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Atlas / Drug / Natalizumab

Natalizumab

drug
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Also known as AN100226MANTEGRANAntegrenNatalizumab elan pharmaTyrukoTysabri

Summary

Natalizumab (CHEMBL1201607) is an approved antibody (ATC L04AG03) targeting ITGA4; indicated across 14 conditions including relapsing-remitting multiple sclerosis and crohn disease.

At a glance

  • Status: Approved (max clinical phase 4)
  • Modality: Antibody
  • ATC class: L04AG03
  • Targets: 1 (ITGA4)
  • Indications: 14 conditions
  • Clinical trials: 74

Identifiers

Drug identity and classification

FieldValue
ChEMBL IDCHEMBL1201607
NameNatalizumab
TypeAntibody
Max phase4
ATCL04AG03

Also known as: AN100226M, ANTEGRAN, Antegren, Natalizumab, Natalizumab elan pharma, Tyruko, Tysabri, NATALIZUMAB

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

GeneTargetActionpAffinityCancer dependencyUniProt
ITGA4integrin, alpha 4 subunit (antigen CD49D, alpha 4 subunit of VLA-4 receptor)Inhibition1.8%P13612
integrin α4β1Inhibition

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

Aggregated over 1 target gene(s): ITGA4.

Top Reactome pathways

17 total, by targets touching each:

PathwayTargetsGenes
Hemostasis1ITGA4
Adaptive Immune System1ITGA4
Extracellular matrix organization1ITGA4
Disease1ITGA4
Immune System1ITGA4
Immunoregulatory interactions between a Lymphoid and a non-Lymphoid cell1ITGA4
Cell surface interactions at the vascular wall1ITGA4
Generic Transcription Pathway1ITGA4
Integrin cell surface interactions1ITGA4
Infectious disease1ITGA4
RNA Polymerase II Transcription1ITGA4
Gene expression (Transcription)1ITGA4
Transcriptional regulation by RUNX31ITGA4
RUNX3 Regulates Immune Response and Cell Migration1ITGA4
Potential therapeutics for SARS1ITGA4
SARS-CoV Infections1ITGA4
Viral Infection Pathways1ITGA4

Dominant GO biological processes

GO termTargets
immune response in gut-associated lymphoid tissue1
cell-matrix adhesion involved in ameboidal cell migration1
leukocyte cell-cell adhesion1
cell-matrix adhesion1
integrin-mediated signaling pathway1
B cell differentiation1
cell-cell adhesion mediated by integrin1
heterotypic cell-cell adhesion1
substrate adhesion-dependent cell spreading1
endodermal cell differentiation1
receptor clustering1
negative regulation of vasoconstriction1
leukocyte tethering or rolling1
diapedesis1
axonogenesis involved in innervation1

Indications & clinical

Indications

3 approved indications. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

IndicationPhaseMONDOEFO
relapsing-remitting multiple sclerosis4MONDO:0005314EFO:0003929
Crohn disease4MONDO:0005011EFO:0000384
multiple sclerosis4MONDO:0005301MONDO:0005301

8 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)PhaseMONDOEFO
primary progressive multiple sclerosis3MONDO:0000451EFO:0008520
secondary progressive multiple sclerosis3MONDO:0000450EFO:0008522
rheumatoid arthritis2MONDO:0008383EFO:0000685
graft versus host disease2MONDO:0013730MONDO:0013730
plasma cell myeloma1MONDO:0009693EFO:0001378
inclusion body myositis1MONDO:0007827EFO:0007323
osteosarcoma1MONDO:0009807EFO:0000637
sickle cell disease1MONDO:0011382MONDO:0011382

3 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 74.

Phase distribution

PhaseTrials
Not specified27
PHASE415
PHASE214
PHASE310
PHASE15
PHASE2/PHASE31
PHASE1/PHASE21
EARLY_PHASE11

