Samumed Phase 3 Trial Is Underway
Updated 2/28/20
Samumed SM04554 Phase 3 Trial Is Now Fully Enrolled
In a company newsletter published on February 28, 2020, Samumed announced that their phase 3 trial of SM04454 in AGA has finally reached its quota of trial participants. That quota was a whopping 625 male subjects between the ages of 18 – 45 years old. It’s no wonder that it took Samumed roughly 15 months to fill up enrollment for its pivotal trial in Turkey. The last few subjects who enrolled in the trial will still have to complete about 48 weeks of daily SM04554 application which will extend the trial into January 2021. We can certainly expect results from the trial to be shared at some point in 2021, which is good news.
Original Article
Earlier this year in August, I announced Samumed was moving towards an imminent phase 3 trial for their topical SM04554 in AGA.
The news of the day is Samumed’s phase 3 trial for androgenic alopecia is underway. It will take some time before the trial comes to completion, but having the trial in progress is a major accomplishment. The update released by the company seen below states the trial is taking place outside the US. It can be noted that Samumed previously conducted a phase 1 trial for SM04554 in Australia.
This would make three treatments currently at the pivotal/phase3 stage in the hair growth industry; Shiseido in Japan, Histogen in Mexico, and now Samumed.
Posted in Samumed
Can anyone confirm that clinical trials which are held out of the US are sufficient for FDA approval?
It would be literally just about “unthinkable” that Samumed would run a phase 3 clinical trial that could not be used for market approval in US, agreed? Also, their phase 1 from Australia permitted their phase 2 in US, so the answer is yes.
How long is the phase 3 trial ?
Typically they last 12 months.
@admin:
1. Have they disclosed the location of the trial yet ?
2. Have they published the detail of the trial yet (such as https://clinicaltrials.gov/) so that everyone would have an overall idea of their trial
Thanks
Location has not been disclosed yet, trial is most likely very similar to their big phase 2.
Hi
it seems there is 3 companies(Replicel and Riken and hairclone) are working on creating new hair follicle the others are finding ways to wake up dormant follicle am i right?
I live in Europe. I was wondering if anyone knows how quickly once there is an FDA approval for a new drug the EU equivalent approval is obtained? Given how big and lucrative the EU market is, and the amount of competition with hair loss products, you would have thought that companies that are proposing to seek approval for the US market would seek approvals for the EU in parallel (?) (The EU has a central agency so it is not necessary to obtain individual approvals in EU member states). But I don’t really know how this works in practice. Can anyone enlighten?
Good news Admin, I have a positive feeling about this! Thanks as always for staying on top of potential treatment news.
Thanks Yoda, SM is moving right along.
I am slightly confused and perhaps just need some additional clarification. The company has NOW 625 participants which is what it wanted originally. The new participants will also be required to complete the mandatory time of 48 weeks.
However, earlier participants, have already started? Thus there could be pre-liminary data? Well before 2021? or at minimum participants done before 2021?
One would imagine that no data will be released until all participants have completed the trial. Then it’s over, the the data will be complied and eventually released. I highly doubt there will be preliminary data released from a professional, clinical trial unless they conclude early it’s an epic failure.
G, Yes the early participants have already started and thus will complete the trial much earlier than the participants who enrolled towards the end.
However, no, I do not think the company will not disclose any results until all of the participants have completed the trial, it’s just standard procedure. Early announcement of a small sample of participants could potentially create an issue if the complete results do not match up later on.
Can I conclude that this product is not suitable for people aged 45 and over?
Pjotre, the product may end up being suitable for someone aged 45 and over. The reason why Samumed restricted the eligibility to males under 45 is because they know that men below 45 would give them the best potential responses to treatment. In clinical trials sometimes even a small difference of improvement (e.g. 15% compared to 18%) can be a big deal. All companies are looking for any way to maximize their efficacy outcomes and this is what Samumed did. That’s the main idea, they are looking to maximize their results, it doesn’t mean that SM04554 will be useless for 45+.
painfully slow
This is very encouraging. Even if there is no immediate cure as yet, if the results from samumed, follica, and breezula are anywhere near decent, maybe all three treatments can be stacked for significant regrowth.
Well, we need any product that can help us. But, do you think this is a reliable company? Since it has reached phase 3, can we just tell for sure that this will be finally out? No more Brotzus please, we had more than enough with that snake oil, besides it was really expensive…
Thanks!
Well, if it succeeds in trials, SM04554 will eventually be a drug with a nice marketing name (e.g. Breezula) and will have some clear and numerous data when it launches unlike Trinov which had one small study and a lot of mystery. Phase 3 will be the final test for SM after 1 year of use. If it does not produce reasonable results then Samumed will not put it on the market and risk their reputation in my opinion.
