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REGN22044

Phase 1

Healthy Volunteer | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Apr 13, 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 Enrollment64
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07526116A First in Human Study to Assess Safety, Tolerability and Pharmacokinetics of a Single Dose of REGN22044 in Healthy AdultsPHASE1 NOT YET_RECRUITING 64May 7, 2026May 27, 2027Apr 13, 2026 -
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Study Endpoints
Primary Endpoints
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Up to 18 weeks
Severity of TEAEs
Up to 18 weeks
Secondary Endpoints
Concentration of REGN22044 in serum
Up to 18 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Intravenous (IV) CohortsEXPERIMENTAL -
Subcutaneous (SC) CohortsEXPERIMENTAL -
Interventions
NameTypeDescription
REGN22044DRUGAdministered per the protocol
PlaceboDRUGAdministered per the protocol
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes

Key Inclusion Criteria: 1\. Is judged by the investigator to be in good health as described in the protocol Key Exclusion Criteria: 1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, a...

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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07526116primaryCompletionDate: changed
LOWMay 24, 2026NCT07526116studyFirstPostDate: changed
LOWMay 21, 2026NCT07526116NEW_TRIAL: changed
LOWMay 21, 2026NCT07526116NEW_TRIAL: changed