Drugs / natalizumab
natalizumab
also known as
Tysabri · BG00002 · Antegren · NTZ · NAT · natalizumab (Tysabri) · Tyruko · Tysabri (natalizumab)
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (5) | US (FDA) | TYSABRI | — | 2006-06-05 – 2013-12-15 | fda.gov ↗ |
| Refused (EMA) | EU (EMA) | Natalizumab Elan Pharma | — | 2008-01-11 | europa.eu ↗ |
| Approved | EU (EMA) | Tysabri | — | 2006-06-27 | europa.eu ↗ |
| Approved | US (FDA) | TYSABRI | — | 2004-11-23 | fda.gov ↗ |
Trials 56 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT00424788 | Jan → Oct 2007 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT05618301 | Jul 2023 → Jun 2025 | sickle cell disease | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT03093064 | Apr 2017 → Jun 2023 | schizophrenia | King's College London | Completed | No outcome recorded |
| Phase 1 | NCT01884935 | Jul 2013 → Sep 2014 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT02483845 | May 2013 → Nov 2017 | inclusion body myositis | Phoenix Neurological Associates, LTD | Unknown | No outcome recorded |
| Phase 1 | NCT00559702 | Oct 2007 → Nov 2011 | relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03811886 | Dec 2024 → Dec 2025 | osteosarcoma | Case Comprehensive Cancer Center | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT00675428 | Sep 2008 → Dec 2009 | plasma cell myeloma | Biogen | Terminated | No outcome recorded |
| Phase 214 trials | ||||||
| Phase 2 | NCT03283371 | Mar 2018 → Jan 2020 | focal epilepsy | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT02133924 | Aug 2016 → Dec 2020 | acute graft versus host disease | John Levine | Completed | No outcome recorded |
| Phase 2 | NCT02730455 | Jul 2016 → Nov 2017 | ischemic stroke | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT02176031 | Jan 2015 → Feb 2019 | acute graft versus host disease | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT02142192 | Dec 2014 → Jun 2015 | multiple sclerosis | Biogen | Terminated | No outcome recorded |
| Phase 2 | NCT01955707 | Jan 2014 → Feb 2015 | ischemic stroke | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT01405820 | Aug 2011 → Apr 2014 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT01416155 | Oct 2010 → Dec 2014 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT01077466 | Mar 2010 → Jan 2012 | primary progressive multiple sclerosis, secondary progressive multiple sclerosis | Rigshospitalet, Denmark | Completed | No outcome recorded |
| Phase 2 | NCT00516893 | Oct 2006 → Oct 2007 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT00831649 | Sep 2004 → Feb 2005 | rheumatoid arthritis | Biogen | Terminated | No outcome recorded |
| Phase 2 | NCT00097760 | Jun 2003 → Mar 2004 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT00055367 | Apr 2002 → May 2004 | Crohn disease | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT00055536 | Apr 2002 → Jul 2003 | Crohn disease | Biogen | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01440101 | Nov 2010 → Aug 2012 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 313 trials | ||||||
| Phase 3 | NCT05265728 | Apr 2022 → Jan 2024 | relapsing-remitting multiple sclerosis | Biogen | Terminated | No outcome recorded |
| Phase 3 | NCT04115488 | Oct 2019 → Aug 2021 | relapsing-remitting multiple sclerosis | Polpharma Biologics S.A. | Completed | No outcome recorded |
| Phase 3 | NCT03689972 | Nov 2018 → Jan 2023 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT01416181 | Sep 2011 → Jul 2015 | secondary progressive multiple sclerosis | Biogen | Terminated | No outcome recorded |
| Phase 3 | NCT01058005 | Mar 2010 → Apr 2012 | relapsing-remitting multiple sclerosis | Biogen | Terminated | No outcome recorded |
| Phase 3 | NCT00297232 | Mar 2006 → Apr 2014 | relapsing-remitting multiple sclerosis | Biogen | Terminated | No outcome recorded |
| Phase 3 | NCT00306592 | Mar 2006 → Dec 2007 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT00078611 | Mar 2004 → Mar 2005 | Crohn disease | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT00276172 | Dec 2003 → Oct 2005 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT00032786 | Mar 2002 → Mar 2004 | Crohn disease | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT00030966 | Jan 2002 → Apr 2005 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT00032799 | Dec 2001 → Sep 2003 | Crohn disease | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT00027300 | Nov 2001 → Nov 2004 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 418 trials | ||||||
