Breezula Phase II Results Positive, Phase III Delayed

Update: February 16, 2023 — Cosmo Pharma’s latest guidance states the following:

“Cosmo expects to have the first patient enrolled in the Breezula® (Clascoterone solution for androgenetic alopecia) phase III trial in males in Q1 2023.”

Also see Cosmo Pharma’s new page on Breezula. The company took over majority ownership of Cassiopea in December 2021 after being a part-owner for years (see bottom of this post).

Update: October 7, 2020 — Cassiopea (Cosmo Pharma) completed enrollment in its Phase II trials for female pattern hair loss. The 6-month study has enrolled 293 patients. The four-arm study will divide volunteers into four treatment groups: clascoterone solution 5% BID (twice daily); clascoterone solution 7.5% BID (twice daily); minoxidil solution 2% BID (twice daily); and vehicle BID (twice daily).

Before Breezula 2023, there is Winlevi 2021

Update: August 27, 2020 — Cassiopea’s Winlevi topical androgen receptor inhibitor has just been approved as an acne treatment by the US FDA. It is the first acne treatment with a new mechanism of action to be approved in 40 years. The key ingredient (clascoterone cream 1%) is the same as in the keenly awaited hair loss product Breezula. The latter will have a higher dosage.

Winlevi Clascoterone Cream 1%CEO Diana Harbort quote:

Dermatologists have said targeting androgen hormonal activity in the skin is ‘the holy grail’ of acne treatment for both males and females.

I expect Breezula will not come to the market till 2023, assuming it gets final approval. However, some people plan to use Winlevi on the scalp, even though this is not recommended by the manufacturer.

Breezula Phase 3 Trials Delay

March 19, 2020

How things can change in just a few weeks. Breezula Phase 3 trials have now been delayed till 4th quarter 2020 or 1st quarter 2021. All due to COVID-19 (Coronavirus), which has hit Italy particularly hard. More information can be found in Cassiopea’s 2019 Annual Report which was released today.

The Clascoterone female pattern hair loss Phase 2 trials are on track to finish enrollment in 2Q 2020. Trials should be completed by year-end 2020. However, delays are still possible depending on progression and recurrence of the current pandemic.

Quote from the accompanying pdf:

“As part of the process in the NDA review, the FDA amongst other, also inspects the facility in which Clascoterone cream 1% is manufactured. Clascoterone cream 1% is planned to be manufactured at Cosmo Pharmaceuticals plant in Lainate in Italy. Given restrictions currently in place because of the COVID-19, the FDA had to postpone the inspection planned for March.”

Nevertheless, Cassiopea is still planning to  release its Winlevi acne cream product by the end of this year.

Update January 19, 2020: A new article in labiotech suggests Breezula sales to total 350 million Euros. Quite impressive.

Update November 13, 2019: Cassiopea’s women’s hair loss clascoterone solution Phase II trials starting soon in Germany.

Cassiopea (Cosmo Pharmaceuticals)

April 16, 2019

I have covered Italian company Cassiopea since 2014 (when it was called Cosmo Pharmaceuticals). The company is developing a topical anti-androgen hair loss product named Breezula (originally called CB-03-01). The chemical name for this product is Clascoterone. Note that Cosmo Pharma still owns 45 percent of Cassiopea.

Breezula will be available for both men and women. Several of my well known physician contacts in the hair loss world have told me great things about this product. Their feedback is based on what they saw at conferences or heard from colleagues.

Breezula Phase II Trials Very Successful

In July of last year, Cassiopea stated that the interim Phase II clinical trial results for Breezula were very positive. Today, they released twelve month Phase II trial results with the same conclusion:

Cassiopea announces very positive Phase II Twelve Months Results for Breezula® (Clascoterone) in treating androgenetic alopecia.

The presentation of the results is confusing, detailed, full of acronyms and somewhat open to interpretation. Note that “BID” in there stands for “twice per day” after conversion from Latin. Hopefully they release before and after photos at some point.

Also note that the previous 6-month interim report had 375 subjects, and the 12-month report has 344 subjects. The trial was conducted in Germany.

Breezula Target Area Hair Count Increase

Breezula Hair Count Increase
Breezula Hair Count Increase.

