Update on Breezula (aka CB-03-01)

In 2014, I wrote about a new yet to be released topical antiandrogen product called CB-03-01.  Historically, antiandrogen products have usually been ingested orally and often led to adverse side effects. Early reports suggest that topical CB-03-01 has no significant side effects.

In 2015, the Italian company (Cosmo Pharmaceuticals) that was compounding CB-03-01 changed the product’s name to the unusual Breezula.  Moreover, Cosmo itself was renamed as Cassiopeia.  I wrote about those developments here.

Phase 2 Results

Yesterday, Cassiopeia released an interesting PowerPoint presentation summarizing 2015 and projecting the outlook for 2016.  For us hair loss sufferers, pages 18-22 summarizing Breezula’s Phase 2 Proof of Concept (PoC) results is the most important section.

To summarize in brief:

  • 95 patients were enrolled in a double blind study that lasted for 6 months and ended in December 2015.
  • 31 patients were on Breezula 5%, 31 patients were on Minoxidil 5% and 33 patients were given nothing except a vehicle (i.e., placebo).
  • Of the 95 patients, 78 lasted till the end of the 6-month treatment period, and 73 of those were deemed to have completed the protocol without any violations.  Of those 73 patients, 23 were on Breezula, 25 were on Minoxidil and 25 were on a placebo.  A fairly even distribution.
  • 39 percent of patients on Breezula had at least some improvement in hair growth, compared to 36 percent of those on Minoxidil.  26 percent of patients on Breezula had at lease some worsening in hair growth, compared to 16 percent of those on Minoxidil.  Status quo was maintained in 35 percent of Breezula patients versus 48 percent of Minoxidil patients.
  • Later in 2016, Cassiopeia will commence further dosing related trials for Breezula.  I wonder if they will compare the effectiveness of higher doses to the effectiveness of the much more rarely used Minoxidil 15%?

I was pleased to see the results.  Overall, Breezula seems as good as Minoxidil, and since the latter is not an anti-androgen, we can use both products topically on our scalp for two separate positive effects.  Perhaps we can also add topical Bimatoprost and topical Finasteride to that combo later this year, and then we would have a quartet of topical products, each tackling a different mechanism of balding.  Of course Breezula is still years from release (even if we assume they can speed up phase 3 trials like in Japan), but some people on hair loss forums are purchasing it illegally or even making it at home. I cannot ever recommend that.  An even more optimistic scenario is the addition of Samumed’s topical SM04554 to the mix whenever that comes out.  It would be funny if in 2020, I started applying a quintet of topical products to my scalp, and then suddenly a simple cure for hair loss came out that made all those topical products obsolete.

For younger people who have only been balding for a few years or less, such incremental developments are probably not too exciting. For those of us who have been following the hair loss industry for many more years, it is very pleasing to finally see new products arriving.  It is ridiculous that there have only ever been two products officially FDA approved to tackle hair loss — 1) Finasteride and 2) Minoxidil.

***Note that on page 8 of the PowerPoint presentation they have labeled CB-03-01 as “Winlevi” and CB-03-11 as “Breezula”.  Winlevi (for acne) and Breezula (for hair loss) contain the same key antiandrogen ingredient (a steroid belonging to the family of cortexolone derivatives), but in different formulations.

82 thoughts on “Update on Breezula (aka CB-03-01)”

  1. These results were terribly frustrating. IF this was being released this year with these results, I’d be happy. But 3 more years to get a mediocre drug??? Is that the best we have to look forward to??

  2. admin,
    are you able to find out which area of the head this substance showed improvementfor the 39% of patients?
    Hairline area I hope…

    1. You are right Khourii…And remember Breezula not caused side effects. Is huge development.

      +1 to this:
      [[ For those of us who have following the hair loss industry for many more years, it is very pleasing to finally see new products arriving. It is ridiculous that there have only ever been two products officially FDA approved to tackle hair loss — 1) Finasteride and 2) Minoxidil. ]]
      Well said admin….well said…


  3. So, years of research from yet another company whos at best, capable of results thats way below mediocre…come on Samumed plz give us better news on the 5th

  4. Samumed is working on wnt pathway, this pathway is crucial for hair growth right?
    Is there any chances that samumed might bring a full cure which can grow full hair?