| Phase 4 | NCT05532163 | Jan → Oct 2023 | relapsing-remitting multiple sclerosis | Biogen | Terminated | No outcome recorded |
| Phase 4 | NCT05177718 | Sep 2022 → Apr 2023 | multiple sclerosis | Vanderbilt University Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT04225312 | Feb 2020 → Mar 2025 | relapsing-remitting multiple sclerosis | Amsterdam UMC, location VUmc | Unknown | No outcome recorded |
| Phase 4 | NCT04048577 | Jul 2019 → Nov 2021 | relapsing-remitting multiple sclerosis | Berkovich, Regina MD, PhD Inc. | Unknown | No outcome recorded |
| Phase 4 | NCT03535298 | Jan 2019 → Jul 2027 expected | relapsing-remitting multiple sclerosis | The Cleveland Clinic | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03516526 | Nov 2016 → Jun 2019 | multiple sclerosis | Amsterdam UMC, location VUmc | Completed | No outcome recorded |
| Phase 4 | NCT03046251 | Aug 2015 → Dec 2023 | multiple sclerosis | State University of New York at Buffalo | Completed | No outcome recorded |
| Phase 4 | NCT02342704 | Nov 2014 → May 2016 | relapsing-remitting multiple sclerosis | Biogen | Terminated | No outcome recorded |
| Phase 4 | NCT02241785 | Sep 2014 → May 2016 | multiple sclerosis | Biogen | Terminated | No outcome recorded |
| Phase 4 | NCT02142205 | May 2012 → Dec 2013 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 4 | NCT01591551 | Mar 2012 → Aug 2013 | relapsing-remitting multiple sclerosis | Cornerstone Health Care, PA | Completed | No outcome recorded |
| Phase 4 | NCT00871780 | Aug 2009 → Jul 2012 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 4 | NCT00942214 | Jun 2009 → Feb 2011 | multiple sclerosis | University Hospital, Toulouse | Completed | No outcome recorded |
| Phase 4 | NCT00801125 | Dec 2008 → May 2010 | Crohn disease | Biogen | Withdrawn | No outcome recorded |
| Phase 4 | NCT00771043 | Nov 2008 → Aug 2009 | relapsing-remitting multiple sclerosis | Biogen | Withdrawn | No outcome recorded |
| Phase 4 | NCT00744679 | Nov → Dec 2008 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 4 | NCT00536120 | Jan 2008 → Nov 2009 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 4 | NCT00280956 | Jul 2002 → Sep 2004 | Crohn disease | Biogen | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT01455220 | Jan 2011 → Oct 2014 | multiple sclerosis | University of South Florida | Completed | No outcome recorded |
| — | NCT01071512 | Apr 2010 → Jan 2016 | multiple sclerosis | University of Chicago | Completed | No outcome recorded |
Also used as a comparator or background therapy in 8 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 24 trials | ||||||
| Phase 2 | NCT05418010 Comparator | Dec 2022 → Oct 2027 expected | multiple sclerosis | Queen Mary University of London | Recruiting | No outcome recorded |
| Phase 2 | NCT01071083 Comparator | Mar 2010 → Nov 2011 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT00273364 Comparator | Nov 2005 → Jan 2017 | multiple sclerosis | Northwestern University | Completed | No outcome recorded |
| Phase 2 | NCT00083759 Comparator | May 2004 → Feb 2005 | rheumatoid arthritis | Biogen | Terminated | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT04047628 Background | Dec 2019 → Oct 2026 expected | relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT02769689 Background | Jun 2019 → Jun 2024 | multiple sclerosis | University Hospital, Clermont-Ferrand | Unknown | No outcome recorded |
| Phase 4 | NCT02325440 Background | Mar 2014 → Apr 2016 | relapsing-remitting multiple sclerosis | University Hospital Muenster | Unknown | No outcome recorded |
| Phase 4 | NCT01144052 Comparator | Jun 2010 → Nov 2011 | relapsing-remitting multiple sclerosis | Claudio Gobbi | Completed | No outcome recorded |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-09-26 | Novartis Pharmaceuticals | Sandoz receives European Commission approval for Tyruko® (natalizumab), first and only biosimilar for multiple sclerosis in Europe novartis.com ↗ |
| 2023-08-25 | Novartis Pharmaceuticals | Sandoz receives FDA approval for Tyruko® (natalizumab-sztn), first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis novartis.com ↗ |
