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VHB937

Phase 2

Alzheimer's Disease | Monoclonal antibody | Neurology |Novartis AG|Trials Updated: Oct 21, 2026

VHB937 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Oct 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment348

FDA Designations

No designations recorded

VHB937 clinical trials

VHB937 · 2 trials · 2 indications

Phase 2 2
NCT07094516A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's DiseaseAlzheimer's Disease
ACTIVE NOT_RECRUITING97 Analytics
NCT06643481A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)
ACTIVE NOT_RECRUITING251 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics
PHASE2ACTIVE NOT_RECRUITING
A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)Unlock trial analytics

Study Endpoints

Primary Endpoints

Change from Baseline in the Clinical Dementia Rating scale - Sum of Boxes (CDR-SB)
Baseline and Week 72

The CDR is a measure of cognition and function, widely used in clinical research in AD. The scale assesses six domains: Memory, Orientation, Judgment \& Problem Solving, Community Affairs, Home \& Hobbies, and Personal Care. Based on in-depth semi-structured interview, each domain is assigned a score, which is summed to obtain the Sum of Boxes (SB) score, ranging from 0 to 18 with higher scores indicating worse condition

The composite of PAV-free survival and change in ALSFRS-R. Analysis method: Combined Assessment of Function and Survival (CAFS)
Baseline to DB Week 40

To compare the efficacy of VHB937 vs. placebo on a composite of permanent assisted ventilation (PAV) free survival and function in DB epoch

Secondary Endpoints

Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
From First treatment to end of study (up to 63 months approximately)
Change from Baseline in Clinical Dementia Rating scale - Sum of Boxes (CDR-SB)
Baseline over time until Week 72
Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog14)
Baseline over time until Week 72
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VHB937 Low DoseEXPERIMENTALI.V. infusions
VHB937 High DoseEXPERIMENTALI.V. infusions
PlaceboPLACEBO_COMPARATORI.V. infusions
Arm 1EXPERIMENTALI.V. infusions
Arm 2PLACEBO_COMPARATORI.V. infusions

Interventions

NameTypeDescription
VHB937BIOLOGICALVHB937 solution for infusion
PlaceboOTHERSolution for infusion
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Eligibility Criteria

Age Range50 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites73

Key Inclusion Criteria * Male or female participants 50 to 85 years of age * Diagnosis of Mild Cognitive Impairment (MCI) due to AD or mild AD * Clinical Dementia Rating (CDR) Global score of 0.5 or 1.0 * Confirmation of AD based on cerebral spinal fluid (CSF) biomarkers or amyloid PET imaging * Re...

Countries:United StatesAustraliaCanadaChinaCzechiaFranceGermanyItalyJapanNetherlandsPolandSouth KoreaSpainSwedenUnited KingdomBelgiumDenmarkIrelandSwitzerland
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Recent Changes (Last 90 Days)

HIGHOct 21, 2026NCT07094516Status: RECRUITING → ACTIVE_NOT_RECRUITING
HIGHOct 21, 2026NCT07094516Status: RECRUITING → ACTIVE_NOT_RECRUITING
HIGHOct 21, 2026NCT07094516Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about VHB937

What is VHB937?

VHB937 is an investigational monoclonal antibody developed by Novartis AG for neurological diseases. It is being studied in Phase 2 clinical trials in early Alzheimer's disease and in amyotrophic lateral sclerosis (ALS). VHB937 has not been approved for any use and remains in clinical development.

What is VHB937 used for in Alzheimer's disease and ALS?

VHB937 is being evaluated as a treatment for early Alzheimer's disease and for amyotrophic lateral sclerosis (ALS). Both are neurological conditions, and the Phase 2 trials are designed to assess the effects of VHB937 in people with these diseases. No approved use has been established.

Who makes VHB937?

VHB937 is developed by Novartis AG, which trades under the ticker NVS. Novartis is sponsoring the Phase 2 clinical program evaluating VHB937 in early Alzheimer's disease and in amyotrophic lateral sclerosis (ALS).

What phase is VHB937 in?

VHB937 is in Phase 2 clinical development. Two Phase 2 trials are ongoing, one in early Alzheimer's disease and one in amyotrophic lateral sclerosis (ALS). Both studies are active but no longer recruiting participants. VHB937 is investigational and has not been approved by the FDA.

What clinical trials is VHB937 in?

VHB937 is being studied in two Phase 2 trials. NCT07094516 evaluates VHB937 in people with early Alzheimer's disease and enrolled 97 participants across the United States, Europe, Asia and Australia. NCT06643481 evaluates VHB937 in amyotrophic lateral sclerosis (ALS) and enrolled 251 participants across a similar international set of countries. Both are randomized, double-blind and placebo-controlled.