Tysabri

(natalizumab)

PreclinicalMonoclonal antibody

Natalizumab is used to treat multiple sclerosis and Crohn's disease by reducing inflammation and preventing immune cells from attacking the body's own tissues and organs.[1] Tysabri is currently being investigated across 1 indication[3], with its most advanced program in Preclinical.[1]

Tysabri is one of 8 small molecule programs targeting Progressive Multifocal Leukoencephalopathy. It is currently in Preclinical.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Progressive Multifocal LeukoencephalopathyActive, not recruiting

Progressive Multifocal LeukoencephalopathyPreclinical

Active, not recruiting

Competition

Competitive Landscape

9 competitors in Progressive Multifocal Leukoencephalopathy

#DrugCompanyPhaseTrials

Keytruda

Merck & Co.

Phase 3

1 2

Tembexa

Emergent BioSolutions

Phase 2

1 3

Vistide

Gilead

Preclinical

1 4

Intron a

Merck & Co.

Preclinical

1 5

Retrovir

BBp Consulting, Inc

Preclinical

2 6

Benemid

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 7

Tysabri

Biogen

Preclinical

1 8

Collection of Stools

UUniversity Hospital, Toulouse

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2031

Recruiting

Pregnancy

NCT05688436

Q3 2032

Recruiting

Multiple Sclerosis

NCT05658497

Clinical

Trials by Indication[1]

Multiple Sclerosis15 trials

NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Multiple Sclerosis Experiencing Fatigue or Sleepiness

Completed·CCornerstone Health Care, PA·Phase 4·NCT01591551·37 enrolled

Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis After Failure on Other Therapies

Terminated· Biogen logo

Biogen·Phase 4·NCT02241785·47 enrolled

Biomarkers and Response to Natalizumab for Multiple Sclerosis Treatment

Completed·UUniversity Hospital, Toulouse·Phase 4·NCT00942214·300 enrolled

Show 12 more trials

Natalizumab Treatment of Progressive Multiple Sclerosis

Completed·RRigshospitalet, Denmark·Phase 2·NCT01077466·24 enrolled

A Study of End of Dose Phenomena in Subcutaneous Natalizumab Treated Multiple Sclerosis (MS) Participants

Terminated· Biogen logo

Biogen··NCT05701423·34 enrolled

Examining the Risk of Skin Cancer in Multiple Sclerosis Patients Using Fingolimod: a Population-Based Study

Completed·UUniversity of British Columbia··NCT06705608·4,000 enrolled

Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants

Completed· Biogen logo

Biogen··NCT04832399·60 enrolled

A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)

Completed· Biogen logo

Biogen·Phase 1·NCT00424788·12 enrolled

Exploratory Study of the Safety, Tolerability and Efficacy of Multiple Regimens of Natalizumab in Adult Participants With Relapsing Multiple Sclerosis (MS)

Completed· Biogen logo

Biogen·Phase 2·NCT01405820·290 enrolled

Towards Personalized Dosing of Natalizumab in Multiple Sclerosis

Completed·AAmsterdam UMC, location VUmc·Phase 4·NCT03516526·61 enrolled

Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis

Completed·SState University of New York at Buffalo·Phase 4·NCT03046251·30 enrolled

Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis

Completed· Biogen logo

Biogen·Phase 3·NCT00030966·1,200 enrolled

Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis

Completed· Biogen logo

Biogen·Phase 3·NCT00027300·900 enrolled

Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)

Completed· Biogen logo

Biogen·Phase 1·NCT00559702·76 enrolled

Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry

Recruiting· Biogen logo

Biogen··NCT05658497·908 enrolled

Relapsing-Remitting Multiple Sclerosis8 trials

Natalizumab (BG00002, Tysabri) Study in Japanese Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)

Completed· Biogen logo

Biogen·Phase 2/3·NCT01440101·106 enrolled

Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants

Terminated· Biogen logo

Biogen·Phase 4·NCT02342704·111 enrolled

A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered Subcutaneously to Japanese Participants With Relapsing-Remitting Multiple Sclerosis

Terminated· Biogen logo

Biogen·Phase 3·NCT05265728·21 enrolled

Show 5 more trials

Extension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple Sclerosis

Completed· Biogen logo

Biogen·Phase 2·NCT01416155·97 enrolled

Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JC Virus Antibody Negative Participants

Completed· Biogen logo

Biogen··NCT01485003·231 enrolled

Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis

Completed· Biogen logo

Biogen·Phase 2·NCT00097760·110 enrolled

A 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)