| 2023-07-24 | Novartis Pharmaceuticals | Sandoz receives positive CHMP opinion for multiple sclerosis biosimilar natalizumab novartis.com ↗ |
| 2022-07-25 | Novartis Pharmaceuticals | Applications for proposed first-of-a-kind multiple sclerosis biosimilar natalizumab accepted by US FDA and EMA novartis.com ↗ |
| 2019-09-03 | Novartis Pharmaceuticals | Sandoz announces global deal to commercialize proposed biosimilar natalizumab, a key multiple sclerosis medicine novartis.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 69 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | natalizumab | “Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer...” NCT00273364 ↗61“Natalizumab (Tyruko®) is a medication currently approved by the Medicines and Healthcare products Regulatory Agency (MHRA) as a disease-modifying treatment for adults with...” NCT05418010 ↗ “Natalizumab (TYSABRI®) or Interferon beta-1a (AVONEX®) treatments initiated at the time of acute optic neuritis (AON)” NCT00771043 ↗ “natalizumab (Tysabri®)” NCT04047628 ↗ “Tysabri (natalizumab)” NCT03535298 ↗ “BG00002 (natalizumab)” NCT02142205 ↗ |
| Known as | Antegren | “A Phase II, International, Multicenter, Open Label Study of the Safety, Tolerability and Effectiveness of Three Intravenous Infusions of Antegren (Natalizumab) in Adolescents...” NCT00055367 ↗4“A Phase 3 International, Multicenter, Double-blind, Placebo-controlled Study of the Safety, Efficacy, and Tolerability of Intravenous Antegren (Natalizumab) in Subjects With...” NCT00032799 ↗ “Intravenous Antegren (Natalizumab) in Crohn's Disease Subjects” NCT00055536 ↗ “Intravenous Antegren(TM) (Natalizumab)” NCT00078611 ↗ “Intravenous Antegren (Natalizumab)” NCT00032786 ↗ |
| Known as | BG00002 | “The primary objective of the study is to determine the efficacy of natalizumab (Tysabri, BG00002) in participants with relapsing forms of multiple sclerosis (MS) who have...” NCT02241785 ↗7“Biological: BG00002 (natalizumab)” NCT00306592 ↗ “Drug: BG00002 (natalizumab)” NCT00675428 ↗ “BG00002 (natalizumab)” NCT00871780 ↗ “Natalizumab (BG00002)” NCT01440101 ↗ “BG00002 (natalizumab)” NCT01058005 ↗ “BG00002 (natalizumab)” NCT02142205 ↗ “BG00002 (natalizumab)” NCT00536120 ↗ |
| Known as | NAT | “Leukocyte sequestration is an established therapeutic concept in multiple sclerosis (MS) as represented by the trafficking drugs natalizumab (NAT) and fingolimod (FTY).” PMID 30050529 ↗ Jul 2018 |
| Known as | natalizumab (Tysabri) | “natalizumab (Tysabri®)” NCT04047628 ↗ |
| Known as | NTZ | “Natalizumab (NTZ) a current treatment for MS can be used as a second line therapy” NCT00942214 ↗2“Natalizumab (NTZ) is a highly effective therapy for multiple sclerosis (MS)” PMID 40988462 ↗ Sep 2025 “Drug: natalizumab (NTZ)” NCT02769689 ↗ |
| Known as | Tyruko | “Natalizumab (Tyruko®) is a medication currently approved by the Medicines and Healthcare products Regulatory Agency (MHRA) as a disease-modifying treatment for adults with...” NCT05418010 ↗ |
| Known as | Tysabri | “The primary objective of the study is to determine the efficacy of natalizumab (Tysabri, BG00002) in participants with relapsing forms of multiple sclerosis (MS) who have...” NCT02241785 ↗10“Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer...” NCT00273364 ↗ “In part 2, participants received natalizumab (Tysabri®) 300 mg via IV infusion Q6W for 36 weeks and then were randomized to 48 weeks of crossover treatment (24 weeks SC Q6W and...” PMID 39046635 ↗ Jul 2024 “All eligible patients will be randomly assigned to one of two treatment groups in a 1:1 ratio, to receive a total of twelve intravenous (IV) infusion of either PB006 or Tysabri...” NCT04115488 ↗ “Natalizumab (TYSABRI) is a protein-based drug that is manufactured by Biogen Idec in partnership with Elan Pharmaceuticals.” NCT00424788 ↗ “Natalizumab (Tysabri) therapy” NCT01591551 ↗ “Tysabri ® (Natalizumab)” NCT01455220 ↗ “TYSABRI® (natalizumab)” NCT00801125 ↗ “Tysabri® (natalizumab)” NCT00536120 ↗ |
| Known as | Tysabri (natalizumab) | “Tysabri (natalizumab)” NCT03535298 ↗ |
| Action | Inhibit | “Natalizumab is the first alpha4 integrin antagonist in a new class of selective adhesion-molecule inhibitors.” PMID 16510744 ↗ Mar 2006 |
| Modality | Monoclonal antibody | “Natalizumab, a humanized monoclonal antibody against alpha4 integrin” PMID 16267322 ↗ Nov 2005 |
| Route | Intravenous | “Natalizumab 300 mg IV infusion” NCT00027300 ↗ |