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Mevidalen

Phase 2

Alzheimer Disease | Small molecule | Neurology |Eli Lilly and Company|Last Updated: Dec 17, 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_CONTROLLEDDMC
Total Trials1
Total Enrollment300
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06538116A Study of Mevidalen (LY3154207) in Participants With Alzheimer's DiseasePHASE2 ACTIVE NOT_RECRUITING 300Aug 26, 2024May 1, 2026Dec 17, 202564 United States, Japan
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Study Endpoints
Primary Endpoints
Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS)
Baseline, Week 24

iADRS assesses the impact of cognitive loss on everyday activities and provides a measure of global AD severity as a single summary score. It comprises of 2 underlying domains "cognitive ability" and "functional ability," and integrates the items in both the domains a single overall score ranging from 0 to 144, with lower scores indicating worse performance.

Secondary Endpoints
Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13)
Baseline, Week 24
Change from Baseline in Verbal Fluency Test
Baseline, Week 24
Change from Baseline in Category Fluency Test
Baseline, Week 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Mevidalen (high dose)EXPERIMENTALMevidalen high dose administered orally.
Mevidalen (low dose)EXPERIMENTALMevidalen low dose administered orally.
PlaceboPLACEBO_COMPARATORPlacebo administered orally.
Interventions
NameTypeDescription
MevidalenDRUGAdministered orally
PlaceboDRUGAdministered orally
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Eligibility Criteria
Age Range50 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites64

Inclusion Criteria: * Have gradual and progressive decline in memory function for greater than or equal to 6 months that is severe enough to interfere with activities of daily living. * Have MMSE score of 13 to 24. * Have eligibile plasma P-tau or historical evidence of AD pathology. * Have a relia...

Countries:United StatesJapan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06538116primaryCompletionDate: changed
LOWMay 24, 2026NCT06538116studyFirstPostDate: changed