WAY-316606 Clinical Trial Update 2019
One of the most popular hair-growth research discoveries in recent years is finally making its way into clinical trials. If successful, a product could become available sooner than expected.
In May 2018, an article published in the PLOS journal by Hawkshaw et al., showed that SFRP1 inhibition was a novel way of promoting human hair growth. The research team also identified an already existing drug which was capable of inhibiting SFRP1. That drug was, of course, WAY-316606. After the news hit media outlets people all over the world were asking to be part of the clinical trial and seeking ways to get their hands on this compound. In September 2018, the Guardian reported that Giuliani Pharma would be moving the project into clinical trials. Since then, there has been no sign of this taking place.
In a recent Follicle Thought article, Ralf Paus commented that Giuliani was actually going to be testing analogs (similar chemical structures) of the drug WAY-316606 which could be used as cosmetic agents to treat hair loss. This was great news. Even if we were just finding out that Giuliani was beginning a trial process for the actual WAY drug which would take 5-7 years, it would be positive. The fact that a product could now reach the market much sooner classified as a cosmetic is something to appreciate. Also recently, I made contact with a representative of Giuliani who directed me to a website featuring the company’s work in hair science. This site contains a list of Giuliani’s current hair-related projects, including the WAY research, which is titled “Wnt liberation therapy” on the webpage.
Exclusive From Giuliani
I’m also happy to present more detailed information on the status of Giuliani’s efforts to turn this promising research into an actual product. Barbara Marzani PhD, Scientific Project Manager at Giuliani was kind enough to share this important message with the readers of Follicle Thought:
“Currently, we are in the process of identifying and developing other compounds than WAY-316606 that may unfold similar hair growth-promoting properties as the latter, but have an even more advantageous safety profile. The most promising among these are being tested in our human scalp hair follicle organ culture as we speak, and relevant issues related to scale up synthesis, product stability, and optimal topical formulation are intensively being investigated.”
We are also in the process of starting a preliminary clinical pilot trial with one of these substances and expect to have results that we can share by the end of this year. Our fingers are crossed that these first results will be encouraging.”
And there you have it, a WAY-316606 analog, which could be be marketed as an over-the-counter product is set to show clinical results by the end of 2019. There’s going to be a lot of fingers crossed for this one.
Posted in Hair Growth Treatment, Hair Loss Cure, Hair Loss Treatment, Ralf Paus
Very coo, thanks for sharing. Can provide more detail on the definition of “clinical results,” i.e., phase I, phase II. Lest ye be reminded, Histogen reported its phase II clinical trial results to great fanfare nearly a decade ago.
So, this would be a pilot trial for the cosmetic. In order for a new cosmetic compound to get on the market I believe it only needs one safety trial. I’m pretty sure that’s how it works in the US. Would assume it is the same in Europe. All in all I would say one or two 3/4 month trials is all that is needed to bring an OTC product to market.
@mp5 one should never compare a trial process to Histogen lol. besides that this is cosmetic route
Sir pls tell me about this medicine and which time comes in indian market
Puneet, when it is available I will share results for all to see on this site.
what are you talking about? there has been no before and after results
Awesome update. This is something I’ve wanted to hear of for a while. Can’t wait to see those initial results. thanks!
why do you say this for Bart
when can we expect this to be purchased over the counter?
If everything goes well with the trial and the development of the product perhaps sometime around Q3/4 2020. Giuliani is a company who specializes in haircare products so one would imagine if they have a successful compound they will be quite efficient at getting it rolled out to market.
over the counter makes me lose faith…
I guess we still need to combine this with VPA, so maybe the combo is still benificial.
Eitherway, VPA seems to still be of importance to me.
I don’t think the fact this is going to be over the counter makes any difference, look at other clinical drugs in trials none of them show that the drug route is superior. Also, minoxidil is over the counter. But the VPA had to with the PTD-DBM research I don’t know how it comes in here?
I agree with JLF and Dee.
The efficiency of these products unfortunately have proven to be somewhat disappointing. I have used Reboost and Trinov. None have worked.
Unless a cure can explicitely take a person from NW 7 to NW 0, it is, in my humbe opinion not worth the difficult fight we are fighting.
