Approval Probability
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VY7523 · 1 trial · 1 indication
Incidence of treatment-emergent adverse events (TEAEs) and clinically significant changes from baseline
| Arm | Type | Description |
|---|---|---|
| Cohort 1 active | EXPERIMENTAL | Low dose VY7523 |
| Cohort 1 placebo | PLACEBO_COMPARATOR | VY7523 matching placebo for Cohort 1 active dose |
| Cohort 2 active | EXPERIMENTAL | mid dose VY7523 |
| Cohort 2 placebo | PLACEBO_COMPARATOR | VY7523 matching placebo for Cohort 2 active dose |
| Cohort 3 active | EXPERIMENTAL | high dose VY7523 |
| Cohort 3 placebo | PLACEBO_COMPARATOR | VY7523 matching placebo for Cohort 3 active dose |
| Name | Type | Description |
|---|---|---|
| VY7523 | DRUG | VY7523 is a recombinant humanized immunoglobulin gamma 4 (IgG4) monoclonal antibody targeting human pathological tau |
| Placebo Comparator | DRUG | Matching placebo to VY7523 |
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...
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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.
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.
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.
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.
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.
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.