Dalosirvat
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| Other names | SM-04554; SM04554 |
| Routes of administration | Topical solution[1][2] |
| Drug class | Wnt signaling pathway stimulant |
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| Formula | C18H16O4 |
| Molar mass | 296.322 g·mol−1 |
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Dalosirvat (INN, USAN; developmental code name SM-04554) is a drug acting as a Wnt signaling pathway stimulant which is under development for the treatment of alopecia (hair loss).[1][3][2][4] It is used topically as a solution.[1][2] The drug is being developed by Biosplice Therapeutics (formerly known as Samumed).[1][3] As of April 2021, it is in phase 2/3 clinical trials for this in Turkey.[1][3] There have been no further updates on the development of dalosirvat as of October 2025.[1] Two phase 2 trials have been completed and preliminary results released.[2] In one of the trials, only a 0.15% concentration and not a higher 0.25% concentration showed effectiveness.[2] A 625-patient phase 3 trial was reportedly started in 2018.[2] It was reported in a 2023 literature review that dalosirvat had completed a phase 3 trial in early 2023 and that Biosplice Therapeutics had cancelled its development based on the trial's results.[5]
See also
[edit]References
[edit]- 1 2 3 4 5 6 "Biosplice Therapeutics". AdisInsight. 19 April 2021. Retrieved 23 October 2025.
- 1 2 3 4 5 6 Ocampo-Garza J, Griggs J, Tosti A (March 2019). "New drugs under investigation for the treatment of alopecias". Expert Opinion on Investigational Drugs. 28 (3): 275–284. doi:10.1080/13543784.2019.1568989. PMID 30642204.
- 1 2 3 Keown A (18 October 2025). "Delving into the Latest Updates on SM-04554 with Synapse". Synapse. Retrieved 23 October 2025.
- ↑ Goswami VG, Patel BD (November 2021). "Recent updates on Wnt signaling modulators: a patent review (2014-2020)". Expert Opinion on Therapeutic Patents. 31 (11): 1009–1043. doi:10.1080/13543776.2021.1940138. PMID 34128760.
- ↑ Castro AR, Portinha C, Logarinho E (June 2023). "The booming business of hair loss". Trends in Biotechnology. 41 (6): 731–735. doi:10.1016/j.tibtech.2022.12.020. PMID 36669948.
Embryonic conserved signaling pathways that have been consistently associated with hair cycle regulation and trichogenicity are Wingless (Wnt), Sonic hedgehog (Shh), Hairy and enhancer of split 1 (Hes1), fibroblast growth factor 7 (FG7), and keratinocyte growth factor (KGF). The Wnt/β-catenin signaling pathway has a key role in hair morphogenesis and cycling during both the embryonic stage and adult life. Therefore, pharmacological activation of the Wnt/β-catenin signaling has been explored for a long time to promote hair regeneration. Samumed (now Biosplice) was the first company to develop a topical solution for Wnt signaling activation in the balding scalp. Biosplice managed to value $12 billion in 2018, but earlier this year, upon conclusion of a phase 3 clinical trial, Biosplice canceled dalosirvat from clinical development.