I have covered Japan-based OrganTech (previously known as Organ Technologies) for many years due to the company’s affiliation with Dr. Takashi Tsuji and RIKEN (Japan). I have covered Dr. Tsuji’s work for over a decade now. I regularly update this post with new developments on top.

Update: December 6, 2024

OrganTech New Lab — OrganTech (Japan)’s new laboratory.

OrganTech has become a member of the prestigious Japanese Business Federation Keidanren (described as the voice of big business in Japan). The Keidanren website has a page on OrganTech in their December 2024 new member introduction (they call the company “Orangtec”).

In the description, they mention that human clinical trials for the company’s next-generation teeth bioimplant will begin this fiscal year. When it comes to hair, OrganTech is described as:

“The first in the world to develop first-generation hair regeneration by transplanting regenerated hair follicle primordia. They have also developed a pipeline that includes second-generation regenerated hair follicle primordia and third-generation regenerated hair follicles. The company will proceed sequentially with clinical development and commercialization.”

In a separate page, they include a message from Dr. Takashi Tsuji and also have two photos of OrganTech’s new laboratory (h/t “Theo”).

Update: October 10, 2024

New CEO Yoshio Shimo

In a surprising turn of events, OrganTech has replaced its young CEO Takashi Kondo with Yoshio Shimo. And they have a new COO named Dr. Yoshitake Yamaguchi. The company did not as yet make any press release about this major change, but long time reader “Theo” let me know via e-mail.

Mr. Shimo was previously the CEO of Hino Motors (Japan), an important subsidiary of Toyota (Japan). Dr. Yamaguchi did make an announcement about his new position on Linkedin three days ago. He has a Phd in Physics and has worked for a range of companies over the past several decades. Often on a part-time basis.

Update: February 23, 2024

More great news. OrganTech (Japan) is entering the South Korean market. Their local partner OrganEcoTech will get exclusive rights to OrganTech’s artificial organ regenerative medicine technology, including hair growth. They also plan to enter the US regenerative medicine sector.

OrganTech and OrganEcoTech — OrganTech (Japan) and OrganEcoTech (South Korrea). New partnership.

Update: February 20, 2024

OrganTech CEO Takashi Kondo Interview

A new interview with OrganTech CEO Dr. Takashi Kondo (h/t “Theo”). Key quote:

In terms of hair regeneration, the future is just around the corner where people who suffer from thinning hair or alopecia will no longer have to worry about it.

He also says that they can increase the number of hairs from 200 to 20,000 via Dr. Tsuji’s autologous hair multiplication process. Hair and teeth regeneration remain their primary areas of focus. He also mentions the progress in artificial skin regeneration technology and and his desire to see a world without the need for animal testing.

The company currently only has six employees. Five researchers at RIKEN in Kobe; and one (himself, the CEO and person in charge of business and finance) in Tokyo. Per the news below from earlier this month, OrganTech will hire and additional six new scientists by summer.

They are being approached by many pharmaceutical and beauty industry companies for partnership opportunities. Ultimately, this will translate into faster fundraising, ecomomies of scale and a lower final cost of treatment.

Update: February 16, 2024

Reader “Theo” regularly e-mails me very unique info from Asia that I would never have found by myself. I could not get the second link below to translate properly, but I trust what “Theo” said. So I am pasting his words in the below three bullet points with minor grammar changes by me.

As always, Dr. Takashi Tsuji sounds very sincere. In the first link below, read his recollection of the two big tragedies at RIKEN. OrganTech seems very focused and is unlikely to repeat the past fundraising related mistakes from the Tsuji team.

OrganTech and Dr. Tsuji from Riken. — Dr. Takashi Tsuji of RIKEN presenting to university students recently. His hair and teeth regeneration work is now undertaken via OrganTech.

Dr. Takashi Tsuji gave an interview and presentation to a Tokyo University student group two months ago. They visited his very expensive lab and he explained to them his vision about OrganTech’s future. They got far more funding that they need, from several different companies. Their vision is to make OrganTech an off-shore company for groundbreaking research from different scientists who are looking for funding.
Dr. Tsuji plans to create a consortium that could be called a “second RIKEN” by establishing companies for each business to socially implement regenerative medicine technology, with OrganTech at its core.

