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varegacestat

Phase 1

Healthy Volunteer | Small molecule | Gastrointestinal |Immunome, Inc.|Last Updated: Mar 10, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials4
Total Enrollment95
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06841315A Varegacestat Hepatic Impairment StudyPHASE1 COMPLETED 35 — — Mar 7, 2025Mar 6, 2026Mar 10, 20262 United States
NCT06845852A Phase 1 Mass Balance Study of VaregacestatPHASE1 COMPLETED 6 — — Feb 25, 2025Mar 26, 2025Sep 26, 20251 United States
NCT06855264A Cardiac Liability Study of Varegacestat in Healthy ParticipantsPHASE1 COMPLETED 32 — — Feb 24, 2025May 6, 2025Sep 24, 20251 United States
NCT06677996A Phase 1 Study to Examine the Effects of Itraconazole After Single Dose Administration of Varegacestat (AL102) to Healthy ParticipantsPHASE1 COMPLETED 22 — — Nov 11, 2024May 7, 2025May 11, 20251 United States
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Study Endpoints
Primary Endpoints
PK of varegacestat and metabolite from a single oral dose of varegacestat in hepatic impaired adult participants to matched healthy adult participants.
Up to 4 weeks

AUC0-t varegacestat and metabolite

The mass balance of varegacestat following administration of a single oral dose (containing ~100 µCi) [14C]varegacestat in healthy adult male participants.
Up to 15 days
Placebo-corrected change from baseline QTc and varegacestat and its metabolite, AL102 MTB, plasma concentrations
24 hours
Effect of itraconazole on the PK of varegacestat in healthy participants.
Up to 5 weeks

AUC0-t for varegacestat administered with and without itraconazole.

Secondary Endpoints
Assess the safety and tolerability of a single oral dose of varegacestat in hepatic impaired adult participants and in matched healthy adult participants.
Up to 4 weeks
The total radioactivity in plasma, whole blood, urine, and feces following administration of a single oral dose (containing ~100 µCi) [14C]varegacestat in healthy adult male participants.
Up to 15 days
The area under the concentration equivalent-time curve (AUC), from time 0 to the last observed non-zero concentration of varegacesatat and AL102-MTB (Varegacestat metabolite) in plasma.
Up to 15 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
Treatment ArmEXPERIMENTALSingle oral dose of varegacestat administered on study day 1
Drug: varegacestatEXPERIMENTALSingle oral dose of varegacestat administered on study Day 1
VaregacestatEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
MoxifloxacinACTIVE_COMPARATOR -
Interventions
NameTypeDescription
varegacestatDRUGexperimental intervention
PlaceboDRUGSingle oral dose of placebo
Moxifloxacin 400 mgDRUGSingle oral dose of moxifloxacin
Itraconazole (200 mg)DRUGIntervention to evaluate DDI with experimental intervention
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Eligibility Criteria
Age Range18 Years — 84 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria (Healthy Participants): * Healthy, adult, male or female (of nonchildbearing potential only), 18 to 84 years of age, inclusive, at the screening visit. Participant will be matched by age (± 10 years) and sex to a participant with hepatic impairment (HI). Each healthy participant ...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMMay 21, 2026NCT06841315TRIAL_REMOVED: changed
MEDIUMMay 21, 2026NCT06841315TRIAL_REMOVED: changed