Dalosirvat (SM04554)

updated

Dalosirvat (SM04554) is a topical Wnt activator that Samumed, now Biosplice, tested for androgenetic alopecia in three registered trials. The registry results for all three (49, 302 and 675 men) show no statistically significant gain over vehicle on the registered hair-count outcome, and no peer-reviewed report of any hair trial was found. The significant gains that sellers cite come from company press statements about narrower analyses, and no approval was found.

Wnt activator (topical)

  • No approval was found: openFDA Drugs@FDA returned no record for dalosirvat, DailyMed returned no label, and a ClinicalTrials.gov search for dalosirvat returned no records on 10 October 2026.
  • In the 302-man phase 2 trial (0.15% or 0.25% solution or vehicle, 90 days), all six posted comparisons against vehicle were non-significant (P between 0.1569 and 0.6869).
  • In the 675-man phase 2/3 trial in Turkey (48 weeks), baseline-adjusted rate ratios against placebo for week-48 non-vellus hair count were 1.0240 (95% CI 0.9492 to 1.1047, P = 0.540) at 0.15% and 1.0136 (95% CI 0.9346 to 1.0993, P = 0.745) at 0.25%.
  • In the 49-man biopsy study, the registered terminal follicle outcome did not differ from vehicle (P = 0.9740 and P = 0.5776).
  • The company reported in press releases that one dose arm beat vehicle in a comparison of the window from day 90 to day 135, which the registry does not reproduce.
  • A PubMed search on 10 October 2026 for dalosirvat or SM04554 returned 1 record, a 2021 patent review, and no peer-reviewed report of any SM04554 hair trial was found.

What is dalosirvat (SM04554), and has anyone approved it?

SM04554 is dalosirvat, a topical Wnt activator tested for androgenetic alopecia by Samumed, now Biosplice. No approval was found: openFDA returned no record and DailyMed no label for dalosirvat on 10 October 2026.

SM04554 is dalosirvat (INN and USAN): PubChem CID 56837361, C18H16O4, 296.3 g/mol, CAS 1360540-81-3, IUPAC name 1-(2,3-dihydro-1,4-benzodioxin-6-yl)-4-phenylbutane-1,4-dione. A 2021 patent review calls SM-04554 a Wnt activator for androgenetic alopecia, and the sponsor of the registered trials is Biosplice Therapeutics, Inc.

openFDA Drugs@FDA returned no record for dalosirvat, DailyMed returned no label, and a ClinicalTrials.gov search for dalosirvat returned no records, all on 10 October 2026. The registered trials are listed under SM04554, and the only ones are the three described below. The 2021 patent review describes SM-04554 as under phase III, which is a status statement and reports no results.

PubChem: dalosirvat identity, INN and USAN

Chemical identity record

National Library of Medicine. PubChem compound record CID 56837361 (dalosirvat).

SM04554 is dalosirvat (INN and USAN): PubChem CID 56837361, C18H16O4, 296.3 g/mol, CAS 1360540-81-3, IUPAC name 1-(2,3-dihydro-1,4-benzodioxin-6-yl)-4-phenylbutane-1,4-dione. The sponsor of the registered trials is Biosplice Therapeutics, Inc.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined small molecule
Follow-up
Not applicable
Study design
NLM chemical record
Funding
not stated in the source

Identity record only; it says nothing about efficacy or safety.

Read the original source
Drugs@FDA, DailyMed and ClinicalTrials.gov, 10 October 2026: nothing under dalosirvat

Regulatory record

U.S. Food and Drug Administration, openFDA Drugs@FDA, DailyMed, U.S. National Library of Medicine, and ClinicalTrials.gov: searches run on 10 October 2026 for dalosirvat.

openFDA Drugs@FDA returned no record for dalosirvat, DailyMed returned no label, and a ClinicalTrials.gov search for dalosirvat returned no records, all on 10 October 2026. The only registered trials are the three listed under SM04554 described on this page.

Participants / model
Not a clinical population
Treatment
Drug applications, labels and registry
Follow-up
Searches run on 10 October 2026
Study design
FDA record and registry searches
Funding
not stated in the source

The absence of a record is a US-scoped statement. Approvals outside the United States are not covered.

Read the original source
2021 patent review: SM-04554 is a Wnt activator, described as under phase III

Human study

Goswami VG et al. Expert Opin Ther Pat. 2021;31(11):1009-1043. PMID 34128760.

A 2021 patent review calls SM-04554 a Wnt activator for androgenetic alopecia and describes it as under phase III, which is a status statement and reports no results.

Participants / model
Review of androgenetic alopecia therapies
Treatment
Not drug-specific
Follow-up
Not applicable
Study design
Patent review
Funding
not stated in the source

A status description, not a trial report. It is the only PubMed record found for dalosirvat or SM04554.

Read the original source

What did the two phase 2 studies in men post?

In 302 men, all six registry comparisons against vehicle were non-significant (P between 0.1569 and 0.6869). In a 49-man biopsy study, the registered terminal follicle outcome did not differ from vehicle.

A phase 2, randomized, double-blind, vehicle-controlled trial in 302 men with androgenetic alopecia, aged 18 to 55 years (NCT02275351), gave 0.15% or 0.25% topical solution or vehicle for 90 days, with follow-up to day 135. The registry-posted change from baseline in non-vellus hair count (mean, SD) was, on 0.15%, 0.25% and vehicle: day 45 4.6 (16.97), 2.6 (14.35) and 5.7 (13.27); day 90 4.2 (17.88), 3.2 (15.66) and 6.2 (14.75); day 135 7.9 (17.95), 3.3 (15.78) and 4.2 (18.77). All six posted comparisons against vehicle were non-significant (P between 0.1569 and 0.6869). The registered primary outcome does not show a hair count gain over vehicle.

