I have covered the novel androgen receptor antagonist Breezula® (clascoterone) for 11 years across numerous posts. The product was originally known as CB-03-01, and manufactured by a company named Cassiopea (Italy). The latter was acquired by Cosmo Pharmaceuticals (Ireland) in December 2021.
Interestingly, Cosmo did not use the word “Breezula” even once in the press release. It does not show up on the company’s pipeline page either. And the Breezula page on their site is not working at present. I really hope they do not change the name yet again. My blog post “categories” about this company and product are already too numerous.
Key notes from the press release:
A massive 1,465 patients were randomized into the two identical clinical studies: Scalp 1 (NCT05910450) and Scalp 2 (NCT05914805). I covered these in detail here and here.
Both studies reached statistically significant endpoints in Target-Area Hair Count (TAHC). The first reached 539% relative improvement compared to placebo; and the second reached 168% relative improvement to placebo.
The safety profile across both studies for positive.
The way they present these numbers is a bit strange and may exaggerate the efficacy. And the large gap between 539% and 168% is very surprising. In the successful 6-month interim Phase 2 trial results that were presented in 2018, they chose to compare Breezula results with finasteride.
Cosmo will complete the required 12-month safety follow-up in spring 2026. Thereafter, Cosmo plans to promptly pursue parallel regulatory submissions in the United States and Europe.
“Clascoterone 5% topical solution is positioned to become the first topical androgen receptor inhibitor ever approved for AGA, subject to regulatory authorization.”
This development also bodes favorably for China-based Kintor Pharma’s androgen receptor antagonist KX-826 (Pyrilutamide). It is currently in Phase 3 trials. A number of other such products are currently in trials or have been released as weaker cosmeceuticals.
On a related note, Cosmo Pharma released Winlevi clascoterone 1% cream in 2020, and it has since become the number 1 most prescribed topical acne brand in the US. Some people were trying to use Winlevi off-label on their scalps in the past, but I suspect that the dose is too low. Moreover, scalp absorption of the cream might be totally different from scalp absorption of the solution.
Also of interest, an August 2025 study concluded that Breezula promotes dermal papilla inductivity and hair matrix keratinocyte proliferation to a similar extent as minoxidil. In addition, Breezula also reduces the secretion of hair growth inhibitor IL-6 in balding skin samples. Some of the scientists involved in this research are affiliated with Cosmo.
Years ago, I mentioned how a hair transplant surgeon raved to me about Breezula based on a presentation (with photos) that he witnessed at an ISHRS conference. Fingers crossed that we finally have a third FDA-approved hair loss treatment by the end of 2027 (30 years after finasteride was approved, and 39 years after minoxidil was approved)!
I originally wrote this post about OliX Pharmaceuticals (South Korea) and its RNA interference (RNAi) based small interfering RNA (siRNA) molecule to treat hair loss in 2021. The company’s drug that is currently in Phase 1b/2a clinical trials is called OLX104C (as well as OLX72021), and it targets the androgen receptor (AR). Make sure to scroll through the entire post to see all updates.
Since I am mentioning RNA, in 2021, I also wrote a post about microRNA (miRNA) and hair growth. In there, I discussed a new company working on messenger RNA (mRNA) based hair regeneration. Thereafter, in 2023, I wrote about a new SAMiRNA™ based hair loss cosmeceutical called CosmeRNA that targets the androgen receptor. SAMiRNA is a new type of siRNA nanoparticle that does not cause immune stimulation.
Update: December 26, 2025
OliX Begins Phase 1b/2a Clinical Trials for OLX72021
OliX Pharmaceuticals has finally begun Phase 1b/2a clinical trials for OLX72021 in Australis. They are using that name in the press release, but sill use OLX104C on their website. Note that OliX completed Phase 1 clinical trials in June 2024 (see my older updates).
