FDA Approves Histogen IND for Female Hair Loss

Histogen Hair Stimulating Complex HSC660
Histogen Hair Stimulating Complex HSC660 for Women.

Update: July 2, 2018 — Histogen has just kicked off Phase 1 trials for its female hair loss product HSC660. The below post was originally published in May 2018.

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.

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 further progress. Follica has made some big statements via its new and improved website during the past year, fingers crossed. 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 loss research (anywhere in the world).

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”.

59 thoughts on “FDA Approves Histogen IND for Female Hair Loss”

  1. Histogen, Follica, Replicel… I have the feeling that our GREATEST NEWS will not come from these guys… but today I feel optimistic… and I know that sometime soon ( for me 2/3 years is soon) something Great will come OUT;)

  2. Let the Histogen haters start squawking! I’m neither a hater nor a lover but will leave you with these words of wisdom I learned early in my medical device career, “If it was that easy everybody would be doing it”. People who have zero clue of what it’s like to work in Biotech startups seem to have all the answers. :-)

    1. This is a wink and a nod to the fact that Histogen will do nothing for most men with MPB. The male market for hair loss is ten times the size of the female market. The company is trying to generate cash flow before they are crushed by the competition.

  3. Just a bit frustrating when they project a 2018 release leaving me sitting here wondering if i should get that HT finally or wait out another 2 to 480 months for these treatments.

    1. I’m in the same boat Brian. I’m hoping for follica by next year. If no release then I’m going with an fue. The other treatments are a few years away if they make it….maybe sisheido next year as well. I’m researching ht docs now. Been in the game since 2001. All these companies just hype then fizzle out.

      1. @mjones, I get my hair system next week. I would suggest that instead as a medium term solution. In the short run it is cheaper and you get a full head of hair definitely and instantly with no scars. With a HT, I have had both FUT and FUE, even if you are a rare candidate that will get the desired results, you will have to put up with looking like Frankenstein’s monster for the first 3 months, and it’s really painful once the anaesthetics have worn off. The swelling is so bad you have to sleep in a chair for the first 3 weeks as you cannot lay horizontally. It’s not worth the money, the pain, or the disappointment when you find it’s not as thick as you thought it would be.

        1. Thank you for the feedback a Scott. That is very good info to know. I just want to straighten out my right side at least. I would need probably 500 grafts to make it look even. So even if the rest thins out I can just shave the 500 grafts down. I was thinking of filling in the diffuse strip I have where I apply Rogaine but afraid of making things worse. I still believe Rogaine accelerated my baldness and now I’m afraid to stop it.

          Netshed- I totally agree with you man. I’ve been waiting for 16 years and nothing. My Propecia and Rogaine are losing effectiveNess and I’m just seeing my hair get worse and worse. I personally crossed out hsc. It won’t come out in time for us. IND approval till a phase 3 completion is at minimum 8 years. Gail started hsc back in late 2000s. Unacceptable! Either this stuff sucks, or its dangerous and they reformulating to make it work. Either way we have follica, sm, follicum, jak, sisheido, tsuji etc to bring something to us before hsc will. Follica maybe in the long haul but they are going through the accurate timeline for fda approvals. Trials started in 2008/9 and drugs take 8 to 12 years to be approved. So 2018 to 2020 release right on the admin estimated timeline for a cure:)

          One more thing…that dr. Couto in Spain has amazing results because he uses synthetic hair grafts with his fue. It’s offered on his site. That’s why we have been seeing such thick fue cure like results with him. I mean either way it looks real and really good. Only problem is how do you cut your hair with synthetic hair? It won’t grow like the rest of your hair.

          1. The IND approval is for women. How did you equate that to men (or your own case) and then extrapolated 8 more years? Or were you actually concerned about only the women’s product?

            I also just deleted one of your recent comments in which you were incorrect about a company still not having started Phase 2 trials when in fact they had finished those.

            I wonder if you do this regularly to get a reaction or are genuinely forgetful?

            “Gail started hsc back in late 2000s. Unacceptable!”

            What year did Follica, the company you always adore, start operations? Funnily enough, you did not have any such comments in my post on Cortsarelis quotes where he predicted cures in various years.

          2. I would never go for Couto then. That fibre stuff will never be accepted by the body. There are other great HT surgeons in Europe. If you want to keep your search in Spain per se (as you mentioned Couto), I believe injerto……. is great as well.

          3. You are very uninformed about the work of Dr. Couto, this doctor has never used synthetic hair, they are authentic FUE procedures with autologous grafts, that is hair of the same person.