Best case result highlighted in yellow (14.3 new hairs per square centimeter, after 12 months of 7.5% BID clascoterone solution dosage). BID means twice per day.

Breezula Target Area Hair Width Increase

Breezula Hair Width Increase
Breezula Hair Width Increase.

Best case result highlighted in yellow (762.5 um width increase, after 12 months of 7.5% BID dosage).

My gut feeling is that Breezula will be at least as effective as Finasteride and Minoxidil.

Clascoterone Summary

Some key points from the above linked article from Cassiopea:

  • If approved, Breezula (Clascoterone) will be the first FDA-approved topical anti-androgen for the treatment of androgenetic alopecia.
  • Moreover, it would also be the first new drug approved for treating androgenetic alopecia since 1997. That year was when Propecia (aka Finasteride) was first approved to treat hair loss. That year was also when Tiger Woods first won the Master’s golf tournament. His 5th surprise victory in that tournament came this past weekend.
  • Based on these great results, Cassiopea plans to proceed with 6-month Phase III trials in men in the fourth quarter of 2019, after consultation with the FDA. The company is also going to start proof-of-concept trials in women.
  • Breezula works by blocking dihydrotestosterone (DHT) interaction with hair follicle androgen receptors.
  • Clascoterone does not interfere with testosterone and other hormones in male subjects. Libido and sexual behavior changes have so far not been observed in clinical trials. Moreover, due to its rapid metabolism and localized activity, Clascoterone (Breezula) does not produce any systemic side effects.

In the past, I used to often state that perhaps an initial cure for hair loss would entail the usage of a cocktail of products. Each working via different mechanisms and chemical or biological reactions.

It is looking likely that Breezula will be one of the main products in this cocktail.

Note that Clascoterone 1% cream to treat acne will be released by Cassiopea before Breezula. The acne product is called Winlevi.

88 thoughts on “Breezula Phase II Results Positive, Phase III Delayed”

  1. Clascoterone
    It is an effective treatment without doubt; which inhibits DHT with no side effects
    I am optimistic in a year to treat baldness.

  2. Agree result presentation is unnecessary complex. I couldn’t see any mention of actual hair count increase.
    One positive is ‘Clascoterone stops the loss of hair and grows new hair.’ Even a loss stopper would be welcome.

  3. I don’t understand the numbers for TAHC and HGA… Could someone smarter than me explain them? Compare them to some other product, perhaps?

  4. Well beggars cant be choosers. Sounds better than nothing to me!
    I wonder if you applied this to your facial hair or body hair over some months if it would also work to stop or prevent facial hair? It seems like in theory it would since facial hair is controlled by testosterone and DHT which would be blocked by this

    1. I am waiting for the breezula medicine..I think so that this medicine bring new hope for baldness people

  5. Sounds like a nice addition to our stack. I wouldn’t call it ground breaking since it doesn’t reverse hair loss enough like a nw6 to a nw2, but stopping further loss is definitely welcomed. 2x a day for someone who still has coverage is going to be a pain. Ex. Nw2 diffuse putting this on 2x daily will make their hair sticky and gross. Unless they have a very good lotion or liquid, or maybe it just require a couple drops in different parts of the scalp. Either way I’ll buy it and use it since fin has weakened its effectiveness. Would have been nice to see 40 cm2 hairs to make a real impact.

  6. How do these results compare with oral finasteride? I can vaguely recall that in the original trials finasteride resulted in hair regrowth of 10%-12% after two years. Compared to 14% after 12 months here with Breezula. Can anyone confirm this?

    As I am already on finasteride (1mg/daily) and both finasteride and Breezula are both anti-androgen compounds, I am supisious that taking both won’t make much difference to hair growth compared to taking just one of them as they both use a similar mechanism. Something like minoxidil which uses a completely different mechanism however would combine quiet well.

  7. When will it release? Please say 2021. If they end III trials in Q1 2020 or then a year for approval… It should be 2021?

    Am I wrong?

