Update: June 29, 2023

Cosmo Begins Phase III Trials for Clascoterone (Breezula)

Cosmo Pharmaceuticals simply introduced the start of Phase III trials of clascoterone resolution in males for the therapy of androgenetic alopecia (AGA). The title of this product is Breezula® per previous bulletins and it’s a novel androgen receptor inhibitor. The zits product with the identical clascoterone ingredient (however decrease dose) known as Winlevi and that one is already accessible out there. Actual Phase 3 scientific trial particulars for Breezula can be found here.

Key quote:

“If approved by the FDA, clascoterone solution has the potential to be the only topical androgen receptor inhibitor for AGA and the first drug with a new mechanism of action for the treatment of AGA in nearly three decades.”

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

“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 firm took over majority possession of Cassiopea in December 2021 after being a part-owner for years (see backside of this publish).

Update: October 7, 2020 — Cassiopea (Cosmo Pharma) accomplished enrollment in its Phase II trials for feminine sample hair loss. The 6-month research has enrolled 293 sufferers. The four-arm research will divide volunteers into 4 therapy teams: clascoterone resolution 5% BID (twice every day); clascoterone resolution 7.5% BID (twice every day); minoxidil resolution 2% BID (twice every day); and automobile BID (twice every day).

Before Breezula 2023, there’s Winlevi 2021

Update: August 27, 2020 — Cassiopea’s Winlevi topical androgen receptor inhibitor has just been approved as an zits therapy by the US FDA. It is the primary zits therapy with a brand new mechanism of motion to be authorized in 40 years. The key ingredient (clascoterone cream 1%) is identical as within the keenly awaited hair loss product Breezula. The latter could have a better dosage.

CEO Diana Harbort quote:

Dermatologists have mentioned concentrating on androgen hormonal exercise within the pores and skin is ‘the holy grail’ of zits therapy for each women and men.

I count on Breezula is not going to come to the market until 2023, assuming it will get remaining approval. However, some individuals plan to make use of Winlevi on the scalp, though this isn’t really helpful by the producer.

Breezula Phase 3 Trials Delay

March 19, 2020

How issues can change in only a few weeks. Breezula Phase 3 trials have now been delayed until 4th quarter 2020 or 1st quarter 2021. All because of COVID-19 (Coronavirus), which has hit Italy notably arduous. More data might be present in Cassiopea’s 2019 Annual Report which was launched right this moment.

The Clascoterone feminine sample hair loss Phase 2 trials are on observe to complete enrollment in 2Q 2020. Trials ought to be accomplished by year-end 2020. However, delays are nonetheless potential relying on development and recurrence of the present 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 continues to be planning to launch its Winlevi zits cream product by the tip of this 12 months.

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

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

April 16, 2019

Cassiopea (Cosmo Pharmaceuticals)

I’ve lined Italian firm Cassiopea since 2014 (when it was known as Cosmo Pharmaceuticals). The firm is growing a topical anti-androgen hair loss product named Breezula (initially known as CB-03-01). The chemical title for this product is Clascoterone. Note that Cosmo Pharma nonetheless owns 45 p.c of Cassiopea.

Breezula can be accessible for each women and men. Several of my well-known doctor contacts within the hair loss world have advised me nice issues about this product. Their suggestions relies on what they noticed at conferences or heard from colleagues.

Breezula Phase II Trials Very Successful

In July of final 12 months, Cassiopea acknowledged that the interim Phase II scientific trial outcomes for Breezula have been very optimistic. Today, they launched twelve month Phase II trial outcomes with the identical conclusion:

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

The presentation of the outcomes is complicated, detailed, stuffed with acronyms and considerably open to interpretation. Note that “BID” in there stands for “twice per day” after conversion from Latin. Hopefully they launch earlier than and after photographs in some unspecified time in the future.

Also word that the earlier 6-month interim report had 375 topics, and the 12-month report has 344 topics. The trial was carried out in Germany.

Breezula Target Area Hair Count Increase

Breezula Hair Count Increase
Breezula Hair Count Increase.

Best case outcome highlighted in yellow (14.3 new hairs per sq. centimeter, after 12 months of seven.5% BID clascoterone resolution dosage). BID means twice per day.

Breezula Target Area Hair Width Increase

Breezula Hair Width Increase
Breezula Hair Width Increase.

Best case outcome highlighted in yellow (762.5 um width enhance, after 12 months of seven.5% BID dosage).

My intestine feeling is that Breezula can be not less than as efficient as Finasteride and Minoxidil.

Clascoterone Summary

Some key factors from the above linked article from Cassiopea:

  • If authorized, Breezula (Clascoterone) would be the first FDA-approved topical anti-androgen for the therapy of androgenetic alopecia.
  • Moreover, it might even be the first new drug authorized for treating androgenetic alopecia since 1997. That 12 months was when Propecia (aka Finasteride) was first authorized to deal with hair loss. That 12 months was additionally when Tiger Woods first received the Master’s golf match. His fifth shock victory in that match got here this previous weekend.
  • Based on these nice outcomes, Cassiopea plans to proceed with 6-month Phase III trials in males within the fourth quarter of 2019, after session with the FDA. The firm can also be going to start out proof-of-concept trials in ladies.
  • Breezula works by blocking dihydrotestosterone (DHT) interplay with hair follicle androgen receptors.
  • Clascoterone doesn’t intervene with testosterone and different hormones in male topics. Libido and sexual habits adjustments have to date not been noticed in scientific trials. Moreover, because of its fast metabolism and localized exercise, Clascoterone (Breezula) doesn’t produce any systemic unintended effects.

In the previous, I used to typically state that maybe an preliminary remedy for hair loss would entail the utilization of a cocktail of merchandise. Each working through completely different mechanisms and chemical or organic reactions.

It is wanting seemingly that Breezula can be one of many important merchandise on this cocktail.

Note that Clascoterone 1% cream to deal with zits can be launched by Cassiopea earlier than Breezula. The zits product known as Winlevi.

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