Kelopesia Update, Brotzu Trial, Cures: Weekly Thoughts 12/16/16

Hey everybody, welcome to another edition of Weekly Thoughts. This week I touch on two topicals that have been at the forefront of the attention of hair growth enthusiasts this past year. Also, I take a look at an intriguing healthcare legislation that was just passed in the United States this week.

Kelopesia Update

Remember when Kelopesia burst onto the scene earlier this year? Man, that was a hoot. It was slated as a new stem cell-conditioned media cream which would be available by the end of April in Turkey. Well, turns out that was not the way it happened. We’re not quite sure what lead to the delay, but that’s not really important anymore. What’s important is that we are actually close to the re-scheduled release date of Kelopesia. This past week I decided it was a good time to get an update from Yeditepe University.

Prof. Fikrettin Sahin, the gentleman and scholar who developed the Kelopesia cream, told me this week that his team is “working hard” to get Kelopesia released to the Turkish market in Spring 2017 and “hopefully” it will be released in January. There you have it.

Yes, he does mention that the release will be for the “Turkish” market. What does that mean for the rest of the world? It does mean that it will take more time for the product to be officially released in the rest of the world. However, it does not mean that the cream will be impossible to get if you do not live in Turkey. You can always visit Turkey or find other options on the internet.

Brotzu Lotion Trialing

It is only right that if we got news about Kelopesia we should hear more about the other top-notch topical making waves in the hairternet. I heard from a representative at Fidia Pharma that the famed Brotzu Lotion is still undergoing a clinical trial with the company and therefore a release date is not certain yet. 

My own personal take is that things should be winding up in the trial soon. The lotion seems to have been in a clinical trial for a good amount of time now; the trial was reported to begin last March. Personally, I have a good feeling about it, I do feel that this product is going to be released by Fidia at some point. For now, the release date is unknown.

America Accelerates Cures

This past week US President Barack Obama signed the 21st Cures Act into law. The bill is referred to as “Cures” and is heralded to advance the discovery, development, and delivery of drugs and therapies in the US market. It will do this by providing major funding to the National Institute of Health over the next several years, modernizing clinical trials, and utilizing health records and patient data in new ways to promote research collaboration. If you do a little internet research on the subject you will find some differing opinions on the impact of Cures among the healthcare industry, but whose really got time for that? 

Readers of this blog pretty much want to know one thing — how does Cures affect hair growth treatment development?  The answer is no one really knows yet. Experts in the regenerative medicine industry are still reviewing this huge piece of legislation to understand it better. Also, the way the bill is written leaves room for variables in how the FDA will actually utilize Cures.

Here’s what we do know about Cures for now:

  • Regerative medicine products, including stem cell therapies, can be granted “accelerated approval” by the FDA
  • Accelerated approval does allow a treatment to be available to patients before completing a phase III trial
  • Accelerated approval is typically intended for medical conditions with unmet needs

The questions of whether hair growth treatments will be allowed to utilize accelerated approval and exactly how all of this will work are unanswered at this point. To be honest though, it’s really nothing to lose sleep over. Treatments will go through the process anyways, if Cures provides some expediency to that, then very good. We’ve got to keep pushing forward, regardless. Time will tell how the FDA intends to utilize the new provisions of the 21st Century Cures Act. I recommend these three articles for more background: STAT, Wired, and TheHill. If there are any scientists or industry persons reading this that can offer some insight on the Cures Act please comment below. 

It has been a good year everybody and unless something major pops up in the next two weeks, I’ll speak to you all in 2017. Have a Happy New Year 🙂

28 thoughts on “Kelopesia Update, Brotzu Trial, Cures: Weekly Thoughts 12/16/16

  1. There is certainly an unmet need in terms of hair loss cures since present treatments don’t work for everyone. This is the first I’ve read that “accelerated approval” would require that a condition is SERIOUS. Every other article I’ve read about the new cures act said only that there has to be an unmet need with no mention that the disease involved must be serious. That aside, I do believe that the pharmacy industry could make a case that hair loss is a serious medical condition anyway.

