Category Archives: Type III 5α-reductase

Dutasteride: Will it be Approved for Hair Loss Soon?

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.

However, recently, Glaxo has become serious about pursuing the final approval process. Here is an interesting recent thread to follow on Reddit regarding Glaxo’s pursuing phase III FDA approval for treating hair loss with Dutasteride.

Dutasteride 0.5mg/day clinical trial for final FDA approval — started in April 2013 and is expected to be completed in October 2014

Dutasteride trial from 2010-2012

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?