Recent Updates
Recently added Catalysts

VY7523

Phase 1

Alzheimer's Disease (AD) | Small molecule | Neurology |Voyager Therapeutics, Inc.|Last Updated: Nov 19, 2025

Target and mechanism

Molecular targettau
Target classProtein
ModalitySmall molecule

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

VY7523 · 1 trial · 1 indication

Phase 1 1
NCT06874621VY7523-102: Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study in Participants With Early Alzheimer's DiseaseAlzheimer's Disease (AD)
ACTIVE NOT_RECRUITING52 Analytics
PHASE1ACTIVE NOT_RECRUITING
VY7523-102: Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study in Participants With Early Alzheimer's Disease
Alzheimer's Disease (AD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Characterization of the safety and tolerability of VY7523 in participants with early AD
Cohorts 1 and 2: up to 6 months Cohort 3: up to 12 months

Incidence of treatment-emergent adverse events (TEAEs) and clinically significant changes from baseline

Secondary Endpoints

To characterize the pharmacokinetics (PK) of VY7523 in serum
Cohort 1 & 2: Month 1 - 6 Cohort 3: Month 1-7, 9, 12
To evaluate the ability of VY7523 to prevent the spread of pathologic tau; Cohort 3 only
Month 6, 12
To evaluate the immunogenicity of multiple, escalating intravenous (IV) doses of VY7523
Cohort 1 & 2: Month 1, 3, 4, 5 & 6 Cohort 3: Month 1, 2, 6, 9, 12
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1 activeEXPERIMENTALLow dose VY7523
Cohort 1 placeboPLACEBO_COMPARATORVY7523 matching placebo for Cohort 1 active dose
Cohort 2 activeEXPERIMENTALmid dose VY7523
Cohort 2 placeboPLACEBO_COMPARATORVY7523 matching placebo for Cohort 2 active dose
Cohort 3 activeEXPERIMENTALhigh dose VY7523
Cohort 3 placeboPLACEBO_COMPARATORVY7523 matching placebo for Cohort 3 active dose

Interventions

NameTypeDescription
VY7523DRUGVY7523 is a recombinant humanized immunoglobulin gamma 4 (IgG4) monoclonal antibody targeting human pathological tau
Placebo ComparatorDRUGMatching placebo to VY7523
Unlock Study Design Details

Eligibility Criteria

Age Range50 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: 1. Clinical diagnosis of early AD, defined as: 1. Meet the NIA-AA core clinical criteria for MCI due to AD or mild AD. 2. Mini Mental State Examination (MMSE) score between 18 and 30, inclusive, at Screening (Cohort 1 and 2) and score between 22 and 30, inclusive, at Scre...

Countries:United StatesCanada
Unlock Eligibility Criteria

Frequently asked questions about VY7523

What is VY7523 used for in Alzheimer's Disease?

VY7523 is an investigational small molecule being developed for the treatment of early Alzheimer's Disease (AD). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in a randomized, placebo-controlled, double-blind trial in participants with early Alzheimer's Disease.

What does VY7523 target?

VY7523 targets tau, a protein that forms neurofibrillary tangles in the brains of people with Alzheimer's Disease. By targeting tau, VY7523 is designed to address a key pathological feature of the disease. The drug is a small molecule, which typically allows for oral administration and potential penetration of the blood-brain barrier.

Who makes VY7523?

VY7523 is being developed by Voyager Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol VYGR. Voyager Therapeutics is focused on developing therapies for neurological diseases, and VY7523 is one of its investigational candidates in clinical development.

What phase is VY7523 in?

VY7523 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is studying the safety, tolerability, and pharmacokinetics of multiple ascending doses of VY7523 in participants with early Alzheimer's Disease.

What clinical trials is VY7523 in?

VY7523 is being evaluated in a single Phase 1 clinical trial with the identifier NCT06874621. This trial, titled VY7523-102, is a randomized, placebo-controlled, double-blind, multiple ascending dose study in participants with early Alzheimer's Disease. The trial is active but not recruiting, with an enrollment of 52 participants across the United States and Canada.

Is VY7523 the same as any other drug?

No alternative names for VY7523 have been disclosed. The drug is identified by its code name VY7523 and is being developed by Voyager Therapeutics. It is a distinct investigational small molecule targeting tau for the treatment of early Alzheimer's Disease.