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Casirivimab+Imdevimab

Phase 2

Healthy | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Oct 20, 2025

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
RandomizedCONTROLLEDBiomarker
Total Trials2
Total Enrollment340
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04852978COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult VolunteersPHASE2 COMPLETED 295 — — Apr 29, 2021Nov 21, 2022Oct 20, 20256 United States
NCT05181683COVID-19 Study Assessing the Safety and Tolerability of Co-Formulated Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) in Adult VolunteersPHASE1 COMPLETED 45 — — Jan 7, 2022Jun 3, 2022Oct 14, 20252 United States
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Study Endpoints
Primary Endpoints
50% Inhibitory Dilution (ID50) Titers of Vaccine-induced Neutralizing Antibodies to the SARS-CoV-2 S Protein in Individuals Who Received High Dose REGN10933+REGN10987 (1200 mg)
56 days after first dose of vaccine

High dose - (1200 mg arms)

50% Inhibitory Dilution (ID50) Titers of Vaccine-induced Neutralizing Antibodies to the SARS-CoV-2 S Protein in Individual Who Received Submaximal Dose Levels of REGN10933+REGN10987 (Less Than 1200 mg)
56 days after first dose of vaccine

Submaximal dose - (150 mg, 300 mg, 600 mg, 48 mg, and 12 mg)

Targeted grade ≥3 treatment-emergent adverse events (TEAEs)
Through end of study, approximately 16 weeks
Grade ≥3 injection-site reactions (ISRs)
Through end of study, approximately 16 weeks
Grade ≥2 infusion-related reactions (IRRs)
Through end of study, approximately 16 weeks
Grade ≥2 hypersensitivity reactions
Through end of study, approximately 16 weeks
Serious adverse events (SAEs)
Through end of study, approximately 16 weeks
Secondary Endpoints
Absolute Values in Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA)
Up to 365 Days from 1st dose of Vaccination
Median Fold Change of Concentrations of Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA)
Up to 365 Days from 1st dose of Vaccination
Relative Difference Expressed as a Percent in Vaccine-induced Antibodies to SARS-CoV-2 Antigens Over Time (S1-RBD IgA)
Up to 365 Days from 1st dose of Vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Wave 1 Dose 1EXPERIMENTAL -
Wave 1 Dose 2EXPERIMENTAL -
Wave 1 Dose 3EXPERIMENTAL -
Wave 1 Vaccine onlyEXPERIMENTAL -
Wave 2 Dose 1EXPERIMENTAL -
Wave 2 Dose 2EXPERIMENTAL -
Wave 2 Vaccine onlyEXPERIMENTAL -
Wave 3 Dose 1EXPERIMENTAL -
Wave 3 Dose 2EXPERIMENTAL -
Wave 3 Vaccine onlyEXPERIMENTAL -
Wave 4 Dose 1EXPERIMENTAL -
Wave 4 Vaccine onlyEXPERIMENTAL -
Co-formulated casirivimab+imdevimab SCEXPERIMENTALRandomized 1:1
Co-formulated casirivimab+imdevimab IVEXPERIMENTALRandomized 1:1
Interventions
NameTypeDescription
casirivimab+imdevimabDRUGWave 1 Intravenous (IV) administration Wave 2 Subcutaneous administration
Moderna mRNA-1273 vaccineBIOLOGICALSingle intramuscular (IM) injection
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Eligibility Criteria
Age Range18 Years — 90 Years
SexALL
Healthy VolunteersYes
Study Sites6

Key Inclusion Criteria: 1. Healthy or has chronic medical condition(s) that are stable and well-controlled in the opinion of the investigator and that are not likely to require significant medical intervention through the end of study 2. Willing and able to comply with study visits and study-relate...

Countries:United States
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