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ABBV-722

Phase 1

Healthy Volunteers | Small molecule | Other |AbbVie Inc.|Last Updated: May 20, 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
CONTROLLEDBiomarker
Total Trials3
Total Enrollment35
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07599761A Phase 1 Study to Assess the Effect of Itraconazole on ABBV-722 in Healthy Adult ParticipantsPHASE1 RECRUITING 12May 5, 2026Jul 1, 2026May 20, 20261 United States
NCT07567781A Phase 1 Study to Assess the Effect of ABBV-722 on Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin Drug Levels in Healthy Adults.PHASE1 RECRUITING 12Apr 30, 2026Jul 1, 2026May 5, 20261 United States
NCT07361367A Phase 1 Study of a Tablet Form of ABBV-722 Taken With and Without Food in Healthy Adult ParticipantsPHASE1 COMPLETED 11Jan 15, 2026Mar 23, 2026Apr 24, 20261 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax) of ABBV-722
Up to Day 8 in Period 1 and Up to Day 14 in Period 2

Cmax of ABBV-722

Time to Cmax (Tmax) of ABBV-722
Up to Day 8 in Period 1 and Up to Day 14 in Period 2

Tmax of ABBV-722

Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-722
Up to Day 8 in Period 1 and Up to Day 14 in Period 2

AUCt of ABBV-722

Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-722
Up to Day 8 in Period 1 and Up to Day 14 in Period 2

AUCinf of ABBV-722

Terminal Phase Elimination Rate Constant (β) of ABBV-722
Up to Day 8 in Period 1 and Up to Day 14 in Period 2

β of ABBV-722

Terminal Phase Elimination Half-Life (t1/2) of ABBV-722
Up to Day 8 in Period 1 and Up to Day 14 in Period 2

t1/2 of ABBV-722

Number of Participants with Adverse Events (AEs)
Up to Approximately 45 Days

An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Maximum Observed Plasma Concentration (Cmax) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Up to Day 7 in Period 1 and between Days 13-18 in Period 2
Time to Cmax (Tmax) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Up to Day 7 in Period 1 and between Days 13-18 in Period 2
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Up to Day 7 in Period 1 and between Days 13-18 in Period 2
Terminal Phase Elimination Rate Constant (β) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Up to Day 7 in Period 1 and between Days 13-18 in Period 2
Terminal Phase Elimination Half-Life (t1/2) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Up to Day 7 in Period 1 and between Days 13-18 in Period 2
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Period 1 & 2EXPERIMENTALIn Period 1, participants will receive a single dose of ABBV-722. In Period 2, participants will receive multiple daily doses of Itraconazole and a single dose of ABBV-722.
Period 1: Single Dose AEXPERIMENTALSingle dose will be administered under fasted conditions
Period 2: Single Dose AEXPERIMENTALSingle dose will be administered under fed (high-fat meal) conditions
Period 3: Single Dose BEXPERIMENTALSingle dose will be administered under fasted conditions
Interventions
NameTypeDescription
ABBV-722DRUGOral Tablet
ItraconazoleDRUGOral Capsule
MidazolamDRUGOral Solution
MetforminDRUGOral Tablet
DigoxinDRUGOral Tablet
PitavastatinDRUGOral Tablet
SitagliptinDRUGOral Tablet
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Laboratory values meet the criteria specified in the protocol. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG). Exclusion Criteria: * History of an...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT07361367TRIAL_REMOVED: changed
LOWMay 26, 2026NCT07567781primaryCompletionDate: changed
LOWMay 24, 2026NCT07599761studyFirstPostDate: changed
LOWMay 24, 2026NCT07567781studyFirstPostDate: changed
LOWMay 24, 2026NCT07361367studyFirstPostDate: changed
LOWMay 21, 2026NCT07599761NEW_TRIAL: changed
LOWMay 21, 2026NCT07567781NEW_TRIAL: changed
LOWMay 21, 2026NCT07599761NEW_TRIAL: changed
LOWMay 21, 2026NCT07567781NEW_TRIAL: changed