Category Archives: siRNA

OliX Pharmaceuticals Asymmetric siRNA Targeting Androgen Receptor




In 2021, I wrote a post on microRNA (miRNA) and hair growth. In there, I discussed a new company working on messenger RNA (mRNA) based hair regeneration. And now we have RNA interference (RNAi) as a hair loss treatment, thanks to OliX Pharmaceuticals (South Korea) and its small interfering RNA (siRNA) based product.

Also not to forget, most recently, we have become excited by CosmeRNA, a SAMiRNA based hair loss treatment cosmeceutical that targets the androgen receptor. SAMiRNA is a new type of siRNA nanoparticle that does not result in innate immune stimulation. The number of different “RNA” acronym containing hair loss treatments in development has become sizable.

The bottom half of this post has a summary of OliX’s hair loss drug OLX104C (OLX72021) that targets the androgen receptor (AR). the top half is all newer updates.

Update: June 19, 2024

OliX Pharmaceuticals 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.
  • Moreover, a Korebiomed article from today has the following quote:

“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 trial participants 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.

Asymmetric siRNA Targeting of the Androgen Receptors

On November 22, 2022, OliX published preclinical 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.

Olix siRNA Hair Growth
Olix siRNA Hair Growth. Source: Molecular Pharmaceutics.

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 RNAi Hair
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 male pattern hair loss gene expression.

Hundreds of millions of people around the world took mRNA vaccines during the past few years. Even thought 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 newer such 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.

Sirnagen CosmeRNA for Hair Loss: Released in May 2023

Update: March 21, 2024

CosmeRNA Amazon
CosmeRNA on Amazon.

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.

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.


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:

  1. 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.
  2. 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.
  3. 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,
  4. 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).