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varegacestat

Phase 1

Healthy Volunteer | Small molecule | Gastrointestinal |Immunome, Inc.|Last Updated: Mar 10, 2026

Target and mechanism

Target class-Stat (Enzyme)
ModalitySmall molecule

Also known as Varegacestat Reference Formulation

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials4
Total Enrollment95

FDA Designations

No designations recorded

Clinical trial landscape

varegacestat · 4 trials · 2 indications

Phase 1 4
NCT06841315A Varegacestat Hepatic Impairment StudyHealthy Volunteer
COMPLETED35 Analytics
NCT06845852A Phase 1 Mass Balance Study of VaregacestatHealthy Volunteer
COMPLETED6 Analytics
NCT06855264A Cardiac Liability Study of Varegacestat in Healthy ParticipantsHealthy Volunteer
COMPLETED32 Analytics
NCT06677996A Phase 1 Study to Examine the Effects of Itraconazole After Single Dose Administration of Varegacestat (AL102) to Healthy ParticipantsHealthy Volunteer
COMPLETED22 Analytics
PHASE1COMPLETED
A Varegacestat Hepatic Impairment Study
Healthy Volunteer
NCT0684131535
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PHASE1COMPLETED
A Phase 1 Mass Balance Study of Varegacestat
Healthy Volunteer
NCT068458526
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PHASE1COMPLETED
A Cardiac Liability Study of Varegacestat in Healthy Participants
Healthy Volunteer
NCT0685526432
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PHASE1COMPLETED
A Phase 1 Study to Examine the Effects of Itraconazole After Single Dose Administration of Varegacestat (AL102) to Healthy Participants
Healthy Volunteer
NCT0667799622
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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 to 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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Frequently asked questions about varegacestat

What is Varegacestat Reference Formulation used for?

Varegacestat Reference Formulation is an investigational small molecule being studied in healthy volunteers. It is being evaluated in Phase 1 clinical trials to examine its effects, including how it interacts with other drugs, how the body processes it, and its bioavailability. It is not approved for any disease and remains in clinical development.

Who makes Varegacestat Reference Formulation?

Varegacestat Reference Formulation is being developed by Immunome, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IMNM. The company is conducting Phase 1 clinical trials of this investigational small molecule in healthy participants in the United States.

What phase is Varegacestat Reference Formulation in?

Varegacestat Reference Formulation is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. Four Phase 1 trials have been conducted or initiated, with one currently recruiting participants and the others completed.

What clinical trials is Varegacestat Reference Formulation in?

Varegacestat Reference Formulation has been studied in four Phase 1 trials. These include NCT06677996, examining effects of itraconazole after single dose administration; NCT06841315, a hepatic impairment study; NCT06845852, a mass balance study; and NCT07610005, a relative bioavailability and bioequivalence study, which is currently recruiting.

What does Varegacestat Reference Formulation target?

Varegacestat Reference Formulation belongs to the -stat class of enzyme inhibitors, indicating it targets an enzyme. The specific molecular target is not disclosed in the available clinical trial information. It is being studied in healthy volunteers to assess its pharmacokinetic properties and safety.

Is Varegacestat Reference Formulation the same as AL102?

Yes, Varegacestat is also known as AL102. In clinical trial NCT06677996, the study title refers to Varegacestat (AL102), confirming these names refer to the same investigational drug. This alternative name may appear in scientific literature and other trial registrations.