Two Part Interview and Presentation

https://note.com/utdiligent/n/n78bd096e3ab5

https://note.com/utdiligent/n/n7fce80d6710f

OrganTech is hiring 6 new scientists by the end of April 2024. After June, they will move to new offices and a research center in the Harumi neighborhood of Tokyo. It seems like they may start clinical trials around that time for both hair and teeth per “Theo” (I could not find anything on trials in the translation I got). Their artificial skin business is also advancing.

https://jp.indeed.com/viewjob?jk=6ce284d70b0a789f&tk=1hmpusbgu2b1p002&from=serp&vjs=3

Update: June 29, 2023

OrganTech Miho Ogawa — OrganTech and its CEO Dr. Miho Ogawa win a prestigious award in Japan.

OrganTech Wins Future Award 2023 for its Organ Regenerative Medicine Technology

Congratulations to Dr. Miho Ogawa of OrganTech for winning Japan’s prestigious “The Economist Future Award 2023“. Per my new Japanese correspondent (old ones were “nosyu” and “Fuji Maru“), this award is sponsored by the “Economist Future Awards 2023 Executive Committee” and supported by the renowned Mainichi Shimbun newspaper agency. There were 225 nominated companies, of whom 15 got awards spread across 5 categories. Dr. Ogawa only became CEO/Director of OrganTech in early 2023.

Make sure to read the detailed interview with Dr. Miho Ogawa that I also posted earlier this month. She started working at Dr. Takashi Tsuji’s lab in 2005 at the Tokyo University of Science when she was a student. Thereafter she joined Organ Technologies, which folded in October 2020 due to fundraising issues that were exacerbated by the Corona crisis.

Now she is back with OrganTech, and I am getting positive vibes yet again for Dr. Tsuji’s hair multiplication work finally reaching fruition. The prior issues with fundraising inexperience and surprise pandemic will surely not be repeated. Japan is home to one of the oldest populations in the world, and also home to one of the fastest clinical trial processes in the world. Especially when it comes to regenerative medicine and anti-aging treatments.

Make sure to keep checking OrganTech’s website for new developments. Per my prior updates, they are aiming to start hair regeneration related human clinical trials in 2024. And they want to offer their hair multiplication treatment in clinics in 2026. I assume they can move this fast due to their past decade of work combined with Japan’s favorable regulations. However, as most readers know, their original goal had been 2020, prior to the earlier mentioned disruptions.

Update: June 1, 2023

Japan: Global Hub for Hair and Tooth Regeneration

An interesting new interview with OrganTech’s confident representative director Dr. Miho Ogawa. It looks like the team is very serious about making Japan the global hub for hair and tooth generation. And they are keen to avoid repeating past fundraising and commercialization related mistakes.

The other representative director is Takashi Kondo (see his recent interview), who is in charge of business planning and fundraising. Ms. Ogawa is in charge of research and development and technology.

Lead scientist and OrganTech owner Dr. Takashi Tsuji remains fully involved of course. The company is scheduled to conduct clinical research within one to two years for practical application. With Japan’s fast track regulations, this treatment could still get to clinics in 2026 as was announced by Dr. Takashi Tsuji last year. Key quote:

“In the near future, this world-first, Japan-originated organ regenerative medicine management will shock the world and contribute to improving the QOL of many people.”

Tsuji Mouse Hair OrganTech — Human hair growing on mice via the work of Dr. Takashi Tsuji and his team at RIKEN.

Update: February 11, 2023

OrganTech: New name for Organ Technologies

After ending its partnership with Riken and Dr. Takashi Tsuji in 2021, Organ Technologies is back. It is renaming itself to OrganTech, and this time the founder himself is Dr. Tsuji. A little confusing, but read the next paragraph. OrganTech plans to start hair regeneration related clinical trials in 2024. And yet again they have a new website. They are also getting funding from Kobayashi Pharmaceutical.

According to the latest press release, it seems like founder Dr. Tsuji will remain the team leader and OrganTech is still affiliated with RIKEN. However, Dr. Tsuji cannot be officially titled CEO, since RIKEN does not allow its top scientists to be CEOs of venture firms. This last point was e-mailed to me by a reader.

