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DNL628

Phase 1

Alzheimer Disease, Early Onset | Small molecule | Neurology |Denali Therapeutics Inc.|Last Updated: Feb 23, 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 Trials1
Total Enrollment68
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07328451A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's DiseasePHASE1 RECRUITING 68Jan 30, 2026Feb 1, 2027Feb 23, 20261 United Kingdom
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Study Endpoints
Primary Endpoints
Incidence and severity of treatment-emergent adverse events (TEAEs) throughout the double-blind period
37 weeks
Secondary Endpoints
PK parameter: Maximum concentration (Cmax) of DNL628 in plasma
37 weeks
PK Parameter: Time to reach maximum concentration (tmax) of DNL628 in plasma
37 weeks
PK Parameter: Minimum concentration (Cmin) of DNL628 in plasma
37 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Experimental ArmEXPERIMENTAL -
Placebo ArmPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
DNL628DRUGMultiple ascending doses
PlaceboDRUGMultiple ascending doses
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Key Inclusion Criteria: * BMI of ≥18 to \< 32 kg/m2 and body weight of ≥45 kg * Have a diagnosis of probable AD dementia based on NIA AA 2011 criteria, including amnestic or nonamnestic presentation at screening * Have supportive evidence of AD pathology via historical records or laboratory testing...

Countries:United Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07328451primaryCompletionDate: changed
LOWMay 24, 2026NCT07328451studyFirstPostDate: changed