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What Is SM04554 (Dalorsivat)?

SM04554
SM04554 is an experimental drug (not approved by the FDA) that has completed clinical testing. It was developed by Samumed, a biotechnology company based in San Diego, California.

Samumed have now changed their name to Biosplice Therapeutics (1). The company also renamed SM04554 to Dalosirvat. Since most people know it as SM04554, this is what we will call it throughout this article.

How Does SM04554  Work?
SM04554 is a so-called Wnt activator. This means it modulates the Wnt pathway.

In simplest terms, the Wnt pathway is a group of protein pathways that pass signals into a cell through cell surface receptors. It is an ancient signaling pathway that goes back hundreds of millions of years in evolution.

The Wnt pathway plays a crucial role in cell growth and migration and is key for the development of embryos. It is also involved in wound healing and recovery from injuries.

What does SM04554  have to do with hair?

In the initial trial, researchers claimed three major things about Wnt signaling and its effects on hair growth.

Wnt signaling initiates and maintains the anagen phase of the hair cycle (2).
Wnt pathway activation induces endogenous dermal progenitor cells to differentiate into a hair bulge, leading to the formation of new hair follicles (3).
Reduction of Wnt pathway signaling is associated with hairline recession in AGA.
Let’s take a closer look at these claims.