A phase 2 scalp biopsy study in 49 men aged 18 to 65 (NCT02503137; 16 on 0.15%, 14 on 0.25% and 19 on vehicle in the analysis) posted the change from baseline in terminal hair follicle number at day 91: 0.15% -1.6 (SD 3.8), 0.25% -0.3 (SD 7.2) and vehicle -1.7 (SD 4.1). Adjusted comparisons with vehicle were P = 0.9740 and P = 0.5776. Of 36 posted comparisons across the six registered primary follicle outcomes, one had P < 0.05 (indeterminate follicles, 0.25% versus vehicle, day 91, P = 0.0292). Of 30 comparisons across five secondary outcomes, 2 had P < 0.05 (both 0.15% versus vehicle, follicle density and terminal-to-miniaturized ratio), none for beta-catenin, with no adjustment for multiple testing. The registered terminal follicle outcome does not show a gain over vehicle.

Phase 2, 302 men: all six registry comparisons against vehicle non-significant

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT02275351.

Registry-posted change from baseline in non-vellus hair count (mean, SD), on 0.15%, on 0.25% and on vehicle: day 45 4.6 (16.97), 2.6 (14.35) and 5.7 (13.27); day 90 4.2 (17.88), 3.2 (15.66) and 6.2 (14.75); day 135 7.9 (17.95), 3.3 (15.78) and 4.2 (18.77). All six posted comparisons against vehicle were non-significant (P between 0.1569 and 0.6869). The registered primary outcome does not show a hair count gain over vehicle. Serious adverse events occurred in 0 of 102 and 0 of 102 on the two strengths and 1 of 98 on vehicle, and discontinuations for adverse events were 11, 13 and 12 across the three arms.

Participants / model
302 men with androgenetic alopecia, aged 18 to 55 years
Treatment
Topical SM04554 solution 0.15% or 0.25% daily, or vehicle
Follow-up
90 days, with follow-up to day 135
Study design
Phase 2 randomized double-blind vehicle-controlled trial, registry-posted results
Funding
not stated in the source

Registry-posted statistics only; no peer-reviewed report was found. Sample sizes are small for rare events, and causality was not assessed here.

Read the original source
Phase 2 scalp biopsy study, 49 men: terminal follicle number did not differ from vehicle

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT02503137.

Registry-posted primary outcome, change from baseline in terminal hair follicle number at day 91 (mean, SD): 0.15% -1.6 (3.8), 0.25% -0.3 (7.2), vehicle -1.7 (4.1); adjusted comparisons with vehicle were P = 0.9740 and P = 0.5776. Of 36 posted comparisons across the six registered primary follicle outcomes, one had P < 0.05 (indeterminate follicles, 0.25% versus vehicle, day 91, P = 0.0292). Of 30 comparisons across five secondary outcomes, 2 had P < 0.05 (both 0.15% versus vehicle, follicle density and terminal-to-miniaturized ratio), none for beta-catenin, with no adjustment for multiple testing. The registered terminal follicle outcome does not show a gain over vehicle.

Participants / model
49 men with androgenetic alopecia, aged 18 to 65 years (16 on 0.15%, 14 on 0.25% and 19 on vehicle in the analysis)
Treatment
Topical SM04554 solution 0.15% or 0.25% daily, or vehicle
Follow-up
To day 91
Study design
Phase 2 scalp biopsy study, registry-posted results
Funding
not stated in the source

Biopsy follicle counts by type, follicle density, beta-catenin and Ki-67 staining were measured. Registry statistics only; no peer-reviewed report was found.

Read the original source

What did the largest study, in 675 men, find?

In 675 men in Turkey, neither strength separated from placebo on the registered week-48 hair count: rate ratios were 1.0240 (P = 0.540) at 0.15% and 1.0136 (P = 0.745) at 0.25%.

The phase 2/3 trial in Turkey (NCT03742518) randomized 675 men aged 18 to 45 with androgenetic alopecia 2:2:1 to 0.15%, 0.25% or vehicle once daily for 48 weeks. The registry-posted primary outcome was absolute non-vellus hair count in the target area, analyzed on observed data in 80 on placebo, 159 on 0.15% and 185 on 0.25%. Baseline counts were 189.3 (SD 84.0), 200.1 (SD 85.6) and 199.9 (SD 90.7), and week-48 counts were 193.8 (SD 92.7), 208.0 (SD 88.1) and 207.2 (SD 96.3).

Baseline-adjusted rate ratios against placebo were 1.0240 (95% CI 0.9492 to 1.1047, P = 0.540) for 0.15% and 1.0136 (95% CI 0.9346 to 1.0993, P = 0.745) for 0.25%. Participant flow shows 86 of 134 on placebo, 174 of 272 and 199 of 269 completed. None of the posted secondary hair count comparisons (non-vellus, vellus, total count and change from baseline at weeks 12 to 48) had P < 0.05. This is the largest trial and the closest thing to a phase 3 outcome, and it did not separate from placebo.

Phase 2/3, 675 men in Turkey: no separation from placebo at week 48

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT03742518.

Registry-posted primary outcome, absolute non-vellus hair count in the target area (mean, SD), analyzed on observed data in 80 on placebo, 159 on 0.15% and 185 on 0.25%: baseline 189.3 (84.0), 200.1 (85.6) and 199.9 (90.7); week 48 193.8 (92.7), 208.0 (88.1) and 207.2 (96.3). Baseline-adjusted rate ratios against placebo were 1.0240 (95% CI 0.9492 to 1.1047, P = 0.540) for 0.15% and 1.0136 (95% CI 0.9346 to 1.0993, P = 0.745) for 0.25%. Participant flow shows 86 of 134 on placebo, 174 of 272 and 199 of 269 completed. None of the posted secondary hair count comparisons (non-vellus, vellus, total count and change from baseline at weeks 12 to 48) had P < 0.05. Serious adverse events occurred in 2 of 134 on placebo, 1 of 272 on 0.15% and 3 of 269 on 0.25%; the adverse event table lists 0, 0 and 2 deaths, and the participant flow lists one discontinuation for death on 0.25%. Serious events in the 0.25% arm included acute myeloid leukaemia, COVID-19 and COVID-19 pneumonia; causality is not stated in the posted fields reviewed.

