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REGN20423

Phase 1

Healthy Volunteer | Small molecule | Immunology |Regeneron Pharmaceuticals, Inc.|Last Updated: Apr 14, 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-BlindCONTROLLED
Total Trials1
Total Enrollment136
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07527923First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic DermatitisPHASE1 NOT YET_RECRUITING 136May 4, 2026Jun 9, 2028Apr 14, 2026 -
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Study Endpoints
Primary Endpoints
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Up to 52 weeks
Severity of TEAEs
Up to 52 weeks
Secondary Endpoints
Concentrations of REGN20423 in serum
Up to 52 weeks
Absolute values from baseline of total Interleukin 13 (IL-13)
Up to 52 weeks
Absolute values from baseline of total Immunoglobulin E (IgE)
Up to 52 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part AEXPERIMENTAL -
Part BEXPERIMENTAL -
Interventions
NameTypeDescription
REGN20423DRUGAdministered per the protocol
PlaceboOTHERAdministered per the protocol
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes

Part A: Enrolls healthy participants Part B: Enrolls participants with atopic dermatitis Key Inclusion Criteria: Part A: 1. Is judged by the investigator to be in good health based on medical history, physical examination, vital signs, Electrocardiograms (ECGs), and laboratory safety testing at s...

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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07527923primaryCompletionDate: changed
LOWMay 24, 2026NCT07527923studyFirstPostDate: changed
LOWMay 21, 2026NCT07527923NEW_TRIAL: changed
LOWMay 21, 2026NCT07527923NEW_TRIAL: changed