Category Archives: Histogen

Histogen Phase 1B/2A Trials for HST 001 Begin

June 23, 2020: New update on Histogen study from Emily (see bottom half of this post for more):

“As of this morning, we are half way enrolled. The last day to screen for the study will be July 10th. If anyone is interested, they should call me this week and I will get them scheduled.”

Update: July 17, 2020 — Completion of patient enrollment.


I first covered San Diego based Histogen (stock ticker HSTO) in 2014. At the time, there was a lot excitement about the company’s Hair Stimulating Complex (HSC) product HST 001. It is supposed to be more effective than Finasteride or Minoxidil in treating male pattern baldness.

This HST 001 product is an injectable that contains key growth factors which benefit hair growth. These include KGF, VEGF, and follistatin, all of which positively impact hair follicle stem cell proliferation. The growth factors are produced by hypoxia-induced conditions.

Between 2014 and 2018, Histogen made steady progress. In 2018, when I last wrote about the company, they were set to start Phase 3 clinical trials in Mexico. The excitement in the hair loss world was palpable. Histogen was also starting trials for its women’s hair loss product HSC660.

Most people assumed that Histogen’s HSC would be available by 2020. Unfortunately, something went wrong and the company never managed to complete those final Phase 3 trails.

Histogen Regenerates Itself

Instead, in 2019, Histogen went “back to the future” on us. They announced that they were starting Phase 1b trials! This major regression on the part of Histogen was shocking. And when combined with the demise of Aclaris Therapeutics’ JAK inhibitor trials for androgenetic alopecia, 2019 ended up being disappointing. The one positive was that at least Histogen did not disband or go bankrupt.

Histogen HST 001
Histogen Hair Stimulating Complex (HST 001) trial schedule from their site today.

However, Histogen is now back on track again and has received FDA approval to proceed with trials in 2020. Moreover, the company merged with Conatus Pharmaceuticals in 2019 and made Richard Pascoe the new CEO.

I was still not planning to write any post covering the company this year. My goal was to only write about Histogen again if they announced completion of Phase 2 trials. I did not want to go on yet another wild goose chase.

However, I was forced to alter my decision because of the below e-mail that I received out of the blue today. I am surprised that they mention Histogen in the e-mail and do not keep the company name private.

Histogen Patient Recruitment for HST 001

Hello Page Admin of Hair Loss Cure,

I am the Manager of Recruitment at California Dermatology and Clinical Research Institute. We are a research site in Encinitas, California focused on dermatology specific clinical research studies.

We just opened enrollment for a male pattern hair loss study testing a new investigational treatment. The sponsor is the San Diego based drug manufacturer, Histogen. Here is a bit more information on the development of this drug so far: June 1 Announcement.

We are looking for participants ages 25 – 55 who are grades 3 vertex, 4 or 5 on the Norwood Hamilton scale and are not currently using finasteride or minoxidil. This study will take place over a 26 week period and has 7 visits to our office in Encinitas. Compensation may be provided to those who qualify and enroll.

If you think any of your viewers would be interested in participating, I would really appreciate you sharing our information!

Anyone who would like to see if they may qualify can reach me at (760) 203-3836. If anyone is interested, they should contact me at their earliest convenience, as the study hopes to fill enrollment within the next month.

Emily Baker
Manager of Recruitment and Digital Presence

California Dermatology & Clinical Research Institute
561 Saxony Place Suite 102, Encinitas, CA 92024
P (760) 203-3839 x102 | F (760) 203-3840 |
www.cdcrinstitute.com

It is encouraging that they are testing HST 001 on men with extensive baldness only.

Please contact this company only if you satisfy all the requirements mentioned in the e-mail. You have to travel to Encinitas (San Diego), California seven times in six months. So I am guessing that you do not want to contact them if you do not live nearby.

Dr. Gail Naughton Presentation

Histogen CEO Dr. Gail Naughton’s 2013 presentation is shown below. In there, it is mentioned that the company’s Hair Stimulating Complex was already in Phase 2 trials :-( Dr. Naughton seems to have a stellar reputation in the biotech and regenerative medicine world.

Histogen Phase 3 Trials on Men Begin in Mexico

Update 2020: Histogen merging with Conatus Pharmaceuticals.

Update 2019: It seems like Histogen’s male hair loss product (HST001) clinical trials never worked out in Mexico. A new article from Histogen states that Phase 1b trials for HST001 (Hair Stimulating Complex) would start later in 2019. Note that their female hair loss product is called HSC660.


Earlier today, commentator “Bekoo” posted some groundbreaking news about Histogen in regards to their men’s hair loss product. The information he posted was part of an article that appeared a few days ago in the San Diego Tribune on July 12th 2018. Note that Histogen is headquartered in San Diego, so the company is often covered in the city’s main local newspapers.

Histogen Hair Stimulating Complex (HSC660) for Women

Histogen Hair Stimulating Complex HSC660
Histogen Hair Stimulating Complex HSC660 for Women. Before and After Photo.

The title and gist of this new article is in regards to Histogen’s women’s hair loss product (HSC660) trials starting. I already discussed this development recently. So even though it was in my Google alerts, I was never planning to read the article in it’s entirety… until “Bekoo” saved us and posted his findings today.

Histogen Starts Phase 3 Trials in Mexico

  • By far the biggest news is that Histogen has started Phase 3 clinical trials in Mexico for its men’s hair product. This product is called “an earlier version of HSC660” in the San Diego Tribune article, so might be slightly different from the newer women’s HSC660.

Note that in 2016, Histogen estimated that their men’s  hair loss product would be available in Mexico in 2018. They were planning to start Phase 3 trials in Mexico “soon” per that 2016 post of mine. So it looks like they got delayed by 1.5 years or so. Better late than never of course.

Gail Naughton

  • Also, per CEO Dr. Gail Naughton, they anticipate success with these Phase 3 trials and are looking towards commercialization:

“We’re in very late-stage negotiations with some huge retail partners. A deal should be concluded in the next few months.”