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LY4064809 Test Formulation

Phase 1

Healthy Participants | Small molecule | Other |Eli Lilly and Company|Last Updated: Apr 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07339735A Study of LY4064809 in Healthy Adult ParticipantsPHASE1 COMPLETED 24Jan 12, 2026Mar 19, 2026Apr 20, 20261 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4064809
Predose on Day 1 Through Day 28

PK: Cmax of LY4064809

PK: Area Under the Concentration Versus Time Curve (AUC) of LY4064809
Predose on Day 1 Through Day 28

PK: AUC of LY4064809

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY4064809 TestEXPERIMENTALLY4064809 test (Phase 3 formulation) formulation administered orally in one of two periods.
LY4064809 ReferenceEXPERIMENTALLY4064809 reference (Phase 1 formulation) formulation administered orally in one of two periods.
Interventions
NameTypeDescription
LY4064809 Test FormulationDRUGAdministered orally
LY4064809 Reference FormulationDRUGAdministered orally
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are healthy as determined by medical evaluation, including medical history, physical examination, vital signs, and electrocardiogram (ECG) at screening and admission. * Have clinical laboratory test results within the normal range * Have normal blood pressure and pulse rate or...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT07339735TRIAL_REMOVED: changed
LOWMay 24, 2026NCT07339735studyFirstPostDate: changed