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ARO-MAPT

Phase 1

Alzheimer Disease | Small molecule | Neurology |Arrowhead Pharmaceuticals, Inc.|Last Updated: Sep 18, 2026

Target and mechanism

Molecular targetMAPT
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 315)

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 Sites4

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)

LOWSep 19, 2026NCT07221344lastUpdatePostDate: changed
LOWSep 19, 2026NCT07221344lastUpdatePostDate: changed
LOWSep 19, 2026NCT07221344lastUpdatePostDate: changed

Frequently asked questions about ARO-MAPT

What is ARO-MAPT used for in Alzheimer Disease?

ARO-MAPT is an investigational small molecule being developed for Alzheimer Disease. It is currently in Phase 1 clinical development, studied in healthy participants and participants with early Alzheimer's Disease. The drug is administered subcutaneously and is being evaluated in a randomized, double-blind, placebo-controlled trial.

What does ARO-MAPT target?

ARO-MAPT targets the MAPT gene, which encodes the tau protein. By targeting MAPT, the drug aims to reduce tau protein production, a key pathological feature in Alzheimer's Disease. This mechanism is being investigated in early-stage clinical trials for its potential to modify the disease course.

Who makes ARO-MAPT?

ARO-MAPT is being developed by Arrowhead Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker ARWR. The company is conducting a Phase 1 clinical trial to evaluate the safety and tolerability of ARO-MAPT in healthy volunteers and patients with early Alzheimer's Disease.

What phase is ARO-MAPT in?

ARO-MAPT is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety, tolerability, and pharmacokinetics in healthy individuals and those with early Alzheimer's Disease.

What clinical trials is ARO-MAPT in?

ARO-MAPT is being studied in a single Phase 1 clinical trial registered as NCT07221344. This trial, titled 'Study of ARO-MAPT-SC in Healthy Participants and Participants With Early Alzheimer's Disease,' is recruiting 112 participants in Canada and New Zealand. The study is randomized, double-blind, and placebo-controlled.

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

Yes, ARO-MAPT is also known as ARO-MAPT-SC. The '-SC' suffix indicates the subcutaneous route of administration used in the clinical trial. Both names refer to the same investigational drug being developed by Arrowhead Pharmaceuticals for Alzheimer's Disease.