Update: March 21, 2024

CosmeRNA is now available in a lower-cost smaller container of just 1mL. It is priced at €84 (but currently has a 10% off sale offer) and will last for 1-2 months.

On Amazon UK, it is still also sold in the 6mL version for £310. It currently has an average rating of 3.5 out of 5 stars based on 27 reviews.

Recently, Bioneer’s CEO Han-Oh Park made a detailed video presentation in English at IMCAS 2024 that is worth watching.

The key active ingredient in CosmeRNA is “SAMI-RNA AR68″ (StearyldisulfidehexylDNA-2-PEG-45/SH-RNA-1). It is designed to selectively inhibit the expression of the androgen receptor (AR) in hair follicle cells.

Watch this video on YouTube

Update: February 21, 2024

Make sure to check this pdf about CosmeRNA that was sent to me by Bioneer. The company has completed CosmeRNA’s Amazon Europe entry into Italy, Germany, France and Spain. Note that it previously only sold CosmeRNA on the Amazon UK website. In future, they will sell the product in Japan, Australia and Singapore.

Update: July 18, 2023

Bioneer has installed five additional high-capacity synthesizers in order to double the production capacity of patented raw materials for CosmeRNA, the world’s first RNA based hair loss relief cosmetic. Bioneer aims to secure more than 100 million of the world’s 2 billion male and female hair loss sufferers as CosmeRNA customers. Hopefully, the resulting economies of scale will allow a reduction in the product’s price.

Update: June 14, 2023

CosmeRNA is Now on Sale on Amazon

CosmeRNA is now available for sale via the UK Amazon site. It can be shipped and delivered to the US and other countries too. Make sure to review and rate the product if you use it for a few months.

Watch this video on YouTube

CosmeRNA Hair Loss — CosmeRNA for hair loss. The solution will come in 6ml dose bottles.

South Korea just keeps on adding groundbreaking companies working on new hair loss treatments. The latest of these is Bioneer’s siRNA based cosmeceutical called CosmeRNA that targets the androgen receptor.

It can supposedly grow 1.3-1.9 hairs/cm per month, which is comparable to finasteride. Make sure to also read my post on how many hairs on a human head?

CosmeRNA was released in Western Europe in May 2023. Note that the top half of this post is all updates.

Update: May 2, 2023

CosmeRNA online shop is now open! The price is €300 ($330) per bottle (vial), higher than originally expected. However, per the company’s site, it seems like the frequency of application will be reduced once all the androgen receptors are inhibited. Initially, the treatment is applied topically every two weeks for the first four months. Afterwards, once a month application may be sufficient to maintain the fuller hair.

Besides the key siRNA technology, the other ingredients are listed as follows:

Aqua, Phosphate Buffered Saline, Alcohol, Butylene Glycol, Betaine, Niacinamide, Stearyldisulfidehexyl DNA-2-PED-45/SH-RNA-1, Panthenol, Menthol, Sodium, Biotin, Citric Acid.

— It looks like Bioneer’s CosmeRNA Mall will finally open tomorrow. They describe the product as:

“The world’s first hair loss relief cosmetic based on RNA technology.”

CosmeRNA Finally Releasing in May 2023

Thanks to “Mathis” for the weekly updates. CosmeRNA’s slightly delayed release date is now confirmed for May 2023 per various news articles. Bioneer aims to get 100 million users within 5 years per CEO Park Han-oh. Release of the product in South Korea has been delayed due to some legal issues, although there is a lot of demand in the country.

The below YouTuber managed to contact a Bioneer employee and estimates the cost to be $67 per month. Based on a single $200 priced 6ml bottle lasting for three months, with 1ml recommended usage every two weeks. For comparison, the best laser hair growth devices cost $1000 or more, although the Lasercomb is much cheaper.

February 22, 2023

CosmeRNA for Sale at the end of March 2023

CosmeRNA related news just keeps coming and seems very encouraging. In the latest article from South Korean media, the company makes some bold claims:

They expect sales of up to 160 billion Won (i.e., $123 million). This is quite extraordinary for a new cosmeceutical hair loss product that will only be sold in one region (Western Europe) for the time being.
They state that “when the shopping mall opens at the end of next month, we will start full-fledged sales for European buyers.” So the product will be on sale by the end of March 2023.
Since siRNA is mainly used for research, very few facilities have mass production capabilities. The scale of siRNA synthesis for most studies is at the mg level. Per this latest news, Bioneer can produce raw materials at a level of 1kg to 1.5kg per month,
There are no major side effects and the product application does not leave any sticky residue.

Note that earlier this month, Bioneer announced that it will even sell on Amazon. And they will be partnering with Ace Biome for marketing and distribution purposes.

