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VHB937

Phase 2

Amyotrophic Lateral Sclerosis (ALS) | Monoclonal antibody | Neurology |Novartis AG|Last Updated: May 27, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment251
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06643481A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS)PHASE2 ACTIVE NOT_RECRUITING 251 — — Oct 17, 2024Jul 10, 2028May 27, 202674 United States, Australia +15
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Study Endpoints
Primary Endpoints
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
ALS Functional Rating Scale Revised (ALSFRS-R) total score
Baseline to DB Week 40 or until death or PAV (whichever occurs first) and Baseline to OLE Week 100 or until death or PAV (whichever occurs first
Slow Vital Capacity (SVC) (% of predicted normal value)
Baseline to DB Week 40 or until death or PAV (whichever occurs first) and Baseline to OLE Week 100 or until death or PAV (whichever occurs first)
Ratio to baseline in Neurofilament Light (NfL) concentration in serum
DB up to Week 40; DB and OLE up to Week 100]
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
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 Range18 Years — 100 Years
SexALL
Healthy VolunteersNo
Study Sites74

Inclusion Criteria: * are 18 years of age or older * male or female, if of childbearing potential, strict contraception required * have ALS confirmed by the trial doctors using different tests. * have mild symptoms of ALS as measured by the ALSFRS-R questionnaire (total score \>=30). * have had sym...

Countries:United StatesAustraliaBelgiumCanadaChinaDenmarkFranceGermanyIrelandItalyNetherlandsPolandSouth KoreaSpainSwedenSwitzerlandUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 28, 2026NCT06643481lastUpdatePostDate: changed
LOWMay 28, 2026NCT06643481lastUpdatePostDate: changed
LOWMay 26, 2026NCT06643481primaryCompletionDate: changed
LOWMay 24, 2026NCT06643481studyFirstPostDate: changed