        2. Scott.. With your having an FUT scar, once everyone knows you with a full head of “hair” (in professional life), it wil be impossible to ever stop wearing it without everyone knowing. It will be impossible to remove it without looking much much older (you’ll require horseshoe pattern hair growth to cover the scar). The issue is that you obviously can’t ever just shave your whole head bald as a way out, due to the scar.

          So, why would you want to take the hair system off someday?.. Well, it’ll cost you at least $400 a month for all needed supplies (indefinitely). Don’t believe the Hair Club first year rates. Second, if you don’t want everyone knowing it’s fake and you want to be clean, the tremendous maintenance will dictate your entire life. You will avoid getting sweaty where possible (which loosens adhesive and quickly gets gross). You probably won’t want to go swimming. You’ll always have to consider the wind and lighting.

          Of course, your hair texture might be easier than mine, and you might not be the type who cares if everyone knows your hair is fake. So, there may be variables that make it easier on you. That said, if you want real looking hair, it requires a life-altering amount of relentless effort and planning.

          Also, you’ll have to be okay with your love interests knowing you wear a wig. There is no way to hide it from them, given maintenance time and the fake hairline. There is no way to make a real looking hairline without a full blown hollywood studio. There is a reason that Enrique Inglesias wears a baseball cap to all of his concerts. Hairlines and sweat are always a challenge with fake hair adhesive, and he probably doesn’t want to risk it being exposed.

          Anyway, maintaining a convincing “hair system” affects all aspects of your life in ways you can’t imagine now. And since you have no option to ditch it and shave your hair completely, you might not be able to ever stop wearing it without the humiliating instant transition to the horseshoe baldness pattern.

          Please seriously consider finding a way to live without it right now. You can have SMP to mask your scar plus get the illusion of a full head of shaved hair. That’s a great option if you find a good clinic. Doing this option once you have fake hair on is a logistical nightmare, because you can’t wear a hair system with the shaved head SMP requires (wig needs 3 weeks plus of growth to blend). SMP takes several weeks of shaved head for them to get the scar looking decent.

          Another option is to embrace a short hair horseshoe pattern (short as possible, long enough to cover scar). If everyone knows you this way from the start, you’ll at least avoid being addicted to the hair system. That said, your thin transplants on top may not look natural with this short option.

          Anyway, I just wanted to give some perspective. A permanent wig is negatively life-altering, especially if you care about it looking real each day. The FUT scar removes your option to shave hair completely to get rid of it (which most men without the strip scar do after a few years of the nightmare). Just know that a permanent wig is nothing like a water sports Hair Club commercial. You will avoid swimming and be more high maintenance than most women.

          I have been in this situation since college 13 years ago (still no cure). There’s always the possibility that the cure will be your way out, so I’ll continue hoping for that!

          Best of luck, my friend. I feel for you. If I had to do it all over, I would go full shaved with SMP or just cut everything short as possible and move on. Wigs certainly don’t help with women. It’s best to be as free as possible before committing to a radically unnatural solution of glues and tapes. I can’t get rid of mine, because I’m psychologically messed up from maintaining my fake hair for thousands of hours, and instantly going to a horseshoe pattern as required to cover FUT scars would be too humiliating for me to handle after the thousands of hours and thousands of dollars spent trying to stay young looking. Also, the thin hair plugs would be a laughing stock following the full wig.

          Take care.

          1. @slick thanks for the warnings. I am not expecting miracles with the hair system. The tech they use has come on a lot in recent years. If it works and is easy to maintain I will keep it up. If not, no worries. What’s the worst that can happen? I have promised @admin a before and after video that you may cross-examine and I will do this even if the results are disappointing just as a warning to others, or to show off if it works.

            As for my FUT/FUE, I have been very lucky. None of the scars are visible even with a marine-style hair cut and so this has not influenced my decision in any way; I could easily go bald. Only 1 barber in the past year could tell I had these operations so I am not suffering in any way.

            I also appreciate the comments about my love life :-) My 3 previous boyfriends this year preferred me with hair, synthetic or not. One of which had a hair system and he looked gorgeous.

            The biggest problem I have is that a lot of my parkour training is recorded on camera and my thin hair does not pigment well, so when I look at myself in the mirror I see full but thin coverage but when viewing myself on camera footage I look completely bald, except the horse shoe. All the other guys are a lot younger than me so it has made me more self conscious of it. If I was training with people all my own age it would not be a problem, but this is rare because most people in their 30s in the western world are obese and they could not run around the block once, let alone jump parkour obstacles.

            1. Okay, it’s great to hear that you’re in a place where you can go to a full head of hair and then have it disappear and nobody would care. My professional world is too widespread and political for that, and I’d never hear the end of it. It sounds like you’re in a more liberal environment with a lot more freedom, so that’s great for you. People in my love life think the fake hair is pretty pathetic and don’t want to be patient with it, and it’s counted as one strike against me. Glad your experience is more open-minded. Also, you’re lucky with the FUT scar being unnoticeable. Best of luck!