Registration on CPNP and SCPN Cosmetic Product Notification Portals

February 2, 2023 — Yet more encouraging news. Bioneer has also completed product registration with Britain’s submit a cosmetic product notification (SCPN) portal. Moreover, in January it participated in “IMCAS World Congress 2023” in France. this was in order to introduce Cosmerna to buyers around the world and to secure a distribution network.

December 26, 2022 — Bioneer announced that it has completed the registration of CosmeRNA on the cosmetic products notification portal (CPNP). The latter is a European cosmetics certification system and means that Bioneer can now distribute CosmeRNA throughout the EU.

November 23, 2022

CosmeRNA from Sirnagen (Bioneer) Releasing in 2023

This post covers a new topical hair loss product called CosmeRNA, whose website is now live. It is made by siRNAgen (South Korea), a subsidiary of Bioneer (South Korea). I briefly covered this company in the past, but now it deserves its own post.

The reason I am writing this post is due to a great new interview with siRNAgen CEO Dr. June Park. Both these new developments were sent to me by a reader who wishes to remain anonymous. Key quote from Dr. Park (also see her Linkedin):

“The first SAMiRNA product will be available for sale in the first half of 2023. We had an unconventional route to commercialization by developing a hair loss cosmeceutical product. CosmeRNA, named after cosmetic RNA, provided an early validation of our platform’s potential as a topical cosmetic product for androgenetic alopecia (hair loss).”

They will not need to conduct clinical trials since this is a cosmetic product! The actual release date is likely to be in early 2023 per another quote in the same interview. After first being done in South Korea, CosmeRNA’s safety study was repeated in Europe by Dermatest in 2022. Note that SAMiRNA is shelf stable in a solution for a year, so it can be applied topically.

Ms. Park anticipates the product launch to occur some time in early 2023. They will focus on the European market first due to the region’s more streamlined cosmeceutical trial and approval process. Via the Cosmetics Product Notification Portal (CPNP).

Note that I previously briefly covered siRNAgen Therapeutics in my post on OliX Pharmaceuticals. The latter is working on a hair loss cure involving RNA interference (RNAi) via asiRNA (asymmetric small interfering RNA). The aim is to reduce androgen receptor (AR) expression on the scalp.

SAMiRNA, Androgen Receptor and Hair Growth

Like OliX, siRNAgen is also working on reducing AR expression and re-growing hair. However, it is doing so via treatment with self-assembled micelle inhibitory RNA (SAMiRNA) nanoparticle-type siRNA. See their site for more on small interfering RNAs (siRNA).

They published an important study on this in Nature Journal in January 2022. The encouraging title of this paper is worth posting: “Weekly treatment with SAMiRNA targeting the androgen receptor ameliorates androgenetic alopecia.”

The product they use for androgenetic alopecia is a topical called AR68. It is classified as a cosmetic ingredient and will be called Cosmerna-68. In the above mentioned paper, they have before and after photos of a patient that I pasted below. The chart on the right shows the actual percent improvement with AR68 0.5mg/ml treatment versus placebo. They also state the following:

“In the low-dose (0.5 mg/ml) clinical study, AR68 was applied three times per week for 24 weeks, and through quantitative analysis using a phototrichogram, we confirmed increases in total hair counts. In the 24-week long high-dose (5 mg/ml) clinical study, AR68 showed average additional hair growth of 1.3-1.9 hairs/cm2 per month, which is comparable to finasteride. No side effects were observed. Therefore, SAMiRNA targeting AR mRNA is a potential novel topical treatment for AGA.”

0.5 mg/ml AR68 (3x a week) Before and After

Sirnagen CosmeRNA AR68 — Sirnagen CosmeRNA SAMiRNA AR68 0.5mg/ml hair loss treatment (3X per week). Source: Yun, SI., Lee, SK., Goh, EA., et al. Sci Rep 12, 1607 (2022).

5 mg/ml AR68 (1x a week) Before and After

The higher dose AR68 5mg/ml cohort’s before and after photos are here. The researchers claim that these results at 24 weeks are comparable to those from Finasteride. Safety was good in both low-dose and high-dose studies.

Sirnagen AR68 5mg per ml Hair Growth. — Sirnagen CosmeRNA SAMiRNA AR68 5mg/ml hair loss treatment (1X per week). Source: Yun, SI., Lee, SK., Goh, EA., et al. Sci Rep 12, 1607 (2022).

Summary

Is this a miracle? Most likely not for most severely balding people people. However, just as with finasteride, some people could see stellar results. And for those who only recently started to go bald, this could be a much needed non-DHT inhibiting product. With few if any side effects.

I am not a big believer in cosmetics, but this latest interview with siRNAgen CEO June Park is encouraging. She comes across as very intelligent and sincere. Note that in Bioneer’s September 2021 presentation, they describe CosmeRNA as a game changer hair loss treatment. It will have no side effect issues such as those seen with Finasteride (Propecia).

