CDEK
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natalizumab

Trade name: tysabri

mAbapproved

Approved

Nov 23, 2004

Natalizumab, sold under the brand name Tysabri among others, is a medication used to treat multiple sclerosis and Crohn's disease. It is a humanized monoclonal antibody against the cell adhesion molecule α4-integrin. It is given by intravenous infusion. The drug is believed to work by reducing the ability of inflammatory immune cells to attach to and pass through the cell layers lining the intestines and blood–brain barrier. — Wikipedia

Clinical trial activity

68 trials · 46 clinical orgs · 2 marketing orgs

Phase 1
9
Phase 2
35
Phase 3
18
Phase 4
20

Earliest trial started Dec 31, 1998

Timeline

1990s

  1. Jan 1, 1998

    Earliest Phase 1 Sponsor

2000s

  1. Jan 1, 2001

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  3. Nov 23, 2004

    Biogen-IDEC — Earliest FDA Approval

  4. Nov 23, 2004

    Biogen-IDEC — Marketing Organization

  5. Nov 23, 2004

    Biogen-IDEC — NDA Organization

2020s

  1. Aug 24, 2023

    Sandoz — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedAcceleratedNov 23, 2004

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • an100226m
  • antegran
  • antegren
  • antegren
  • antegren
  • antegren
  • antegren
  • anti-alpha4 integrin
  • anti-vla4
  • natalizumab
  • natalizumab
  • natalizumab
  • natalizumab
  • natalizumab
  • natalizumab
  • natalizumab
  • natalizumab
  • plavina
  • tysabri
  • tysabri
  • tysabri
  • tysabri

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05771155Phase 3May 31, 2023Polpharma
NCT05618301Phase 1Mar 31, 2023BioLineRx, Ltd., Washington University in St. Louis
NCT05418010Phase 2Nov 30, 2022Barts & The London NHS Trust, Biogen, University of London
NCT05532163Phase 4Nov 1, 2022Biogen
NCT05177718Phase 4Sep 16, 2022Biogen, Vanderbilt University
NCT05265728Phase 3Apr 26, 2022Biogen
NCT04427475N/AJun 8, 2020Fudan University
NCT04225312Phase 4Jan 2, 2020Free University of Amsterdam, Innovatiefonds Zorgverzekeraars, Stichting MS Research
NCT04115488Phase 3Oct 31, 2019Polpharma
NCT04048577Phase 4Sep 1, 2019Biogen, Cedars-Sinai Medical Center, Regina Berkovich MD, PhD Inc.
NCT03811886Phase 1/Phase 2 (Phase 2)Jul 31, 2019Case Western Reserve University
NCT03689972Phase 3Dec 14, 2018Biogen
NCT03283371Phase 2Mar 20, 2018Biogen
NCT03093064Phase 1Apr 1, 2017South London and Maudsley NHS Foundation Trust, University of London
NCT03516526Phase 4Nov 3, 2016Erasmus University Rotterdam, Free University of Amsterdam, Rijnstate Hospital, Sanquin, St. Antonius Hospital, Nieuwegein
NCT02133924Phase 2Aug 1, 2016Biogen, Icahn School of Medicine at Mount Sinai
NCT02730455Phase 2Jul 18, 2016Biogen
NCT02769689Phase 4Apr 1, 2016University Clermont Auvergne
NCT03046251Phase 4Aug 1, 2015State University of New York, State University of New York, Buffalo
NCT02176031Phase 2Jan 1, 2015Biogen, Harvard University
Showing 20 of 68 trials
Page 1 / 4

Organizations

Research & Development (46)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
BiogenFor profit494151998
Elan PharmaceuticalsFor profit19042001
Free University of AmsterdamAcademic/Hospital3222001
PolpharmaFor profit2212019
Sheffield Hallam UniversityAcademic/Hospital2112006
University of LondonAcademic/Hospital2222017
Bangkok Drug companyFor profit1012013
Barts & The London NHS TrustAcademic/Hospital1012022
Biogen-IDECFor profit1012003
BioLineRx, Ltd.For profit1012023
Case Western Reserve UniversityAcademic/Hospital1112019
Cedars-Sinai Medical CenterAcademic/Hospital1012019
Cornerstone Health Care, PAAcademic/Hospital1112012
Erasmus University RotterdamAcademic/Hospital1012016
Fudan UniversityAcademic/Hospital1112020
Harvard UniversityAcademic/Hospital1112015
Icahn School of Medicine at Mount SinaiAcademic/Hospital1112016
Innovatiefonds ZorgverzekeraarsAcademic/Hospital1012020
KhonKaen UniversityAcademic/Hospital1112013
Northwestern UniversityAcademic/Hospital1112006
46 organizations
Page 1 / 3

Marketing (3)

OrganizationOrg typeRelationshipDate
Biogen-IDECFor profitMKTGNov 23, 2004
Biogen-IDECFor profitNDANov 23, 2004
SandozFor profitMKTGAug 24, 2023