              1. @slick parkour is just my hobby. During the normal week I work in IT in an office, similar to the environment you describe and they may have something to say about it. But I remember the phrase “The people that matter don’t mind, the people that mind don’t matter”.

                The truth is most people are so obsessed about their own problems (obesity, status, debt) they have already stopped listening by the time you have nearly answered their question about what you have done and why so you are sort of free in a way. Psychology is not my field but I am on to something here.

                1. Scott.. I admit to being psychologically adicted to the hair for many reasons, and I think it’s had a negative effect on me in many aspects of life. It relentlessly makes nearly everything tougher. That said, it’s my own ocd personality and the fact that I’m hiding it. If you’re okay with everyone knowing from the start, then that could make a world of difference. It sounds like you have a great attitude. I hope it’s a better experience for you. The time and resources required are pretty substantial. In any case, I already feel guilty for clogging up Admin’s baldness cure website with wig talk, so that’s all from me! I’ll be interested to hear how you’re doing in a few months! My next solution is more SMP work, so wish me luck. I hope the best for you.

                  1. No problem at all “Slick”. There are many posters who post off-topic all the time and have very few useful things to add, unlike yourself.

                    I am especially OCD about the hair that sheds in the shower, on my bed, on the floor etc… Hate seeing it and feel the urge (and usually act on it) to dispose of it right away.

                    That is why I am so happy that Avodart has reduced my scalp hair shedding.

                    1. Admin, Thanks for understanding. Given my history, I’ll just go ahead and say that no one will be happier than me to hear of a hair loss cure! It’s been quite a struggle for a lot of years. I appreciate the occasional venting, and I wanted to make sure Scott had considered all potential issues with the hair system. That said, I’m glad your having some success with Avodart. Thanks again for all your work staying on top of the latest :-)

    2. Go for the transplant, the technologies already there. Albeit it’s not a cure but the top surgeons can work semi miracles. Bare in mind you’ll need 2/3 ops and supporting/supplementing meds are crucial. I’m gearing up for my second, I naively though one procedure would suffice so make sure you have the money ready for a follow up. I’ve found a lot of guys who lose their hair never had great hair even in teens, thin, spaced out, limp (maybe whys it’s harder to lose it, it’s like a double blow). So for transplant receivers when a topical treatment is available in theory they’ll regrow old hair and have the existing transplanted hairs. Sufferers in the aforementioned bracket will have hair thicker and denser when in their follicle prime.

      1. To add re: Fue scarring.

        It is absolutely minimal, I have a medium brown hair and pale skin, my sides get cut to a grade 3 and there is nothing visible. You can also blame any scarring to the more observant as alopecia areata. It’s common for men to experience it on the sides of their head and can be caused by stress etc. I too Slick have had my life almost shattered as a result of mpb, it’s taken almost everything from me. 6 months after my op my life went back to normal for 3 months, I ditched that “glued” cap and could style my hair again – I have never remembered feeling so liberated. Hence having the money ready for a second op – after 6 months it started shedding again, possibly stopping regain is to blame. My hair has never properly recovered since and I’m back to the cap look. People have no clue what it’s like for some of us experiencing constant hair loss.

  4. Does no one remember how terribly shady the photos released were by the know shady doctor? If they had something good the wouldn’t try to manipulate the picture/angle/hair direction and ob top of that, they’d have real funding behind them. It’s Follica, then we wait for Riken or whatever co can multiple or hair for a drastically improved and effective transplant.

  5. How long will take Follica´s pivotal trial? It is expected to start soon. Is a 2019 release possible?

  6. By the time HSC is on the market I am 40+ and part of the “difficult-to-treat-populations”.

    The biggest nightmare concerning all these delaying companies would be that they keep finetuning, we keep balding, and by the time something is released, we enter their office and they will say:” You are too far gone, we can’t help you with this treatment.”

  7. Is the problem that Histogen and the others over-promise and fail to deliver, or is the cost of developing drugs/treatments, conducting trials, and getting regulatory approval too much for these relatively minor players? I imagine the profit potential for expensive treatments that require clinics and all the attendant overhead would be small compared to the potential for companies developing an easy pill or topical.

    I guess I’m wondering if the problem is the science, or if the problem is the business.

