This page describes pharmacological agents that may have legal restrictions, side effects, and drug interactions in your jurisdiction. Information is for educational research only — consult a clinician before considering any compound.

Browse

SM-04554

Extensively Studied

Samumed/Biosplice's topical small-molecule Wnt/β-catenin pathway activator (dalosirvat) — designed to drive hair follicle stem cells back into anagen by amplifying endogenous Wnt signaling. Modest hair-count gains in Phase 2 (the lower 0.15% concentration unexpectedly outperformed 0.25%), and Phase 3 results were never publicly disclosed before the program was effectively shelved.

Aliases (7)

Samumed SM-04554 · SM04554 · dalosirvat · Wnt activator (Biosplice) · CAS 1360540-81-3 · 1-(2,3-dihydro-1,4-benzodioxin-6-yl)-4-phenylbutane-1 · 4-dione

TYPICAL DOSE

0.15% topical solution

Once daily topical

ROUTE

Topical (scalp)

Topical 1 mL to scalp

CYCLE

Continuous daily — trial protocol was 90 days

90 days in trial; no real-world maintenance protocol

STORAGE

Room temp; original container

Room temp; sealed

Overview

What is SM-04554?

SM-04554 (INN: dalosirvat) is an investigational topical small-molecule Wnt/β-catenin pathway activator developed by Samumed (later Biosplice Therapeutics) for androgenetic alopecia. It completed Phase 1, 2, and 3 trials between roughly 2014 and early 2021. Phase 3 results were never publicly disclosed and Biosplice subsequently removed the asset from active development, signaling almost certain trial failure. Not FDA-approved and not marketed anywhere.

Key Benefits

In trials: modest, statistically significant increase in non-vellus hair count (~9.5% from baseline at the 0.15% concentration) over 90 days, with continued gains during a 45-day washout — consistent with a 'reactivate dormant stem cells' mechanism rather than an ongoing-suppression mechanism like finasteride. Mostly mild local side effects, no serious systemic events.

Mechanism of Action

Activates canonical Wnt/β-catenin signaling (IC50 ~28-29 nM in reporter assays), stabilizing nuclear β-catenin in hair follicle bulge stem cells and dermal papilla. Drives quiescent follicle stem cells back into anagen and induces follicular neogenesis in animal models — a mechanism distinct from minoxidil's anagen prolongation and finasteride's DHT suppression. Despite the elegant mechanism, Phase 3 efficacy did not translate.

Research Protocols

Disclaimer: These are commonly discussed research protocols and not medical advice.

Goal

Dose

Frequency

Solo Use

Cycle

Goal:0.15% topical solution, once daily, 1 mL to dry scalp

Dose:—

Frequency:—

Solo:—

Cycle:—

Goal:Washout behavior

Dose:—

Frequency:—

Solo:—

Cycle:—

Peptide Interactions

finasteride / dutasteride (5α-reductase inhibitors)

Synergistic

DHT suppression de-represses Wnt/β-catenin in susceptible follicles; SM-04554 directly activates β-catenin downstream. Pathway-converging combo, mechanistica…

minoxidil (topical)

Synergistic

Mechanistically distinct (anagen prolongation + vasodilation + minor Wnt activation by minoxidil sulfate) vs primary Wnt activation. Plausible additive on di…

CB-03-01 (clascoterone topical)

Synergistic

topical AR antagonist, mechanistically orthogonal to Wnt. Theoretically combinable in the same way minoxidil + RU58841 is combined. Never tested.

PP-405 (Pelage)

Synergistic

different next-generation "wake stem cells" thesis (mitochondrial pyruvate carrier inhibitor → glycolytic shift in follicle stem cells). Mechanistically para…

Other Wnt-pathway activators (lithium chloride, GSK-3 inhibitors, BIO, CHIR99021)

Avoid

redundant amplification of a developmental pathway with off-target proliferation risk. Theoretical only; no documented case.

Topical retinoids at high concentration on the same area

Avoid

vehicle/penetration interactions unstudied; if combined, separate by hours.

Quality Indicators

✓

Clinical-trial-grade or research-chem CoA

If sourced (research-only), look for HPLC purity ≥98%, 1H NMR consistent with C18H16O4 1,4-diketone, third-party CoA. CAS 1360540-81-3 verified.

Compounded research-chem from gray-market vendor

Topical formulations sold online (Umbrella Labs, NutraBiotech, MedChemExpress) are research-grade — vehicle composition, sterility, and concentration accuracy are not GMP-controlled. Bioactivity in a real-world topical preparation is unproven outside Samumed's vehicle.

✗

No vendor-provided HPLC / CoA

Without a third-party purity assay, you have no idea whether you're applying SM-04554, the inactive enantiomer/regioisomer, or degradation products.

✗

Cloudy, separated, or off-color topical solution

1,4-diketones are reasonably stable in alcohol vehicles but discoloration / phase separation suggests degradation or contamination.

What to Expect

Week 1
Tolerability and dose-response.
Week 2-4
Early effect window.
Week 4-8
Peak benefit assessment.
Week 8+
Cycle decision point.

Side Effects & Safety

From human trials (low burden)

Common (>10%): Mild scalp irritation / minor erythema, generally vehicle-related rather than active-drug-related
Less common (1-10%): Minor scalp burning or stinging on application; minor itching
Rare: Eye irritation if accidentally splashed (one Phase 1 case at 0.45%); no systemic AEs of any frequency reported in published trial materials
Serious AEs: None reported in Phase 1 or Phase 2 publications

Theoretical / mechanism-derived concerns (not observed clinically)

Wnt activation is pleiotropic. Wnt/β-catenin drives proliferation across many tissues — skin, gut, breast, colon. Topical exposure with minimal systemic absorption is the design rationale for keeping this localized, but chronic topical activation of a developmental proliferation pathway is not a long-term-validated safety profile. Phase 3 silence may or may not reflect a long-term safety finding (we have no public data on this).
β-catenin pathway is implicated in tumorigenesis (colon cancer, hepatocellular carcinoma, basal cell carcinoma drivers). Local scalp exposure is not the same as systemic exposure, but a multi-year topical-application profile has not been characterized.
Hair-cycle artifact: Like minoxidil, theoretical possibility of a transient telogen effluvium ("shed") at treatment start as quiescent follicles synchronize into a new anagen. Phase 2 trials at 90 days probably weren't long enough to capture and document this.