Update: June 30, 2025
OliX Launches U:BERNA Hair Loss Tonic
OliX has officially launched a new functional cosmetic hair loss tonic product called U:BERNA that helps alleviate hair loss symptoms. They do not specify if this is the RNAi based OLX104C (OLX72021), which targets the androgen receptor (AR) and is currently in Phase 1b/2a clinical trials.
While U:BERNA is currently only available in South Korea, OliX plans to enter the global market in the near future. This trend of hair loss companies launching cosmecuticals before they get through clinical trials for their main product is great in my opinion, even if the cosmetic product turns out to be weak. On a related note, Kintor (China) launched its KX-826 androgen receptor targeting product as a cosmetic spray in 2024. A stronger version of the same product is currently in Phase 3 clinical trials.
OliX U:BERNA Hair Loss Tonic.
Update: June 9, 2025
OliX Partners with L’Oréal for Skin and Hair Regeneration Research
OliX and L’Oréal (France) are partnering in an exclusive multi-year scientific collaboration aimed at developing breakthrough solutions in the hair and skin regeneration sector. They will make use of OliX’s proprietary RNA interference (RNAi) platform technology. Note that I have covered L’Oréal a few times in the past due to their significant interest in the hair loss sector.
Update: March 15, 2025
OliX Pharmaceuticals Submits a Phase 1b/2a Clinical Trial Plan for OLX104C
OliX Pharmaceuticals has filed for a Phase 1b/2a clinical trial plan for its hair loss treatment candidate OLX104C. The trial will be conducted on 120 men with androgenetic alopecia at 10 trial sites in Australia. Surprisingly, the clinical trial is scheduled to last a lengthy 30 months from the date of approval. OliX’s stock price responded favorably to this news.
Also of interest, in February 2025, Eli Lilly (US) paid OliX $630m for rights to the company’s metabolic-associated steatohepatitis (MASH) candidate OLX75016. The Phase 1 clinical trials for this produce began in Australia in February 2024.
Update: June 19, 2024
OliX Completes Phase 1 Clinical Trials
In a very surprising development, OliX Pharmaceuticals just announced that it completed its Phase 1 clinical trials in Australia ahead of schedule. Note that they call their hair loss treatment drug OLX104C, but call the “substance name” OLX72021.
The trial was conducted via a step-by-step increase in dosage. The drug was injecting intradermally into the hair loss patient’s crown region. Based on follow-up observations, safety was found to be excellent in three cohorts of treated volunteers. The company then decided to skip the fourth cohort. Official results are expected before the end of this year after 8 weeks of follow-up.
Meanwhile, apart from the injectable treatment, Olix is also developing a hair loss cosmeceutical and plans to launch it this year.
Update: April 12, 2024
At the just ended WCHR2024 conference, OliX Pharmaceutical made a presentation via Dr. Won Chong-hyun. This doctor is a dermatology professor at Asan Medical Center and is collaborating with OliX on the hair loss drug OLX104C (OLX72021) that targets the androgen receptor.
In the news release on OliX’s own website, it says that OliX announced the “research results” of its hair loss treatment drug ‘OLX104C’ at WCHR 2024. Which would imply that the Phase 1 trials that started in June 2023 in Australia must have ended.
“OliX Pharmaceuticals, a Korean biotech firm specializing in RNA interference technologies, recently announced the promising results of its hair loss treatment, OLX104C, at the 13th World Congress for Hair Research (WCHR 2024).”
Neither of the two news items discuss actual results. However, they must have been favorable enough for the South Korean company to attend and present at this conference in the US.
The presentation itself was titled: “Efficacy of Asymmetric siRNA Targeting Androgen Receptor for the Treatment of Androgenetic Alopecia.”
Update: June 13, 2023
Olix Pharmaceuticals Begins Clinical Trials in Australia
OliX Pharmaceuticals just announced that it has commenced Phase 1 clinical trials for OLX72021. This investigational RNAi therapeutic suppresses the hormonal activity that causes androgenic alopecia by reducing the expression of the androgen receptor (AR). OLX72021 is topically injected into the scalps of men with male pattern hair loss.