I previously mentioned how Dr. Tsuji took over Organ Technologies’ debt in 2021 in order to prevent patent loss. He also announced that they plan to offer their hair multiplication treatment in 2026. So this new development means they are on schedule. Note that Japan has favorable regulations in relation to clinical trial speed when it comes to regenerative medicine.

They are also very serious about fundraising this time. On March 6th 2023, they plan to present their technology on Tokyo Innovative Business Day. On OrganTech’s website, it says that the company’s purpose is to “create functional organs.” They they emphasize the two main areas of Dr. Tsuji’s past work:

“Technologies that can contribute to hair regenerative medicine and dental regenerative medicine.”

Also of interest, the following patents are assigned to Organ Technologies. These now belong to OrganTech.

Jan 5, 2020

I have mentioned many times that Dr. Takashi Tsuji and his hair loss treatment protocol holds the best short-term prospects for a hair loss cure. Mr. Tsuji is working in partnership with RIKEN, Organ Technologies and Kyocera. The treatment can come to market faster because 1) It is autologous in nature; and 2) Clinical trials in Japan get finished faster due to favorable government regulations.

All four of these Japan-based partners have their own sites (in Japanese and English). So it is hard to keep a track of new developments.

Organ Technologies and Takashi Tsuji

Organ Technologies has updated its website (Update: They replaced it yet again with a new one in 2023. See upper sections of this post for latest updates). A goldmine of information is available on the new site.

The hair regeneration page has a list of publications at the bottom. Apparently, the company has developed three generations of its technology over the years. Mostly via the work of Dr. Takashi Tsuji and RIKEN (in Kobe, Japan).

I will add more to this post in the coming days, but wanted to start the discussion now. Please only post comments about Organ Technologies and the work of its partners in this post.

Organ Technologies Hair Regeneration Treatment. — Organ Technologies Hair Growth.

AR Antagonist, AR Degrader, GT20029, Kintor Pharmaceutical, KX-826, Pyrilutamide

Kintor Pharmaceutical Phase 3 Trial Results for KX-826 and GT20029

November 29, 2024 admin 134 Comments

Note that Kintor is already selling KX-826 (Pyrilutamide — androgen receptor antagonist) as a cosmetic on Amazon.

Update November 29, 2024

Earlier this week, scientists from Kintor Pharmaceutical (and Koshine Medical) did a Reddit AMA. Several of the interesting responses are pasted below:

They are currently developing a 2% foam version of KX-826, though the timeline for its release is yet to be determined.
Phase 3 trials for GT20029 are planned in China in 3Q 2025. US will be 6 months later. This is for the actual medication, and not for a cosmetic (for which such trials are not required).
GT20029 has the potential “to be revolutionary” for AGA treatment. They have found that once-a-week dosing with GT20029 demonstrated similar efficacy to daily dosing. this is a significant advantage compared to the twice-a-day dosing required for treatments such as Minoxidil, CB-03-01 (Breezula), and KX-826 (Pyrilutamide).

Update October 17, 2024

Kintor Releases Phase 3 Results for KX-826 at a 0.5% Dosage. Now they will Test 1.0%.

A new update on KX-826 (Pyrilutamide) Phase 3 Trials from Kintor that is not yet on their website.

They have completed the first subject enrollment in the pivotal Phase II/III clinical trial of KX-826 tincture 1.0% for the treatment of male adult androgenetic alopecia in China. The company’s preclinical studies have shown that the KX-826 tincture 1.0% has a significantly higher retention rate in human scalp cells compared to the KX-826 tincture 0.5%. and good chance at showing greater efficacy. The latter lower dose was used in the previous Phase III clinical trial (see next point).
They also give results of the Chinese Phase III clinical trials for the 0.5% dosage. This trial entailed the use of KX-826 tincture 0.5% BID (twice per day) on 95 male patients for 52 weeks. There were no serious adverse events reported. In terms of efficacy, after 12, 24, 36 and 52 weeks of treatment, both total area hair count (TAHC) and target area non-vellus hair width (TAHW) showed an increase from baseline. The TAHC increased by 9.5%, 13.0%, 11.4% and 9.7% respectively, while the TAHW increased by 12.1%, 18.6%, 15.7% and 10.0% respectively. So the best results are at 24 weeks, though there is still significant positive growth at 52 weeks.

