The Cb (breezula [clascoterone]) Community Thread

Jim lahey

Established Member
My Regimen
I am aware that Google exists but in case you haven't noticed there's a lot of conflicting information and I was hoping to find something more reliable here.
Sorry I forgot about all the conflicting data on whether breezula is an anti androgen or not. If only Cassiopea had a website where they held all the official information on the drug.
 

John Difool

Senior Member
My Regimen
From the manufacturer page:
Clascoterone solution 7.5% is a novel AR inhibitor that targets androgen receptors in the scalp and is currently being studied for the treatment of androgenetic alopecia (Androgenetic Alopecia).

I am not sure what else you are looking for.
 

pegasus2

Senior Member
My Regimen
Ok guys, please talk to me.

I can't possibly afford the Tsuji treatment, so I'm betting all my money on Breezula and I really want this to work.

Two questions:

a) I read somewhere that Breezula is an antiandrogen. Is this correct? I thought that Breezula only protected hair follicles and didn't alter hormone levels, thus being safer than finasteride.

b) Is there a release date? Cassiopea is an Italian company and Italy was severely hit by the new coronavirus, did the covid-19 crisis delay this?

Thanks in advance!

I'm in a good mood so I'm going to help you out on the off chance that your DNS has Cassiopea's website blocked. If you're betting your money on Breezula saving you then you're going to go bankrupt. Better to bet your money on a hair system. Breezula is indeed safer than finasteride, not that finasteride is dangerous. Hair loss is caused by DHT binding to androgen receptors in the hair follicle. Finasteride inhibits the systemic production of DHT. Breezula works by binding to the androgen receptors in your scalp, which prevents DHT from binding to them. Within minutes of hitting the bloodstream Breezula is metabolized into an inert substance, which means it only has effects where it is locally applied. Sounds great so far, right? The problem is that Breezula has a weak affinity for the androgen receptor. It is easily outcompeted by DHT. That's why you have to use so much of it(75mg twice a day). You have to flood your scalp with it so that it will attach to enough receptors to make a difference before DHT does. At such a high dose it is very effective over the short-term, but its effects don't last as long as minoxidil's. We need confirmation of this from their next trial, but in their last trial its effectiveness quickly declined after 6 months. This might be due to androgen receptor upregulation caused by blocking the androgen receptors continuously, thus requiring higher doses to block greater numbers of receptors. So it is certainly an effective and safe treatment in the short-term, but in the long-term it may not be very effective.

There is no release date, but it could be released in a few years. The acne version, which contains the same active ingredient, should be released next year. However, the concentration of the active drug in the acne version is only 1%, whereas you need a concentration of 7.5% to effectively combat hair loss. It should be fairly easy to get the acne version prescribed off-label for hair loss, but it will probably be very expensive since the pricing will be based on a marketed concentration of 1%, and you will have to get it compounded at 7.5%. SM04554 is the other new drug on the horizon. I think that one is more promising as a long-term treatment, but don't expect that to outperform minoxidil either.
 

Breyfogle

Established Member
Best case scenario: They start the trial in 01.09.2020 take half a year trial 01.03.2021 and wait one year for approval which takes in best case 1 year. So best case 01.03.2022.

Now lets take a look at a realistic timeline:
Start 01.09.2020
End of enrolement (sasumed needed 15 month for phase 3 enrolement) 01.12.2021
End of trial (6 month later) 01.06.2022
Getting approval (takes 12-18 month so lets assume 15) 01.09.2023
And that is really a realistic approximation and not a conservative. And keep in mind that half of the phase 3 trial candidates are droped by the developing company during or after the pase 3 trial and half of the ones, that are not droped are rejected by the fda.



So a realistically we have a 25% chance it hits the market 01.09.2023 and best case it hits the market 01.03.2022.

