drugs emerge, the likelihood of previously untreated patients entering the market increases significantly. The emergence of Clascoterone is expected to be an important milestone in enlarging the pie of the hair loss market.
In conclusion, Clascoterone offers new treatment possibilities for patients suffering from hair loss and has become an opportunity to attract attention to related companies like Cosmo and Hyundai Pharmaceuticals.
However, since this medication has yet to receive formal approval, it is essential to approach carefully by analyzing regulatory and competitive situations alongside clinical results.
#Clascoterone, #Breezula, #hairlossnewdrug, #topicalhairlossmedication, #androgeneticalopecia, #malehairloss, #CosmoPharmaceuticals, #Cosmostock, #pharmaceuticalstockanalysis, #newdrugdevelopment, #Winlevi, #HyundaiPharmaceuticals, #HyundaiPharmaceuticalstock, #dermatologicalnewdrug, #acnetreatment, #hairlosstreatmentmarket, #DHTinhibition, #topicalandrogenblocker, #hairlossmedicationsideeffects, #finasteridealternative, #hairlossinvestment, #biostockanalysis, #Europeanpharmaceuticalcompany, #domesticintroductionlicense, #gamechangernewdrug, #Phase3success, #FDAapprovalpending, #hairlosspatientinformation, #longterminvestmentitem
Frequently Asked Questions (FAQ)
Q. What hair loss treatment effect does Clascoterone 5% solution show?
In Phase 3, the number of hairs increased by up to 5.39 times, demonstrating excellent hair growth effectiveness.
Clascoterone 5% solution has been proven to have excellent hair growth effects in the global Phase 3 trial SCALP 1·2, where after 6 months of use, the number of hairs increased by up to 5.39 times compared to the placebo. In another trial, an increase of 1.68 times was confirmed, receiving evaluation as an innovative hair loss treatment after 30 years, in addition to existing minoxidil and finasteride.
Q. What is the mechanism of action of Clascoterone?
It blocks the binding of DHT to the androgen receptors in the scalp during topical application, suppressing hair loss.
Clascoterone is the world's first topical androgen receptor blocker. When applied to the scalp, it allows DHT (dihydrotestosterone) to competitively bind to the androgen receptors surrounding hair follicles, blocking DHT signaling. This inhibits the miniaturization process of hair follicles, with low systemic absorption, and it is quickly converted to inactive metabolites, leading to excellent safety.
Q. What is the relationship between Clascoterone and Winlevi?
They use the same ingredient, Clascoterone; Winlevi is for acne treatment, while Breezula is for hair loss treatment.
Clascoterone is the same active ingredient used in Winlevi (1% cream for acne treatment) and Breezula (5% solution for hair loss treatment). Winlevi received FDA approval in 2020, proving its effectiveness and safety, and high concentrations of Clascoterone are being applied to the scalp, establishing it as a new hair loss drug.
Q. What kind of company is Cosmo Pharmaceuticals, and what is the trend of its stock prices?
A Swiss pharmaceutical company whose stock surged over 20% on expectations for the hair loss new drug.
Cosmo Pharmaceuticals is a specialized pharmaceutical and medtech company focused on dermatology. Following the success news of Clascoterone's clinical results, the stock price rose by more than 20% in a single day. The projected sales for 2024 are expected to increase by over 180% compared to the previous year, and its financial health and AI-based healthcare business are also positively evaluated.
Q. What is the relationship between Hyundai Pharmaceuticals and Clascoterone and Winlevi?
Hyundai Pharmaceuticals has secured the exclusive rights to sell Winlevi in Korea, and the possibility of introducing the new hair loss drug is being discussed.
Hyundai Pharmaceuticals signed an exclusive licensing agreement with Cosmo Pharmaceuticals for Winlevi 1% cream in Korea in 2023, receiving product approval from the Ministry of Food and Drug Safety in 2025. Although the contract for the introduction of Breezula, the Clascoterone 5% hair loss treatment, is not yet confirmed, investor expectations are focused on the potential market introduction of the same active ingredient.
Q. What is the market outlook for Clascoterone-based hair loss treatments?
It is a game changer that will expand the global hair loss treatment market with a new mechanism and excellent effectiveness.
Clascoterone reduces the side effects of existing hair loss medications while simultaneously inhibiting DHT and improving the scalp environment, embodying innovation. It has a high possibility of being used in combination with minoxidil and finasteride, and with the inflow of previously untreated patients, it is expected that the market size will grow significantly. However, careful attention must be paid to the approval process and competitive drug situations.
