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Psilocybin

Phase 2

Chronic Neuropathic Pain | Small molecule | Neurology |Unity Biotechnology, Inc.|Last Updated: Mar 30, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06731335Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAINPHASE2 RECRUITING 30Mar 5, 2025Dec 1, 2026Mar 30, 20252 Canada
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Study Endpoints
Primary Endpoints
Feasibility to recruit 30 participants into a trial of psilocybin and active placebo to prepare for a larger multicentre trial
18 months

Recruitment rate and withdrawal rate (Acceptability and feasibility study)

Secondary Endpoints
Change in pain intensity from baseline to one month after interventions
one month
Change in pain interference from baseline to one month after interventions
one month
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Intervention Arm with PsilocybinEXPERIMENTALIntervention Arm with Psilocybin 25 mg single dose PO + psychological support
PlaceboPLACEBO_COMPARATORPlacebo (Active) Dextromethorphan 400 mg single dose PO + psychological support
Interventions
NameTypeDescription
PsilocybinDRUGPSILOCYBIN (PEX010) 25 mg PO single dose
Active PlaceboDRUGDextromethorphan 400 mg PO single dose
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * 18-65 years of age * Diagnosis of chronic neuropathic pain as determined by a pain specialist * Moderate-to-severe neuropathic pain determined by Patient Reported Outcomes Measurement Information System (PROMIS) * Previous trials of at least two medications recommended in the ...

Countries:Canada
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06731335primaryCompletionDate: changed
LOWMay 24, 2026NCT06731335studyFirstPostDate: changed