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LY4256984

Phase 1

Amyotrophic Lateral Sclerosis | Small molecule | Neurology |Eli Lilly and Company|Last Updated: May 13, 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 Trials2
Total Enrollment64
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07571174A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral SclerosisPHASE1 NOT YET_RECRUITING 32May 1, 2026Jun 1, 2029May 13, 20263 Belgium, Canada
NCT07571200A Master Protocol (OLMP): A Study of LY4256984 in Participants With Amyotrophic Lateral Sclerosis (ALS)PHASE1 NOT YET_RECRUITING 32May 1, 2026Jun 1, 2029May 6, 20263 Belgium, Canada
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Study Endpoints
Primary Endpoints
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline Up to Week 96
Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA)
Baseline Up to Week 96
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Study Design & Arms
AllocationNA
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY4256984EXPERIMENTALLY4256984 administered intrathecally (IT)
Interventions
NameTypeDescription
LY4256984DRUGAdministered IT
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites3

Participants must meet eligibility criteria in the \[L0U-MC-OLMP\] screening protocol before entry into the treatment study. Inclusion Criteria: * Have completed the main treatment period/phase as well as any off-treatment period/phase of Study OWAA, the parent study for this ISA. Exclusion Crite...

Countries:BelgiumCanada
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07571174studyFirstPostDate: changed
LOWMay 24, 2026NCT07571200studyFirstPostDate: changed
LOWMay 21, 2026NCT07571174NEW_TRIAL: changed
LOWMay 21, 2026NCT07571200NEW_TRIAL: changed
LOWMay 21, 2026NCT07571174NEW_TRIAL: changed
LOWMay 21, 2026NCT07571200NEW_TRIAL: changed