Participants / model
675 men with androgenetic alopecia aged 18 to 45, in Turkey
Treatment
Topical SM04554 solution 0.15% or 0.25% once daily, or vehicle, randomized 2:2:1
Follow-up
48 weeks
Study design
Phase 2/3 randomized double-blind placebo-controlled trial, registry-posted results
Funding
not stated in the source

This is the largest trial and the closest thing to a phase 3 outcome, and it did not separate from placebo. Sample sizes are small for rare events, and causality was not assessed here.

Read the original source

What did the company say about the first phase 2 trial?

The company reported significant gains for one dose arm using a narrower analysis, a comparison of the window from day 90 to day 135, that the registry does not reproduce. No peer-reviewed paper was found.

The company reported in a 4 December 2015 press release (preliminary analysis) that one dose arm beat vehicle on non-vellus hair count and hair density using the pre-specified statistical model. In a 7 March 2016 release on an American Academy of Dermatology late-breaking presentation, the company reported that under the a priori analysis plan, between day 90 and day 135 the 0.15% arm had a significantly higher increase in hair count and hair density than vehicle.

That is a comparison of the window from day 90 to day 135, not the change from baseline at day 45, 90 and 135 posted on the registry, where no comparison reached significance. The 2015 release describes 300 subjects and the 2016 release 302. These are company statements, not peer-reviewed results.

Company statements, 2015 and 2016: significance in a narrower analysis than the registered outcome

Regulatory record

Samumed. Press releases of 4 December 2015 (preliminary analysis) and 7 March 2016 (American Academy of Dermatology late-breaking presentation) on the phase 2 androgenetic alopecia trial. PR Newswire copy of the 2016 release.

The company reported in a 4 December 2015 press release (preliminary analysis) that one dose arm beat vehicle on non-vellus hair count and hair density using the pre-specified statistical model. In a 7 March 2016 release on an American Academy of Dermatology late-breaking presentation, the company reported that under the a priori analysis plan, between day 90 and day 135 the 0.15% arm had a significantly higher increase in hair count and hair density than vehicle. That is a comparison of the window from day 90 to day 135, not the change from baseline at day 45, 90 and 135 posted on the registry, where no comparison reached significance. The 2015 release describes 300 subjects and the 2016 release 302. No peer-reviewed paper was found.

Participants / model
302 men with androgenetic alopecia
Treatment
Topical SM04554 0.15% or 0.25% daily, 90 days
Follow-up
90 days, with follow-up to day 135
Study design
Company press releases (sponsor's own account), not peer reviewed
Funding
not stated in the source

These are the company's own statements. The registry results for the same trial show no significant comparison on the registered primary outcome.

Read the original source
Phase 2, 302 men: all six registry comparisons against vehicle non-significant

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT02275351.

Registry-posted change from baseline in non-vellus hair count (mean, SD), on 0.15%, on 0.25% and on vehicle: day 45 4.6 (16.97), 2.6 (14.35) and 5.7 (13.27); day 90 4.2 (17.88), 3.2 (15.66) and 6.2 (14.75); day 135 7.9 (17.95), 3.3 (15.78) and 4.2 (18.77). All six posted comparisons against vehicle were non-significant (P between 0.1569 and 0.6869). The registered primary outcome does not show a hair count gain over vehicle. Serious adverse events occurred in 0 of 102 and 0 of 102 on the two strengths and 1 of 98 on vehicle, and discontinuations for adverse events were 11, 13 and 12 across the three arms.

Participants / model
302 men with androgenetic alopecia, aged 18 to 55 years
Treatment
Topical SM04554 solution 0.15% or 0.25% daily, or vehicle
Follow-up
90 days, with follow-up to day 135
Study design
Phase 2 randomized double-blind vehicle-controlled trial, registry-posted results
Funding
not stated in the source

Registry-posted statistics only; no peer-reviewed report was found. Sample sizes are small for rare events, and causality was not assessed here.

Read the original source

Did SM04554 show significant terminal hair count gains over placebo?

Not in the posted registry results. Three registered trials (49, 302 and 675 men) have results, and none shows a statistically significant gain over placebo or vehicle on its registered primary hair-count outcome. The significant gains appear only in company statements about narrower analyses.

The supplier claim is that Samumed, now Biosplice, ran multiple phase 2 trials of a topical SM04554 with significant terminal hair count gains over placebo, and that there may be a phase 3 outcome. Multiple phase 2 trials is accurate in number: two phase 2 studies plus a phase 2/3. Significant gains are not shown in the posted registry results.

The significant gains appear in company press statements about prespecified analyses of a window from day 90 to day 135 and of a subset of dose arms, and the registry does not reproduce them. The one phase 3-like outcome, the 675-man phase 2/3 at the same two strengths used in phase 2, did not separate from placebo. A PubMed search on 10 October 2026 for dalosirvat or SM04554 returned 1 record, the patent review, and a Samumed or Biosplice alopecia search returned only unrelated records. No peer-reviewed report of any SM04554 hair trial was found, and ClinicalTrials.gov returned only these 3 SM04554 studies.

Phase 2, 302 men: all six registry comparisons against vehicle non-significant

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT02275351.