Active, not recruiting· Biogen logo

Biogen··NCT05925049·400 enrolled

A Study to Investigate the Radiological Onset of Action After Treatment Initiation With Subcutaneous (SC) Natalizumab in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)

Terminated· Biogen logo

Biogen·Phase 4·NCT05532163·1 enrolled

Treatment4 trials

Clinical Disease Activity With Long Term Natalizumab Treatment

Completed· Biogen logo

Biogen··NCT02677077·277 enrolled

A 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

Completed· Biogen logo

Biogen·Phase 3·NCT03689972·585 enrolled

Treatment Interruption of Natalizumab

Completed· Biogen logo

Biogen·Phase 2·NCT01071083·175 enrolled

Show 1 more trial

JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With Natalizumab

Completed· Biogen logo

Biogen··NCT01070836·35,895 enrolled

Safety and Efficacy4 trials

Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri

Completed· Biogen logo

Biogen··NCT02137109·400 enrolled

Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease

Completed· Biogen logo

Biogen·Phase 2·NCT00055536·60 enrolled

Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease

Completed· Biogen logo

Biogen·Phase 3·NCT00032786

Show 1 more trial

Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease

Completed· Biogen logo

Biogen·Phase 3·NCT00032799·905 enrolled

Crohn's Disease3 trials

Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease

Completed· Biogen logo

Biogen·Phase 2·NCT00055367·30 enrolled

Open Label Natalizumab Safety Extension Study for Subjects With Crohn's Disease

Completed· Biogen logo

Biogen·Phase 4·NCT00280956·2,000 enrolled

A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's Disease

Completed· Biogen logo

Biogen·Phase 3·NCT00078611·462 enrolled

25 more indications

Ischemic stroke2 trials

Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke

Completed· Biogen logo

Biogen·Phase 2·NCT01955707·161 enrolled

Safety and Efficacy of Intravenous Natalizumab in Acute Ischemic Stroke

Completed· Biogen logo

Biogen·Phase 2·NCT02730455·277 enrolled

Rheumatoid Arthritis2 trials

Natalizumab in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate

Terminated· Biogen logo

Biogen·Phase 2·NCT00083759·299 enrolled

A 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

Terminated· Biogen logo

Biogen·Phase 2·NCT00831649

Methylprednisolone1 trial

Methylprednisolone During the Switch Between Natalizumab and Fingolimod

Unknown status·UUniversity Hospital, Clermont-Ferrand·Phase 4·NCT02769689·56 enrolled

Effectiveness1 trial

Real World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort

Completed·UUniversity Hospital, Caen··NCT04580381·500 enrolled

Secondary Progressive Multiple Sclerosis1 trial

A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple Sclerosis

Terminated· Biogen logo

Biogen·Phase 3·NCT01416181·889 enrolled

Infusion1 trial

Analysis of MS Patients Who Have Had Greater Than 60 Infusions of Natalizumab

Unknown status·MMultiple Sclerosis Center of Northeastern New York··NCT04964700·42 enrolled

Inflammatory Response1 trial

Inflammatory Response In Schizophrenia

Completed·KKing's College London·Phase 1·NCT03093064·66 enrolled

TIA1 trial

Natalizumab (Tysabri) Re-Initiation of Dosing

Terminated· Biogen logo

Biogen·Phase 3·NCT00297232·1,094 enrolled

Immune Function1 trial

Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya

Unknown status·UUniversity Hospital Muenster·Phase 4·NCT02325440·15 enrolled

Inclusion Body Myositis1 trial

Natalizumab in Inclusion Body Myositis (IBM)

Unknown status·PPhoenix Neurological Associates, LTD·Phase 1·NCT02483845·6 enrolled

Pregnancy1 trial

A 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

Recruiting· Biogen logo

Biogen··NCT05688436·1,178 enrolled

Epilepsy1 trial

Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy

Completed· Biogen logo

Biogen·Phase 2·NCT03283371·67 enrolled

Progressive Multifocal Leukoencephalopathy1 trial

TOPIK Study: A Study to Report Progressive Multifocal Leukoencephalopathy and Other Serious Opportunistic Infections in Natalizumab Treated Participants

Completed· Biogen logo

Biogen··NCT05236777·675 enrolled

Osteosarcoma1 trial

Natalizumab in Recurrent, Refractory or Progressive Pulmonary Metastatic Osteosarcoma

