What it is

SM04554 is a topical solution at 0.15% and 0.25%, applied once daily, developed by Samumed and then Biosplice Therapeutics. It was never approved. We found no peer-reviewed paper on the trials in PubMed, only registry records.

How it works

The sponsor describes it as a Wnt/beta-catenin pathway modulator intended to push follicles into the growth phase. See valproic acid and WAY-316606 for the same pathway.

What the studies show

In a phase 2 trial of 302 men over 90 days, non-vellus hair count changed by +4.2 (0.15%) and +3.2 (0.25%) versus +6.2 on vehicle: no benefit (trial record).
In a phase 2/3 trial of 675 men over up to 48 weeks, the week-48 hair count ratio versus vehicle was 1.024 (P=0.54) for 0.15% and 1.014 (P=0.745) for 0.25% (trial record).
Both trials were industry-sponsored and the results appear only on the registry.

How it's used in studies

0.15% or 0.25% topical solution once daily for 90 days to 48 weeks.

Side effects and safety

Not characterised beyond the registry; no safety stop was reported in the records read.

Bottom line

SM04554 failed in humans: a plausible Wnt story met a large vehicle-controlled trial and nothing happened. Compare the small positive valproate trial. It is not available. Discuss with a doctor.

Fun facts

Despite two sizeable trials, no peer-reviewed results appeared, a typical fate for failed industry hair trials.

Studies 2

ClinicalTrials.gov NCT02275351. SM04554 topical solution in men with androgenetic alopecia, phase 2. Samumed

Design: rct
People: 302
Duration: 90 days
Who: men with androgenetic alopecia

Tested: SM04554 0.15% or 0.25% vs vehicle

Result: Non-vellus hair count rose +4.2 and +3.2 vs +6.2 on vehicle: no benefit.

Read the study ↗

ClinicalTrials.gov NCT03742518. SM04554 topical solution in men with androgenetic alopecia, phase 2/3. Biosplice

Design: rct
People: 675
Duration: 48 weeks
Who: men with androgenetic alopecia