Ceruvia Lifesciences
Phase II2 active candidates2 trials
shared compound: Psilocybinsame indication: Obsessive-Compulsive Disorder (OCD)similar active pipeline sizeboth have forecast coverage
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Lead program: Phase I
Categories
1 domain / 2 areas / 1 specialization
MycoMedica Life Sciences
Data updated
1 Drug Candidate3 Trials
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.
Pipeline Intelligence
Developer Momentum
- Active candidates
- 1
- Active programmes
- 1
- Lead stage
- Phase I
- Forecast coverage
- 1 of 1
All tracked candidates active
All tracked programmes active
Current furthest stage
1 active programme with forecast fields
Latest sourced update
MycoMedica Programs - Low-Dose Psilocybin Trials
Jun 27, 2026 - company-website - MycoMedica Life Sciences - MLS101 (Low-Dose Psilocybin)
Next known catalyst
Phase I publication
Q4 2026 - MLS101 (Low-Dose Psilocybin) / MLS101 Phase 1 Programme (SAD/MAD/Neuroimaging) — Australia - Confidence: 40%
5 sources0 pipeline-linked trials0 pipeline-linked papers
Development Programmes
1MLS101 (Low-Dose Psilocybin)
PsilocybinPhase I
PMDD, OCD, OUD — novel low-dose paradigm targeting 5-HT1A and 5-HT2A receptors
Programme Tracker
Obsessive-Compulsive Disorder (OCD)
Primary: Australia (TGA)
Phase IActive
Forecast
Phase I publication - Likely: Q4 2026
Three MLS101 Phase 1 studies are completed on ClinicalTrials.gov, including the fMRI/translational study NCT07050368 with actual completion on 2026-01-13 and last update posted 2026-02-13. No public Phase 1 data package or Phase 2 start was found in this pass.
Milestones
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 started
CompletedActual: Jun 19, 2024
Two 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 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
Jun 19, 2024: Phase I started
Jan 1, 2024: Phase I started
Jun 1, 2022: Funding milestone
Evidence Links
MycoMedica Programs - Low-Dose Psilocybin Trials
company-website - MycoMedica Life Sciences - Jun 27, 2026 - Verified
Company programmes page describes safety-focused low-dose psilocybin trials and the dosing paradigm for MLS101.
ClinicalTrials.gov NCT06326606 - MLS101 Dose Escalation Study
clinical-trial-registry - ClinicalTrials.gov - Oct 9, 2024 - Verified
ClinicalTrials.gov registry for completed Phase 1 MLS101 dose-escalation study; last update posted 2024-10-09.
ClinicalTrials.gov NCT06643637 - Multiple Doses of MLS101
clinical-trial-registry - ClinicalTrials.gov - Jun 12, 2025 - Verified
ClinicalTrials.gov registry for completed Phase 1 multiple-dose MLS101 study; last update posted 2025-06-12.
ClinicalTrials.gov NCT07050368 - MLS101 Brain Activity Study
clinical-trial-registry - ClinicalTrials.gov - Feb 13, 2026 - Verified
ClinicalTrials.gov registry for completed Phase 1 fMRI/translational MLS101 study; last update posted 2026-02-13.
MycoMedica secures $60M funding for fungi-based drug development
Press release - MycoMedica Life Sciences / Yahoo Finance - Jun 1, 2022 - Verified
Release reports $60M financing to fuel fungi-based drug development for psychiatric and neurological disorders.
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Quick Facts
- Type
- Public Benefit Corporation
- Lead Stage
- Phase I
- Website
- Visit