Top trials by phase / activity

NCTPhaseStatusTitle
NCT00280956PHASE4COMPLETEDOpen Label Natalizumab Safety Extension Study for Subjects With Crohn’s Disease
NCT00744679PHASE4COMPLETEDA Pharmacokinetic (PK) Study of Natalizumab (Tysabri) at Steady State
NCT00771043PHASE4WITHDRAWNA Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-a
NCT00801125PHASE4WITHDRAWNStudy of Tysabri (Natalizumab) in Patients Who Failed Anti-TNF-α Therapy
NCT00942214PHASE4COMPLETEDBiomarkers and Response to Natalizumab for Multiple Sclerosis Treatment
NCT01144052PHASE4COMPLETEDNatalizumab De-escalation With Interferon Beta-1b
NCT01591551PHASE4COMPLETEDNAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Multiple Sclerosis Experiencing Fatigue or Sleepiness
NCT02241785PHASE4TERMINATEDNatalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis After Failure on Other Therapies
NCT02325440PHASE4UNKNOWNStudy to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya
NCT02342704PHASE4TERMINATEDImpact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants
NCT02769689PHASE4UNKNOWNMethylprednisolone During the Switch Between Natalizumab and Fingolimod
NCT02775110PHASE4COMPLETEDNatalizumab Temporary Discontinuation Study
NCT03046251PHASE4COMPLETEDNatalizumab in Preventing Post-partum Relapses in Multiple Sclerosis
NCT03516526PHASE4COMPLETEDTowards Personalized Dosing of Natalizumab in Multiple Sclerosis
NCT05532163PHASE4TERMINATEDA Study to Investigate the Radiological Onset of Action After Treatment Initiation With Subcutaneous (SC) Natalizumab in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
NCT00027300PHASE3COMPLETEDSafety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis
NCT00030966PHASE3COMPLETEDSafety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis
NCT00032786PHASE3COMPLETEDSafety and Efficacy of Natalizumab in the Treatment of Crohn’s Disease
NCT00032799PHASE3COMPLETEDSafety and Efficacy of Natalizumab in the Treatment of Crohn’s Disease
NCT00078611PHASE3COMPLETEDA Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn’s Disease
NCT00276172PHASE3COMPLETEDOpen-Label Natalizumab Safety Extension Study
NCT00297232PHASE3TERMINATEDNatalizumab (Tysabri) Re-Initiation of Dosing
NCT01416181PHASE3TERMINATEDA Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple Sclerosis
NCT01440101PHASE2/PHASE3COMPLETEDNatalizumab (BG00002, Tysabri) Study in Japanese Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
NCT03689972PHASE3COMPLETEDA Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab Administration
NCT05265728PHASE3TERMINATEDA Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered Subcutaneously to Japanese Participants With Relapsing-Remitting Multiple Sclerosis
NCT00055367PHASE2COMPLETEDSafety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn’s Disease
NCT00055536PHASE2COMPLETEDSafety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn’s Disease
NCT00083759PHASE2TERMINATEDNatalizumab in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate
NCT00097760PHASE2COMPLETEDNatalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis
NCT00831649PHASE2TERMINATEDA Phase II, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Natalizumab in Subjects With Rheumatoid Arthritis Who Have Previously Participated in Study ELN100226-RA201
NCT01071083PHASE2COMPLETEDTreatment Interruption of Natalizumab
NCT01077466PHASE2COMPLETEDNatalizumab Treatment of Progressive Multiple Sclerosis
NCT01416155PHASE2COMPLETEDExtension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple Sclerosis
NCT01955707PHASE2COMPLETEDEffect of Natalizumab on Infarct Volume in Acute Ischemic Stroke
NCT02133924PHASE2COMPLETEDMulticenter Study Of Natalizumab Plus Standard Steroid Treatment For High Risk Acute Graft-Versus-Host Disease
NCT02142192PHASE2TERMINATEDNatalizumab Subcutaneous Immunogenicity and Safety Study
NCT02176031PHASE2COMPLETEDPhase II Trial of Natalizumab + Prednisone for Initial Therapy of Acute GI GVHD
NCT02730455PHASE2COMPLETEDSafety and Efficacy of Intravenous Natalizumab in Acute Ischemic Stroke
NCT03283371PHASE2COMPLETEDPhase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy
NCT03811886PHASE1/PHASE2WITHDRAWNNatalizumab in Recurrent, Refractory or Progressive Pulmonary Metastatic Osteosarcoma
NCT00559702PHASE1COMPLETEDSafety Study of Natalizumab to Treat Multiple Sclerosis (MS)