Thx byebyehair your math seems about right. Helpful post.
 

petersonKj

Banned
My Regimen
I'm in a good mood so I'm going to help you out on the off chance that your DNS has Cassiopea's website blocked. If you're betting your money on Breezula saving you then you're going to go bankrupt. Better to bet your money on a hair system. Breezula is indeed safer than finasteride, not that finasteride is dangerous. Hair loss is caused by DHT binding to androgen receptors in the hair follicle. Finasteride inhibits the systemic production of DHT. Breezula works by binding to the androgen receptors in your scalp, which prevents DHT from binding to them. Within minutes of hitting the bloodstream Breezula is metabolized into an inert substance, which means it only has effects where it is locally applied. Sounds great so far, right? The problem is that Breezula has a weak affinity for the androgen receptor. It is easily outcompeted by DHT. That's why you have to use so much of it(75mg twice a day). You have to flood your scalp with it so that it will attach to enough receptors to make a difference before DHT does. At such a high dose it is very effective over the short-term, but its effects don't last as long as minoxidil's. We need confirmation of this from their next trial, but in their last trial its effectiveness quickly declined after 6 months. This might be due to androgen receptor upregulation caused by blocking the androgen receptors continuously, thus requiring higher doses to block greater numbers of receptors. So it is certainly an effective and safe treatment in the short-term, but in the long-term it may not be very effective.

There is no release date, but it could be released in a few years. The acne version, which contains the same active ingredient, should be released next year. However, the concentration of the active drug in the acne version is only 1%, whereas you need a concentration of 7.5% to effectively combat hair loss. It should be fairly easy to get the acne version prescribed off-label for hair loss, but it will probably be very expensive since the pricing will be based on a marketed concentration of 1%, and you will have to get it compounded at 7.5%. SM04554 is the other new drug on the horizon. I think that one is more promising as a long-term treatment, but don't expect that to outperform minoxidil either.
Bullshit only one group deteriorated after 6 months and that was the 7.5 percent group. The other groups have basically maintained what they had at 6 months in terms of progress. The sample sizes are extremely small and this adds a lot of potential bias meaning that a few people from that 7.5 group could draw down the entire end results. It's not significant anyway, a larger study with a larger group is required that's why they do a phase 3 trial. I don't think it has anything to do with binding time or any molecular stuff. If so why did the 5% group actually gain after 6 months
 

pegasus2

Senior Member
My Regimen
Bullshit only one group deteriorated after 6 months and that was the 7.5 percent group. The other groups have basically maintained what they had at 6 months in terms of progress. The sample sizes are extremely small and this adds a lot of potential bias meaning that a few people from that 7.5 group could draw down the entire end results. It's not significant anyway, a larger study with a larger group is required that's why they do a phase 3 trial. I don't think it has anything to do with binding time or any molecular stuff. If so why did the 5% group actually gain after 6 months
Source?
 

pegasus2

Senior Member
My Regimen
Read the study
In the study I read every treatment arm lost ground from months 6 to 12. Maybe you know of another study, or I just don't know how to read?
 

Dimitri001

Established Member
My Regimen
Breezula is indeed safer than finasteride, not that finasteride is dangerous.

Why do you say that finasteride is not dangerous? I know people talk about sexual dysfunction and post finasteride syndrom all the time, is it that the rates of that are very low?
 

pegasus2

Senior Member
My Regimen
Why do you say that finasteride is not dangerous? I know people talk about sexual dysfunction and post finasteride syndrom all the time, is it that the rates of that are very low?
Yes, the rates of serious side effects are very low, and the very existence of pfs is debatable. If it is a real thing, the chances of it happening are so low its not even worth considering. 99.99999% of people who develop sides will recover after discontinuation.
 

Pigeon

Senior Member
My Regimen
Yes, the rates of serious side effects are very low, and the very existence of pfs is debatable. If it is a real thing, the chances of it happening are so low its not even worth considering. 99.99999% of people who develop sides will recover after discontinuation.
Complete lie. But I don't want to go into the 100th discussion about this though.
 

Dimitri001

Established Member
My Regimen
One point regarding judging a future treatment by comparing it to Minoxidil:

While this is certainly informative and important, keep in mind that there is a wide spectrum in terms of how effective M is for people. For some people M does nothing and for others it gives great results.

So, if some study shows that some future drug is 1/2 as effective as M, well, maybe you're a Minoxidil non responder for whom this drug will overperform the way M overperforms for some people relative to what you'd normally expect from M.

That's kind of praying for it, but for any drug that works to some degree for some people, there's a possibility you'll be among the people who are on the extreme high end of that.
 
Top