  5. Im by no means really into the complex wnt pathway theory but I dont think you should expect at cure from Samumed . I think the best we can hope for is a product good for maintaining and maybe get some small amount of regrowth

    1. Does anyone know the percentage of SM04554 they will be using in Phase 2? Because .45% was used in the first trial and the satisfaction ratings weren’t particularly high.

      Honestly, i don’t think we will find anything from Phase 2 if the protocol percentage remains the same.

    2. Also, this is good news for those like me who can’t take Finasteride. But unfortunately it seems like both this and Samumed won’t be out for another few years?

      Jesus. I want hair now.

  6. Im a little bit depressed with this article. Not only the patethic results after so many years of waiting but from what i have read it seems that even admin dont believe in a cure by 2020

  7. @breezy what documents are your speculations based on? How do you know that they have been producing results that werent satisfying?

    1. https://www.samumed.com/files/WHC_OP_SM04554-01_Final.pdf

      There is a questionnaire in there, i guess this is based on peoples perception. I guess it was only 28 days, but i just have a gut feeling that this doesn’t bode as cure but something that will stave off hairloss and maybe grow a few vellus hairs into non-vellus.

      “Exploratory endpoints at 28 days demonstrated a trend
      • Increased hair growth in some treated subjects (#Q3)
      • Slowing of hair loss in some treated subjects (#Q4)
      – 6/8 subjects enrolled in Cohort 2 had a positive response
      (p=0.01) ”

      Increased hair growth and slowing of hair loss, not increased hair count and stopping of hair loss. I think i’m not going to get my hopes on Samumed. Maybe it needs more time or a higher dosage, but if that’s the strength they will run with to product it doesn’t sound effective.

      1. Yeah but you really can’t measure something like that after only 4 weeks whether the results are good or bad. 4 weeks on min or fin and you would be likely to see no noticeable effect.

        1. Yes you can, on a shiny bald head, you can see hair coming out in less than a week, off course. I guess that’s why they chose to test it in very high Norwoods… to see any results faster.. don’t you think?

      2. Breezy, you’re over estimating the HAIR COUNT, man… You are forgetting all the hair that you’ve already have but just needs to grow, but it’s there!! Hair growth can be all those tiny hairs that resumed their normal growth, wouldn’t that be awesome? … I mean, you don’t need to grow more hair (increase hair count), if you grow the hair that you already have, but wasn’t growing (increase hair growth).

      3. Phase one testing isn’t for regrowth or dosing amount. It’s just to see if it’s safe.

        Phase two is where they crank up the dosage and really try to make it effective.

        SM will be publishing phase two results on 3/5. I’m rather excited.

  8. and what about Ru? does it works? a friend of mine told me like a year ago, he used it and he got better results than minox but the only bad thing it was too expensive.

    What do u think guys?


  9. Cris – I used RU for about 8 months. To be honest I believe I did have some results with it, but not in terms of regrowth just slowing hairloss down. Eventually it gave me sides similar to FIN so I think it went systemic after a while. Not as bad but I think if you are susceptible to FIN sides then RU will give you similar sides. And it is very expensive – $25 just for shipping every time. I eventually coupled it with Minox and had regrowth, but it was just thin, wispy hairs that wouldnt grow past an inch and just looked weird since I have longer hair. Eventually I dumped both, the money and time werent worth the results.

  10. It’s important to keep in mind that CB is an anti-androgen. Anti androgens, much like cutting off your balls, do not give a whole lot of regrowth. So it is unreasonable to expect regrowth from CB. CB’s role should be that of side-effect-free maintenance. If it can accomplish a 90% maintenance success rate without side effects, that is already huge.

    However, I will agree with the majority about the release date of the drug. CB should have been here several years ago, not in 2020 or whenever.

