The molecule SM04554 was an experimental treatment for hair loss under development by the company Samumed LLC. Unfortunately, the research was halted during the final testing phase, which is Phase 3.

The precise reasons behind discontinuing the research at this advanced stage remain unclear. It can be speculated that the results obtained in human trials may not have been conclusive. It is possible that SM04554 exhibited significant side effects, or external factors may have influenced the decision, but these specifics are undisclosed.

Samumed LLC made an announcement: ‘Samumed is not pursuing further independent development of SM04554 for androgenetic alopecia and is evaluating global out-licensing opportunities for further development and commercialization of this program.’

This indicates that Samumed has decided not to proceed with additional research and development of SM04554 for androgenetic alopecia and is exploring opportunities to license the existing research and development for potential commercialization.

How does the SM04554 molecule work ?

SM04554 is a small molecule that interacts with the Wnt protein signaling pathway. It is applied topically to the scalp and operates by activating the receptors within the Wnt signaling pathway.

In simpler terms, the activation of the Wnt signaling pathway plays a role in promoting the growth of new hair and maintaining existing hair in the anagen phase (the growth phase).

In reality, the Wnt signaling pathway is involved in various biological processes beyond just hair growth. Establishing precise connections between this pathway and hair growth is still a subject of ongoing research. What we do know is that by activating this pathway, it is possible to stimulate hair growth. Interestingly, numerous plant-based oils also have the capacity to activate the Wnt pathway.

Studies on the SM04554 Molecule

As of now, we have access to studies conducted in Phase 1 and Phase 2.

In the Phase 1 study, the results were promising, demonstrating that the use of SM04554 at concentrations of 0.15% and 0.25% effectively maintained hair in the anagen phase throughout the 135-day study duration.

Phase 2 trials involved a larger participant group and yielded even more favorable outcomes. Researchers observed a 10% increase in hair density among participants using SM04554 at 0.15% and a 13% increase among those using the 0.25% concentration. This study also spanned 135 days.

Aside from these studies, no further information is available at this time.

Final Thoughts

WNT signaling pathways offer a fresh perspective on understanding hair loss. Although the SM04554 molecule has been abandoned, ongoing research suggests that we may witness the emergence of numerous products aimed at activating WNT pathways in the market.

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.’

As of 2023, you can find products designed to activate WNT signaling pathways available online. Furthermore, several oils also have the potential to activate these pathways. For instance, olive oil, evening primrose oil, canola oil, or soybean oil are known to possess this capability.