  8. So I guess these results are the hint that Winlevi will also work for AGA. The lower dosage in Breezula also was effective so next year I will use Winlevi in combination with other drugs which hopefully come out soon.
    Pipeline says Breezula will launch 2022 like so many other Company Pipelines say launch latest 2022 … next 3 years will be fun! :-)

  9. While this may be the first product in 22 years to be of use, it does not seem to promise anything more than the product released 22 years ago.

    I think with the promising treatments due soon by Replicel, Aclaris, Riken and the like, this particular product is 5 or 10 years too late.

    They will be lucky if they can recoup their initial investment before a better treatment from one of the above blows them out of the water.

    1. I think your’re very wrong. In all honesty this product is developing and showing actual physical clinical trial data that none of those other companies have. All those other companies are giving you is heresay and speculation. No clinical proof which shows actual efficacy like cassiopea has. Yes it’s not the magic bullet people have been looking for but it will satisfy alot of current hairloss sufferers in regards to halting and possibly reversing some hairloss without the added effect of serious sexual side effects. I think for those who haven’t started balding but are genetically prone to it, this product will be a game changer. All those other companies you mentioned (Alcaris, Riken, Replicel), haven’t shown JAK!…pardon the pun. Nothing but smoke and mirrors. I’m actually glad to hear of some kind of potential treatment with actual published data and an estimated release date is going to be able to help alot of people because theres no way those other treatments are gonna be that magic bullet you’re looking for. If those treatments were game changers like reversing significant amounts of hairloss you would’ve heard something, anything. No way they would keep that on the hush hush because investors would be dumping mad money on them if they had something viable. When jak inhibitors showed that it had the potential to almost completely reverse AA, they released that info immediately upon discovering this. The news was everywhere. And how long have they been working on a JAK treatment for AGA? Quite awhile now with little to no info. People just being dangled along to continue funding. This treatment right here is realistic, and reasonable with todays modern medicine everything else is experimental speculation hoping for a cure. At least with this people have some kind of hope especially for younger generations like my son. I for one am very happy that at least I know he may not have to deal with the same depressing issue of hairloss that I had to endure.

      1. Without cosmetically-significant results, yes it means nothing. You may as well drink water; water has no sides either.

      2. It does have side effects…

        Hypothalamic-pituitary-adrenal (HPA) axis suppression may occur during or after treatment with
        WINLEVI. In the PK trial, HPA axis suppression was observed in 1/20 (5%) of adult subjects and
        2/22 (9%) of adolescent subjects at Day 14. All subjects returned to normal HPA axis function at
        follow-up 4 weeks after stopping treatment. Conditions which augment systemic absorption
        include use over large surface areas, prolonged use, and the use of occlusive dressings. Attempt
        to withdraw use if HPA axis suppression develops.

        1. “Cassiopea believes that topical Clascoterone (Breezula®) will not have the contraindications and safety warnings of the orally administered androgen modulator approved for the treatment of men with AGA.
          Clascoterone does not interfere with the hormonal and, in particular, testosterone profiles of male subjects;
          libido and sexual behavior changes have not been observed in clinical trials to date. Clascoterone is quickly metabolized to cortexolone, a naturally occurring metabolite found throughout all human tissues, cells, blood and urine; cortexolone’s safety and metabolic fate are well characterized. Due to its rapid metabolism and local activity, Clascoterone does not produce systemic side effects.”

          1. Derek your statement is released by Cassiopea so it’s biased.
            If you read Cassiopea’s pharmacodynamics study ( they say:

            “At steady-state, (Clascoterone) plasma concentrations increased ~1.8 to 2.1 fold.”

            Also as mentioned above they observed HPA axis suppression that went away after stopping the drug. That would not be possible if it was only acting topically.
            That said it might still be much safer than finasteride.

  10. It would be nice to know if this helps miniaturized hair, if it reverses miniaturization. Would The mixture with finasteride be better to fight the AGA? I hope that in Phase 3 we get out of doubt.

  11. Agree with John for the most part, shocked at the negativity.. This is one genuine, result based, no BS, seriously positive bit of news!

    A minox, possibly better, without sides, from a reputable European company.

