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LY3439539

Phase 1

Alzheimer Disease | Small molecule | Neurology |Eli Lilly and Company|Last Updated: May 20, 2026

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07598370A Study of LY3439539 in Participants With Alzheimer's DiseasePHASE1 NOT YET_RECRUITING 30 — — May 1, 2026May 1, 2027May 20, 20267 Australia, Singapore
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Study Endpoints
Primary Endpoints
Change from Baseline in Cerebrospinal Fluid (CSF) Neurofilament Light Chain (NfL)
Baseline through end of the Follow-up Period (Week 24)
Secondary Endpoints
Change from Baseline in Phospho-Tau (pTau)
Baseline through end of the Follow-up Period (Week 24)
Change from Baseline in Plasma NfL
Baseline through end of the Follow-up Period (Week 24)
Pharmacokinetics (PK) Maximum LY3439539 Serum Concentration (Cmax)
Baseline through end of the Follow-up Period (Week 24)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3439539EXPERIMENTALLY3439539 administered intravenously (IV)
Interventions
NameTypeDescription
LY3439539DRUGAdministered IV
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Eligibility Criteria
Age Range50 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Have gradual and progressive change in memory function reported by the participant or informant for 6 months or longer consistent with a diagnosis of dementia due to Alzheimer's disease * Have a Mini Mental Score Examination score of 16 to 24, inclusive * Meet plasma pTau crit...

Countries:AustraliaSingapore
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Competitive Landscape -Alzheimer's Disease 68 trials
CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY9PHASE3KarXT, KarX-EC, Xanomeline/Trospium Chloride, Xanomeline Enteric, BMS-986446
Eli Lilly and CompanyLLY13PHASE3Donanemab, Dexamethasone, Remternetug, Mevidalen, LY3954068
Biogen Inc.BIIB2PHASE3Lecanemab
Annovis Bio IncANVS1PHASE3buntanetap/posiphen
ACADIA Pharmaceuticals Inc.ACAD2PHASE3ACP-204
Novartis AG Sponsored ADRNVS2PHASE2VHB937, NIO752
Merck & Co., Inc.MRK2PHASE2MK-1167, MK-2214
GSK plc Sponsored ADRGSK2PHASE2GSK4527226
Cognition Therapeutics, Inc.CGTX2PHASE2CT1812
Johnson & JohnsonJNJ1PHASE2JNJ-64042056
Acumen Pharmaceuticals, Inc.ABOS1PHASE2sabirnetug
Lantheus Holdings IncLNTH2PHASE3Nilotinib BE, PI-2620
Aclaris Therapeutics, Inc.ACRS1PHASE2ATI-045
IGC Pharma, LLCIGC1PHASE2IGC-AD1-Active
Alnylam Pharmaceuticals, IncALNY2PHASE1ALN-5288, ALN-APP
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE1ARO-MAPT-
Denali Therapeutics Inc.DNLI1PHASE1DNL628
AC Immune SAACIU2PHASE1ACI-24.060 at Dose A in Study Part 1a, ACI-24.060 at Dose B in Study Part 1a, ACI-24.060 at Dose C in Study Part 1a, ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b, ACI-24.060 at Dose A in Study Part 2
Alzamend Neuro, Inc.ALZN1PHASE1ALZN002 .
Voyager Therapeutics, Inc.VYGR1PHASE1VY7523
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07598370studyFirstPostDate: changed
LOWMay 21, 2026NCT07598370NEW_TRIAL: changed
LOWMay 21, 2026NCT07598370NEW_TRIAL: changed