  11. I don’t understand why people are frowning at the post about SM. In 28 days it slowed hairloss and increased density… what drug do we have right now that can do that? Hair loss INCREASES when first starting Fin, minox, RU etc and I can def vouch for that. Along with that, it takes up to 6 months to see results on min and up to a year on FIN. If SM is slowing it down and increasing density in 28 days that’s a huge plus right away. Not to mention im pretty sure that was the first trial. They probably didnt even have the best dosage yet.

  12. Re: Samumed…

    I’m not familiar with what exactly Samumed is doing, but I think the effectiveness of Wnt stimulation would probably be limited in treating AGA.

    See: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2682470/

    Notice how in DP cells of the AGA male, beta-catenin accumulates in the cytoplasm when Wnt is added, but beta-catenin doesn’t translocate the nucleus to stimulate hair growth because it gets bound to AR, even in the absence of DHT.

    1. Well Bob… maybe they found a way to make their Wnt make its beta-catenin translocate the nucleus to stimulate hair growth, maybe that’s the secret.. lol… how about that?

    2. This doesn’t necessarily mean anything.

      The vast majority of vasodilators do nothing to treat hair loss. This doesn’t mean minoxidil is ineffective. every molecule interacts with the body in a different way.

      The fact that these particular WNT proteins don’t appear to do much in vitro, doesn’t mean that there is no WNT pathway to treat hairloss.

      Samumed isn’t even using proteins, but a small molecule, so the mechanism of action is likely to be completely different.

      1. @julian

        Samumed does say they can “generate new follicles” as well, so maybe the condition of the old follicles won’t be such a big issue?


        Yes, but I thought Sm04554 was designed to stimulate the Wnt pathway, which wouldn’t really change beta-catenin’s affinity to AR downstream…? Maybe Sm04554 has some other effects that take care of this problem, but I’m not getting my hopes up.

        1. Really nice study @Bob Ross’s Hair. Thanks for share it.

          Regards. Best Blog. And that’s the best hair loss forum.


    1. Yup, land on the moon, grow bones to make people taller ( limb lengthening ), shoot particles at 99.999 percent of light speed, make sperm, we are told head transplants are a thing in the next year or so. When it comes to hair, you know the stuff that grows on your ass, legs, arms, pits, face?? no way!

  13. Hey Admin, pardon me but I don’t see how you can get excited over this new useless drug.. Neither do I share your excitement about having to add this and use 3, 4… topicals on your head.. It doesn’t mean they together will be stronger. And costs and the trouble that it is having to do that (if at least we had a guarantee that all together would be awesome, very unlikely… it would make sense and pay the work and cost… BUT.. big but…

    Sorry, this one didn’t impress me.. Next, please…

  14. It will be fine. We could all just get hair transplants between now and then. Anybody here had one and would they recommend it?

    I think they could do a scalp biopsy to see after 28 days to see whats going on. Look at the JAK inhibitors, boosting hair growth in a few weeks lol. Anyway guys, 7 days untill we know for sure. I hope they have pictures..

    Besides the concentration is extremely low, maybe they might do another phase with a stronger dose?

    Also, all these people on the trial do they get to continue after all the phases are done? Guessing if the stuff grows hair.

    1. Breezy I had fue and would recommend it if you are really desperate.. It cane out really good.. But the thing is if your hair loss is progressive in a fast pace then not worth it

      1. thats the thing tho, if they can come out with a product that can stop hair loss without side effects, then this combined to FUE might be a pretty good solution

  15. Also, considering Alopecia Areata.. the people with this are completely bald. Yet on these JAK drugs they completely regrow all their hair.

    God, i would love to see that for AGA. No more HTs, just rub a topical for a year to kick start hair growth and try again when you start losing again.

    Probably those will have a shelf life of effectiveness until we can modify our genes. I’ve noticed my balding has become agressive since last year. Considering my family history, it’s another 5 and by then i will be really badly receeded.

    1. People need to stop getting hyped abut JAK inhibitors for AGA. JAK inhibitors work in auto-immune alopecia because it stops the immune system from attacking follicles.