It seems like OLX104C has been renamed to OLX72021, although the former name is still the one listed on the company’s pipeline page. It could also end up being two separate products, with one being a drug and the other a cosmeceutical. I infer this from the earlier CEO update with quotes (see further below).
The 30-person trial participants in Australia will be split into 5 cohorts that will get one intradermal injection of various doses (or placebo) and come back for follow-up after 8 weeks. The injection will be spread across 6 areas of alopecia near the crown region of the patients’ scalps.
Update: March 10, 2023
OliX just got approval from Australia’s Human Research Ethics Committees (HREC) to begin a phase 1 clinical trial of OLX72021. This candidate “inhibits the activity of hormones that cause male hair loss”. The effect lasted for more than three weeks in animal tests.
Update: In a March 23 article on this same development, CEO Dong Ki Lee states the following:
“We are also planning to launch hair loss cosmeceuticals in due time for the safety of OLX72021 to be confirmed in this clinical trial.”
“The company will develop OLX72021 not only as an RNAi technology-based new drug, but also as a cosmeceutical, which offers consumers accessibility and convenience of use.”
So far, we have only heard about Olix’s RNAi based candidate for the treatment of male pattern hair called OLX104C. It reduces the expression of the androgen receptor via small interfering RNA (siRNA). Perhaps the new product is just the old one renamed. I will update this post when I find out.
Update: November 23, 2022
Asymmetric siRNA Targeting of the Androgen Receptors
On November 22, 2022, OliX published pre-clinical research on its androgenetic alopecia treatment program, OLX104C. The results are very encouraging. Actual study is here and the researchers demonstrated:
“Efficacy of androgen receptor reduction, hair loss inhibition, and long duration of action in primary cultured human follicle dermal papilla cells (HFDPC) and rodent models of hair loss.”
They call this technology “cp-asiRNA targeting AR” and “AR-targeting asiRNA (cp-asiAR)”. The asiRNA stands for asymmetric small interfering RNA.
In May 2022, OliX raised $45 million and announce that its androgenetic alopecia product (OLX104C) will enter clinical trials later this year. Moreover, in August 2021, OliX obtained a Notice of Allowance from the US Patent and Trademark Office for OLX104C.
In June 2021, OliX signed an agreement with LGC Biosearch Technologies to accelerate production of asymmetric siRNA for the treatment of androgenic alopecia. Olix CEO Dong-ki Lee also presented at SMi’s 12th Annual RNA Therapeutics virtual conference.
February 10, 2021
OliX Pharma’s RNAi Hair Loss Product OLX104C
OliX Pharmaceuticals (South Korea) just made a major announcement. Their RNAi based hair loss product OLX104C successfully grew back hair in mice following just one single injection. The mice were suffering from androgenetic alopecia due to them being given excess dihydrotestosterone (DHT).
“We are advancing a novel and potentially durable approach to treating hair loss” — CEO Dong Ki Lee
OliX Pharmaceuticals and its RNAi product OLX104C. Before and after hair growth in mice.
In this preclinical study, OLX104C was administered topically to a mouse model via an injection. The before and after photos are amazing. Interestingly, they compare the results to the anti-androgen Flutamide.
More importantly, OliX is the real deal. Their news page is very impressive with regular significant developments. This includes raising $37.2 million in December 2020. They also received US FDA Phase 2a approval in November, 2020 to treat hypertrophic scars.
siRNA
On OliX’s pipeline page, they state that small interfering RNA (siRNA) has limitations in terms of stability, delivery and toxicity. This is not a problem with RNAi therapeutics. Per their patent, they are using asymmetric siRNA to inhibit the male pattern hair loss gene expression.
Hundreds of millions of people around the world took mRNA vaccines during the past few years. Even though they did not go through rigorous clinical trials for five plus years. In effect, this will speed up scientific progress. Many people will no longer worry about long-term side effects for such new RNA related drug candidates. Perhaps not a good idea, but I will not complain if it speeds up the realization of a hair loss cure.