    I do take the point that for higher NW’s it might not be much, but for lower end this is a Godsend if it works to time, effectively save us until the “cure”

    1. The negativity is based on the fact that the TAHC dropped significantly after 6 months, making it less effective than finasteride. We also dont know if it will continue to drop after 12 months, which makes impossible to see it as a ‘maintenance’ treatment

      1. Although the 6-month report had 375 subjects and this one has 344 subjects (some probably stopped coming back for measurements).

        Also, several of the doses in the 6-month report do not show TAHC decrease at 12 months, but rather, increases.

        1. As you suggest, these differences could easily be due to subjects dropping out and altering the mean rather than the effects of the treatment fading. No way to know for sure at this point but I think this option will be a huge positive for many many people with enough hair left to fight for………and I like the fact that the “experts” are abuzz about this. My questions would be 1) How long do they believe this will maintain with a neutral to positive hair count……I’m guessing they have no idea at this point; and 2) Will this have any effect for those who have been on Fin and/or Dut for years but have now faded…….sounds like there is some hope in this regard if the method of action is blocking DHT at the receptor rather than inhibiting the conversion of T to DHT.

        2. True. But another thing to keep in mind is the following:

          – The results are “change from vehicle TAHC” at 12 months compared to “change from baseline” at 6 months
          – This means the results are less comparable
          – If anything, the results when compared to baseline at 12 months would have been lower as vehicle patients continued to lost hair.
          – This is Cassiopea make the numbers look pretty whilst it’s clear efficacy fell from 6 months to 12 months. What’s sad is it STILL fell from 6 months to 12 months, even when switching from comparing “to baseline” to comparing to “vehicle results”

          1. Very interesting, but why would two of the doses show an increase between 6 and 12 months, and two of the doses show a decrease? All four should show a downward or upward trend if you really wanted to reach a firm conclusion right (even after accounting for baseline versus vehicle)?

            1. Just to note that at 6 months results there wasn’t a significant change between baseline and vehicle (-0.1114; p value: 0.9660), we don’t have the difference data for 12 months but it may also not be significant. Another interesting thing to note is that it was the lowest and highest doses that saw decrease in 12 months compared to 6 months.

          2. Good point…………….I didn’t see that. We don’t know what the drop outs did to the mean and we don’t know how much vehicle dropped from baseline so I will look forward to more details as they are released. Still, at this point I have nothing else left to try, so if I could be +14 over where I would have been without it, or if I could stay neutral for 2-3 years hoping for a real game changer to come along, I’d take it. I may very well try Winlevi at the hairline until this comes out. Maybe Admin can ask some of these questions to his contacts.

  12. I wonder how pharmaceutical companies will manage to water down this treatment and make a profit.

    In all reality admin is more closer to the cure for baldness that the so called experts. Admin keep up the great work and this excellent forum.

    On a positive note the cures only five more years away gentlemen. Seriously, it’s frustrating hearing the same nonsense over and over again. Especially after reading that McDonald fries are the cure. Where do they come up with this insane theory’s. Oh well at least the “rats” have a nice mane.

    5 years to go and counting!

    1. And every 5 years will be another 5 years and then this time for real guys in 5 years 100% will be out a cure and then oh well this time 100% again is for real and so on.
      But as some people mentioned at least this company showed some data, some real facts (even tho is not a cure, just some better version of minoxidil, but still is something) while giant companies remain silent. As someone said above, if any of those big companies registered some really good results, everyone would know by now. I mean finding the cure for AGA would be the holy grail and it would rain with investors.
      So I guess there are 2 options: they have something working but they are still waiting for the final results so they don t play with our expectations, or they are silent because they got nothing. Their tests didn t record any progress(or very low one) and try to see if they can do anything to improve it to make it work.
      If the 2nd option applies, people are screwed, we ll probably get other breaking news like Mc Donald s fries Sandalwood oil and wait 5 years forever before they start “making” something out of that experiment. Speaking of devil what happened with that Sandalwood hype? It was so much fuzz then silence.

  13. This stuff is from Italy… another Brotzu lotion… They all still try to make some cash with our bald heads… this time in a more legitimate way… but it still snake oil…

  14. ” Libido and sexual behavior changes have so far not been observed in clinical trials. Moreover, due to its rapid metabolism and localized activity, Clascoterone (Breezula) does not produce any systemic side effects.”
    I’ll count to ten and someone will claim sides on the internet from this stuff. Hell, there are guys who probably got sides just by reading the post! The same ones that crap all over everything no matter what the data states. Unfreakin real!