But what does a product with a formula that is completely different than another formula have to do with it? The way research is from a peer review journal based on wnt pathway. Is like saying an fue transplant at one surgeon who is not good means another surgeon cannot do a fue.
@ Admin thats actually amazing. With the Electric Cap Story and Giuliani we again have Two more Players out of the blue which could be available soon.
For Giuliani Way Analogs what does this “Preliminary Trial” mean in Terms of time? For Cosmetics we dont Need the classic Clinical Trials but how Long does this Need to bring this to the counter? And also did you ask for the Sandalore Cosmetics? Maybe they could bring a 2 component Treatment? … Sandalore in the morning, WAY in the evening. And in between the Electric Cap. 🙂
Thanks John. In terms of time I imagine it’s around a 3 month trial, especially if they will have results by the end of the year. An estimated timeline to bring this to the counter would be around 1 – 1.5 years. Maybe towards the end of 2020 is a reasonable time it could be approaching the market. Sandalore already exists in a Giuliani product, I believe it is called Bioscalin. I like your ideas of combining these treatments to potentially bring some synergistic results.
Would a 3 month trial yield accurate results? Most of what I read about hair growth is to give a treatment about 6 months to determine if it works since the hair growth cycle changes would not be immediate. Or is this mainly to reduce hair falling out?
A 3 month trial is sufficient, it’s probably considered the earliest landmark for adequate hair growth assessment. For example the pharmaceutical drug SM04554 from Samumed did a 3 month trial for a phase 2 which is a very important trial and costs in the range of several million $. https://folliclethought.com/what-about-samumed-phase-ii/
Some doctors will advise to wait up until 6 months to see if a product is working if results are not seen in 3-4 months. Hair growth can be noticed within 3 months even in hair transplants.
Excellent! Cross our fingers we have good news at the end of the year.
WAY was the most sought after drug which does the same as cyclosporine A what has shown hair growth in humans for a long time. This is the best bet right now I;d say.
Excellent news admin. This is the best hope we’ve got at the moment for sure. I hope it could be something special!!
I mean, there’s literally not much of a better chance that we could have hoped for regarding possible timelines, credible science, and turn around for results. Super news IMO
Let’s get it all out of the “way” (pun intended):
When will this be available?
How much does it cost?
Where can I buy it?
Where are the pictures?
I’m not impressed with the results…oh wait, there isn’t any yet!
The pics are scammy, comb over, toppik, lighting, etc…oh wait, there aren’t any pics yet!
Sarcasm again…thanks Admin, great scoop once more!
Ha, thanks Yoda. What are your thoughts on this product from Giuliani?
Too early to tell, I’m in wait and see mode. While the cosmetic approach lends to me being somewhat skeptical the fact that Ralf Paus called it out acts as somewhat of a counter balance. We’ve been down the path enough to know not to get overly excited but I am not one to predict failure either. Possibly a mamby pamby answer but my feeling is we have to wait for the results of the clinical trial(s) and data from them.
All jokes aside this is easily one of the most important announcements of the year so far. No one really knows where cloning is at and a new topical that could match or top minox is a gift. Lets hope it is working well friends.
bravo admin! This is a poignant update. I put hopes in Giuliani now to create a good product.
Is this thought to produce more hair than minoxidil by research so far?
Because of the published paper behind this I am holding out good hope. The fact that pictures could be released before end of January is encouraging. One would think that a company involved in hair products will put out clear photos.
I believe there is actually, result foto, coming from conferences.
https://i.imgur.com/FDAKX5x.jpg
Good call Adam!! CsA is one of the most powerful compounds that exists to grow hair, even more than minox. Are some people missing the point here?
I have to agree Zach. When the WAY-316606 news hit the headlines it was one of the most popular discoveries in recent years. To this day people still ask about WAY being available. Now, we find out that Giuliani is working on a cosmetic product with the same mechanism of action as WAY and it could come to market much sooner. The drug would have taken until 2025 to come out. As far as news of viable products coming to market in a short amount of time this is among the most important news of the year. I’m kind of surprised there is not an overwhelming response for this. I can’t think of too much better news than this at this point?
