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| Other names | SM-04554; SM04554 | 
| Routes of administration | Topical solution [1] [2] | 
| Drug class | Wnt signaling pathway stimulant | 
| ATC code | 
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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]
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.