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Male Hair Loss Treatment Samumed SM04554 Unveils Trial Data

Regenerative bioscience and technology is proving a fruitful area for hair loss researchers at the moment with the likes of Shiseido and RepliCel investigating stem cell applications for addressing male pattern baldness.

As updates from the weekend’s 74th Annual Meeting of the American Academy of Dermatology (AAD) announcements leak, could Samumed LLLC have developed a new treatment for advanced male hair loss?

Hair Loss Research into New TreatmentTopical treatment SM04554

The proposed treatment for androgenic alopecia (AGA) which seems specifically aimed at men given no women were involved in the clinical trial, involves a once-per-day topical application of SM04554 – a drug developed by the Californian pharmaceutical and regenerative medicine company, Samumed LLC.

Known for its innovative work with the Wnt pathway, according to a company press release, Samumed has managed to ‘develop small molecule drugs that potentially address numerous degenerative conditions’. SM04554 is described in the same release as a ‘novel small molecule compound’ but no other information is yet available as to its ingredients or precise makeup.

The drug has been in development for a number of years already, with the safety results from this phase II study and the phase I clinical trial precursor having already been declared in November 2015 at the World Congress for Hair Research.

The phase II multi-centre trial involved 300 male participants aged between 18 and 55, with male pattern baldness classified as stage IV, V, VA, VV or VI on the Norwood Scale. What makes this drug and its trials different to others currently underway is that it is concentrating on treating men with the more advanced stages of hair loss.

These men were treated once a day for 90 days with one of three different products, which were randomly assigned in equal measure to allow for effective comparisons. The three products, distributed on a blind basis so that none of the volunteers knew what they or anyone else was using, were a placebo solution, a 0.15 per cent SM04554 solution and a 0.25 per cent SM04554 solution.

Following the initial daily treatment period, participants were also subject to a follow-up at 45 days after treatment. Using high resolution macrophotography and self-assessment via a survey questionnaire, changes in their non-vellus hair count and hair density were recorded.

Lower dose more effective

Whilst the findings state that men using the placebo solution lost hair during the study dropping from an average 114 hairs/sq cm to 111.5, those using the lower 0.15 per cent dose achieved an average hair count gain (104.9 at start rising to 115 following treatment). Interestingly those applying the higher 0.25 per cent SM04554 solution did not achieve as large an increase, with the average increase being 118.5 from 110.8.

The company’s press release states that ‘The findings are consistent with preclinical in vivo animal models, in which SM04554 has been shown to generate new hair follicles and increase hair count’.  However, a report in Forbes suggests that, given only the lower of the two dosages tested during the trial proved significantly effective at regrowing hair, this outcome may have an effect on the drug’s future development.

Journalist Matthew Harper states, ‘Usually drug makers like to see what’s called a dose response: you give more drug, you get more efficacy and side effects. For some companies, lack of a dose response can be seen as reason to cancel a drug development program.’

More studies needed

The Phase II safety and efficacy data so far are very promising and support moving this program into pivotal studies. We are analyzing the efficacy data further,” said Chief Medical Officer of Samumed, Yusuf Yazici, M.D. The hope is that the data from the pursuant research will allow the drug to achieve FDA approval in the USA.

No timeline has been mentioned in relation to when Samumed is aiming to have the drug ready to market – assuming it meets the necessary safety, tolerability and efficacy criteria – and hair loss treatments can take years to be made publically available. Luckily for anyone concerned that they are losing their hair now there are already clinically-proven and MHRA and FDA approved treatments available.

Belgravia offers a range of topical high strength minoxidil products which are applied directly to the scalp where needed, and can be used alongside the daily oral tablet finasteride 1mg to treat male hair loss and promote regrowth.

Evidencing the effects of following a personalised, monitored programme featuring clinically-proven treatments, which can be supplemented with boosters to aid the action of the pharmaceutical components, is our extensive collection of Male Hair Loss Treatment Success Stories featuring images of clients from before and after starting their treatment plans to visually demonstrate their progress.

Further information on the latest SM04554 phase II trial findings are expected to be released shortly, following their presentation at the American Academy of Dermatology in Washington on Saturday 5th March 2016. Once these details are released we will report on these findings here on the Belgravia blog so do check back for the latest updates.

Belgravia Centre Hair Loss Clinic Hair Loss Specialist Free ConsultationThe Belgravia Centre

The Belgravia Centre is the leader in hair loss treatment in the UK, with two clinics based in Central London. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation Form from anywhere in the UK or the rest of the world. View our Hair Loss Success Stories, which are the largest collection of such success stories in the world and demonstrate the levels of success that so many of Belgravia’s patients achieve. You can also phone 020 7730 6666 any time for our hair loss helpline or to arrange a free consultation.

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19th August, 2016 at 2:04 am


I am interested in your hair restoral medications I am 60 years and my front hair is starting to go away!

19th August, 2016 at 9:40 am

Sarah Belgravia

Hi William, the best thing to do if you are interested in male hair loss treatment to combat a receding hairline is to contact the clinic to book a free consultation if you are based in or near London. Otherwise, if you are based outside London or abroad, please complete an Online Consultation and one of our team will get back to you to go through all the details.

7th November, 2016 at 7:42 am

Mary Njora

I saw your article in the Internet and im very excited. I lost my Hair 20 years ago and i can't go out without covering my head. I did all test in hospital and results were no disease its baldness. How can i get your drug SM04554. I hope it will be out soonest possible.Eagerly waiting.

7th November, 2016 at 12:02 pm

Sarah Belgravia

Hi Mary, SM04554 is not our drug - this is something that is being developed by a company called Samumed. It is still in the early stages of testing so is unlikely to be made available for a number of years yet. We will update our blog with the latest information on this as it becomes available.

2nd January, 2017 at 3:31 pm


Bonjour, j'espère que vous parlez français :) , avez vous des information concernant la phase 3 de développement du SM04554 ? J'ai 27 ans je suis atteint d'alopécie androgénique et ce n'est vraiment pas facile d'assumer sa calvitie. Pour le moment d'après l'échelle d'Hamilton je suis en catégorie III mais vue mon père, je pars sur une catégorie 7.

11th January, 2017 at 1:56 pm

Sarah Belgravia

Bonjour Mustapha, bien sur, SM04554 est toujours en cours d'essais cliniques. Il n'est pas encore disponible et il peut être un certain nombre d'années jusqu'à ce que les études nécessaires ont été achevés. Nous publierons des histoires sur la progression de ce médicament au fur et à mesure que l'information sera disponible.

*Hi Mustapha. Absolutely. SM04554 is still undergoing clinical trials. It is not yet available and it may be a number of years until the necessary studies have been completed. We will publish stories on the progress of this drug as the information becomes available.

22nd July, 2017 at 3:10 pm


i am also waiting your valuable medicine please quickly release the date.

24th July, 2017 at 11:04 am

Sarah Belgravia

Hi Muthiah, we are not involved in the development of this product but will report on its latest clinical trial updates as they become available. It can take a number of years to pass the necessary tests for safety, efficacy and tolerability, before a new medication can come to market so if you are interested in dealing with your hair loss now, there are already clinically-proven male hair loss treatment options available that may be worth your while exploring.

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