Even still as a cosmetic it won’t reach market sooner than Samumed or Histogen. And we don’t know the side-effects.
Actually, mate histogen is scheduled for around 2025-26 now. And if you’ve been following the updates around here Samumed is going to be in 2022 Turkey first, no telling when the rest of the world.
The whole point of this being a cosmetic is it has almost 0 chance of side effects.
Admin when will the Tissues company answer for the questions. They are my only hope?
I did just hear back from the CEO at J Hewitt today. Though, questions are not answered yet. As I’ve said in recent replied to comments he is being considerate on how what he shares about the therapy, I believe, until the trial has begun. For now we know it is one of the “advanced” hair multiplication therapies. The only thing I’ve heard so far is that if the treatment is successful it would be much more inexpensive than other grandiose quotes we’ve heard recently.
Does he asked about your health or something if he didn’t answers questions yet?
I don’t understand what you mean. There’s nothing wrong with his health, basically he wanted to put out a little announcement originally to create some attention for what his company was doing and he was surprised at the overwhelming initial response and amount of questions from the readers. Now he has to be strategic about exactly what he shares before the trial is started.
@FT So it’ll be less expensive but the result won’t last very long? So I guess less than 100K or even 50K or maybe a whole different range but let’s just wait to here from the ceo first. You think you’ll get a hold of him before or in December?
At this point I don’t know how long the results will last and I don’t even think the company who created the treatment will know for sure. I continue to be in touch with him but cannot predict whether he will decide if sharing more information now is good for his own development and competitive edge. More info could be shared anytime though, I’d say almost def before Dec.
Man, got to say this is better coverage than what the Guardian or big media sites get. Real details about what counts. Thanks much for this update. As far as relevant treatments coming anytime soon this is easily 1 or 2 on watchlist now.
I think soimething ppl are missing out on is yes we have seen cosmetic products before, but no we have not see a analog molecule of a drug like way. It’s very similar to trying the drug way316606.
i think this has best chance of cosmetic so far….
Everyone’s not in the same boat nor is everyone a nw6/7. Getting a cloned follicle implant is not to be the answer for all. More than anything I want something that;s going to keep the hair I have growing or thicken it. The possibility of dermarolling with a wnt stimulator sounds very intriguing to me. Going to keep an eye on this.
Gentleman. I tripped playing tennis, broke some ribs. I’m going to go get checked for Osteo. So could I ask for internal “Way?” Would internal Way make my hair grow back? Side effects? Im a NW6 -7 btw. But it would be a nice excuse to get the product no?
The only thing is it is not really possible to get it for prescription… I don’t think the drug ever made it to pharmacies becuz if it did everyone would be trying to get it and then compound it to use on hair. This is also why a product with same chemistry as way is good news. I like the way you think haha.
At any given time we’ve got to be looking toward something and right now what do we have to look for? Follica, maybe J Hewitt and this. Would this work well with Follica admin?
What are others looking forward to right now?
My gut tells me this will give us results similar to Rogaine. I hear cosmetic and I automatically think of neogenics by loreal where they claimed 2000 new hairs. Nobody got those results lol. I don’t see this giving us thick density regrowth that would compete with a fue. I really hope I’m completely wrong and this stuff ends up being a blockbuster because I’m tired of my hair loss and need something new.
gotta be able to look towards the future HG. At some point we all expect science to piggyback off of past research to bring something that works right? Why not this one? Got to happen sometime I say. Cheers from a fellow hopeful.
Where had Lee Buckler said that he is Expecting RCH-01 results in October/November?
What do your Source of Shiseido say?
This was a response to an email that a reader on a message board shared. Lee often does reply to personal emails. It seems likely, I don’t remember exactly where I saw it but Lee said the doctors would be getting their data returns in July/August and sometime after that they should be sharing it. Ultimately, that decision ends with Shiseido. My old source of Shiseido is not responding anymore, was one of the scientists working on the trials and therefore can’t share any information until Shiseido does it publicly. For such a big company this is understandable, the only strange this is why it takes so long now.
