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REGN9533

Phase 1

Healthy Volunteer | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Feb 6, 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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06665828Phase 1 Safety and Tolerability Study of REGN9533 in Healthy AdultsPHASE1 COMPLETED 72Mar 4, 2025Jan 29, 2026Feb 6, 20261 Belgium
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Study Endpoints
Primary Endpoints
Incidence of Treatment Emergent Adverse Events (TEAEs)
Up to 100 days
Severity of TEAEs
Up to 100 days
Secondary Endpoints
Change in activated Partial Thromboplastin Time (aPTT)
Baseline up to 100 days
Change in Prothrombin Time (PT)
Baseline up to 100 days
Concentrations of REGN9533
Up to 100 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
REGN9533EXPERIMENTALRandomized as described in the protocol Escalating Cohorts including Optional Cohorts
PlaceboEXPERIMENTALRandomized as described in the protocol
Interventions
NameTypeDescription
REGN9533DRUGAdministered per the protocol
Matching PlaceboDRUGAdministered per the protocol.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: 1. Has a body mass index between 18 and 32 kg/m2, inclusive 2. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECGs) performed at screening and/or prior to administration of i...

Countries:Belgium
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