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Updated: CB0301 (Breezula/ Clascoterone) Phase 2 Results

CB0301 Breezula

If you haven’t heard about it yet, CB0301 (brand name Breezula) is a topical anti-androgen that is being trialled for hair loss. It’s just finished phase 2 dose-ranging testing and shows promise. So does it work? When will it be available? Let’s take a look at this exciting future hair loss treatment.

What is CB0301?

CB0301, also referred to as Clascoterone or by its brand name Breezula, has anti-androgenic effects when applied to the skin.

Dihydrotestosterone (DHT)
Dihydrotestosterone (DHT)

As we know, androgenetic alopecia (male pattern hair loss) is an effect of the hormone dihydrotestosterone (DHT) on hair follicles.

The hormone binds to the follicle and over time this causes it to get smaller and smaller until it stops producing hair.

There are already treatments available that stop this process. Finasteride and dutasteride reduce levels of DHT in the body by approximately 70% and 90% respectively.

But this isn’t an ideal solution.

DHT affects the body in other ways besides causing hair loss. It’s an important male hormone – especially during early development – and so reducing levels of DHT causes serious side effects in many men. For many, these side effects aren’t worth the increased hair growth.

Ideally, a hair loss treatment would reduce the effects of DHT locally, not systemically. Rather than lowering overall DHT levels, it would be preferable to reduce its effects in the scalp only.

This is what CB0301 is designed to do.

How CB0301 works
CB0301 reduces the effects of DHT at the receptor only, whereas drugs like finasteride lower overall DHT levels in the body

Rather than being ingested orally, CB0301 is a topical treatment. It’s applied to the scalp and should – in theorynegate the hair loss causing-effects of DHT. What’s more, it’s also said to reduce levels of prostaglandin D2 (PGD2).

cb0301 structure

Its anti-androgenic effects were first recognized as a potential treatment for acne. Acne, like male pattern hair loss, is caused by androgenic hormones. And CB0301 is currently in phase 3 – the finals stage before release – clinical trials for this skin condition.

The hair loss version – named Breezula – is not far behind either. Phase 2 trials for hair loss have just recently been completed.

So… what were the results?

CB0301 phase 2 trial results

Initial results from the Phase 2 trial for androgenetic alopecia suggest CB0301 is slightly more effective than minoxidil:

CB0301 phase 2 results

This is promising as minoxidil is known to be an effective hair loss treatment. Also, CB0301 has a different mechanism of action, meaning it can potentially be used in conjunction with minoxidil to further improve results.

And this mechanism of action may be more desirable. As described in this article, minoxidil doesn’t tackle the root cause of hair loss: DHT. For this reason, it’s doubtful how effective it is as a long term solution. CB0301, however, does appear to tackle the hormones responsible for hair loss. This is likely to make it far more effective for maintaining hair in the long run.

But based on these results, CB0301 doesn’t look like a miracle hair loss cureyet.

It’s still early days, though. Additional trials are now being conducted to refine the appropriate CB0301 dosage for hair loss. It’s likely that this will lead to even more impressive results than we’ve already seen.

When will CB0301 be available for hair loss?

Not for a few years.

According to Cassiopea, we’ll have to wait until 2018 to find out the dose-ranging results of CB0301.

Edit: 12 month dose-ranging results have since been published. Scroll down for a summary of these results.

And even then, phase 3 trials need to be completed as well.

So we’re looking at a 2022 release at the earliest – that’s if it’s even successful at all.

But it’s not all doom and gloom. As mentioned, the initial results look promising and are likely to improve with further adjustments.

And we’re likely to see the acne version of CB0301 – Winlevi – released much sooner. Based on current results, this treatment could be available as soon as 2019.

But if you can’t wait that long, you can already buy the compound online (not recommended!). Many hair loss sufferers have taken it upon themselves to acquire CB0301 and test it on themselves. There are various forum threads (such as this one and this one) that discuss the results.

Reviews are mixed – but these results aren’t the most reliable. For one, the vehicle used to get CB0301 to hair follicles is currently unknown. Further, there’s no way to be sure if what you’re buying is even genuine CB0301!

For these reasons, it’s probably best to wait until CB0301 is commercially available and has been thoroughly tested before using it as a hair loss treatment.

The future hair loss cure?

CB0301 is one of many candidates for a future hair loss cure.

It may not be powerful enough to transform someone with Norwood 7 hair loss into Norwood 1, but it will be an effective tool to maintain your existing hair. It also looks very safe in terms of side effects.

And while it’s unlikely to be the hair loss cure, initial results look promising. With so many potential hair loss treatments in the pipeline, there is every reason to be positive.

2019 Update: 12 Month Dose-Ranging Results

“The eligible subjects were randomly assigned to one of the following five treatment groups: 2.5% solution [twice daily]; 5.0% solution [twice daily]; 7.5% solution [twice daily]; 7.5% solution QD (once a day) and vehicle solution; vehicle solution [twice daily]… For the [hair count], statistically highly significant changes vs. vehicle were observed in all active groups with the highest change observed in the 7.5% [twice daily] group, which reached statistical significance at all timepoints, beginning with the third month (first follow-up visit), while the placebo group had a decrease in [hair count], representing the progression of AGA over time if left untreated. These results indicate that Clascoterone stops the loss of hair and grows new hair… Based on these results, we plan to meet with the FDA mid-year to discuss the planned six-month Phase III trials in men. Hopefully, we will begin our Phase III program in 4Q 2019.

Cassiopea Press Release, April 16 2019

Cassiopea / Breezula / CB0301 Results
Acronyms: TAHC = Target Area Hair Count; TAHW = Target Area Hair Width; HGA = Hair Growth Assessment; BID = Twice Daily; QD = Once Daily

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