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SPY002-091

Phase 2

Undisclosed | Small molecule | Other |Spyre Therapeutics, Inc.|Trials Updated: Aug 25, 2026

SPY002-091 development status

Highest phase Phase 2 (NCT07652294)
Phase scored for SYREPhase 1
Registered trials 3 across 1 sponsor since Nov 2024

SPY002-091 target and mechanism

ModalitySmall molecule

Also known as SPY002

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

SPY002-091 clinical trials

SPY002-091 · 1 trial · 1 indication

Phase 1 1
NCT06672718A Study of SPY002-091 in Healthy VolunteersHealthy
COMPLETED50 Analytics
PHASE1COMPLETED
A Study of SPY002-091 in Healthy Volunteers
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Treatment emergent adverse events
Up to 40 weeks

Incidence, severity, and causal relationship of TEAEs

Secondary Endpoints

Cmax
Up to 40 weeks
Tmax
Up to 40 weeks
AUC
Up to 40 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
SAD Cohorts 1-5, Experimental ArmEXPERIMENTALParticipants will receive a single dose of SPY002-091 in a dose escalation format
SAD Cohorts 1-5, Placebo ArmPLACEBO_COMPARATORParticipants will receive a single dose of placebo
SAD Cohort 6 Experimental ArmEXPERIMENTALParticipants of Chinese descent will receive a single dose of SPY002-091
SAD Cohorts 6 Placebo ArmPLACEBO_COMPARATORParticipants of Chinese descent will receive a single dose of placebo

Interventions

NameTypeDescription
SPY002-091DRUGExperimental
PlaceboOTHERPlacebo
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy men and women * Willing and able to attend the necessary visits to the CRU, comply with all testing requirements, remain at the study site unit for the duration of the confinement period and return for the outpatient visits Exclusion Criteria: * Participation in more...

Countries:United States
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Recent Changes (Last 90 Days)

MEDIUMSep 25, 2026NCT06672718TRIAL_REMOVED: changed
MEDIUMSep 25, 2026NCT06672718TRIAL_REMOVED: changed
MEDIUMSep 25, 2026NCT06672718TRIAL_REMOVED: changed
HIGHAug 25, 2026NCT06672718Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHAug 25, 2026NCT06672718Status: ACTIVE_NOT_RECRUITING → COMPLETED

Frequently asked questions about SPY002-091

What is SPY002-091?

SPY002-091 is an investigational small molecule developed by Spyre Therapeutics, Inc. (ticker SYRE). It has been studied in a Phase 1 clinical trial in healthy adult volunteers in the United States. The specific disease indications being pursued for SPY002-091 have not been publicly disclosed.

Who is developing SPY002-091?

SPY002-091 is being developed by Spyre Therapeutics, Inc., which trades on the Nasdaq under the ticker SYRE. Spyre is the sponsor of the clinical program evaluating this small molecule asset.

What phase is SPY002-091 in?

SPY002-091 is in Phase 1 clinical development. Its single reported trial, NCT06672718, was a Phase 1 study in healthy volunteers that has been completed. The drug remains investigational and is not approved by the FDA.

What clinical trials is SPY002-091 in?

SPY002-091 has been evaluated in one clinical trial, NCT06672718, titled A Study of SPY002-091 in Healthy Volunteers. The Phase 1 trial enrolled 50 participants in the United States, was randomized, double-blind, and placebo-controlled, and has been completed.

What was the design of the SPY002-091 Phase 1 trial?

The Phase 1 trial NCT06672718 studied SPY002-091 in 50 healthy adult volunteers aged 18 years and older in the United States. It was a randomized, double-blind, placebo-controlled study, and it has been completed.