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Natalizumab

Generic Name
Natalizumab
Brand Names
Tysabri, Tyruko
Drug Type
Biotech
Chemical Formula
-
CAS Number
189261-10-7
Unique Ingredient Identifier
3JB47N2Q2P
Background

Natalizumab is a recombinant humanized IgG4κ monoclonal antibody that binds to α4-integrin. While natalizumab was originally approved by the FDA to treat multiple sclerosis in 2004, it was withdrawn from the market following multiple reports of fatal progressive multifocal leukoencephalopathy (PML). In 2006, the FDA reintroduced the drug to the market for multiple sclerosis. Natalizumab was further approved by the FDA for the treatment of Crohn's Disease in January 2008.

On August 24, 2023, the first biosimilar to natalizumab, natalizumab-sztn, was approved by the FDA.

Indication

Natalizumab is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.

It is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s disease with evidence of inflammation who have had an inadequate response to or are unable to tolerate, conventional therapies and inhibitors of TNF-α. It is not to be used in combination with immunosuppressants or inhibitors of TNF-α.

Associated Conditions
Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), Severe Crohn's Disease, Moderate Crohn’s Disease
Associated Therapies
-

Natalizumab in Recurrent, Refractory or Progressive Pulmonary Metastatic Osteosarcoma

Phase 1
Recruiting
Conditions
Pulmonary Metastatic Osteosarcoma (pOS)
Interventions
First Posted Date
2019-01-22
Last Posted Date
2024-07-25
Lead Sponsor
Case Comprehensive Cancer Center
Target Recruit Count
20
Registration Number
NCT03811886
Locations
🇺🇸

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

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

Phase 3
Completed
Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
First Posted Date
2018-10-01
Last Posted Date
2024-06-12
Lead Sponsor
Biogen
Target Recruit Count
585
Registration Number
NCT03689972
Locations
🇧🇪

CHU de Tivoli, La Louvière, Belgium

🇺🇸

MS Center of California, Laguna Hills, California, United States

🇺🇸

UCI MIND, Irvine, California, United States

and more 104 locations

Towards Personalized Dosing of Natalizumab in Multiple Sclerosis

Phase 4
Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2018-05-04
Last Posted Date
2019-07-12
Lead Sponsor
Amsterdam UMC, location VUmc
Target Recruit Count
61
Registration Number
NCT03516526
Locations
🇳🇱

Rijnstate Hospital, Arnhem, Netherlands

🇳🇱

St. Antonius Hospital, Utrecht, Netherlands

🇳🇱

VU medical center, Amsterdam, Netherlands

and more 2 locations

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

Phase 2
Completed
Conditions
Epilepsy, Focal Seizures, Partial Seizures
Interventions
Drug: Natalizumab
Other: Placebo
First Posted Date
2017-09-14
Last Posted Date
2021-12-14
Lead Sponsor
Biogen
Target Recruit Count
67
Registration Number
NCT03283371
Locations
🇺🇸

Research Site, Renton, Washington, United States

Inflammatory Response In Schizophrenia

Phase 1
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2017-03-28
Last Posted Date
2024-03-08
Lead Sponsor
King's College London
Target Recruit Count
66
Registration Number
NCT03093064
Locations
🇬🇧

Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom

Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis

Phase 4
Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2017-02-08
Last Posted Date
2024-02-23
Lead Sponsor
State University of New York at Buffalo
Target Recruit Count
30
Registration Number
NCT03046251
Locations
🇺🇸

SUNY Buffalo, Buffalo, New York, United States

Safety and Efficacy of Intravenous Natalizumab in Acute Ischemic Stroke

Phase 2
Completed
Conditions
Acute Ischemic Stroke
Interventions
Drug: natalizumab
Drug: Placebo
First Posted Date
2016-04-06
Last Posted Date
2019-01-08
Lead Sponsor
Biogen
Target Recruit Count
277
Registration Number
NCT02730455
Locations
🇬🇧

Research Site, Stoke on Trent, Staffordshire, United Kingdom

Clinical Disease Activity With Long Term Natalizumab Treatment

Completed
Conditions
Relapsing-Remitting Multiple Sclerosis
Interventions
First Posted Date
2016-02-09
Last Posted Date
2019-01-04
Lead Sponsor
Biogen
Target Recruit Count
277
Registration Number
NCT02677077
Locations
🇨🇿

Research Site, Prague, Czechia

🇧🇪

Research Site 2, Brussels, Belgium

🇧🇪

Research Site 1, Brussels, Belgium

Natalizumab in Inclusion Body Myositis (IBM)

Phase 1
Conditions
Inclusion Body Myositis (IBM)
Interventions
First Posted Date
2015-06-29
Last Posted Date
2017-02-09
Lead Sponsor
Phoenix Neurological Associates, LTD
Target Recruit Count
6
Registration Number
NCT02483845
Locations
🇺🇸

Phoenix Neurological Insitutute, Phoenix, Arizona, United States

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

Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2015-03-12
Last Posted Date
2018-09-13
Lead Sponsor
Biogen
Target Recruit Count
48
Registration Number
NCT02386566
Locations
🇨🇭

Research Site, Zurich, Switzerland

🇨🇭

Research site - private practice, Luzern, Switzerland

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