CB-03-01 Release Date

[Paigems]

Does anyone know when CB-03-01 should be available to the public for acne?

I'm actually not a hair loss sufferer, but an acne sufferer. I've tried contacting cosmo and intrepid with this question, but I haven't heard back.

I guess to make this a bit more related to hair loss... The reason I'm interested in CB-03-01 is because anti-androgens like spironolactone clear me, but they also make my hair fall out. I lost about half my hair on spironolactone.

Hope this isn't too off topic. I appreciate any responses

 

[maher]

I'm not even sure if phase II of clinical trials has started.. Around 2017, 2018.

It looks like phase 2 is completed:
http://www.cosmopharmaceuticals.com/news/press/2014/2014-07-08.aspx

Cosmo Pharma. is a "limited" company. They have no experience with FDA approval.. And I don't put much faith in Italians- they tend to **** up.

 

[isishearmyplea]

phase II for acne is over. spironolactone is spposd to maintain hair, better than even finasteride :crazy:

 

[Paigems]

phase II for acne is over. spironolactone is spposd to maintain hair, better than even finasteride :crazy:

Thanks. I know phase II is over; I'm just not really sure how long it should take from that point?

I know spironolactone is supposed to maintain hair, but it definitely makes me lose mine! I've tried taking it several times and I've always had the same experience. I thought maybe it was a "dread shed", but it went on for months and months and I started to get some scalp showing through so I had to give it up. I know a few other people who had the same experience as me. Interestingly, metformin (which I also tried for acne) also makes me lose my hair.

 

[Python]

Thanks. I know phase II is over; I'm just not really sure how long it should take from that point?

I know spironolactone is supposed to maintain hair, but it definitely makes me lose mine! I've tried taking it several times and I've always had the same experience. I thought maybe it was a "dread shed", but it went on for months and months and I started to get some scalp showing through so I had to give it up. I know a few other people who had the same experience as me. Interestingly, metformin (which I also tried for acne) also makes me lose my hair.

Well that's tough, when your hair falls off with a drug like spironolactone, it means regrowth is coming. Maybe you jumped ship too fast.

 

[Paigems]

Well that's tough, when your hair falls off with a drug like spironolactone, it means regrowth is coming. Maybe you jumped ship too fast.

I had never had hair loss before taking spironolactone. I gave it over a year and my hair just kept falling out. Not only that, but it continued to fall out for about 6 months after I quit the spironolactone.

 

[isishearmyplea]

hmmm. . . you know you have to wait for like a year on anti andorgens to see the effects, maybe you did jump the ship quickly . . . no sides on spironolactone??? anyway are the people on acne forums excited about cb? people expect it to be available in 2016 - 2017 in asian markets(dunno why). there is a thread on CB at BTT check that out. good day.

 

[Paigems]

hmmm. . . you know you have to wait for like a year on anti andorgens to see the effects, maybe you did jump the ship quickly . . . no sides on spironolactone??? anyway are the people on acne forums excited about cb? people expect it to be available in 2016 - 2017 in asian markets(dunno why). there is a thread on CB at BTT check that out. good day.

I was on the spironolactone for over a year and the hair loss never stopped. It worked great at clearing up my acne, though.

I don't know if a lot of people are very excited about the cb for acne. I've posted a thread about it on acne.org and I didn't get any feedback so maybe not? I am personally very excited about it since I've tried every topical treatment, accutane, and spironolactone and my acne is still here. I know anti-androgens work for my acne, but when I take them orally my body just seems to reject them. For this reason I am very excited about CB

Do you know if CB is expected to come out first in Asia?

 

[abcdefg]

I dont think spironolactone is strong enough or has a good enough vehicle to actually make a big difference for hair loss. Acne needs a less potent AA so maybe its strong enough to have some effect there. For all the spironolactone hype I remember bryan pointing a long time ago that spironolactone actually has very little evidence it works for male pattern baldness

 

[lifelonglearning]

Half Year Update From Cosmo - http://www.cosmopharmaceuticals.com/~/media/Files/C/Cosmo-Pharmaceuticals/140730_Cosmo_HYR2014.pdf

-Work on Proof of Concept trial for CB-03-01 in alopecia continues. It is target to be completed in 2015

-It penetrates the skin well and acts by displacing the androgen from the sebaceous gland or hair follicle. In blood it quickly metabolizes to cortexolon and thus only has very minimal side effects

 

[kantian]

"Phase II proof of concept trial for CB-03-01 in alopecia is scheduled to start in the second half of 2014. It will take a year to complete"

Is there any difference between Phase II clinical trials and Phase II "proof of concept" trials? Do you think the FDA will require some more trials if they want to market it here?