Also check out my July 2024 post on KX-826 Hair Growth Spray Launched.

Kintor Pharma Pyrilutamide (KX-826) — Kintor Pharmaceutical Pyrilutamide (KX-826) Androgen Receptor Antagonist.

Kintor Pharmaceutical: KX-826 and GT20029 for Androgenetic Alopecia

My original post on Kintor Pharmaceutical (China) has become way too lengthy after so many updates. Therefore I will add all new developments in this post (below this product introduction section).

This rapidly moving well funded company is in Phase 2 and Phase 3 trials in the US and China for both its male androgenetic alopecia (AGA) products. Kintor (pipeline here) is conducting hair loss trials for:

Two separate androgen receptor (AR) targeting products: a degrader (GT20029) and an antagonist (KX-826 aka Pyrilutamide).
Each of these trials is being conducted in both China and the US.
Each of these products is being tested for both males and females with androgenetic alopecia (aka pattern hair loss).

i.e., a total of 8 types of clinical trials times 3 phases in each = 24 developments we have to track. A bit too much if all of these do end up taking place, but a most welcome development. Over one-half of these 24 potential trials are already finished.

The GT20029 product is an androgen receptor degrader (AR Degrader). It is developed using Kintor’s proprietary Proteolysis Targeting Chimera (PROTAC) platform. This is the world’s first topical androgen receptor (AR) compound (AR-PROTAC) to enter clinical trials. GT20029 degrades the AR protein via the E3 ubiquitin ligase pathway. During preclinical studies, GT20029 did not cause any notable side effects or systemic drug accumulation.
Kintor’s main product for treating male pattern hair loss is KX-826 (Pyrilutamide) and is an androgen receptor antagonist (AR Antagonist). KX-826 is currently in Phase 3 clinical trials in both China and the US per the pipeline chart. In China, these trials are now completed.

Note that Cassiopea’s Breezula (Clascoterone) is an AR antagonist that is also currently in Phase 3 trials in the US. Kintor’s website has an interesting article discussing both these competing AR antagonist products and hair loss.

Make sure to also read my related past post on destroying the androgen receptor to reverse hair loss.

Kintor GT20029 Androgen Receptor Degrader.

Update: July 11, 2024

Kintor Launches Cosmetics with KX-826 as the Main Ingredient

Kintor Pharmaceutical has officially launched a line of cosmetics with KX-826 as the main ingredient. This is the second widely discussed hair loss product that has been launched in the past two years as a cosmeceutical (with the first being CosmeRNA).

Update: June 5, 2024

KX-826 Receives The INCI Cosmetic Designation

Kintor Pharmaceutical’s KX-826 (Pyrilutamide) has received the International Nomenclature Cosmetic Ingredient (INCI) approval from the International Cosmetic Ingredient Nomenclature Committee. The assigned INCI name is Methylpyridinyl Fluoromethoxybenzonitrile Dimethyloxothiooxoimidazolidine. INCI names are recognized worldwide when identifying cosmetic ingredients. This development will facilitate the potential future global launch of Kintor’s line of cosmetics that have KX-826 as the main ingredient.

Update: May 24, 2024

More Effective KX-826 Tincture 1.0% versus 0.5%

Kintor’s clinical trial of KX-826 tincture 1.0% for treating male androgenetic alopecia in China just received clearance. The company’s pre-clinical studies showed that KX-826 tincture 1.0% had a significantly higher retention concentration level on human scalp cells compared to KX-826 tincture 0.5%. The latter was used in the Kintor’s previous phase III clinical trial.

Update: April 22, 2024

Positive Update on GT20029 Phase 2 Clinical Trial

Kintor Pharmaceutical just announced that its China Phase II clinical trial of its first-in-class androgen receptor (AR) proteolysis targeting chimera (PROTAC) compound GT20029 for treating androgenetic alopecia has reached the primary endpoint. The results are statistically significant and clinically meaningful, while safety and tolerability is good.

GT20029 demonstrated statistically significant efficacy compared to placebo in both the QD (once a day) and BIW (twice a week) dosing cohorts.