Breezula, Androgen Receptors, Cassiopea, Clascoterone, Cosmo Pharmaceuticals, Topical Antiandrogen

Breezula Phase III Trials Begin

March 21, 2024 admin 120 Comments

Breezula® (clascoterone solution) is a novel androgen receptor antagonist that is currently in Phase 3 trials for the treatment of androgenetic alopecia (AGA). If approved, it will be sold by Cosmo Pharmaceuticals NV (Ireland). Breezula was originally called CB-03-01 and manufactured by Cassiopea (Italy), prior to the latter’s 2021 takeover by Cosmo. Breezula product details can be seen here.

I have written about Cassiopea/Cosmo/Breezula in well over a dozen past posts. Feel free to read all of them, going back to the very first one in 2014 when the product was known as CB-03-01. Its key ingredient is known as clascoterone, an androgen receptor (AR) antagonist. Similar to Kintor Pharma’s KX-826 (Pyrilutamide).

Breezula Cosmo Pharma — Breezula from Cosmo Pharmaceuticals.

Update: March 21, 2024

Breezula will come out in 2026 and cost $110 per month

Cosmo Pharma just released a detailed new pdf regarding the company’s 2023 full year performance. Breezula details are from page 31-39. Some great new information that suggests the company is very confident about Breezula (clascoterone) being approved and coming to market at the end of 2026 in the US and EU.

The US launch price will be $110 per month. Cosmo plans to target the existing physician-driven AGA market where doctors usually prescribe their balding patients oral finasteride or OTC topical minoxidil. Breezula expects to capture 35 percent of this market.

Update: March 20, 2024

Breezula Phase 3 Trials Update

Cosmo Pharma just reported excellent full-year 2023 financial results and doubled its dividend payment. More importantly, regarding the Breezula (clascoterone solution) Phase III trial in males for the treatment of androgenetic alopecia:

348 out of a planned 726 patients have been recruited in study CB-03-01/37.
507 out of a planned 726 patients have been recruited in study CB-03-01/38.

The Phase 3 trials are across four countries (US, Poland, Germany and Georgia) and 50 centers.

Update: September 13, 2023

Breezula Phase 3 Trial Enrollment Opportunities

Edit: It seems like there are around 30 US locations. You have to scroll through a separate box in the SCALP1 and SCALP2 links above.

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Earlier this week, someone I trust sent me a link in regards to a new androgenetic alopecia related clinical trial that is taking place in New Jersey, US. There are two very interesting keywords in the URL that I was sent:

https://cenexelresearch.com/hri/trials/androgenetic-alopecia/?utm_source=Facebook&utm_medium=Paid&utm_campaign=Cassiopea%20CB-03-01%2F37&utm_content=Dermatology

The shortened version of the link on CenExel clinical research organization (CRO)’s androgenetic alopecia page does not mention the involvement of Cassiopea (or its new owner Cosmo Pharmaceuticals). Neither does it mention any product name.

However, in my last update of this post in June, I mentioned that Cosmo is finally starting its Breezula topical anti-androgen Phase 3 clinical trials in the US and Georgia. A total of 750 males will be enrolled between the two countries. The trials will end in January 2025. The above mentioned trials in New Jersey are almost certainly for Breezula.

Note that you have to be a male of 18 years age or older who has androgenetic alopecia.

Update: June 29, 2023

Cosmo Begins Phase III Trials for Clascoterone (Breezula)

Cosmo Pharmaceuticals just announced the beginning of Phase III trials of clascoterone solution (5%) in males for the treatment of androgenetic alopecia (AGA). The name of this product is Breezula® and it is a novel androgen receptor inhibitor. Trials will involve 750 patients in the US and Georgia. The company’s acne product with the same clascoterone ingredient (but lower dose of 1%) is called Winlevi and is already available in the market.

Key quote:

“If approved by the FDA, clascoterone solution has the potential to be the only topical androgen receptor inhibitor for AGA and the first drug with a new mechanism of action for the treatment of AGA in nearly three decades.”

Update: February 16, 2023

Cosmo Pharma’s latest guidance states the following:

“Cosmo expects to have the first patient enrolled in the Breezula® (Clascoterone solution for androgenetic alopecia) phase III trial in males in Q1 2023.”

Also see Cosmo Pharma’s new page on Breezula. The company took over majority ownership of Cassiopea in December 2021 after being a part-owner for years (see bottom of this post).

Update: October 7, 2020

Cassiopea (Cosmo Pharma) completed enrollment in its Phase II trials for female pattern hair loss. The 6-month study has enrolled 293 patients. The four-arm study will divide volunteers into four treatment groups: clascoterone solution 5% BID (twice daily); clascoterone solution 7.5% BID (twice daily); minoxidil solution 2% BID (twice daily); and vehicle BID (twice daily).

