Category Archives: Cassiopea

Breezula Phase II Results Positive, Phase III Delayed

Update 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 Results presentation, 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.


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.

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 last won the Master’s before this past weekend’s surprise.
  • 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.

Follicum and Cassiopea Updates

Update: Yesterday, Follicum sent a new developments and update link to people on its email list. Sounds very encouraging. Proof-of-concept and top-line-data for their FOL-005 hair loss product are on target for 2020.

They have also entered into a collaboration with Bioglan to make their FOL-005 hair loss topical cream. Follicum is also on target to get final US patent approval soon that will grant rights through 2032.

February 9, 2019

I have covered both Follicum and Cassiopea numerous times on this blog in the past.

Follicum is based in Sweden and has done a stellar job in updating us regularly when it comes to the company’s peptide-based FOL-005 topical hair loss product. Projected release date: My guess is 2022, but one year sooner would not surprise me.

Cassiopea is based in Italy. Last year I mentioned how several very well known insiders of the hair loss industry have emailed me about their excitement in regards to Cassiopea’s Breezula topical antiandrogen product. Projected release date: Officially listed on their site as 2022.

Follicum Update

Follicum provided us with two updates this week.

  • The first was an important February 4th press release. In animal model in vivo testing, Follicum’s FOL-005 hair loss product was as successful as Minoxidil 5% in growing new hair. Moreover, while the latter must be used twice per day, FOL-005 need only be applied once per day.

Since results were dose dependent, I am hopeful that the company will test higher doses in future that may give even better new hair growth results. Considering that to-date, only two products (Finasteride and Minoxidil) have ever been officially approved to treat male pattern hair loss, this development is groundbreaking if true.

  • On February 9th, BioStock magazine published an interview with Follicum’s Research & Development director Maria Ekblad. Original Swedish version here. It seems like the latest version of FOL-005 that is being tested is a new formulation.

One interesting point made was that Follicum only managed to test the product for 3-month results in humans in recently completed Phase IIa trials. Ms. Ekblad hopes that longer-term usage will give even better results.

Follicum has historically worked with researchers at Charité Hospital (Berlin, Germany) and Bioskin (Hamburg, Germany). In late 2018, the company announced that they were now also working with the Centre for Skin Sciences at the University of Bradford (UK).

I would be very surprised if this once-a-day home use FOL-005 cream-like product ends up being less effective than Minoxidil. Unfortunately, it will probably not be released till 2021 at the  earliest.

Cassiopea Summarizes 2018

Yesterday, Cassiopea (Italy) provided an update of its 2018 results.

Both the company’s hair loss product (Breezula) and acne product (Winlevi) are based on a synthetic antiandrogen called Clascoterone. Six-month interim Phase II results for Breezula® used in solution form in men with androgenic alopecia demonstrated statistically significant improvement in:

  1. Target Area Hair Count (TAHC)
  2. Hair Growth Assessment (HGA)

Nothing too meaningful as yet, but: there is excitement in the hair loss world about this product due to some results that were presented by Cassiopea at a conference in 2018. I cannot divulge my sources.

I would be surprised if Breezula does not provide significantly superior results to Spironolactone (another antiandrogen) in regrowing hair. Otherwise, it would not be worth pursuing.

Moreover, this product will be in topical form, and most likely result in minimal side effects. Most oral antiandrogens have significant side effects.