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5-MeO-DMT

Phase 1

Pharmacokinetics in Healthy Adults | Small molecule | Other |AtaiBeckley Inc.|Last Updated: Oct 12, 2022

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05032833Single Ascending Dose Study With 5-MeO-DMT in Healthy SubjectsPHASE1 COMPLETED 36Sep 22, 2021Jul 7, 2022Oct 12, 20221 United Kingdom
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Study Endpoints
Primary Endpoints
Percentage of subjects with treatment emergent AEs (TEAES)
From screening through to the follow up visit, up to 65 days
Secondary Endpoints
Peak plasma concentration (Cmax)
Day 1 (dosing day) and Day 2
Time to reach Cmax (tmax)
Day 1 (dosing day) and Day 2
Area under the plasma concentration- time curve
Day 1 (dosing day) and Day 2
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
5-MeO-DMT armEXPERIMENTAL -
Placebo armPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
5-MeO-DMTDRUGA single dose of 5-MeO-DMT will be administered intranasally
PlaceboOTHERA single dose of placebo will be administered intranasally
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Eligibility Criteria
Age Range25 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: \* Medically healthy based on medical records and study specific assessments Exclusion Criteria: \* Presence or history of severe adverse reaction to any drug or drug excipient

Countries:United Kingdom
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