NCT01884935PHASE1COMPLETEDPK and PD Study of Natalizumab in Pediatric Subjects With RRMS
NCT02483845PHASE1UNKNOWNNatalizumab in Inclusion Body Myositis (IBM)
NCT03093064PHASE1COMPLETEDInflammatory Response In Schizophrenia
NCT05618301PHASE1COMPLETEDMotixafortide and Natalizumab to Mobilize CD34+ Hematopoietic Stem Cells for Gene Therapies in Sickle Cell Disease (SCD)
NCT00424788EARLY_PHASE1COMPLETEDA Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)
NCT03500328Not specifiedACTIVE_NOT_RECRUITINGTraditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial
NCT05658497Not specifiedRECRUITINGPregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
NCT05688436Not specifiedRECRUITINGA Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies
NCT05925049Not specifiedACTIVE_NOT_RECRUITINGA Study Utilising Data From European Union (EU) National Multiple Sclerosis (MS) Registries to Assess the Incidence of Anti-Natalizumab Antibody Among Participants Who Receive Subcutaneous Administration of Natalizumab for Treatment of Relapsing-remitting Multiple Sclerosis (RRMS)
NCT00493298Not specifiedCOMPLETEDTysabri Observational Program
NCT00707512Not specifiedTERMINATEDCD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring
NCT00884481Not specifiedCOMPLETEDEffects of Tysabri (BG00002) Over 12 Months on MS Related Fatigue in Participants With RRMS
NCT00937677Not specifiedCOMPLETEDEffect of Tysabri in Patients With Relapsing-Remitting Multiple Sclerosis: A Follow-up Magnetization Transfer Imaging (MTI) Study
NCT01065727Not specifiedUNKNOWNImpact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple Sclerosis
NCT01070836Not specifiedCOMPLETEDJC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With Natalizumab
NCT01071512Not specifiedCOMPLETEDTysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis
NCT01485003Not specifiedCOMPLETEDObservational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JC Virus Antibody Negative Participants
NCT01943526Not specifiedCOMPLETEDIreland Natalizumab (TYSABRI) Observational Program
NCT02137109Not specifiedCOMPLETEDSafety and Efficacy in Pediatric MS Patients Prescribed Tysabri
NCT02159573Not specifiedCOMPLETEDReal-world Outcomes on Tecfidera (BG00012, Dimethyl Fumarate) Post-Tysabri (BG00002, Natalizumab)
NCT02386566Not specifiedCOMPLETEDObservational Study to Assess the Correlation of EDSS With Quality of Life in MS Participants Treated With Natalizumab
NCT02677077Not specifiedCOMPLETEDClinical Disease Activity With Long Term Natalizumab Treatment
NCT03399981Not specifiedCOMPLETEDTysabri Observational Cohort Study - Multiple Sclerosis (MS) Registries
NCT04565431Not specifiedUNKNOWNExamining Effects of Tysabri on Cognitive Fatigue Using fMRI
NCT04832399Not specifiedCOMPLETEDStudy of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants
NCT04964700Not specifiedUNKNOWNAnalysis of MS Patients Who Have Had Greater Than 60 Infusions of Natalizumab
NCT05236777Not specifiedCOMPLETEDTOPIK Study: A Study to Report Progressive Multifocal Leukoencephalopathy and Other Serious Opportunistic Infections in Natalizumab Treated Participants
NCT05304520Not specifiedCOMPLETEDA Study for Tysabri Participant Preference
NCT05627271Not specifiedCOMPLETEDThe ‘Wearing Off’ Effect of DMT
NCT05701423Not specifiedTERMINATEDA Study of End of Dose Phenomena in Subcutaneous Natalizumab Treated Multiple Sclerosis (MS) Participants
NCT05762003Not specifiedCOMPLETEDCzech Pharmaco-epidemiological Study on Disease Modifying Drugs
NCT06705608Not specifiedCOMPLETEDExamining the Risk of Skin Cancer in Multiple Sclerosis Patients Using Fingolimod: a Population-Based Study

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).

About this page

Generated deterministically by Sugi Atlas from primary biomedical databases via BioBTree. Every record on this page traces to a primary source.

Generated
Atlas version
v1.1.4
BioBTree
v2.0.2

Sources 30

This page pulls from 30 datasets indexed by BioBTree:

chebichembl_activitychembl_moleculechembl_targetcivic_evidenceclingen_dosageclinical_trialsdepmapefoensemblentrezgogoparentgtopdbgtopdb_interactiongtopdb_ligandhgncmeshmondomsigdbpatent_compoundpharmgkbpharmgkb_guidelinepubchempubchem_activityreactomereactomeparentrefseqtranscriptuniprot