Update: November 8 2019 — Cassiopea announces US FDA reviewing new drug application (NDA) for clascoterone cream 1% to treat acne.
I have covered Italian company Cassiopea numerous times on this blog. Primarily due to its Breezula topical product for male pattern hair loss. Earlier this year, Cassiopea announced very good 12-month Phase 2 clinical trial results for Breezula.
Clascoterone, Winlevi and Acne
Cassiopea is also working on an acne product called Winlevi. Both Breezula and Winlevi are based on the same key ingredient: Clascoterone. However, the dosage in Winlevi is significantly lower at 1%. Winlevi is almost ready to come to market per Cassiopea’s product pipeline.
Earlier this week, Cassiopea made a major announcement. The company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for clascoterone cream 1% for the treatment of acne.
Some interesting points in the press release and my thoughts:
Clascoterone cream 1% targets androgen receptors at the site of application. This inhibits the local (skin) effects of dihydrotestosterone (DHT). Apparently, DHT is a key driver of acne lesion development. Most people wrongly assume it is solely testosterone.
This acne treatment product will be safe to use in both males and females.
If approved, clascoterone cream 1% will represent the first new mechanism of action in the treatment of acne in almost 40 years. Interestingly, if Breezula is approved for hair loss in 2021, it will be the first new topical or oral treatment for hair loss in almost 25 years.
Update: In 2015, Dutasteride was approved in Japan to treat hair loss. Moreover it was approved as a hair loss treatment in South Korea even earlier in around 2010. No wonder that some of the main studies involving Dutasteride and hair growth in men are coming from those two countries. I think there is a decent chance that the same will happen in the US and EU in the near future.
Dutasteride (brand name Avodart) was approved in the US in 2002 to treat benign prostate hyperplasia (BPH — aka prostate enlargement in men). Around that time, Dr. Marty Sawaya became the most discussed and popular person on hair loss forums due to her stunning conclusions about the excellent results she had witnessed on people who used the drug to combat hair loss. These results were significantly superior to Finasteride. Dr. Sawaya even appeared on The Bald Truth radio show and gave a number of interviews to hair loss related websites in the early 2000s. It seemed like hair loss was essentially going to be cured via a medication. Besides stopping hair loss, Dutasteride also seemed to grow back hair that was thought to have become permanently vellus and miniaturized. A real miracle drug that inhibited almost all dihydrotestosterone (DHT) in the body, as well as all three isoforms of 5α-reductase: Type I 5α-reductase, Type II 5α-reductase and Type III 5α-reductase (Finasteride only inhibits Type II and Type III).
Dr. Sawaya’s most famous patient was was Dr. Monahan, and this interview with him on Hairsite is very good. Unfortunately, Dutasteride’s manufacturer GlaxoSmithKline never seriously attempted to get final Phase III FDA approval for its use as a hair loss medication. Dr. Sawaya mentioned that the main reason behind that decision was due to the fact that based on annual sales of Propecia (Finasteride) and Rogaine (Minoxidil), it was unlikely that Dutasteride would ever become a blockbuster drug with sales of over $500 million.
Unfortunately, barring a few exceptions, most hair loss forum members who have been using Dutasteride over the past decade do not seem to have seen and major new hair growth based on anecdotal evidence. It is nevertheless likely that on average, the reported results on the forums have been superior to those attained from Finasteride as the various studies have predicted. Countless people have witnessed a cessation in hair loss after getting on Dutasteride. Once Dutasteride (Avodart) is approved as a hair loss drug, there will hopefully be many more forum members taking the drug, and we will therefore have far more data points to compare results relative to Finasteride.
Will Dr. Sawaya be proved correct after all in her optimism regarding Dutasteride being a miracle drug? Will we finally see a third non-surgical FDA approved hair loss treatment option after Finasteride and Minoxidil by the end of 2015?