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VHB937

Phase 2

Alzheimer's Disease | Monoclonal antibody | Neurology |Novartis AG|Last Updated: Jul 7, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment407

FDA Designations

No designations recorded

Clinical trial landscape

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
RECRUITING407 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
PHASE2RECRUITING
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 Sites74

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)

LOWJul 7, 2026NCT06643481primaryCompletionDate: changed
LOWJul 7, 2026NCT06643481primaryCompletionDate: changed
LOWJun 26, 2026NCT07094516lastUpdatePostDate: changed
LOWJun 26, 2026NCT06643481lastUpdatePostDate: changed
LOWJun 26, 2026NCT07094516lastUpdatePostDate: changed
LOWJun 26, 2026NCT06643481lastUpdatePostDate: changed

Frequently asked questions about VHB937

What is VHB937 used for?

VHB937 is an investigational monoclonal antibody being developed for amyotrophic lateral sclerosis (ALS) and early Alzheimer's disease. It is currently in Phase 2 clinical trials for both conditions, with separate studies evaluating its effects in people with ALS and in people with early Alzheimer's disease.

Who makes VHB937?

VHB937 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting Phase 2 clinical trials to evaluate the drug's effects in patients with amyotrophic lateral sclerosis and early Alzheimer's disease.

What phase is VHB937 in?

VHB937 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in two separate Phase 2 trials: one for amyotrophic lateral sclerosis and one for early Alzheimer's disease.

What clinical trials is VHB937 in?

VHB937 is being evaluated in two Phase 2 clinical trials. The first, NCT06643481, is an active but not recruiting study in 251 participants with amyotrophic lateral sclerosis across multiple countries. The second, NCT07094516, is a recruiting study in 407 participants with early Alzheimer's disease, also conducted internationally.

Is VHB937 being studied in Alzheimer's disease?

Yes, VHB937 is being studied in early Alzheimer's disease. The Phase 2 clinical trial NCT07094516 is currently recruiting participants aged 50 years and older with early Alzheimer's disease. The study is randomized, double-blind, and placebo-controlled, with an enrollment target of 407 participants across multiple countries.

Is VHB937 being studied in ALS?

Yes, VHB937 is being studied in amyotrophic lateral sclerosis (ALS). The Phase 2 clinical trial NCT06643481 is active but not recruiting, with 251 participants enrolled. This randomized, double-blind, placebo-controlled study is being conducted in numerous countries, including the United States, Australia, and several European and Asian nations.