      People with auto-immune alopecia can have miraculous recoveries from complete baldness to a full head of hair because they aren’t going bald from follicle miniaturization, they’re bald because the immune response stops hairs from entering the anagen phase. The individual follicle itself is relatively undamaged, which is why when you remove the immune response, the follicles enter the anagen phase again and resume healthy function. This is how they can go completely bald in months and also regain all their hair in the same time, because the follicle is just being switched on and off, not slowly shrunk.

      The main cause of AGA is not an auto-immune response, its having follicles that are genetically susceptible to damage/cell senescence from androgens which leads to progressive follicle miniaturization, until the follicles are no longer large enough to producer terminal hair.

      While the inflammatory response of the immune system might hasten AGA to some degree (having a chronic scalp inflammation probably isn’t going to help you keep your hair), the effect JAK inhibitors would have in these cases will be minor.

      There is already a drug (ketoconazole) which helps reduce scalp inflammation in cases of microbial infection, and it has a fairly minor effect that is likely mostly down to the anti-androgen effects of the drug.

      People are setting themselves up for huge disappointment when they look at the results for treating auto-immune alopecia and assume the same results are possible in AGA.

  16. @Farhaan..

    Hey buddy i enjoys your comments. Like mouse costume wearing and put all topicals in blender… Ha ha ha…
    I hope SM will definately give some treatment to us. Because some person from their company must be kept watch for people comments and wishes, on hair loss forums..

    But Farhan you keep posting. It relax’s atleast me… From frustration.. Ha.. Haa

      1. Masterbation may not be the real cause but it is one of the cause of AGA that I believe & I think it impacts not for all men but some.

  17. Topical Treatment of Hair Loss with Formononetin by Modulating Apoptosis.

    Kim MH1,*Choi YY1,*Lee JE1,*Kim K2,*Yang WM1.

    Author information

    1College of Korean Medicine and Institute of Korean Medicine, Kyung Hee University, Seoul, Korea.2Department of Ophthalmology, Otorhinolaryngology and Dermatology of Korean Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.


    Formononetin is one of the main components of red clover plants and its role on hair regrowth against hair loss has not been established yet. In the present study, we assessed the potential effects of formononetin on alopecia, along with impaired hair cycles by induction of apoptosis-regression.Depilated C57BL/6 mice were used for monitoring the hair cycles. Formononetin (1 and 100 µM) was topically treated to the dorsal skin for 14 days. Topical formononetin treatment induced miniaturized hair follicles to recover to normal sizes. Tapering hair shaft began to grow newly, emerging from the hair follicles by formononetin. In addition, formononetin inhibited the activation of caspase-8 and decreased the procaspase-9 expression. As a result of formononetin treatment, anti-apoptotic Bcl-2 was up-regulated, whereas pro-apoptotic Bax and p53 were down-regulated, resulting in a decrease of caspase-3 activation. Formononetin showed the obvious inhibition of apoptosis under terminal deoxynucleotidyl transferase dUTP nick end labeling staining thereafter.Taken together, our findings demonstrate that formononetin exerted the hair regrowth effect on hair loss, in which the underlying mechanisms were associated with Fas/Fas L-induced caspase activation, thus inhibiting apoptosis.

    Georg Thieme Verlag KG Stuttgart · New York

  18. people, please can somebody answer on my question?
    even one day scientists regrow all hair with fat stem cells or hair cloning what is with enzyme alpha 5 rectase?
    how stop that enzyme?
    thank you

  19. Its like every month there is a new study on some other contributor to baldness or new “hopeful” drug that that could end baldness lol. Its a never ending game that is driving me mad.

