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REGN22044

Phase 1

Healthy Volunteer | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Aug 25, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment88

FDA Designations

No designations recorded

Clinical trial landscape

REGN22044 · 1 trial · 1 indication

Phase 1 1
NCT07526116A First in Human Study to Assess Safety, Tolerability and Pharmacokinetics of a Single Dose of REGN22044 in Healthy AdultsHealthy Volunteer
RECRUITING88 Analytics
PHASE1RECRUITING
A First in Human Study to Assess Safety, Tolerability and Pharmacokinetics of a Single Dose of REGN22044 in Healthy Adults
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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 to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:Belgium
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Recent Changes (Last 90 Days)

LOWAug 25, 2026NCT07526116Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 25, 2026NCT07526116Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about REGN22044

What is REGN22044?

REGN22044 is an investigational small molecule being developed by Regeneron Pharmaceuticals, Inc. (REGN). It is currently in Phase 1 clinical development for healthy volunteers. The drug is being studied in a first-in-human trial to assess its safety, tolerability, and pharmacokinetics.

What is REGN22044 used for?

REGN22044 is being studied in healthy volunteers as part of a Phase 1 clinical trial. The primary purpose is to evaluate the safety, tolerability, and pharmacokinetics of a single dose. It is not yet approved for any medical condition and remains in early-stage clinical development.

Who makes REGN22044?

REGN22044 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker REGN. The company is conducting a first-in-human study of this investigational small molecule in healthy adults.

What phase is REGN22044 in?

REGN22044 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. It is currently being evaluated in a first-in-human study to assess its safety, tolerability, and pharmacokinetics in healthy adult volunteers.

What clinical trials is REGN22044 in?

REGN22044 is being studied in a Phase 1 clinical trial with the identifier NCT07526116. This first-in-human study is assessing the safety, tolerability, and pharmacokinetics of a single dose of REGN22044 in healthy adults. The trial is recruiting participants in Belgium and aims to enroll 88 individuals.

Is REGN22044 FDA approved?

REGN22044 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The ongoing trial is designed to evaluate its safety, tolerability, and pharmacokinetics in healthy volunteers, and regulatory approval has not been granted.