Registry-posted change from baseline in non-vellus hair count (mean, SD), on 0.15%, on 0.25% and on vehicle: day 45 4.6 (16.97), 2.6 (14.35) and 5.7 (13.27); day 90 4.2 (17.88), 3.2 (15.66) and 6.2 (14.75); day 135 7.9 (17.95), 3.3 (15.78) and 4.2 (18.77). All six posted comparisons against vehicle were non-significant (P between 0.1569 and 0.6869). The registered primary outcome does not show a hair count gain over vehicle. Serious adverse events occurred in 0 of 102 and 0 of 102 on the two strengths and 1 of 98 on vehicle, and discontinuations for adverse events were 11, 13 and 12 across the three arms.

Participants / model
302 men with androgenetic alopecia, aged 18 to 55 years
Treatment
Topical SM04554 solution 0.15% or 0.25% daily, or vehicle
Follow-up
90 days, with follow-up to day 135
Study design
Phase 2 randomized double-blind vehicle-controlled trial, registry-posted results
Funding
not stated in the source

Registry-posted statistics only; no peer-reviewed report was found. Sample sizes are small for rare events, and causality was not assessed here.

Read the original source
Phase 2 scalp biopsy study, 49 men: terminal follicle number did not differ from vehicle

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT02503137.

Registry-posted primary outcome, change from baseline in terminal hair follicle number at day 91 (mean, SD): 0.15% -1.6 (3.8), 0.25% -0.3 (7.2), vehicle -1.7 (4.1); adjusted comparisons with vehicle were P = 0.9740 and P = 0.5776. Of 36 posted comparisons across the six registered primary follicle outcomes, one had P < 0.05 (indeterminate follicles, 0.25% versus vehicle, day 91, P = 0.0292). Of 30 comparisons across five secondary outcomes, 2 had P < 0.05 (both 0.15% versus vehicle, follicle density and terminal-to-miniaturized ratio), none for beta-catenin, with no adjustment for multiple testing. The registered terminal follicle outcome does not show a gain over vehicle.

Participants / model
49 men with androgenetic alopecia, aged 18 to 65 years (16 on 0.15%, 14 on 0.25% and 19 on vehicle in the analysis)
Treatment
Topical SM04554 solution 0.15% or 0.25% daily, or vehicle
Follow-up
To day 91
Study design
Phase 2 scalp biopsy study, registry-posted results
Funding
not stated in the source

Biopsy follicle counts by type, follicle density, beta-catenin and Ki-67 staining were measured. Registry statistics only; no peer-reviewed report was found.

Read the original source
Phase 2/3, 675 men in Turkey: no separation from placebo at week 48

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT03742518.

Registry-posted primary outcome, absolute non-vellus hair count in the target area (mean, SD), analyzed on observed data in 80 on placebo, 159 on 0.15% and 185 on 0.25%: baseline 189.3 (84.0), 200.1 (85.6) and 199.9 (90.7); week 48 193.8 (92.7), 208.0 (88.1) and 207.2 (96.3). Baseline-adjusted rate ratios against placebo were 1.0240 (95% CI 0.9492 to 1.1047, P = 0.540) for 0.15% and 1.0136 (95% CI 0.9346 to 1.0993, P = 0.745) for 0.25%. Participant flow shows 86 of 134 on placebo, 174 of 272 and 199 of 269 completed. None of the posted secondary hair count comparisons (non-vellus, vellus, total count and change from baseline at weeks 12 to 48) had P < 0.05. Serious adverse events occurred in 2 of 134 on placebo, 1 of 272 on 0.15% and 3 of 269 on 0.25%; the adverse event table lists 0, 0 and 2 deaths, and the participant flow lists one discontinuation for death on 0.25%. Serious events in the 0.25% arm included acute myeloid leukaemia, COVID-19 and COVID-19 pneumonia; causality is not stated in the posted fields reviewed.

Participants / model
675 men with androgenetic alopecia aged 18 to 45, in Turkey
Treatment
Topical SM04554 solution 0.15% or 0.25% once daily, or vehicle, randomized 2:2:1
Follow-up
48 weeks
Study design
Phase 2/3 randomized double-blind placebo-controlled trial, registry-posted results
Funding
not stated in the source

This is the largest trial and the closest thing to a phase 3 outcome, and it did not separate from placebo. Sample sizes are small for rare events, and causality was not assessed here.

Read the original source
Company statements, 2015 and 2016: significance in a narrower analysis than the registered outcome

Regulatory record

Samumed. Press releases of 4 December 2015 (preliminary analysis) and 7 March 2016 (American Academy of Dermatology late-breaking presentation) on the phase 2 androgenetic alopecia trial. PR Newswire copy of the 2016 release.

The company reported in a 4 December 2015 press release (preliminary analysis) that one dose arm beat vehicle on non-vellus hair count and hair density using the pre-specified statistical model. In a 7 March 2016 release on an American Academy of Dermatology late-breaking presentation, the company reported that under the a priori analysis plan, between day 90 and day 135 the 0.15% arm had a significantly higher increase in hair count and hair density than vehicle. That is a comparison of the window from day 90 to day 135, not the change from baseline at day 45, 90 and 135 posted on the registry, where no comparison reached significance. The 2015 release describes 300 subjects and the 2016 release 302. No peer-reviewed paper was found.

Participants / model
302 men with androgenetic alopecia
Treatment
Topical SM04554 0.15% or 0.25% daily, 90 days
Follow-up
90 days, with follow-up to day 135
Study design
Company press releases (sponsor's own account), not peer reviewed
Funding
not stated in the source

These are the company's own statements. The registry results for the same trial show no significant comparison on the registered primary outcome.