Thanks for your reply. I can’t understand why it takes so long too. I am wondering if they prepare there commercialization of RCH-01 already or if they will start with planning of commercialization after they public their results… If they havent think already about ways to implement RCH-01 in the clinics and offering for a lot of patients it could last at least 1 year i think if they have a marketable product. What do you think ADMIN on how long it could take to bring RCH-01 to market after releasing results? Do you think they make parallel ideas while the trial about commercial implementation for a big amount of international and national patients?
So You won‘t answer me @ADMIN?
Sorry, I didn’t see your question. Shiseido absolutely has commercialization in place for RCH-01 if the product is ready to go. Their facility in Kobe Biomedical Innovation Cluster serves as a processing center for RCH-01 as well as a commercialization space to treat patients. This was mentioned in a Replicel press release from May 20, 2014. So, if the treatment is successful I’m sure they would be prepared for international/national patients. After releasing results it could take perhaps 6-8 months to begin treatments for patients, an estimate.
Thank You very much for your answer! So we Hope for Q2 2020
Thanks Follicle Thought for the uplifting news. I look forward to the clinical results.
Thanks for the great news FT. By the way, do you know if the tests on the exact molecule are also done by Giuliani? Or the pharmaceutical formula is tested by another firm? Thank you !
Thank you belgianboy, I am not certain but more than likely the collaboration is done with certain labs like the Monasterium laboratory which is owned by Ralf Paus who originally worked on the WAY-316606 research at Manchester University. But I imagine Giuliani had their own scientists too. You can check their collaborations here https://www.hairsciencegiuliani.com/en/partnerships
people on the internet: we need better treatments! we need something good now! *clicks refresh*
news: way316606 cosmetic might be coming very soon
people on the internet: stares at screen
lol in sept 19′ what better treatment could you have heard of coming out soon?
You just ordered methyl sulfonyl methane (MSM Gel /
Is it useful in hair growth and non-hair loss?
MSM is supportive to hair growth but would not likely be a significant treatment against AGA. Where did you get the product?
https://saudi.mumzworld.com/sa-en/ionic-msm-hair-growth-gel-100ml
After this news many of you will find the following irrelevant almost. But Celino emailed me back to say that they are setting up a website to sell NGF-574H, to overseas customers, within the next month or 2. They will announce it on their FB page. So for those of you who are interested in trying this you should be able to purchase it before the end of the year. To temper this news, they, at this time are not releasing any pictures from the recent trial and they are actually pointing people toward the guy on YouTube giving monthly updates on the product. Make of that what you will.
Cheers
Frankly, I prefer Tissuse, Tsuji, HairClone, etc to be successful in their clinical trials and be reasonable priced. I saw the bloke’s videos of his usage of NGF-574H; I am on the fence. Something tells me when it becomes available, it will be a few hundred quids for a small bottle. That one bottle might afford one about a month of usage. Albeit I am a pessimist/realist, I have no qualms about eating my words/humble pie…if you get my drift! 🙂
Yeah, might as well cheers these guys on. It’s very highly unlikely these guys will charge a few hundred a bottle, that’s just unreasonable. Maybe 85-100. I think the only thing to consider here is if the product is going to work great.
Welsh are you still buying once the site is available?
I will give it a go. Cost will be $90 – $95 USD.
I agree, potentially better options in the future.But I don’t think anybody is kidding themselves in believing this is a cure. But could be a better alternative to fin and minox for some people.
This update is so encouraging! Thanks so much. this website gives lots of hope for me.
Expecting results still within the next month?
Hi John, I’ve just asked Giuliani for an update about the product and trials. Thanks
Have you recieved word from Giuliani about the clinical data and expected release of this product?
I haven’t received an update from Giuliani yet, no doubt they are working and continuing progress.
Any update yet?
D1, unfortunately no update at the moment. Giuliani has gone quiet. I will try again in the future to ask for an update.
so many companies but yet nothing yet so sad …we had trinov and it was a huge lie
So… mid December and no news on way316. I hope this is not another bust .. but it looks like it’s going that way. Bummer .
I’m honestly not overly concerned at the moment, development is still early, they had multiple candidate compounds, and could very well be on track with the first candidate compound trial. I will email them at the very beginning of next year if I do not hear back from them first.
