August 8, 2020

SM04554 for hair loss – a new miracle treatment on the horizon?

Recently, while doing online research on hair loss treatments, I came across a new hair loss treatment called SM04554 – a drug being developed and tested by California based biotech company Samumed. I hear a lot about new hair loss treatments being developed, but this one has caught my eye and really made me excited.

In this post I’ll be writing about SM04554 for hair loss, and why this could potentially be a new promising treatment in the near future.

What is SM04554?

SM04554 is an experimental drug being developed by Samumed to treat androgenetic alopecia. It is currently at phase 3 trials, which is an advanced phase that tests the safety and how well a new treatment works compared with a standard treatment. If it passes this phase successfully, it will most likely be approved for use.

SM04554 is a topical treatment which is applied to the scalp, like minoxidil, but works in a completely different way. It is believed that SM04554 selectively activates and deactivates WNT signaling pathways – a group of signal transduction pathways which begin with proteins that pass signals into a cell through cell surface receptors. Sounds pretty complicated.

These pathways are indeed complex and not much is known about their connection to hair loss, but what is known from studies is that WNT signaling causes hair to move into the anagen growth phase of the hair cycle and stay in that phase. Anagen is the good phase of the hair growth cycle, in which hair keeps growing and hair loss doesn’t occur.

WNT signaling also leads to the formation of new hair follicle, and it is believed that reduction of WNT signaling pathway is associated with hair loss in male pattern baldness.

Phase 2 results of SM04554

After successfully passing phase 1 trials which focused mainly on safety, phase 2 trials which focused more on the drug’s took place sometime during 2015-2016.

Phase 2 trials included 305 subjects at an advanced hair loss stage (ranging from 4-6 on the Norwood-Hamilton scale) who were randomly assigned either a placebo, a 0.15%, or a 0.25% drug concentration.

Subjects would apply SM04554 on the scalp once a day for 90 days. Clinical assessments were done at the beginning of trials, day 45, day 90, and day 135.

Results summary found that:

  • SM04554 improved hair count and density better than the placebo
  • Hair count increased by about 10% after 135 days with SM04554 0.15%
  • Hair density increased by about 13% after 135 days with SM04554 0.15%
  • Surprisingly, the 0.15% concentration performed much better than the 0.25%
  • SM04554 increased the numbers of hair in the anagen phase

Reasons to be excited about SM04554

Although these results are not amazing, they are definitely very promising and clearly show that hair count and density increased, as well as the number of hairs in the anagen growth phase.

The fact that SM04554 showed these results on men in advanced balding stages is impressive, and suggests that SM04554 is a treatment that can not only maintain hair, but actually reverse hair loss!

During trials, there were no serious side effects observed in subjects. There were a few non serious side effects that went away after a few days, but none of them made subjects quit the study.

Can we expect SM04554 to be available soon?

SM04554 is currently at phase 3 trails, which can take at least 18 months. Samumed’s site states that the study started on November 1, 2018, and is estimated to end on June 2020.

Even after trials, it is not guaranteed to be FDA approved. FDA approval is a very long and complex process, and most drugs are not approved. If it does get approved though, it might take another few years until SM04554 hits the market, so a commercial release before 2023 seems unlikely.

Final thoughts on SM04554

Though it does not yet seem like a miracle drug, SM04554 trials have shown promising results for reversing baldness. It is quite possible that after phase 2 trails Samumed made changes to their drug and found the right dosage to improve results even more.

It would also be very interesting to see how effective this drug is when taken for a longer period than 3 months, perhaps for 6 months, or even a year.

Unfortunately though this drug still has a long way to go to get FDA approved, and even if it does, SM04554 is still a few years away from hitting the market.

In the meantime I would recommend traditional treatments such as Minoxidil, Finasteride (if you’re not concerned about the side effects), or topical Finasteride with Minoxidil.

I hope you enjoyed this post. If you have any comments or questions, please leave them down below.

3 thoughts on “SM04554 for hair loss – a new miracle treatment on the horizon?

  1. Hi Michael,

    As someone who comes from a long line of very bald men I took great interest in this LOL. I don’t keep up with the research on it much but it’s exciting that there are drugs coming out or being tested that show some promise! I know that they can figure out a cure for baldness one way or another eventually. They’ve made so much progress in other areas but it just seems like they don’t know much more about baldness than they did 50 years ago. Thank you so much for this information! I am going to keep an eye on this for future reference!

  2. This definitely sounds like a miracle treatment for hair loss and I for one am looking forward to it hitting the market.

    Over the years I have come across many different treatments for hair loss and sadly nothing has really worked for me.

    It’s a shame sm04554 will not be hitting the market for a few years, it could be worth a try and who knows maybe they really have discovered a cure for baldness!

    You mention Minoxidil just how effective is that?

    1. Hi and thank for you comment. It is indeed a shame that SM04554 is not available yet. Hopefully it will get FDA approved soon and become available.
      Minoxidil is quite effective, especially in maintaining hair at relatively early balding stage. After a few years it might work less effectively.
      I have been using Minoxidil for 7 years, and just recently started a new treatment which is a stronger 15% Minoxidil with topical Finasteride. You can read more here:

Leave a Reply

Your email address will not be published. Required fields are marked *