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-Free Mirikizumab

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Dec 30, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment498
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06475729A Bioequivalence Study of Citrate Free Mirikizumab (LY3074828) in Healthy ParticipantsPHASE1 COMPLETED 498 — — Jun 24, 2024Dec 27, 2024Dec 30, 20256 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab
Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.

Cmax of Mirikizumab is reported.

PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Mirikizumab
Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.

AUC \[0-∞\] of Mirikizumab is reported.

PK: Area Under the Concentration Versus Time Curve From Time 0 to the Last Measurable Concentration (AUC [0-tlast]) of Mirikizumab
Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.

AUC \[0 to tlast\] of Mirikizumab is reported.

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
200 mg Mirikizumab (Test)EXPERIMENTALParticipants received 200 mg mirikizumab test formulation, 1 × 2-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.
200 mg Mirikizumab (Reference)EXPERIMENTALParticipants received 200 milligrams (mg) mirikizumab reference formulation, 2 × 1-milliliter (mL) subcutaneous (SC) injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.
Interventions
NameTypeDescription
Citrate-Free MirikizumabDRUGAdministered SC
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: Type of participant and disease characteristics 1. Overtly healthy males and females as determined by medical evaluation including: * Medical history, * Physical examination, * Clinical laboratory tests, * Electrocardiogram (ECG), * Vital signs Note: partici...

Countries:United States
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