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REGN9533

Phase 1

Healthy Volunteer | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Feb 6, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

REGN9533 · 1 trial · 1 indication

Phase 1 1
NCT06665828Phase 1 Safety and Tolerability Study of REGN9533 in Healthy AdultsHealthy Volunteer
COMPLETED72 Analytics
PHASE1COMPLETED
Phase 1 Safety and Tolerability Study of REGN9533 in Healthy Adults
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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 to 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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Frequently asked questions about REGN9533

What is REGN9533?

REGN9533 is an investigational small molecule being developed by Regeneron Pharmaceuticals, Inc. It is currently in Phase 1 clinical development. The drug has been studied in a completed trial involving healthy volunteers, with a total enrollment of 72 participants.

What is REGN9533 used for?

REGN9533 is being studied for use in healthy volunteers. The completed Phase 1 trial assessed its safety and tolerability in healthy adults. The drug is not approved for any condition and remains in early clinical development.

Who makes REGN9533?

REGN9533 is developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. The company conducted a Phase 1 trial of the drug in healthy volunteers.

What phase is REGN9533 in?

REGN9533 is in Phase 1 clinical development. A Phase 1 safety and tolerability study in healthy adults has been completed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is REGN9533 in?

REGN9533 has one completed clinical trial, identified as NCT06665828. This was a Phase 1 safety and tolerability study in healthy adults, conducted in Belgium with 72 participants. The trial was randomized, double-blind, and controlled.