  15. Mice and rats don’t suffer from human PATTERN hairloss. End of the story.

    My assumption concerning MPB:

    There is a human standard (female) embryonic hair pattern.
    DHT is (alongside other functions) the secondary (male) hair patterning hormone via androgen receptor density and sensitivity, hence the extremely linear loss and growth of hair in different parts of DHT sensitive skin. It is possibly a sexual dimorphism mechanism reaching far back into hominid evolution.

    We know that Finasteride works, Clascoterone tackles the same preventive mechanism from a different end. There is strong hope on my side for a safer hair maintenance treatment.

  16. Maybe I’m the only one, but 3 years for the next release seems so far off…maybe not for those of you in your 20s and 30s…

    1. Just be grateful if it happens in your lifetime, considering a cure has been searched for since ancient Egyptian times 3,000 years ago. I wonder if the high priest used to say to the Pharaoh – don’t worry my Lord, a cure is only 5 years away :-)

  17. They need to show pics. Clear professional pictures of results. All that data has assuming left and right of its effectivevess. I am going try winlevi when it comes out. It has to work at least to some extent if it can stop acne by blocking androgens on the face right?

    1. Pictures are not enough. Admittedly a hair system is not a cure and that makes me the bad guy for cheating, but I set the standard with my before and after videos, showing alternate angles at different lighting. Still images don’t cut it anymore. Even people in Sierra Leone have mobile phones that can record videos, I was there in February. There is no excuse. If you see still images run a mile.

    2. Mjones I believe an NDA has been filed and Winlevi will be out 1st Qtr. 2020. Now i’m sure it will be prescribed off label by HT Surgeons.

  18. It is far off for a treatment that should have been out in 2010. Topical androgen blocker. I’m waiting for follica results:) we have SM set for 2021 I think or earlier.

  19. Samumed, Breezula, Follicum, and Follica, should/will/might complete their phase 3 trials all around the same time. Maybe the stars are aligning or maybe they’re burning out.

    1. I’m keeping my fingers crossed re: Follica but I have to admit that I find it concerning that we are still waiting on the results of the optimization studies (which formulation works best….not does it work?) which were supposed to be completed over a year ago. And unlike the buzz being generated among experts in the field with Breezula, my source says he has heard nothing regarding Follica. I would be curious to see if admin’s sources have heard anything.

  20. Release Products! Let our heads be the judge.

    Aclaris stock has AGA its shrinking. But, I believe in Aclaris and Tszui and all the others once they just get a product out. If we can get a product that is very safe and even if it works just marginally a lot of money will come in with competitors trying to improve those existing formulas and that will spur the innovation that we need to finally solve this problem.

  21. Winlevi is slated to be released by 2020, 2 years before breezula. Their website says it’s the same drug just different formulations. I suppose you could take winlevi to a compounding pharmacy to up the formulation to match breezula at ~7-8%. Any thoughts on this? My only concern is that breezula may have a different delivering agent as well, necessary to penetrate thicker scalp tissue.

  22. People here seem to be comparing the patient assesment on a questionaire with the actual hair count numbers. It goes without saying this is apples and oranges. I would focus on the hair count figures

  23. Hi Ahmed,

    I hope you are doing well.

    Our exosome procedure starts at $5000 and that is to do 2 zones. I will attach our zone diagram chart for you to reference. There are no known side effects from the exosome procedure and is completely safe.

    I will attach some links below to some videos for you to learn more about how Exosome works. Let me know if you have any questions and I am happy to help.
    Thank you.

    Is the treatment 100% effective?
    Does hair fall out after years of treatment?

    Treatment is very expensive.
    What do you think about that?

  24. “Conditional approval from FDA received for Winlevi™ proprietary name”

    Does mean it can be released soon?

    1. See the last part of post where I mention that they had original Phase 3 trails scheduled to start in 4Q 2019. Later they moved that date to 1Q 2020. Now it will be 4Q 2020 due to this virus.