Well your optimistic hope your right. Frustrating thing also is the stupid fda regulations doctors here follow .. why dont they give avodart like they do in Korea Japan are those people not human ..well they are and look after their we being better than we do in north america it seems. Any idea who gives this med over finasteride which eventually declines in effectiveness??
any update, when can we expect this to be purchased over the counter?
Are you going to approach guiliani for the way 316 results we were all waiting for end 2019?
Yes I am
I’m very excited to see what you can find out for us, thanks for your work 🙂
Any update on WAY-316606 or any other products this company giuliani?
Dimitri, oddly enough Dr. Marzani from Guiliani Pharma has not responded for comment lately. This could be for a number of reasons. Potentially, the company might have received a number of inquiries from people after the article was published and have decided it’s best not to release anymore information until a product is about to come out. Or, perhaps the initial pilot trial did not produce good results, or maybe both of these options are true.
It is disappointing, but I will try back with her around March to see if I can get a small update.
Hey Admin,
Any word on the way 316606 analog from Giuliani Pharma? Are the clinical results out yet? Is Giuliani Pharma not the same company that was testing sandalore? Do you know if anything ever came from that?
Does Giuliani Pharma promote and manufacture other hairloss products?
Sorry for all the questions I’m just trying to better understand their business.
Getting a little discouraged with no new treatments Slated for 2020 or 2021 for that matter?
Hi Hope, please see my response to Dmitri regarding Giuliani at the moment. Giuliani is the same company who made sandalore, yes. They’ve already put that into a product which I believe is the Bioscalin Signal Revolution product https://giulianipharma.com/en/product/bioscalin/. It’s probably not a groundbreaking product, but one that can keep hair growing a little longer than usual before shedding. It is kind of tough looking at a pipeline with no scheduled releases in 20/21, but there is always hope for a surprise. HairClone will all but definitely be out in 2021 now, and there’s potential for other cosmetic products to come, perhaps in Giuliani if the project works out.
Thank you for your reply, a surprise product would be amazing, keeping my fingers crossed. Really wishing the Giuliani way product panned out too.
There has to be a breakthrough at some point…
No one is willing to spent on clinical trials. This is why we need group buys. If it wasnt for that I would never have gotten my hand on way. This shit will never work. They think they can find a wnt agonist that they can sell as cosmetic? Really? Does no one realize the contradict themselves?
No news regarding this one?
Not yet Mike, my guess is they could be looking into a different molecule in their group of candidates. I think we will get an update around summer perhaps.
Il y a t’il des nouvelles par rapport aux essai clinique au WAY-316606? Ou d’autres solutions peut-être contre la perte de cheveux ?
Please translate before commenting. It makes it easier for the community to understand.
Any update?
Uhhhh was this removed from their website? https://www.hairsciencegiuliani.com/projects/
It looks like it was Fgs, I wonder if they dropped the project completely or just being quiet about it.
Hi admin can you find out from the company what’s up. Is that possible. Thank you!
L, I will do this soon, thank you.
L, thanks again, I should have an update on this within a month.
Thank you!
Hi admin, has the company gotten back to you? Thank you!!
L, yes they did! Please subscribe for updates with your email in the right sidebar on desktop or bottom sidebar on mobile. I published an article on the update a few days ago. There is good news.
Thanks for this site. It’s a real public service that you do here. I salute you sir!
I felt compelled to comment because I had a couple burning questions about this whole Wnt pathway modulation male pattern baldness treatment paradigm:
1) Has anyone tried using WAY-316606 themselves? And why did they discontinue development of this specific molecule and move to other analogue molecules instead?
[ science.bio/product/way-316606-hcl-powder ]
2) This is probably ages old and has already been well delved into, but why not just use topical Cyclosporine?
pubmed.ncbi.nlm.nih.gov/2312805/
This immunosuppressive drug caused unexpected hair growth and ultimately spurred the development of this current research into the Wnt pathway.
HI Admin
any update?
Sure, please subscribe for email updates on right sidebar for desktop or bottom bar on mobile. Also, bookmark the Updates page and check daily or similar. The update came out about a year ago https://folliclethought.com/way-316606-product-release-update-2020/
Hi Follicle Thought and others. Any further news on the subject? I’m very curious
All info is located in the product release article ?