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Enpatoran

Phase 3

Systemic Lupus Erythematosus (SLE) | Small molecule | Immunology |Merck & Company, Inc.|Last Updated: Apr 27, 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 Enrollment202
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07332481A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic DiseasePHASE3 RECRUITING 202 — — Mar 10, 2026May 24, 2029Apr 27, 20263 United States
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Study Endpoints
Primary Endpoints
Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) 70 Response, Defined as >= 70 Percent (%) Decrease in CLASI-A Score From Baseline
At Week 24
Secondary Endpoints
Percentage of Participants With British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response
At Week 24
Number of Participants With Treatment Emergent adverse events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)
From Day 1 to Week 24
Number of Participants With Abnormal (greater than and equal to [>=] Grade 3) laboratory parameters
From Day 1 to Week 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
EnpatoranEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
EnpatoranDRUGParticipants will receive a dose of Enpatoran orally twice daily from Day 1 to Day 168.
PlaceboDRUGParticipants will receive a single oral dose of a placebo matching Enpatoran tablet twice daily from Day 1 to Day 168.
Standard of care (SoC)DRUGParticipants will receive Investigator-recommended SoC.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria * Vaccinations are up to date according to local guidelines/recommendations. Recombinant zoster vaccination is encouraged but not mandatory. * Participants with diagnosis of Discoid Lupus Erythematosus (DLE) and/or Subacute Cutaneous Lupus Erythematosus (SCLE) documented in medic...

Countries:United States
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Competitive Landscape -Systemic Lupus Erythematosus 94 trials
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07332481studyFirstPostDate: changed