  25. At least we know how expensive this will be… Taken from slide #32 of the presentation – Clascoterone Solution could be priced like other cash pay lifestyle drugs ie $100-200 per month.

  26. I spend more on hair vitamins and volumizers.
    I think this is an awakening. Science has been moving awfully slow. For instance, Dentistry is still stuck in the 1970s. When science wants to move it can move. Hopefully, after this delay and the impact the virus has had on the medical community, fda, and researchers we will see faster strides for all afflictions that affect humans. Hair loss is devastating and debilitating, something that should have been cured a long time ago. Hopefully, we are not forgotten but rather our suffering is cured in the near future.

    1. Id save your money. vitamins and volumizers are just gimmicks and pseudoscience. Personally I think vitamins have zero effect on hair.
      I would like to see a lab test on hair where its deprived of all vitamins but given a blood supply what happens to it.

  27. Hey admin ,
    Clascoterone Cream 1% PDUFA Date – Aug 27, 2020

    Does this mean they’ll release the acne version soon after this date ? Im sorry to ask i’m kinda retarded if someone more knowledgable could give me an answer i’d appreciate . . And if so are they going to release it in europe first ince cassiopea is from italy?

    1. On Aug 27, 2020 (today) the FDA officially has approved Winlevi for acne.

      They release beginning 2021.

      Now we wait for Breezula for AGA announcement.

    2. On Aug 27, 2020 (today) the FDA officially has approved Winlevi for acne.

      They release Winlevi beginning 2021.

      Now we wait for the announcement that Breezula for AGA is approved.

  28. how screwed up are you?… the only problem I have with coronavirus is the problem that its causing to hair loss research… that’s how screwed up I am.

  29. The cutting edge stuff like using ips cells to grow new skin+hair from scratch is the ultimate cure, but the time and expenses with that is just so far out. I mean 10+ years maybe a lot longer if it even gets funding all the way to the end.
    Really right now we need this. At phase 2 we already can say its probably safer than propecia. Let people try to save the hair they have right now.
    An ounce of prevention is worth a pound of cure couldnt be more true than for MPB where you cant reverse it ever. Propecia is not a very safe drug to take long term either.

  30. Joey, I agree with you 5 to 10+ years still in the United States. Lol but not in Japan I’ve said this many times. We will have the cure in Japan by 2024. I’ve placed my bets gentlemen. :)

      1. Jan I’m a realist :) Just watch it will happen by no later than 2024 in Japan I would bet you a million dollars and not have a heart attack about losing it.

        1. Woofy Tsuji hasn’t started his human trials yet, first, and second, how are you sure their treatment will be effective in humans?

          1. jan, i don’t know if it will be affective in humans we all don’t know, but tsuji and the other scientist seem to think it will work why would they waist years of research and millions dollars or Japanese yen into this? And who cares if trials have not started yet, Tsuji said trials will begin this year that was like 2 weeks ago update

            1. Woofy Ken Washenik also claimed that they would make it, and we all know how it ended. I’m not saying that it will be the same this time, but the fact that there are studies does not mean that there will be a cure, it may happen that it will not work on humans, how do they know if there were only tests on mice? did the hair also grow on artificial human skin made in a laboratory? how is it Woofy? I am asking because I have no idea about Tsuji technology, what else is underdeveloped?

                    1. I have a question for you: will it be possible to obtain hair thicker than the ones on our head with the Tsuji method?

  31. “1997. That year was when Propecia (aka Finasteride) was first approved to treat hair loss. That year was also when Tiger Woods last won the Master’s before this past weekend’s surprise.”

    just to nitpick, 97 was Tiger’s 1st Master’s win. Also won 2001, 2002, 2005, then the 2019.

  32. Good news at last! the 2.5% solution had positive outcome and it’s just 2.5 times the concentration of the acne solution. only question is whether the scalp skin may be thicker and require other vehicle… I guess we’ll know the answer soon enough with self trials.

  33. This is solid news. However I do get nervous seeing that cassiopeia stated 9% of adolescents will have problems with the HPA axis and that 5% of adults will as well. Being I’m an antenna for side effects, this makes me nervous.

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