    • Thanks for visiting, Joe. I was really just citing the STAT and Hill article which I linked in the article. But you know what? I’ve decided to take that wording out now because hair loss is a condition that deserves accelerated approval anyways. Thanks for commenting.

  2. I just want to thank you so much, Joe, not only you keep us informed, but also you spread the right attitude of being positive and grateful.
    You must be an awesome person!

  3. What’s up with the beffort after of kelopesia I’ve only found photos hopped images on Google and sahin nephew who hasn’t had much success

  4. Thanks for your posting i enjoy reading it.

    anyway, when did you hear from a representative at Fidia Pharma that the famed Brotzu Lotion is still undergoing a clinical trial with the company and therefore a release date is not certain yet?

    brotzu sphere is AA and AGA is fidia?
    or brotzu takes part in fidia’s trual?
    i want to know if your info is latest one.

  5. News from a moderator on the IESON forum.. Called fidia and they said they will be releasing a statement about the lotion before the holidays in the next week

  6. we are all very excited about the turkish and the italian product … hopefully this will be the much sought after ”cure”… thumbs up! admin thanks very much for all the info..
    greetings ffrom Chile,

    Matias

  7. Follicle Thought, did you get an impression from the Fidia rep that they are aware of the interest in the lotion? Do they know that people are very excited for its release?

  8. Thank you for keeping our hopes up with all of your posts!
    Have you talked directly with anyone at Fidia?
    I tried emailing them maybe a week ago but all i got was a generic response about “We will keep you abreast of the company’s future steps through an official press release.” Like the post above states, an administrator allegedly spoke to someone at Fidia and there were supposed to be a press release this week, but i does not look like it is going to happen…

    • You’re welcome. My latest update from Fidia is in the latest Weekly Thoughts. Maybe today, maybe next month but Fidia will put out a press release.

        • Xander,

          Thanks for the question. I think a lot of people do not realize that in businesses and in life in general plans sometimes change. I do not know why there is a delay, but I’m sure it is no big deal. Perhaps they wanted to do a formal meeting with the board of directors before they released a statement, or they are waiting on approval of the press release from someone at the company. Either way, the product was not going to be released today. Things are going fine at Fidia, they have an important product sitting in their lap. We should all give them time to do this right.

  9. Hey, thanks for the excellent site! Did Fidia explicitly mention Brotzus lotion to you? Some people are worried that we’re all just getting generic mail responses from them, that aren’t even related to the product.

    • Hi Ben,
      I don’t really understand the question. Are you implying that Fidia is not aware of the Brotzu lotion? They have been involved with the product and trialing it for almost a year now…
      Breathe easy my friend. Merry Christmas

      • They’re being so quiet about it, I just want to make sure they didn’t give up on it. But, yeah, should probably just relax a bit, haha.

          • I think
            the fact that too much rumor about press release exist means majority people have deep desperation including me.

            up to now, we think brotzu is the best of bunch
            and at best, it could bridge to tsuji’ cure delaying hairloss without sides.

            such being the case, many people feel deep disappointment everytime rumor turn out to be nothing.

            i really really thank you admin. in this situation, i could get info about lotion here.

            Hope that fidia understand our feeling and everything goes well.
            and again thanks for your effort admin.

  10. Hello Joseph, Happy new year. It’s 2017. What happens with new treatments for MPB? 20 years without a improvement in MPB treatments…what a shame!

    Thanks for all.

  11. Should we have high hopes for the new Brotzu lotion. I want to believe it will be helpful but there have seen so many let downs over time that I really have no idea. I stopped taking everything last year as I felt anxiety type side effects.

    • I believe it’s always important to have hopes, and also important to maintain a perspective that will not leave you let down depending on how things turn out. The progress is real, it’s coming; let’s hope that the Brotzu lotion impresses us.

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