Dalosirvat (INNTooltip International Nonproprietary Name, USANTooltip United States Adopted Name; 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). It is used topically as a solution. The drug is being developed by Biosplice Therapeutics (formerly known as Samumed). As of April 2021, it is in phase 2/3 clinical trials for this in Turkey. There have been no further updates on the development of dalosirvat as of October 2025. Two phase 2 trials have been completed and preliminary results released. In one of the trials, only a 0.15% concentration and not a higher 0.25% concentration showed effectiveness. A 625-patient phase 3 trial was reportedly started in 2018. 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.
See also List of investigational hair loss drugs
References
External links A small-molecule Wnt pathway modulator (SM04554) as a potential topical treatment for androgenetic alopecia - Samumed