Read the original source
PubMed, 10 October 2026: 1 record; no peer-reviewed report of any SM04554 hair trial

PubMed search record

PubMed search run on 10 October 2026: dalosirvat[tiab] OR "SM04554"[tiab] OR "SM-04554"[tiab] OR "SM 04554"[tiab] (1 record). A Samumed or Biosplice alopecia search was also run. ClinicalTrials.gov returned 3 SM04554 studies.

The PubMed search returned 1 record, the patent review, and a Samumed or Biosplice alopecia search returned only unrelated records. No peer-reviewed report of any SM04554 hair trial was found. ClinicalTrials.gov returned only 3 SM04554 studies (49, 302 and 675 men), all with posted results, and none shows a statistically significant gain over placebo or vehicle on its registered primary hair-count outcome. The significant gains appear in company press statements about prespecified analyses of a window from day 90 to day 135 and of a subset of dose arms, and the registry does not reproduce them.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Literature and registry search
Funding
not stated in the source

A search result shows what PubMed and the registry returned on that date. It is not proof that no unindexed study exists.

Read the original source

How does SM04554 work, and what is known about its exposure?

A 2021 patent review calls SM-04554 a Wnt activator. The registered biopsy study did not confirm the mechanism, and no pharmacokinetic data appear in the sources reviewed.

A 2021 patent review calls SM-04554 a Wnt activator for androgenetic alopecia. The registered biopsy study measured follicle counts by type, follicle density, beta-catenin and Ki-67 staining, and it did not confirm that mechanism: none of its posted beta-catenin comparisons had P < 0.05, and the registered terminal follicle outcome did not differ from vehicle.

No half-life, Tmax or systemic exposure values appear in the sources reviewed. Only the 0.15% and 0.25% strengths were studied.

2021 patent review: SM-04554 is a Wnt activator, described as under phase III

Human study

Goswami VG et al. Expert Opin Ther Pat. 2021;31(11):1009-1043. PMID 34128760.

A 2021 patent review calls SM-04554 a Wnt activator for androgenetic alopecia and describes it as under phase III, which is a status statement and reports no results.

Participants / model
Review of androgenetic alopecia therapies
Treatment
Not drug-specific
Follow-up
Not applicable
Study design
Patent review
Funding
not stated in the source

A status description, not a trial report. It is the only PubMed record found for dalosirvat or SM04554.

Read the original source
Phase 2 scalp biopsy study, 49 men: terminal follicle number did not differ from vehicle

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT02503137.

Registry-posted primary outcome, change from baseline in terminal hair follicle number at day 91 (mean, SD): 0.15% -1.6 (3.8), 0.25% -0.3 (7.2), vehicle -1.7 (4.1); adjusted comparisons with vehicle were P = 0.9740 and P = 0.5776. Of 36 posted comparisons across the six registered primary follicle outcomes, one had P < 0.05 (indeterminate follicles, 0.25% versus vehicle, day 91, P = 0.0292). Of 30 comparisons across five secondary outcomes, 2 had P < 0.05 (both 0.15% versus vehicle, follicle density and terminal-to-miniaturized ratio), none for beta-catenin, with no adjustment for multiple testing. The registered terminal follicle outcome does not show a gain over vehicle.

Participants / model
49 men with androgenetic alopecia, aged 18 to 65 years (16 on 0.15%, 14 on 0.25% and 19 on vehicle in the analysis)
Treatment
Topical SM04554 solution 0.15% or 0.25% daily, or vehicle
Follow-up
To day 91
Study design
Phase 2 scalp biopsy study, registry-posted results
Funding
not stated in the source

Biopsy follicle counts by type, follicle density, beta-catenin and Ki-67 staining were measured. Registry statistics only; no peer-reviewed report was found.

Read the original source

What risks and side effects were posted?

In the 675-man trial, serious adverse events occurred in 2 of 134 on placebo, 1 of 272 on 0.15% and 3 of 269 on 0.25%, with 2 deaths listed in the adverse event table and acute myeloid leukaemia among the 0.25% events. Causality is not stated in the posted fields reviewed.

In the phase 2/3 trial in Turkey (675 men), serious adverse events occurred in 2 of 134 on placebo, 1 of 272 on 0.15% and 3 of 269 on 0.25%. The adverse event table lists 0, 0 and 2 deaths across the three arms, and the participant flow lists one discontinuation for death on 0.25%. Serious events in the 0.25% arm included acute myeloid leukaemia, COVID-19 and COVID-19 pneumonia. Causality is not stated in the posted fields reviewed.

In the 302-man phase 2 trial, serious adverse events occurred in 0 of 102 and 0 of 102 on the two strengths and 1 of 98 on vehicle, and discontinuations for adverse events were 11, 13 and 12 across the three arms. Sample sizes are small for rare events, causality of the deaths and the leukaemia event was not determined, and no peer-reviewed safety report was found.

Phase 2/3, 675 men in Turkey: no separation from placebo at week 48

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT03742518.

Registry-posted primary outcome, absolute non-vellus hair count in the target area (mean, SD), analyzed on observed data in 80 on placebo, 159 on 0.15% and 185 on 0.25%: baseline 189.3 (84.0), 200.1 (85.6) and 199.9 (90.7); week 48 193.8 (92.7), 208.0 (88.1) and 207.2 (96.3). Baseline-adjusted rate ratios against placebo were 1.0240 (95% CI 0.9492 to 1.1047, P = 0.540) for 0.15% and 1.0136 (95% CI 0.9346 to 1.0993, P = 0.745) for 0.25%. Participant flow shows 86 of 134 on placebo, 174 of 272 and 199 of 269 completed. None of the posted secondary hair count comparisons (non-vellus, vellus, total count and change from baseline at weeks 12 to 48) had P < 0.05. Serious adverse events occurred in 2 of 134 on placebo, 1 of 272 on 0.15% and 3 of 269 on 0.25%; the adverse event table lists 0, 0 and 2 deaths, and the participant flow lists one discontinuation for death on 0.25%. Serious events in the 0.25% arm included acute myeloid leukaemia, COVID-19 and COVID-19 pneumonia; causality is not stated in the posted fields reviewed.

