What Is CB-03-01?
Clascoterone, also known more commonly as its developmental code name CB-03-01 is a synthetic steroidal antiandrogen.
It acts as an androgen receptor antagonist and is being developed by Cassiopea as a potential treatment of androgen-dependent conditions including acne vulgaris and androgenic alopecia (male-pattern baldness).
The tentative brand name for the preparation of CB-03-01 intended for androgenic alopecia is “Breezula”.
This topical antiandrogen has a lot of hype in the hair loss community becuase of its recent clinical trial results.
So, as far as CB-03-01, and my thoughts.
First of all, I see the cost-effectiveness of it relative to the next best alternative as a huge limiting factor right now.
Even if you bought it now, it's much more expensive than other commonly used topical antiandrogens.
And as far as its efficacy, I have yet to see it outperform anything else in the topical antiandrogen category.
Clinical data shows it's somewhere in the ballpark of Finasteride's efficacy.
But as you probably already know, Finasteride is just a band-aid at the end of the day.
It might sustain you for 10, 20, or even 30 years if you're lucky, but eventually, you're going to start losing your hair again, as that's just what happens when you don't take care of testosterone as well.
However, in the case of CB-03-01, because it is an antiandrogen that binds to the androgen receptor and prevents testosterone and DHT from inducing their harmful miniaturizing effects, in theory, this would in the long-term likely outperform standard 5-alpha reductase inhibitors that do not protect you from testosterone.
CB-03-01 Vs RU58841 And Other Topical AntiAndrogens
Comparing CB-03-01 to RU58841 and the other next best alternatives has not been promising.
Granted, RU58841 is still hit or miss for many people as well as a standalone treatment, as are all other topical antiandrogens as of now.
With that being said, I have yet to hear of anybody having significantly better results from CB-03-01 than RU58841 or any other topical antiandrogen, and it might even be worse according to some people.
Milligram for milligram CB-03-01 doesn't seem to be any better than the alternatives that are already being used in the community as is.
Its topical potency was determined to be greater than that of progesterone, flutamide, and finasteride, but was roughly equivalent to that of Cyproterone acetate
CB-03-01 Vs. Cyproterone Vs 17α-Estradiol
RU58841 exhibited a 20% increase in androgen receptor binding when compared to Cyproterone.
By extension, this implies that RU58841 is more potent than CB-03-01, and it seems to hold up in practical application anecdotally in the hair loss prevention community.
I haven't used CB-03-01 personally, but it's on my list of compounds to delve deeper into.
Based on what I've heard from guys I know, I do not have high hopes for it though.
There are undoubtedly some promising attributes that we should look at seriously though.
The First FDA Approved Topical AntiAndrogen For Androgenic Alopecia
CB-03-01 is in a pipeline right now to become FDA approved as the first topical antiandrogen for hair loss prevention.
Its safety profile is the main thing that should be taken into account in contrast to something like RU58841.
In a clinical setting, there's more safety data on CB-03-01.
It's not some experimental compound from 20 years ago that only had a few trials on it.
It's literally almost approved right now for androgenic alopecia and acne treatment.
Interestingly, RU was being evaluated as an acne treatment as well.
Obviously there's some correlation there between acne, androgenic alopecia, and androgen receptor activation.
The question arises as to why CB-03-01 is being approved and not other topical antiandrogens like RU58841.
I assume that it has a lot of it has to do with the business side of the pharmaceutical industry, as opposed to the overall efficacy of the product.
In the case of RU58841, a company called Proskelia Pharmaceuticals (a part of ProStrakan Pharmaceuticals) completed clinical trials and purportedly found no red flags.
Once it came time to seek investors to get RU58841 closer to FDA approval there was a company merger and that side of the business was closed.
CB-03-01 Side Effects
CB-03-01 supposedly has a lower incidence of side effects, meaning you could use more of it to achieve the same results you would of a lower dosed, more side-effect ridden antiandrogen, in theory.
Or potentially even use more of it to achieve greater results than an antiandrogen that outperforms it milligram for milligram, but is more side-effect ridden.
From what I've seen, the side effects are the same as you would expect from any antiandrogen that goes systemic.
Obviously the incidence of side effects is going to be largely individual dependent based on scalp porosity, application technique, scalp sebum levels, and a variety of other factors that will greatly impact how this compound is going to work (or not work) on your head.
If CB-03-01 does get FDA approval, the potential issue I see is that even if it gets approved in the next two to three years (which is probably conservative), the price of it for the dose you're going to get is very likely not going to be acceptable.
And when you go into the underground space to try and get it, the price point is several times higher than the alternatives.
So, when it comes to cost, it doesn't seem to be an improvement from our current options, at least right now.
That remains to be seen in the future.
Anecdotally, CB-03-01 monotherapy has already shown to work for some men with less aggressive male pattern baldness, but it is not side-effect free.
Unfortunately, topical antiandrogens all still have their deficiencies in terms of overall efficacy for the general population.
There's also going to be people which it doesn't work for, but that's just what happens with every drug to be honest.
There's also going to be people who will experience side effects and people who don't experience side effects, this is a given.
I think it's going to be a good tool, as are other some of the other notable topical antiandrogens, but it isn't the beacon of hope hair loss sufferers are hoping it is.
Can CB-03-01's Application Cause Difficulties?
Unfortunately when it comes to topicals, there are a lot of factors that can cause vast variations in the sufficient delivery of a compound.
Any idiot can pop a pill, but not every single person is going to apply a topical antiandrogen properly.
Ensuring the scalp is clean, there's no sebum inhibiting absorption, there's no hair sucking up excessive amounts of the solution, the solution is being applied correctly, not even accounting for the likely possibility that the thickness of the scalp of a balding person compared to a non-balding person is quite a bit different, there are so many variables that will greatly impact if CB-03-01 (or any other topical) works or not.
This isn't even accounting for the fact that different men will require different dosages and volumes of solution.
You're going to be limited by your doctor and whatever they think you need.
I would be surprised if they prescribed a CB-03-01 dosage high enough for a diffuse thinner to apply it all over his head.
1 mg of Finasteride is 1 mg of Finasteride, no matter who takes it.
But with CB-03-01 and other topical antiandrogens, the amount of solution being applied to someone who has mild recession and just uses it on small portions of their head relative to someone who is diffuse thinning and needs to apply it all over the top of their head will be hugely different overall dosages.
I see it as a good thing that there's a topical antiandrogen in the pipeline that's almost FDA approved, but I'm not super excited about it.
At the end of the day, despite the fact that I anticipate that it will be hit or miss as a form of monotherapy, it is certainly still a big step forward in the industry.