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MK-4646

Phase 1

HIV Infection | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: May 26, 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 Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07042945MK-4646 Multiple Dose Trial in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-4646-003)PHASE1 RECRUITING 28Jul 9, 2025Aug 17, 2026May 26, 20262 Moldova, Romania
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Study Endpoints
Primary Endpoints
Participants with averse events (AEs)
14 days post last dose (Up to Day 23)

Percentage of participants with one or more AEs

Participants who discontinued study medication due to an AE
Up to Day 7

Percentage of participants who discontinued study medication due to an AE

Viral load decline of plasma HIV-1 ribonucleic acid (RNA)
Predose, 1,2, 3, 4 and 5 days postdose

Time course of plasma HIV-1 RNA viral load decline.

Secondary Endpoints
Area under the curve from time 0 to 24 hours (AUC0-24) of MK-4646
Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose
Maximum plasma concentration (Cmax) of MK-4646
Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 hours postdose
Concentration at 24 hours (C24) of MK-4646
24 hours postdose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MK-4646 Panel AEXPERIMENTALMK-4646 160 mg every 24 hours (q24h) for 7 days
MK-4646 Panel BEXPERIMENTALMK-4646 ≤460 mg q24h for 7 days
MK-4646 Panel CEXPERIMENTALMK-4646 ≤460 mg q24h for 7 days
MK-4646 Panel DEXPERIMENTALMK-4646 ≤460 mg every 12 hours (q12h) for 7 days
Interventions
NameTypeDescription
MK-4646DRUGMK-4646 in capsular form administered orally
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Other than having HIV-1, is in good health * Is antiretroviral therapy (ART)-naïve * If ART-experienced has not received any antiretroviral therapy within 60 days (or 5 half-lives, whichever is longer) prior to screening * Is willing to receive no other ART prior to Day 8 post...

Countries:MoldovaRomania
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Recent Changes (Last 90 Days)
LOWMay 27, 2026NCT07042945Completion: 2026-07-17 → 2026-08-17
LOWMay 27, 2026NCT07042945Completion: 2026-07-17 → 2026-08-17
LOWMay 26, 2026NCT07042945primaryCompletionDate: changed
LOWMay 24, 2026NCT07042945studyFirstPostDate: changed