Update: August 27, 2020

Cassiopea’s Winlevi topical androgen receptor inhibitor has just been approved as an acne treatment by the US FDA. It is the first acne treatment with a new mechanism of action to be approved in 40 years. The key ingredient (clascoterone cream 1%) is the same as in the keenly awaited hair loss product Breezula. The latter will have a higher dosage.

CEO Diana Harbort quote:

Dermatologists have said targeting androgen hormonal activity in the skin is ‘the holy grail’ of acne treatment for both males and females.

I expect Breezula will not come to the market till 2023, assuming it gets final approval. However, some people plan to use Winlevi on the scalp, even though this is not recommended by the manufacturer.

Update: March 19, 2020

Phase 3 Trials Delay

How things can change in just a few weeks. Breezula Phase 3 trials have now been delayed till 4th quarter 2020 or 1st quarter 2021. All due to COVID-19 (Coronavirus), which has hit Italy particularly hard. More information can be found in Cassiopea’s 2019 Annual Report which was released today.

The Clascoterone female pattern hair loss Phase 2 trials are on track to finish enrollment in 2Q 2020. Trials should be completed by year-end 2020. However, delays are still possible depending on progression and recurrence of the current pandemic.

Quote from the accompanying pdf:

“As part of the process in the NDA review, the FDA amongst other, also inspects the facility in which Clascoterone cream 1% is manufactured. Clascoterone cream 1% is planned to be manufactured at Cosmo Pharmaceuticals plant in Lainate in Italy. Given restrictions currently in place because of the COVID-19, the FDA had to postpone the inspection planned for March.”

Nevertheless, Cassiopea is still planning to release its Winlevi acne cream product by the end of this year.

Update November 13, 2019: Cassiopea’s women’s hair loss clascoterone solution Phase II trials starting soon in Germany.

April 16, 2019

Cassiopea (Cosmo Pharmaceuticals)

I have covered Italian company Cassiopea since 2014 (when it was called Cosmo Pharmaceuticals). The company is developing a topical anti-androgen hair loss product named Breezula (originally called CB-03-01). The chemical name for this product is Clascoterone. Note that Cosmo Pharma still owns 45 percent of Cassiopea.

Breezula will be available for both men and women. Several of my well known physician contacts in the hair loss world have told me great things about this product. Their feedback is based on what they saw at conferences or heard from colleagues.

Breezula Phase II Trials Very Successful

In July of last year, Cassiopea stated that the interim Phase II clinical trial results for Breezula were very positive. Today, they released twelve month Phase II trial results with the same conclusion:

Cassiopea announces very positive Phase II Twelve Months Results for Breezula® (Clascoterone) in treating androgenetic alopecia.

The presentation of the results is confusing, detailed, full of acronyms and somewhat open to interpretation. Note that “BID” in there stands for “twice per day” after conversion from Latin. Hopefully they release before and after photos at some point.

Also note that the previous 6-month interim report had 375 subjects, and the 12-month report has 344 subjects. The trial was conducted in Germany.

Breezula Target Area Hair Count Increase

Best case result highlighted in yellow (14.3 new hairs per square centimeter, after 12 months of 7.5% BID clascoterone solution dosage). BID means twice per day.

Breezula Target Area Hair Width Increase

Best case result highlighted in yellow (762.5 um width increase, after 12 months of 7.5% BID dosage).

My gut feeling is that Breezula will be at least as effective as Finasteride and Minoxidil.

Clascoterone Summary

Some key points from the above linked article from Cassiopea:

If approved, Breezula (Clascoterone) will be the first FDA-approved topical anti-androgen for the treatment of androgenetic alopecia.
Moreover, it would also be the first new drug approved for treating androgenetic alopecia since 1997. That year was when Propecia (aka Finasteride) was first approved to treat hair loss. That year was also when Tiger Woods first won the Master’s golf tournament. His 5th surprise victory in that tournament came this past weekend.
Based on these great results, Cassiopea plans to proceed with 6-month Phase III trials in men in the fourth quarter of 2019, after consultation with the FDA. The company is also going to start proof-of-concept trials in women.
Breezula works by blocking dihydrotestosterone (DHT) interaction with hair follicle androgen receptors.
Clascoterone does not interfere with testosterone and other hormones in male subjects. Libido and sexual behavior changes have so far not been observed in clinical trials. Moreover, due to its rapid metabolism and localized activity, Clascoterone (Breezula) does not produce any systemic side effects.

In the past, I used to often state that perhaps an initial cure for hair loss would entail the usage of a cocktail of products. Each working via different mechanisms and chemical or biological reactions.

It is looking likely that Breezula will be one of the main products in this cocktail.

Note that Clascoterone 1% cream to treat acne will be released by Cassiopea before Breezula. The acne product is called Winlevi.

Hair Loss Cure 2020

Sirnagen CosmeRNA for Hair Loss: Released in May 2023