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Lemuteporfin

Phase 1

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

Lemuteporfin development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Dec 2001

Success Probability

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Market & Valuation

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Trial Design

Double-BlindUNCONTROLLED
Total Trials1
Total Enrollment129

FDA Designations

No designations recorded

Lemuteporfin clinical trials

Lemuteporfin · 1 trial · 1 indication

Phase 1 1
NCT01490736Phase 1/2 Sequentially Staged Safety Study in Healthy Subjects and Subjects With Mild AcneAcne
COMPLETED129 Analytics
PHASE1COMPLETED
Phase 1/2 Sequentially Staged Safety Study in Healthy Subjects and Subjects With Mild Acne
AcneUnlock trial analytics

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 to 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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Competitive Landscape -Acne 12 trials

Frequently asked questions about Lemuteporfin

What is Lemuteporfin used for?

Lemuteporfin is being studied for the treatment of acne. It is a small molecule dermatology asset that Eli Lilly and Company has taken into Phase 1 clinical development. It has not been approved for any use, and the only recorded clinical study in acne has been completed.

Who is developing Lemuteporfin?

Lemuteporfin is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor associated with the drug's clinical program in dermatology, where the asset has reached Phase 1 testing for acne.

What phase is Lemuteporfin in?

Lemuteporfin is in Phase 1 development. One Phase 1/2 study has been run and it is now completed, with no active trials currently listed. The program enrolled 129 participants in total, and the drug remains investigational rather than approved.

What clinical trials is Lemuteporfin in?

Lemuteporfin has been evaluated in a single registered study, NCT01490736, titled a Phase 1/2 sequentially staged safety study in healthy subjects and subjects with mild acne. That trial was completed, enrolled 129 participants, was double blind, and was conducted in Canada.

Is Lemuteporfin FDA approved?

No. Lemuteporfin is an investigational small molecule and has not been approved for acne or any other indication. Its development has reached Phase 1, and the one completed study, NCT01490736, was a safety-focused trial rather than a pivotal registration program.

How was the Lemuteporfin acne trial designed?

The completed trial, NCT01490736, was a Phase 1/2 sequentially staged safety study in healthy volunteers and participants with mild acne. It enrolled 129 people aged 18 years and older of any sex, used a double-blind design without a control arm, and was run in Canada.