Participants / model
675 men with androgenetic alopecia aged 18 to 45, in Turkey
Treatment
Topical SM04554 solution 0.15% or 0.25% once daily, or vehicle, randomized 2:2:1
Follow-up
48 weeks
Study design
Phase 2/3 randomized double-blind placebo-controlled trial, registry-posted results
Funding
not stated in the source

This is the largest trial and the closest thing to a phase 3 outcome, and it did not separate from placebo. Sample sizes are small for rare events, and causality was not assessed here.

Read the original source
Phase 2, 302 men: all six registry comparisons against vehicle non-significant

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT02275351.

Registry-posted change from baseline in non-vellus hair count (mean, SD), on 0.15%, on 0.25% and on vehicle: day 45 4.6 (16.97), 2.6 (14.35) and 5.7 (13.27); day 90 4.2 (17.88), 3.2 (15.66) and 6.2 (14.75); day 135 7.9 (17.95), 3.3 (15.78) and 4.2 (18.77). All six posted comparisons against vehicle were non-significant (P between 0.1569 and 0.6869). The registered primary outcome does not show a hair count gain over vehicle. Serious adverse events occurred in 0 of 102 and 0 of 102 on the two strengths and 1 of 98 on vehicle, and discontinuations for adverse events were 11, 13 and 12 across the three arms.

Participants / model
302 men with androgenetic alopecia, aged 18 to 55 years
Treatment
Topical SM04554 solution 0.15% or 0.25% daily, or vehicle
Follow-up
90 days, with follow-up to day 135
Study design
Phase 2 randomized double-blind vehicle-controlled trial, registry-posted results
Funding
not stated in the source

Registry-posted statistics only; no peer-reviewed report was found. Sample sizes are small for rare events, and causality was not assessed here.

Read the original source

Why does SM04554 sit in D tier?

D fits a trial program that did not separate from vehicle. All three registered trials missed on the hair-count primary outcome, no peer-reviewed publication was found, and no approval exists.

The registry results for all three registered trials, including a 675-man phase 2/3 at the same two strengths used in phase 2, show no statistically significant separation from vehicle on the hair-count primary outcome. No peer-reviewed publication was found for any of them, and no regulatory filing or approval exists.

The mechanism was not confirmed in the registered biopsy study. The supplier's significant gains come from company press statements about narrower analyses, and the registry does not reproduce them.

Phase 2, 302 men: all six registry comparisons against vehicle non-significant

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT02275351.

Registry-posted change from baseline in non-vellus hair count (mean, SD), on 0.15%, on 0.25% and on vehicle: day 45 4.6 (16.97), 2.6 (14.35) and 5.7 (13.27); day 90 4.2 (17.88), 3.2 (15.66) and 6.2 (14.75); day 135 7.9 (17.95), 3.3 (15.78) and 4.2 (18.77). All six posted comparisons against vehicle were non-significant (P between 0.1569 and 0.6869). The registered primary outcome does not show a hair count gain over vehicle. Serious adverse events occurred in 0 of 102 and 0 of 102 on the two strengths and 1 of 98 on vehicle, and discontinuations for adverse events were 11, 13 and 12 across the three arms.

Participants / model
302 men with androgenetic alopecia, aged 18 to 55 years
Treatment
Topical SM04554 solution 0.15% or 0.25% daily, or vehicle
Follow-up
90 days, with follow-up to day 135
Study design
Phase 2 randomized double-blind vehicle-controlled trial, registry-posted results
Funding
not stated in the source

Registry-posted statistics only; no peer-reviewed report was found. Sample sizes are small for rare events, and causality was not assessed here.

Read the original source
Phase 2 scalp biopsy study, 49 men: terminal follicle number did not differ from vehicle

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT02503137.

Registry-posted primary outcome, change from baseline in terminal hair follicle number at day 91 (mean, SD): 0.15% -1.6 (3.8), 0.25% -0.3 (7.2), vehicle -1.7 (4.1); adjusted comparisons with vehicle were P = 0.9740 and P = 0.5776. Of 36 posted comparisons across the six registered primary follicle outcomes, one had P < 0.05 (indeterminate follicles, 0.25% versus vehicle, day 91, P = 0.0292). Of 30 comparisons across five secondary outcomes, 2 had P < 0.05 (both 0.15% versus vehicle, follicle density and terminal-to-miniaturized ratio), none for beta-catenin, with no adjustment for multiple testing. The registered terminal follicle outcome does not show a gain over vehicle.

Participants / model
49 men with androgenetic alopecia, aged 18 to 65 years (16 on 0.15%, 14 on 0.25% and 19 on vehicle in the analysis)
Treatment
Topical SM04554 solution 0.15% or 0.25% daily, or vehicle
Follow-up
To day 91
Study design
Phase 2 scalp biopsy study, registry-posted results
Funding
not stated in the source

Biopsy follicle counts by type, follicle density, beta-catenin and Ki-67 staining were measured. Registry statistics only; no peer-reviewed report was found.

Read the original source
Phase 2/3, 675 men in Turkey: no separation from placebo at week 48

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT03742518.