  8. Admin mark my word follica will be the only thing coming out. Top hair loss researcher in the world vs bankrupt gail working with shady ht docs with combiner pics. Come on bro you can’t be that ignorant to even compare the two. Histogen is a joke. Plain and simple. I’m talking about the women’s version will take 8 years. The male ones maybe 5 more years but even then I don’t see it happening. They were flying through trials early on and even mentioned it in their Web page for 2013 release in the usa. Explain why they are taking 10 more years to complete another trial? They are releasing other products for skin care but can’t move e forward with hsc? They need to run trials in Mexico ? It’s all too fishy.

    1. Yeah, I think we have to be real here, it’s exactly as you say…Histogen is an utter joke with a distinct lack of credibility now

  9. Puretech’s pipeline states an interesting figure: Only 2% of hair loss sufferers pursue treatments. Yet, the hair loss market in the US alone is 1 billion… and that’s only 2% of us! I also read an article that found 85% of hair loss sufferers want a treatment.

    Hey Admin, here’s hoping something gives us as many new hairs as Pujols’ hits. ; )

  10. HISTOGEN is so low on my radar I have to be reminded it exist. Gail said 2017 Mexico with hellousee btw now she’s saying. 2020 lol ok. Release HSC during the year of riken.

  11. Meanwhile can anyone tell me…when they say Minoxidil helps with hairloss, do they mean it eases your pain by loosing the rest of what is left….

  12. Hey admin, have you caught this guy on reddit who has been experimenting with black market setipiprant and PGE2 in varying incarnations over the last two years? He just posted some comparison pics in r/tressless and it looks like he’s getting some serious regrowth. I know it’s n=1 but it’s worth looking at.

  13. a good friend of mine said this, hair is like money, you always want more. It is indeed true.. even though a product makes NW5 to NW3 we would still want to be NW0. even if we are NW0, some people would want curly hair or blond hair…etc..
    In fact there is a lot to progress in the hairloss market. The good thing is ALL the companies know about it. The bad thing is cure hasnt been discovered in 1.000.000 years…
    I am really curious will we ever get to witness that moment in our lifetime…

    1. I dont think so. The rate of progress is so slow I just dont see it. We really need something better at safely just preventing MPB because keeping hair is the best case I see in the next 40 years or so.

  14. I see hair loss more like age related.. We cant cure it totally… May be improve it… What we need is a cosmetic approach which is safe, looks natural and no maintenance… The way woman get like botox, breast job and all those things… I’m not talking about toupees … They are shit

  15. Yeah its probably true only 2% of people with hair loss pursue treatments. Because the treatments suck, dont work that well, and are life long commitments. Is this even that surprising? For a cosmetic problem your going to take a hormone drug forever? Its not hard to imagine why this is plus propecia is still very expensive, and next month the price could quadruple or propecia is stop being made. Nothing is certain, and you need it or you wasted all your money when it all just falls out anyway

    1. And let’s not forget that President Donald Trump is now the testimonial for Finasteride ” Propecia” about that!!!;-)

  16. I dont trust any of these OLD Companies anymore. They all failed! Lets face it the new shit is Metabolism, JAKs, Anti Aging, Senescent Cells, Tregs, KROX, FOXO, Stem Cells, Autoimmune and Inflammation, Growth Factors, Cloning, CRISPR, Organs on Chip and 4D Bioprinting. Welcome to the new world!!!

  17. Histogen is like waiting for your Gran to cross the road. Maybe it’ll be ready in 2055! I agree with John Doe. I’m more hopeful for the new stuff.

  18. 1000% agree with the above comment. anything regrows which looks natural is a cure. it doesnt have to be our original hair.
    indeed rugs suck.. mankind has been wearing it for 1.000.000 years already…

  19. If Tsuji team will start human trials in March 2019.
    And maybe is the first hair cloning technology, why the desesperation for injectios, creams, and lotions…
    This technology is “unlimited hair”
    only 10 months… patience! the ultimate technology is around the corner…

  20. Histogen just got jealous and needed to make the news and show they have some sort of credibility. They know they are behind. Newer companies are moving faster than they are.

  21. Hey Admin – I have been following your blog for several years (great job) and I like many are hoping for a cure – but since I have had HT’s over the years (I am in my 50’s now) I am also interested in hair cloning – but I never see any new news on it. Do you follow this anymore?

  22. Hey admin,

    I don’t know if you remember this. Histogen got hit with a lawsuit from SkinMedica if I recall correctly that took some time to go through. Histogen wound up winning, but it really set them behind in their hair loss treatment. That played a huge factor as to why they’re behind now.

      1. Unfortunately admin, the USA doesn’t have their FDA more like what Japan does in terms of regulatory agencies. There was the 21st Century Cures Act back in 2016 (or 2015) which made it possible for approvals at phase 2 or a leaner system to approve drugs but still have safety precautions.

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