Withdrawn·—·Phase 1/2·NCT03811886

Immunogenicity1 trial

Natalizumab Subcutaneous Immunogenicity and Safety Study

Terminated· Biogen logo

Biogen·Phase 2·NCT02142192·2 enrolled

Acute Graft Versus Host Disease1 trial

Multicenter Study Of Natalizumab Plus Standard Steroid Treatment For High Risk Acute Graft-Versus-Host Disease

Completed·JJohn Levine·Phase 2·NCT02133924·76 enrolled

Chronic Inflammation1 trial

Natalizumab and Chronic Inflammation

Terminated·VVanderbilt University Medical Center·Phase 4·NCT05177718·1 enrolled

Outcome1 trial

Real-world Outcomes on Tecfidera (BG00012, Dimethyl Fumarate) Post-Tysabri (BG00002, Natalizumab)

Completed· Biogen logo

Biogen··NCT02159573·530 enrolled

Observational Study1 trial

Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Participants Treated With Natalizumab

Completed· Biogen logo

Biogen··NCT02386566·48 enrolled

Phase II1 trial

Phase II Trial of Natalizumab + Prednisone for Initial Therapy of Acute GI GVHD

Completed·—·Phase 2·NCT02176031·21 enrolled

Sickle Cell Disease1 trial

Motixafortide and Natalizumab to Mobilize CD34+ Hematopoietic Stem Cells for Gene Therapies in Sickle Cell Disease (SCD)

Completed·WWashington University School of Medicine·Phase 1·NCT05618301·10 enrolled

Pediatric1 trial

PK and PD Study of Natalizumab in Pediatric Subjects With RRMS

Completed· Biogen logo

Biogen·Phase 1·NCT01884935·13 enrolled

ART1 trial

A Study for Tysabri Participant Preference

Completed· Biogen logo

Biogen··NCT05304520·318 enrolled

Multiple Sclerosis, Relapsing-Remitting1 trial

Biomarker for Cognitive Fatigue Using Functional Imaging in Multiple Sclerosis

Completed·KKessler Foundation··NCT04565431·7 enrolled

Unspecified6 trials

Ireland Natalizumab (TYSABRI) Observational Program

Completed· Biogen logo

Biogen··NCT01943526·191 enrolled

Open-Label Natalizumab Safety Extension Study

Completed· Biogen logo

Biogen·Phase 3·NCT00276172·1,615 enrolled

Study of Tysabri (Natalizumab) in Patients Who Failed Anti-TNF-α Therapy

Withdrawn· Biogen logo

Biogen·Phase 4·NCT00801125

Show 3 more trials

Natalizumab De-escalation With Interferon Beta-1b

Completed·CClaudio Gobbi·Phase 4·NCT01144052·19 enrolled

CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring

Terminated· Biogen logo

Biogen··NCT00707512·87 enrolled

A Pharmacokinetic (PK) Study of Natalizumab (Tysabri) at Steady State

Completed· Biogen logo

Biogen·Phase 4·NCT00744679·20 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 23, 2004

TYSABRI

BLA BLA125104

Sources

References

[1]
ClinicalTrials.gov — 66 trial records for natalizumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — natalizumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for natalizumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA125104). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Biogen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Integrin Alpha-4/beta-1 Inhibitor; Integrin Alpha-4/beta-7 Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Preclinical[1]
Company: Biogen

Tysabri

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2031

Q3 2032

Trials by Indication[1]

Multiple Sclerosis15 trials

Relapsing-Remitting Multiple Sclerosis8 trials

Treatment4 trials

Safety and Efficacy4 trials

Crohn's Disease3 trials

Ischemic stroke2 trials

Rheumatoid Arthritis2 trials

Methylprednisolone1 trial

Effectiveness1 trial

Secondary Progressive Multiple Sclerosis1 trial

Infusion1 trial

Inflammatory Response1 trial

TIA1 trial

Immune Function1 trial

Inclusion Body Myositis1 trial

Pregnancy1 trial

Epilepsy1 trial

Progressive Multifocal Leukoencephalopathy1 trial

Osteosarcoma1 trial

Immunogenicity1 trial

Acute Graft Versus Host Disease1 trial

Chronic Inflammation1 trial

Outcome1 trial

Observational Study1 trial

Phase II1 trial

Sickle Cell Disease1 trial

Pediatric1 trial

ART1 trial

Multiple Sclerosis, Relapsing-Remitting1 trial

Unspecified6 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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