Registry-posted primary outcome, absolute non-vellus hair count in the target area (mean, SD), analyzed on observed data in 80 on placebo, 159 on 0.15% and 185 on 0.25%: baseline 189.3 (84.0), 200.1 (85.6) and 199.9 (90.7); week 48 193.8 (92.7), 208.0 (88.1) and 207.2 (96.3). Baseline-adjusted rate ratios against placebo were 1.0240 (95% CI 0.9492 to 1.1047, P = 0.540) for 0.15% and 1.0136 (95% CI 0.9346 to 1.0993, P = 0.745) for 0.25%. Participant flow shows 86 of 134 on placebo, 174 of 272 and 199 of 269 completed. None of the posted secondary hair count comparisons (non-vellus, vellus, total count and change from baseline at weeks 12 to 48) had P < 0.05. Serious adverse events occurred in 2 of 134 on placebo, 1 of 272 on 0.15% and 3 of 269 on 0.25%; the adverse event table lists 0, 0 and 2 deaths, and the participant flow lists one discontinuation for death on 0.25%. Serious events in the 0.25% arm included acute myeloid leukaemia, COVID-19 and COVID-19 pneumonia; causality is not stated in the posted fields reviewed.

Participants / model
675 men with androgenetic alopecia aged 18 to 45, in Turkey
Treatment
Topical SM04554 solution 0.15% or 0.25% once daily, or vehicle, randomized 2:2:1
Follow-up
48 weeks
Study design
Phase 2/3 randomized double-blind placebo-controlled trial, registry-posted results
Funding
not stated in the source

This is the largest trial and the closest thing to a phase 3 outcome, and it did not separate from placebo. Sample sizes are small for rare events, and causality was not assessed here.

Read the original source
PubMed, 10 October 2026: 1 record; no peer-reviewed report of any SM04554 hair trial

PubMed search record

PubMed search run on 10 October 2026: dalosirvat[tiab] OR "SM04554"[tiab] OR "SM-04554"[tiab] OR "SM 04554"[tiab] (1 record). A Samumed or Biosplice alopecia search was also run. ClinicalTrials.gov returned 3 SM04554 studies.

The PubMed search returned 1 record, the patent review, and a Samumed or Biosplice alopecia search returned only unrelated records. No peer-reviewed report of any SM04554 hair trial was found. ClinicalTrials.gov returned only 3 SM04554 studies (49, 302 and 675 men), all with posted results, and none shows a statistically significant gain over placebo or vehicle on its registered primary hair-count outcome. The significant gains appear in company press statements about prespecified analyses of a window from day 90 to day 135 and of a subset of dose arms, and the registry does not reproduce them.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Literature and registry search
Funding
not stated in the source

A search result shows what PubMed and the registry returned on that date. It is not proof that no unindexed study exists.

Read the original source
Drugs@FDA, DailyMed and ClinicalTrials.gov, 10 October 2026: nothing under dalosirvat

Regulatory record

U.S. Food and Drug Administration, openFDA Drugs@FDA, DailyMed, U.S. National Library of Medicine, and ClinicalTrials.gov: searches run on 10 October 2026 for dalosirvat.

openFDA Drugs@FDA returned no record for dalosirvat, DailyMed returned no label, and a ClinicalTrials.gov search for dalosirvat returned no records, all on 10 October 2026. The only registered trials are the three listed under SM04554 described on this page.

Participants / model
Not a clinical population
Treatment
Drug applications, labels and registry
Follow-up
Searches run on 10 October 2026
Study design
FDA record and registry searches
Funding
not stated in the source

The absence of a record is a US-scoped statement. Approvals outside the United States are not covered.

Read the original source

Studies and sources

PubChem: dalosirvat identity, INN and USAN

Chemical identity record

National Library of Medicine. PubChem compound record CID 56837361 (dalosirvat).

SM04554 is dalosirvat (INN and USAN): PubChem CID 56837361, C18H16O4, 296.3 g/mol, CAS 1360540-81-3, IUPAC name 1-(2,3-dihydro-1,4-benzodioxin-6-yl)-4-phenylbutane-1,4-dione. The sponsor of the registered trials is Biosplice Therapeutics, Inc.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined small molecule
Follow-up
Not applicable
Study design
NLM chemical record
Funding
not stated in the source

Identity record only; it says nothing about efficacy or safety.

Read the original source
Drugs@FDA, DailyMed and ClinicalTrials.gov, 10 October 2026: nothing under dalosirvat

Regulatory record

U.S. Food and Drug Administration, openFDA Drugs@FDA, DailyMed, U.S. National Library of Medicine, and ClinicalTrials.gov: searches run on 10 October 2026 for dalosirvat.

openFDA Drugs@FDA returned no record for dalosirvat, DailyMed returned no label, and a ClinicalTrials.gov search for dalosirvat returned no records, all on 10 October 2026. The only registered trials are the three listed under SM04554 described on this page.

Participants / model
Not a clinical population
Treatment
Drug applications, labels and registry
Follow-up
Searches run on 10 October 2026
Study design
FDA record and registry searches
Funding
not stated in the source

The absence of a record is a US-scoped statement. Approvals outside the United States are not covered.

Read the original source
2021 patent review: SM-04554 is a Wnt activator, described as under phase III

Human study

Goswami VG et al. Expert Opin Ther Pat. 2021;31(11):1009-1043. PMID 34128760.

A 2021 patent review calls SM-04554 a Wnt activator for androgenetic alopecia and describes it as under phase III, which is a status statement and reports no results.

Participants / model
Review of androgenetic alopecia therapies
Treatment
Not drug-specific
Follow-up
Not applicable
Study design
Patent review
Funding
not stated in the source

A status description, not a trial report. It is the only PubMed record found for dalosirvat or SM04554.

Read the original source
Phase 2, 302 men: all six registry comparisons against vehicle non-significant

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT02275351.

