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ARO-MAPT

Phase 1

Alzheimer Disease | Small molecule | Neurology |Arrowhead Pharmaceuticals, Inc.|Last Updated: Jun 23, 2026

Target and mechanism

ModalitySmall molecule

Also known as ARO-MAPT-SC

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment112

FDA Designations

No designations recorded

Clinical trial landscape

ARO-MAPT · 1 trial · 2 indications

Phase 1 1
NCT07221344Study of ARO-MAPT-SC in Healthy Participants and Participants With Early Alzheimer's DiseaseAlzheimer Disease
RECRUITING112 Analytics
PHASE1RECRUITING
Study of ARO-MAPT-SC in Healthy Participants and Participants With Early Alzheimer's Disease
Alzheimer DiseaseUnlock trial analytics

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 to 80 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria (All Participants): * Body mass index between 18.0 and 35.0 kilograms (kg)/square meter (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 childbea...

Countries:CanadaNew Zealand
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Recent Changes (Last 90 Days)

LOWJun 23, 2026NCT07221344lastUpdatePostDate: changed
LOWJun 23, 2026NCT07221344lastUpdatePostDate: changed
LOWMay 29, 2026NCT07221344lastUpdatePostDate: changed
LOWMay 29, 2026NCT07221344lastUpdatePostDate: changed
LOWMay 29, 2026NCT07221344lastUpdatePostDate: changed
LOWMay 26, 2026NCT07221344primaryCompletionDate: changed

Frequently asked questions about ARO-MAPT

What is ARO-MAPT used for?

ARO-MAPT is an investigational small molecule being developed for Alzheimer's disease. It is currently in Phase 1 clinical development, studied in healthy participants and participants with early Alzheimer's disease, including early-onset Alzheimer's disease.

Who makes ARO-MAPT?

ARO-MAPT is being developed by Arrowhead Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ARWR. The company is conducting a Phase 1 clinical trial of ARO-MAPT-SC, an alternative name for the drug.

What phase is ARO-MAPT in?

ARO-MAPT is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants in Canada and New Zealand.

What clinical trials is ARO-MAPT in?

ARO-MAPT is being studied in a Phase 1 clinical trial with the identifier NCT07221344. The trial is titled 'Study of ARO-MAPT-SC in Healthy Participants and Participants With Early Alzheimer's Disease' and is currently recruiting 112 participants.

Is ARO-MAPT the same as ARO-MAPT-SC?

Yes, ARO-MAPT is also known as ARO-MAPT-SC. The Phase 1 clinical trial NCT07221344 uses the name ARO-MAPT-SC to refer to the same investigational drug being developed by Arrowhead Pharmaceuticals.

Is ARO-MAPT being studied in a randomized controlled trial?

Yes, the Phase 1 trial of ARO-MAPT is randomized, double-blind, and placebo-controlled. The study enrolls 112 participants, including healthy volunteers and individuals with early Alzheimer's disease, and is actively recruiting.