- After 12 weeks of treatment, the 0.5% QD GT20029 group showed an increase of 16.80 hairs/cm² from baseline. This was 6.69 hairs/cm² more than the placebo group.
- The total area hair count (TAHC) of GT20029 1.0% BIW group showed an increase of 11.94 hairs/cm² from baseline. This was 7.36 hairs/cm² more than the placebo.
- The 1% BIW dosage of GT20029 was identified as the optimal dosing level and has been recommended for the phase III clinical trial in China.

Key Quote:

“Based on the results of the Phase II clinical trial, the company will actively deploy subsequent clinical strategies for GT20029, such as initiating a phase III clinical trial in China and a phase II clinical trial in the US for male AGA.”

Update: February 1, 2024

Clinical Trial of KX-826 and Minoxidil

Kintor Pharma is undertaking clinical trials for two different androgen receptor targeting hair loss products (KX-826 and GT20029); in two countries (US and China); and for both males and females.

Now comes news that Kintor will also undertake Phase 1b/III clinical trials of KX-826 in combination with minoxidil for the treatment of androgenetic alopecia (AGA). The trial was just cleared by the National Medical Products Administration in China.

Update: November 27, 2023

Maybe Bad News for KX-826 Phase 3 Trial Results

According to this Reddit source, the results of the Chinese Phase 3 trials for KX-826 (aka Pyrilutamide) were ok, but not good enough. There were no serious adverse events or side effects. And positive hair growth was observed when compared to baseline (at all visit points) after 24 weeks. However, compared with the placebo group, the total area hair count (TAHC) improvement in the KX-826 treated group had no statistical significance. Albeit there was a “trend in efficacy observed”.

On a positive note, Kintor plans to continue with its multiple KX-826 related trials (in the US and China) for the topical treatment of androgenetic alopecia. I appreciate the speed with which the company released these findings. I expect there will be an official press release in the next few days. Edit: Seems like this never happened?

November 18, 2023

Phase 3 Trials for KX-826 (Pyrilutamide)

KX-826 (Pyrilutamide) is currently in the most advanced stage and has a good chance of coming to market in China by the end of 2024. In Kintor’s pipeline page, it is shown to be in the final stage of Phase 3 trials for men in China; and early stage of Phase 3 trials for men in the US. Moreover, it is also in the early stage of Phase 3 trials for women in China.

Kintor is also undertaking a second Phase 3 trial in China for long-term safety of KX-826, which I discussed in detail in my original post. Even more exciting, one my Chinese readers sent me the below partial translation of a new October 2023 presentation by Kintor. He said that his English is not good, but I only changed a few words that were confusing or out of place.

“KX-826 is a topical androgen receptor (AR) antagonist independently developed by Pioneer Pharmaceutical. It is the first AR antagonist in the world to enter phase III clinical trials for the treatment of hair loss. KX-826 binds the AR by competing with dihydrotestosterone (DHT) to locally block androgen-mediated signaling to limit hair follicle miniaturization and promote peripheral hair growth. After reaching the circulatory system, KX-826 is rapidly metabolized into inactivated metabolites, which has little influence on the whole body AR signaling pathway and has good safety.
The Phase II clinical trial in China included 120 men with hair loss. Of these, 90 subjects were randomly assigned to KX-826 0.25% twice daily, KX-826 0.5% once daily, and KX-826 0.5%, and the remaining 30 subjects were randomly assigned to placebo. After 24 weeks of treatment, the 0.5% concentration group of KX-826 showed a significant improvement in the amount of non-vellus hair in the target area. An increase of 22.73 roots per square centimeter compared to baseline.
Finally, news about Phase III: KX-826 is currently in or planned for five Phase III clinical trials (two in China and three in the United States). Among them, the Chinese Phase III clinical trial of KX-826 for male alopecia has completed the last subject visit, and the company is making full efforts to promote the data collation, library un-blinding and data statistical analysis of this clinical trial.”

Phase 2 Trials for GT2009

In Kintor’s August 22, 2023 update, they announced the completion of patient enrollment in Phase II clinical trials of GT20029 for male pattern hair loss in China. The current pipeline shows that these trials are almost over in China, and close to beginning in the US.

Hair Loss Cure 2020

OrganTech Aims to Regenerate Hair and Teeth