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Lemuteporfin

Phase 1

Acne | Small molecule | Dermatology |Eli Lilly and Company|Last Updated: Jul 20, 2021

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
Double-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment129
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01490736Phase 1/2 Sequentially Staged Safety Study in Healthy Subjects and Subjects With Mild AcnePHASE1 COMPLETED 129Dec 1, 2011Jun 1, 2013Jul 20, 20211 Canada
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Study Endpoints
Primary Endpoints
Change in sebum excretion rate
Baseline to Day 14
Secondary Endpoints
Change in biomarkers (e.g., caspase-3, CD163, neutrophil elastase)
Baseline to Day 14
Change in acne lesion count
Baseline to Day 14
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Study Design & Arms
AllocationNA
MaskingTRIPLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LTS/VehicleEXPERIMENTALWithin subject control study
Interventions
NameTypeDescription
LemuteporfinDRUGlemuteporfin topical solution, 1%
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Stage 1 only: healthy subjects * Stage 1-4: male or female subjects age 18 years or older * Stage 2: subjects with sebum excretion rate of 4 or higher on forehead * Stage 2-4: subjects with at least 2 inflammatory acne lesions on the forehead * Stage 3-4: subjects with sebum e...

Countries:Canada
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