Registry-posted change from baseline in non-vellus hair count (mean, SD), on 0.15%, on 0.25% and on vehicle: day 45 4.6 (16.97), 2.6 (14.35) and 5.7 (13.27); day 90 4.2 (17.88), 3.2 (15.66) and 6.2 (14.75); day 135 7.9 (17.95), 3.3 (15.78) and 4.2 (18.77). All six posted comparisons against vehicle were non-significant (P between 0.1569 and 0.6869). The registered primary outcome does not show a hair count gain over vehicle. Serious adverse events occurred in 0 of 102 and 0 of 102 on the two strengths and 1 of 98 on vehicle, and discontinuations for adverse events were 11, 13 and 12 across the three arms.

Participants / model
302 men with androgenetic alopecia, aged 18 to 55 years
Treatment
Topical SM04554 solution 0.15% or 0.25% daily, or vehicle
Follow-up
90 days, with follow-up to day 135
Study design
Phase 2 randomized double-blind vehicle-controlled trial, registry-posted results
Funding
not stated in the source

Registry-posted statistics only; no peer-reviewed report was found. Sample sizes are small for rare events, and causality was not assessed here.

Read the original source
Company statements, 2015 and 2016: significance in a narrower analysis than the registered outcome

Regulatory record

Samumed. Press releases of 4 December 2015 (preliminary analysis) and 7 March 2016 (American Academy of Dermatology late-breaking presentation) on the phase 2 androgenetic alopecia trial. PR Newswire copy of the 2016 release.

The company reported in a 4 December 2015 press release (preliminary analysis) that one dose arm beat vehicle on non-vellus hair count and hair density using the pre-specified statistical model. In a 7 March 2016 release on an American Academy of Dermatology late-breaking presentation, the company reported that under the a priori analysis plan, between day 90 and day 135 the 0.15% arm had a significantly higher increase in hair count and hair density than vehicle. That is a comparison of the window from day 90 to day 135, not the change from baseline at day 45, 90 and 135 posted on the registry, where no comparison reached significance. The 2015 release describes 300 subjects and the 2016 release 302. No peer-reviewed paper was found.

Participants / model
302 men with androgenetic alopecia
Treatment
Topical SM04554 0.15% or 0.25% daily, 90 days
Follow-up
90 days, with follow-up to day 135
Study design
Company press releases (sponsor's own account), not peer reviewed
Funding
not stated in the source

These are the company's own statements. The registry results for the same trial show no significant comparison on the registered primary outcome.

Read the original source
Phase 2 scalp biopsy study, 49 men: terminal follicle number did not differ from vehicle

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT02503137.

Registry-posted primary outcome, change from baseline in terminal hair follicle number at day 91 (mean, SD): 0.15% -1.6 (3.8), 0.25% -0.3 (7.2), vehicle -1.7 (4.1); adjusted comparisons with vehicle were P = 0.9740 and P = 0.5776. Of 36 posted comparisons across the six registered primary follicle outcomes, one had P < 0.05 (indeterminate follicles, 0.25% versus vehicle, day 91, P = 0.0292). Of 30 comparisons across five secondary outcomes, 2 had P < 0.05 (both 0.15% versus vehicle, follicle density and terminal-to-miniaturized ratio), none for beta-catenin, with no adjustment for multiple testing. The registered terminal follicle outcome does not show a gain over vehicle.

Participants / model
49 men with androgenetic alopecia, aged 18 to 65 years (16 on 0.15%, 14 on 0.25% and 19 on vehicle in the analysis)
Treatment
Topical SM04554 solution 0.15% or 0.25% daily, or vehicle
Follow-up
To day 91
Study design
Phase 2 scalp biopsy study, registry-posted results
Funding
not stated in the source

Biopsy follicle counts by type, follicle density, beta-catenin and Ki-67 staining were measured. Registry statistics only; no peer-reviewed report was found.

Read the original source
Phase 2/3, 675 men in Turkey: no separation from placebo at week 48

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT03742518.

Registry-posted primary outcome, absolute non-vellus hair count in the target area (mean, SD), analyzed on observed data in 80 on placebo, 159 on 0.15% and 185 on 0.25%: baseline 189.3 (84.0), 200.1 (85.6) and 199.9 (90.7); week 48 193.8 (92.7), 208.0 (88.1) and 207.2 (96.3). Baseline-adjusted rate ratios against placebo were 1.0240 (95% CI 0.9492 to 1.1047, P = 0.540) for 0.15% and 1.0136 (95% CI 0.9346 to 1.0993, P = 0.745) for 0.25%. Participant flow shows 86 of 134 on placebo, 174 of 272 and 199 of 269 completed. None of the posted secondary hair count comparisons (non-vellus, vellus, total count and change from baseline at weeks 12 to 48) had P < 0.05. Serious adverse events occurred in 2 of 134 on placebo, 1 of 272 on 0.15% and 3 of 269 on 0.25%; the adverse event table lists 0, 0 and 2 deaths, and the participant flow lists one discontinuation for death on 0.25%. Serious events in the 0.25% arm included acute myeloid leukaemia, COVID-19 and COVID-19 pneumonia; causality is not stated in the posted fields reviewed.

Participants / model
675 men with androgenetic alopecia aged 18 to 45, in Turkey
Treatment
Topical SM04554 solution 0.15% or 0.25% once daily, or vehicle, randomized 2:2:1
Follow-up
48 weeks
Study design
Phase 2/3 randomized double-blind placebo-controlled trial, registry-posted results
Funding
not stated in the source

This is the largest trial and the closest thing to a phase 3 outcome, and it did not separate from placebo. Sample sizes are small for rare events, and causality was not assessed here.

Read the original source

Why is Dalosirvat (SM04554) in D tier?

D fits a trial program in which the registry results show no statistically significant separation from vehicle. All three registered trials, including a 675-man phase 2/3 at the same two strengths used in phase 2, missed on the hair-count primary outcome. No peer-reviewed publication was found for any of them, no regulatory filing or approval exists, and the mechanism was not confirmed in the registered biopsy study. The favorable statements come from company press releases about narrower analyses.