Dutasteride — will it be approved for hair loss treatment in 2015?

Update: In 2015, Dutasteride was approved in Japan to treat hair loss.  Moreover it was approved in South Korea even earlier in around 2010 it seems (no wonder some of the main studies involving Dutasteride and hair growth in men come from that country)!  So now I think there is a very good chance that the same will happen in the US and EU in 2016.


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 both  Type 1 5AR and Type 2 5AR (Finasteride only inhibited Type 2 5AR).

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 did not seriously attempt to get final Phase III FDA approval for its use as a hair loss medication.   At the time, Dr. Sawaya gave some interesting reasons behind Glaxo’s decision to suspend the final phase III approval process.  The main reason given was that based on annual sales of Propecia (Finasteride) and Rogaine (Minoxidil) at the time, 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, most hair loss forum members who have been using Dutasteride over the past decade do not seem to have seen stunning results 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. 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?

26 thoughts on “Dutasteride — will it be approved for hair loss treatment in 2015?”

  1. What’s the point on testing on dutasteride if there are a lot of investigations on cloning and that seems to be the potential solution?

  2. Hey Leo, cloning is the solution, but if it does not work out for another 5 years or more, Dutasteride (Avodart) can still make Glaxo a few hundred million dollars in sales… and maybe a lot more if the drug really proves to be substantially better than Finasteride (Propecia).

    1. I hope some labs will realize that curing this can make them get more money than snoozing a problem for good and making bald people spend for ever.

      I took dutasteride under my own risk for a year and a half and apart from stopping the loss I did not see any mayor improvements. Was on finasteride before but could not handle the side effects any more. There is a good site (http://www.propeciahelp.com/) which help me a lot when getting of both drugs.

      God bless Dr. Cristiano, Dr. Xiaowei “George” Xu, and Dr. Cotsarelis and all the others working hard trying to help us improving our lives.

  3. From my experience as a long time dutasteride user, it works very well, much better than anything else.
    In my early 20s I started loosing my hair in a male pattern way. One year of finasteride did absolutely nothing and couldn’t take minoxidil because it caused irritation.

    Tried dutasteride and within about a month, shedding stopped and hair grew noticeably thicker and longer. For many years I continued to rely on dutasteride and now in my 30s, I still have a full head of hair. It has hardly changed since when I started taking it. I’m 100% certain that I’d be completely bald today if I had not taken it.

    I also didn’t notice any side effects at all. So for me it would be great if I could get it from the local chemist instead of having to find reliable sources online.

    1. please help with references of where I can get dutasteride for hair loss. MD’s are hard to find that will prescribe dutasteride. especially dutasteride solution. thank you. randy sato

      1. Hi Randy, try a local hair transplant surgeon. They might charge you a small fee, but will usually be more willing to prescribe Dutasteride compared to a regular doctor.

      1. I’m going to try Avodart after doing Rogaine for years, then having to stop due to extreme irritation. Since I stopped rogaine I’ve lost so much more hair and the dermatologists say I have either chronic telogen effluvium or androgenic alopecia. I’d love to know what other females have experienced on avodart.

    2. Hi Danny,

      The same with me.
      It totally stopped my hair loss.
      I’ve been taking it for 10 years without any side effects.
      There should be FDA approval for cases in which
      Propecia did not work. Propecia did not work for me.
      I used Propecia for two years until the middle of my
      head was almost with no hair. Only Avodart – Dutasteride
      succeeded to make the difference and to reverse hair loss.

      Blessings,
      Eytan.

  4. I have been on Avodart 0.5 mg since its introduction in 2003. Used in conjunction with topical 5% minoxidil, it is wonderful for retaining–and regrowing–vertex hair. Unfortunately, like most treatments, it is less effective for frontal hair loss. Avodart goes off-patent in 2015. I’m hoping that higher strength generic preparations become available since the early trials for hair loss showed that a 2.5 mg strength was much more effective.

  5. i have been using dutasteride for a few years now and it works very well for me. i tired propecia and it did nothing and regaine was difficult to put on twice a day, didn’t work very well and irritated my skin. i would recommend dutasteride. it has saved me a lot of distress as going bald was driving me mental.

  6. I was on propecia for over a year and i was continually shedding hair on it. Switched to generic dut (dutas) and have had no problems with it. Hair has maintained and thickened. Have been on dut around 5 years and only take in mon-fri with rest at weekend.

  7. He usado Dutasteride y los resultados son excelentes el pelo cree, detiene la caida y mejora la densidad, en mi caso tengo 50 años y he usado minoxidil, finasteride, lejos los resultados de Dutasteride son superiores.

  8. I am 40 years old lady..i am losing hair for last one year.. i took fincar for first8 months.. Hair fall reduced but there was fluctuations.. then i started dutas. 5 daily and after 2 months my hairfall increased a loooot… very sad.. cant stop crying.. if i switch back to fincar 5 mg daily. will it cause more ha

    1. Sorry to hear you’re going through that. I wish women would think of other women like you when they tell me “it’s just hair, who cares?”

  9. Hi,

    Can anyone tell me where should I buy Dutasteride? I live in the U.S! I’ve been using Finansteride. It was helpful in the beginning but after couple years, it stopped working.

    Thanks,
    David

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