MycoMedica Life Sciences
MycoMedica Life Sciences PBC is a public benefit corporation developing low-dose psilocybin medicines for psychiatric and neurological disorders. Their lead candidate MLS101 is in Phase 1 clinical development, with PMDD as the lead indication and OUD and OCD as additional targets. Based in Shelton, Washington.
Development Programmes
1MLS101 (Low-Dose Psilocybin)
PsilocybinPMDD, OCD, OUD — novel low-dose paradigm targeting 5-HT1A and 5-HT2A receptors
Programme Tracker
Obsessive-Compulsive Disorder (OCD)
Three Phase 1 trials in Australia: NCT06326606 (SAD/MAD, completed ~May 2025), NCT06643637 (multiple-dose safety/PK, ongoing), NCT07050368 (brain activity/neuroimaging, ongoing). No results publicly disclosed yet. Co-founded by Paul Stamets and Pamela Kryskow. ~$60-89M raised.
Milestones
Phase I started
In progressTwo additional Phase 1 studies initiated: NCT06643637 (multiple-dose) and NCT07050368 (brain activity/neuroimaging)
Why it matters: Progressive Phase 1 programme — from single-dose safety to multiple-dose to neuroimaging — builds a comprehensive clinical pharmacology package for IND/regulatory submission. The neuroimaging study will provide mechanistic evidence for the low-dose paradigm.
Watch next: Phase 1 results disclosure and Phase 2 planning
Phase I started
CompletedActual: Jan 1, 2024
NCT06326606 Phase 1 SAD/MAD study initiated in Adelaide, Australia — safety, tolerability, PK of MLS101 in healthy volunteers
Why it matters: First-in-human study for MLS101. Conducted in Australia via TGA Clinical Trial Notification scheme for regulatory speed. SAD/MAD design establishes dose range and safety profile for the low-dose paradigm.
Watch next: Phase 1 data disclosure
Phase I completed
CompletedActual: May 1, 2025
NCT06326606 SAD/MAD study completed
Why it matters: Completion of the first Phase 1 enables dose selection for subsequent multiple-dose and neuroimaging studies. Results not yet publicly disclosed.
Funding milestone
CompletedActual: Jun 1, 2022
$60M Series A-II raised (ARTIS Ventures, True Ventures, Obvious Ventures)
Why it matters: MycoMedica is one of the best-funded private psilocybin companies, with ~$60-89M raised. Co-founded by Paul Stamets (legendary mycologist) and Pamela Kryskow (physician). The low-dose paradigm is genuinely differentiated — MLS101 targets 5-HT1A and 5-HT2A at doses designed to reduce patient burden and eliminate the need for clinical supervision.
Recorded Events
May 1, 2025: Phase I completed
Jan 1, 2024: Phase I started
Jun 1, 2022: Funding milestone
Quick Facts
- Type
- Public Benefit Corporation
- Lead Stage
- Phase I
- Website
- Visit