    I turn 25 march 8th. Maybe ill get lucky and hear good news on SM from this meeting the 4th-8th. Thatd be the best birthday news ever! Lol

  20. I’ve been following this site for a few months now having been a hairloss sufferer since the age of 16 (now 26) and wanting to stay updated on new findings. Firstly i’d like to convey my thanks to admin for all that he does for the hairloss community. I thought it’s about time i gave my two pence in an unbiased manner to try and help others who may be at the beginning of their hairloss journey. My hairloss was gradual and i maintained a relatively good amount through oil massages, natural herbs (such as nettle root etc) however there came a point whereby this was no longer as effective (around age 23) and decided to go on to fin. I didn’t like the brain fog it gave me and so reverted to minox. It sorted me out for a year and a half and then the frontal area became resistant. Within 6 months, the hairloss progressed very quickly and so as a last ditch attempt..prepared myself for fin again and have now been on it for nearly a year (mental preparation is extremely important as the body will naturally go through a changing phase as the hormone balance changes and so you have to be ready to deal with that). It has stabilised the hairloss and thickened up all areas except temples and frontal region which is why i believe a hair transplant (by a reputable doctor only) should not be dismissed as so often seems to be the case on this site by those commenting (i am considering it myself). This is because it can provide the filling in of areas that medication is resistant to and gives us more time whilst new products hopefully come out. Looking at the pipeline of new treatments, i am not sure how confident to be however i do believe an upgrade would be a minox/fin alternative without side effects..we are well overdue for that! I am personally looking forward to results of Samumed and Shiseido (Replicel’s Japan partner) though am not going to be over optimistic as the last 10 years naturally installs some cynicism with many stories about ‘cures and breakthroughs.’ The Sanford-Burnham discovery last January is something i was much looking forward to however have not heard anything of note since in regards to partnering for trials etc. otherwise felt that in terms of stem cell research, they had the most scientifically sound and effective discovery as opposed to duplication (though i hope this works obviously). The hairloss journey overall has been very challenging with bouts of depression however i do believe it’s important to surround yourself with positivity one way or another (for me it’s a combination of meaningful work + a good social life with good friends and family + playing sports + practising meditation). Hope this helps someone in some way!

  21. @np125, Thank you for sharing your story. I think all who visits this site are keeping their fingers crossed for some positive Samumed news which will hopefully be here early next week:O Im 37 and strongly considering Fin. Actually, a few weeks ago I was sure that i’d take the plunge but then decided to read a little more. I still havent decided cuz of the sides…im terrified to have a massive shedding and a irreversible shrunken limp dick… a suicide scenario

  22. @Spanky..the way I worked into was to take 0.25mg every two days initially then I graudally built it up from there as I felt comfortable. I thankfully had no sexual side effects but my main concern was always the mental side of things because of reading other stories on forums and my first fin experience however I think because I knew it was my last chance saloon otherwise i’d get bald pretty damn quick, I was mentally strong enough to overcome any obstacle. I think if nothing else works then fin should definitely be tried gradually to see if it can be handled or not 🙂 (also..minox gave me sides towards the ends too..dark eye circles, bloated looking face etc.)

  23. @np125, actually 0.25 is exactly the way I have been reading about and considering. Did you have a bad shedding period? I still have thick hair but with diffused thinning in the front. So you didnt get any sexual sides at all with 0.25? No shrinkage or low libido?

  24. I really hope that there will be good news on saturday.

    I am going to be extremely depressed if there is bad news..

    I can’t use finasteride (experienced horrible side effects from it), and minoxidil gave me dark circles under the eyes + a bloated face + chest pains..

    If SM is effective and without side effects, we are saved (we as in the ones can’t use fin or minox). Let’s pray

  25. @farhan haha thankfully haven’t had the urge yet.
    @Spanky I thankfully had no sexually-related issues on fin and have actually been on 1mg as of the last 4 months. If you are thinning on the frontal only then maybe minox foam is a good bet? Fin seems to provide mixed results on frontal area (didn’t work great for me) and docs themselves seem to differ in opinion having done some research. If you can take minox and experience no sides I would take this option, especially if the rest of your hair is in good condition. Fin for me was a last resort. Minox sides generally go after ceasing use ( I stopped usage and they did go albeit after a couple months) which is good to know beforehand.

    1. True, but you need an AA because minox helps grow hair through different mechanisms. Your going bald because of androgens though so no AA means the process continues.

  26. Why does it take 4 years to test and release another AA that has 25 past years of research and trials on. A bit silly because that is a very long time to wait for what will be a very expensive treatment probably not much better than propecia.

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