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LY4515100

Phase 2

Acute Pain | Small molecule | Pain |Eli Lilly and Company|Last Updated: May 1, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment212
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07511816A Study of LY4515100 in Participants With Pain Following Third Molar RemovalPHASE2 RECRUITING 212Apr 1, 2026Dec 1, 2026May 1, 20261 United States
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Study Endpoints
Primary Endpoints
Change from Baseline in Self-Reported Pain Intensity
Baseline, Up to Day 1
Secondary Endpoints
Time to Reduction in Pain Intensity as Measured by an 11-Item Numerical Scale
Baseline, Up to Day 1
Change in Self-Reported Pain Relief as Measured by 5-Item Categorical Scale
Baseline, Up to Day 1
Time to Rescue Medications
Baseline, Up to Day 1
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY4515100EXPERIMENTALAdministered Orally
PlaceboPLACEBO_COMPARATORAdministered Orally
Interventions
NameTypeDescription
LY4515100DRUGAdministered Orally
PlaceboDRUGAdministered Orally
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Participant has a body mass index (BMI) between 18.5 and 35.0 kilograms per meter squared (kg/m²) inclusive. * Participant requires extraction of 2 or more third molars, including 2 mandibular molars with partial or full bony impaction, confirmed by panoramic X-ray. Exclusion...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07511816studyFirstPostDate: changed