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Varegacestat Reference Formulation

Phase 1

Healthy | Small molecule | Other |Immunome, Inc.|Last Updated: Jun 8, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07610005A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy ParticipantsPHASE1 RECRUITING 20May 21, 2026Jun 1, 2026Jun 8, 20261 United States
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Study Endpoints
Primary Endpoints
Evaluate the rBA of varegacestat by AUC0-t
Approximately 3 weeks
Evaluate the rBA of varegacestat by AUC0-inf
Approximately 3 weeks
Evaluate the rBA of varegacestat by Cmax
Approximately 3 weeks
Secondary Endpoints
Assess the safety and tolerability of varegacestat by incidence of treatment emergent adverse events
Approximately 4 weeks
Assess the safety and tolerability of varegacestat by incidence of laboratory abnormalities
Approximately 3 weeks
Assess the safety and tolerability of varegacestat by incidence of changes in vital signs from baseline
Approximately 3 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Reference Formulation, then Test FormulationEXPERIMENTAL -
Test Formulation, then Reference FormulationEXPERIMENTAL -
Interventions
NameTypeDescription
Varegacestat Reference FormulationDRUGOral administration
Varegacestat Test FormulationDRUGOral administration
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy, adult, female of non childbearing potential or male, 18 to 55 years of age, inclusive, at the screening visit * Male participants must follow protocol-specified contraception guidance * Continuous non-smoker who has not used nicotine and tobacco containing products fo...

Countries:United States
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Recent Changes (Last 90 Days)
LOWJun 8, 2026NCT07610005startDate: changed
LOWJun 8, 2026NCT07610005startDate: changed
LOWJun 8, 2026NCT07610005startDate: changed
LOWMay 28, 2026NCT07610005NEW_TRIAL: changed
LOWMay 28, 2026NCT07610005NEW_TRIAL: changed