Category Archives: Dutasteride

Avodart, Dutasteride, GlaxoSmithKline

GSK Publishes Japanese Dutasteride Study Results

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I previously wrote about dutasteride possibly being approved by the US FDA to treat hair loss in 2015. In August 2014, GlaxoSmithKline (GSK) published 6-month interim results from a Japanese clinical study of 120 male patients with androgenetic alopecia taking 0.5 mg of dutasteride daily. You can download the findings from here.

It should be noted that all patients were Japanese and four patients withdrew from the trial. Key findings:

  1. 81 percent of patients saw at least some increase in vertex hair count (10 percent saw a great increase, 33 percent saw a moderate increase).
  2. 71 percent of patients saw at least some increase in frontal hair count (8 percent saw a great increase, 32 percent saw a moderate increase).
  3. Only one patient saw a decrease in vertex hair count, and only one patient saw a decrease in frontal hair count. It is not clear if this was the same patient. Both saw only a slight decrease.
    (My note: For all intents and purposes, this implies that Dutasteride guarantees at the very least hair loss cessation after 6 months of use).
  4. 11 percent of patients reported erectile dysfunction as a side effect and slightly smaller percentages of patients reported decreased libido, ejaculation disorders and sexual dysfunction.(My note: Since each patient can report more than one side effect, I am guessing that most of the 11 percent reporting erectile dysfunction also reported the other sexual side effects I listed above. However, the end of the pdf states that 38 percent of patients had side effects, which I think is an error as they are ignoring multiple side effect reports).

For 6 months, I found the hair loss related results slightly better than expected, but the side effects slightly worse than expected. I am assuming here that something like 15-20 percent of patients had side effects rather than 38 percent as reported, based on my assumption that multiple side effects on one person were reported individually (i.e., double, triple… counted) for some reason.

If 38 percent of patients really did get side effects, we will not see Dutasteride getting approved to treat hair loss in the US or Japan in my opinion.

Dutasteride, Avodart, Dihydrotestosterone (DHT), Marty Sawaya, Type I 5α-reductase, Type II 5α-reductase, Type III 5α-reductase

Dutasteride: Will it be Approved for Hair Loss Soon?

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Dutasteride Capsule.
Dutasteride Capsule.

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 future.

Dutasteride Approved for BPH

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 his interview 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.

Approval for Hair Loss

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. Just 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?