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Foralumab · NI-0401, TZLS-401

Monoclonal antibody · Antagonist of CD3 epsilon (CD3E) · developed by Tiziana Life Sciences

Phase 2 Most advanced trial
TLSA Developer
5 Registered trials

What is Foralumab?

Foralumab is a monoclonal antibody against CD3 epsilon that binds to T cells and prevents T cell activation, suppressing immune responses. It is administered intranasally and is studied in Alzheimer's disease, mild cognitive impairment, multiple sclerosis, and multiple system atrophy.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
NI-0401, TZLS-401
Drug type
Monoclonal antibody
Targets
CD3 epsilon (CD3E)
Mechanism
Antagonist of CD3 epsilon (CD3E)
Pathways
T cell activation
Therapy area
Immunology, Neurology
Developer
Tiziana Life Sciences LTD (TLSA)
FDA status
Investigational, not approved in the US. Most advanced trial: Phase 2
UNII
J43DL56H6M

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT06489548 Phase 2 Dementia Recruiting TLSA
NCT06868628 Phase 2 Multiple System Atrophy Recruiting TLSA
NCT06890923 Phase 2 Non-Active Secondary Progressive Multiple Sclerosis Recruiting TLSA
NCT06292923 Phase 2 Secondary Progressive Multiple Sclerosis Active not recruiting TLSA
NCT05029609 Phase 1 Primary Progressive Multiple Sclerosis Withdrawn TLSA

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Alzheimers DiseaseDementiaMild Cognitive Impairment Due to Alzheimer's DiseaseMultiple System AtrophyNon-Active Secondary Progressive Multiple SclerosisMultiple SclerosisPrimary Progressive Multiple SclerosisSecondary Progressive Multiple Sclerosis

Other drugs acting on CD3E

More from Tiziana Life Sciences

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the TLSA page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.