 

[fml]

I see Cosmo's share price has risen 500% in the last 18 months. Not that this necessarily means anything about a hair loss product.

 

[hellouser]

Do you think the FDA will require some more trials if they want to market it here?

You bet. The FDA does more damage than good for treatments to make it to the market. Do not get your hopes up with the FDA, they are incredibly incompetent.

 

[dreamermerlin]

the FDA, they are incredibly incompetent.

Dude, FDA must do their job, to control and assess the safety of each drug put on the american market.
They are incompetent because they don't immediately release everything, although it could be potentially dangerous??
Your frustration is exaggerate...
Do you think the only FDA work is with hair-loss products???
They have some laws and regulations they must follow.
It's just childish and naive for you to call imcompetent or other names anyone/anything that simply doesn't cure your hair loss TODAY.

 

[kantian]

I think his frustration is from the fact that the FDA paternalizes mentally healthy adults and prevents them from taking risks with their own bodies. The FDA is also self interested and is more likely to be too cautious in approving a drug.

 

[zzzzz]

Thanks. I know phase II is over; I'm just not really sure how long it should take from that point?

I know spironolactone is supposed to maintain hair, but it definitely makes me lose mine! I've tried taking it several times and I've always had the same experience. I thought maybe it was a "dread shed", but it went on for months and months and I started to get some scalp showing through so I had to give it up. I know a few other people who had the same experience as me. Interestingly, metformin (which I also tried for acne) also makes me lose my hair.

lol bro

it didn't make you lose your hair

You think the drug made you lose your hair because you were on it? What foods did u eat? Did those foods make you lose your hair? Who knows? Did you exercise during that time? That is what must have made you lose your hair! not srs.

The truth is spironolactone is garbage and it didn't "make you lose your hair" your male pattern baldness was just progressing and spironolactone didn't have sht to do with it, same with that other drug. And spironolactone is NOT better than finasteride, just lol

 

[isishearmyplea]

lol bro

it didn't make you lose your hair

You think the drug made you lose your hair because you were on it? What foods did u eat? Did those foods make you lose your hair? Who knows? Did you exercise during that time? That is what must have made you lose your hair! not srs.

The truth is spironolactone is garbage and it didn't "make you lose your hair" your male pattern baldness was just progressing and spironolactone didn't have sht to do with it, same with that other drug. And spironolactone is NOT better than finasteride, just lol

oral spironolactone?

 

[hellouser]

Dude, FDA must do their job, to control and assess the safety of each drug put on the american market.
They are incompetent because they don't immediately release everything, although it could be potentially dangerous??
Your frustration is exaggerate...
Do you think the only FDA work is with hair-loss products???
They have some laws and regulations they must follow.
It's just childish and naive for you to call imcompetent or other names anyone/anything that simply doesn't cure your hair loss TODAY.

Drugs/treatments under clinical trials can only be proven for efficacy and side effects if a drug or treatment is actually used.

The FDA stifles use and therefor limits what we may know about new drugs. So yeah, they're incompetent.

 

[abcdefg]

I dont think the FDA is incompetent they are just slow and a government branch so bureaucracy is a big thing that slows them down. Testing things to make sure they are safe is just a slow time consuming thing in general. I do think certain treatments like CB being a topical could be fast tracked since the chemical is already being shown to be safe for acne. You would think for acne they tested high doses like male pattern baldness would use so you could assume its generally safe for male pattern baldness already so it could move faster through the stages.

 

[Python]

There is serious problems with the FDA and that is a fact. But is not so much that they don't want to pass certain drugs. It's their policies that are seriously flawed. They are so sh!t scared about passing even those that seem safe because if something does happen, they get fired. So the people inside are always looking out for their own skin. There has been documentaries on this, just so you know that it's the regulations that need to see a paradigm shift.