Category Archives: Hair Stimulating Complex (HSC)

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

Update: September 10, 2020 — Histogen just announced completion of dosing milestone in its 1b/2a trial for androgenic alopecia in men.

Update: 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.”


June 16, 2020

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. Histogen’s Linkedin page currently shows them with 28 employees and 584 followers.

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 Hair Stimulating Complex 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.

FDA Approves Histogen IND for Female Hair Loss

Update: Histogen has just kicked off Phase 1 trials for its female hair loss product HSC660. (h/t John Doe). The below post was originally published in May 2018. Also see this 2011 study on Histogen’s Hair Stimulating Complex (HSC). Dr Gail Naughton is a co-author.


When it comes to the speed of progress in a company developing and bringing forth to market a hair loss product, the most disappointing company for me has been Histogen (at least since I first started writing this blog).

Replicel and Follica have also been major letdowns in their speed of progress, although the former is perhaps now reliant on its partner Shiseido for movement, while the latter has made some big statements via its new and improved website during the past year.

In earlier years, the biggest disappointments were Aderans and Intercytex.

Histogen Background

I first covered Histogen in 2013, just a few months after starting this blog. In that post, I said that Histogen’s “male hair loss product (Hair Stimulating Complex — HSC) is in phase 2 trials, while the female product is yet to enter phase 1 trials“. Around the same time, I happened to be in San Diego and even visited Histogen’s offices and very briefly talked to a key staff member. I am clearly into hair.

Note that Histogen’s product supposedly increases hair count via the injection of key growth factors in the form of KGF, VEGF, follistatin, placental growth factor, angiogenin and hepatocyte growth factor.

Since that original post, I have covered Histogen numerous times on this blog, with most developments entailing either 1) Conference presentations from CEO Gail Naughton; or 2) Brief mentions of Histogen getting some new financing and funding. In one of my past posts about Histogen, someone from the company even replied to a reader comment on this blog.

The one exception to the above was this upbeat post from 2016, in which we learnt from Dr. Naughton that Histogen’s HSC treatment would be made available in Mexico first in 2018. They were also planning to soon conduct a large-scale 330-person clinical trial in Mexico with a local partner. They were also close to getting a partner in China for further clinical trials.

In 2017, Dr. Naughton then said the following in an interview:

“The U.S. trials are planned to commence in 2018; we expect it to gain approval in Mexico first, perhaps in 2020, and then in the U.S. sometime after that.”

And now in April 2018, Dr. Naughton said:

“Naughton said Histogen also is moving toward a late-stage clinical trial in Mexico for use of its HCS in men for treating baldness.”

US FDA Approval for Histogen IND for Females

Earlier today, I got a bunch of alerts in my e-mail about Histogen. The big news is that the US FDA has just approved Histogen’s Investigational New Drug (IND) for Female Hair Loss Trial. For those who do not know, an IND is the first step before Phase 1 clinical trials, and primarily focuses on drug safety.

So 11 years after Histogen was founded, they are possibly soon entering Phase 1 clinical trials for their female hair loss product. Makes one want to cry, but perhaps they will be able to speed these trials up due to already having tested the product in males. In their latest press release, they call their Hair Stimulating Complex product “HSC660”.

The only reason I decided to write this post was because of the below encouraging paragraph from this latest press release:

Pilot and Phase 1/2 Clinical Trials of an HSC660 predecessor were completed in male pattern baldness outside the US, with results that produced statistically significant efficacy indicators and a clear safety profile. More recently, a physician-sponsored 10 patient study in the US showed cosmetically significant results in both men and women. In addition to seeing a 100% female responder rate in the physician-sponsored study, previous trials have shown efficacy in other difficult-to-treat populations including men over 40 years of age and temporal recession hair loss.