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ARO-MAPT-

Phase 1

Alzheimer Disease | Small molecule | Neurology |Arrowhead Pharmaceuticals, Inc.|Last Updated: May 28, 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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment112
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07221344Study of ARO-MAPT-SC in Healthy Subjects and Subjects With Early Alzheimer's DiseasePHASE1 RECRUITING 112Nov 18, 2025Jun 1, 2027May 28, 20263 Canada, New Zealand
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Study Endpoints
Primary Endpoints
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Over Time
Through End of Study (EOS), Day 270
Secondary Endpoints
PK of ARO-MAPT-SC: Maximum Observed Plasma Concentration (Cmax)
Through 48 hours postdose
PK of ARO-MAPT-SC: Time to Maximum Plasma Concentration (Tmax)
Through 48 hours postdose
PK of ARO-MAPT-SC: Area Under the Plasma Concentration (AUC) Versus Time Curve From Time Zero to 24 Hours (AUC0-24)
Through 24 hours postdose
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ARO-MAPT-SCEXPERIMENTALARO-MAPT-SC injection
PlaceboPLACEBO_COMPARATORSterile normal saline (0.9%)
Interventions
NameTypeDescription
ARO-MAPT-SCDRUG• single or multiple doses of ARO-MAPT-SC by subcutaneous (SC) injection
PlaceboDRUG• calculated volume to match active treatment by SC administration
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria (All Participants): * Body mass index between 18.0 and 35.0 kg/m\^2 at Screening * Not pregnant or breast-feeding * Able and willing to provide written informed consent prior to the performance of any study specific procedures * Participants of childbearing potential must agree t...

Countries:CanadaNew Zealand
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT07221344lastUpdatePostDate: changed
LOWMay 29, 2026NCT07221344lastUpdatePostDate: changed
LOWMay 29, 2026NCT07221344lastUpdatePostDate: changed
LOWMay 26, 2026NCT07221344primaryCompletionDate: changed
LOWMay 24, 2026NCT07221344studyFirstPostDate: changed