Agree with admin… SM and Trinov are apples and oranges. Call me a skeptic but I believe this will always be the case when comparing a cosmetic treatment with one that has gone thru the rigors of multiple clinical trial and gain regulatory approval(s), e.g. FDA, EU, etc.
market release 2022, almost 30 years after finasteride/minoxydil
Am I right in saying the earlier phase results weren’t exactly mind blowing? Growth of c. 10% plus some thickening of existing hair?
This is true, the product is not a game changer but will be another treatment in the arsenal, so to speak. One thing it did demonstrate is the ability to create new hair follicles, albeit not a huge amount. This is something that could work together with minoxidil or finasteride.
Might they be optimizing the treatment (percentage/strength, frequency, etc.) to improve upon the results of earlier trial(s)? I doubt they would be moving forward and/or commercially release something that had meh results. Maybe not the holy grail that some seek, NW7 to NW0, but impressive to most.
It’s funny, I had thought this trial had an arm which was using SM twice a day which I thought was a good idea but I just revisited the trial listing and it looks like both treatment arms are still once a day. Anyways, the duration is 48 weeks so we shall see what it that can do for that length of treatment.
Concentration is the same? The length of treatment is longer then? If so, one would think that can probably make a lot of difference.
They’re doing 2 different concentrations in this trial, which is longer than previous trials, so yes the results will be interesting.
Hello Admin!
H2 year reports of 2019 are supposed to be published until 29 of February.
Do you have any news about that? Follica or sut?
Thanks in advance!
*SHT
Hi glammetal, I have a brief update from J Hewitt as stated at the bottom of this thread. Not much on Follica for now.
2022? Really? Oh, gosh! Thought it could be in 2021… :s
somebody knows the increase rate of precedent trials of samumed?
I ain’t holding my breath for this hair loss treatment. Come on, J. Hewitt and Tsuji…don’t disappoint me!!
Holding your breath for Tsuji…you must be a world record holder in diving! If that’s what your waiting for, be ready to wait for years before it (if) becomes commercially available to the regular, average Joe. As far as J. Hewitt, maybe…maybe not, nobody knows. I believe we are closer to an evolutionary step like Samumed, Follica, etc. rather than next gens like cloning, cell therapies, etc. But then again, what do I know? It’s all speculation, however I cringe when I see guys thinking their going to pop over to Japan and come back with a full head of hair in the next 1-2 years.
yah kudos to Yoda. what’s the point of some to come here and look past this drug. long time people thought tsuji was the best but it’s still quiet there. don’t take news for granted.
I just wanted to add here that I’ve received a little more feedback from J Hewitt about their situation with the trial. There’s no mention of a date, but the CEO has been reading the comments and wanted to give more background. You can check it here https://folliclethought.com/j-hewitt-to-trial-hair-multiplication-in-2019/
I wanted to let everyone know that I’ve received a little more feedback from J Hewitt about their situation with the trial. There’s no mention of a new date, but the CEO has been reading the comments and wanted to give more background. You can check it here at the bottom of the comments https://folliclethought.com/j-hewitt-to-trial-hair-multiplication-in-2019/
@FollicleThought it feels like things are slowing a bit in the hair loss world right now. i was hoping for a topical out soon (
Hi Admin, do you know about Topical Cetirizine against AGA?
This is already in Phase 4 Trials … does that mean its already available? Where can I buy it to give it a try?
https://www.clinicaltrials.gov/ct2/show/NCT04293822
This looks like it is the Shisiedo study on DSC cells;
http://www.sciencedirect.com/science/article/abs/pii/S0190962220302723
I wonder if HAIRCLONE will take the same path, since SHISEIDO seems to have taken “SC cells”, these cells will eventually die. How different will HAIRCLONE be?
https://gramho.com/media/2233081671372250791
Off topic, they claim these are exosomes therapy results, great outcome in just 5 months if true.
los.
Please see how your hairstyle is in “curtain”. I also have a great density with that hairstyle
Interesting result…
Tissuse update
Jamal, please see the latest words I’ve received from Jon Knight. I posted a link to them in a comment in this thread.
THank you admin!
SM is moving along but it had weak results in previous studies.
Hi Admin,
Any news on Samumed phase 3 trial ?
shouldn’t the trial be finished by ?
Thankyou 🙂
Zero logic to why it would take 18 months to get 625 trial participants for a hair loss drug! It’s the most common condition you can get! Also people would have killed to get on this trial.