Natalizumab
- Generic Name
- Natalizumab
- Brand Names
- Tysabri, Tyruko
- Drug Type
- Biotech
- 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 While natalizumab was originally approved by the FDA to treat multiple sclerosis in 2004, it was withdrawn from the market following multiple reports of fatal progressive multifocal leukoencephalopathy (PML).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
Natalizumab in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate
- First Posted Date
- 2004-06-03
- Last Posted Date
- 2016-07-18
- Lead Sponsor
- Biogen
- Target Recruit Count
- 299
- Registration Number
- NCT00083759
- Locations
- 🇺🇸
Clinical Pharmacology Study Group, Worcester, Massachusetts, United States
🇺🇸Justus Fiechtner, MD, PC, Lansing, Michigan, United States
🇨🇦The Arthritis Program Research Group Inc., Newmarket, Ontario, Canada
A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's Disease
- Conditions
- Crohn's Disease
- First Posted Date
- 2004-03-08
- Last Posted Date
- 2016-06-16
- Lead Sponsor
- Biogen
- Target Recruit Count
- 462
- Registration Number
- NCT00078611
- Locations
- 🇺🇸
Morowitz, Marion, Laessing, Shocket, Bashir, Steinberg, Salcedo, Washington, District of Columbia, United States
🇨🇦University of Calgary, Calgary, Alberta, Canada
🇨🇦University of Alberta, Edmonton, Alberta, Canada
Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease
- Conditions
- Crohn's Disease
- First Posted Date
- 2003-03-06
- Last Posted Date
- 2016-06-16
- Lead Sponsor
- Biogen
- Target Recruit Count
- 60
- Registration Number
- NCT00055536
- Locations
- 🇺🇸
Wake Research Associates, Raleigh, North Carolina, United States
🇺🇸University of Kentucky Medical Center, Lexington, Kentucky, United States
🇺🇸Memphis Gastroenterology Group, Memphis, Tennessee, United States
Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease
- Conditions
- Crohn's Disease
- First Posted Date
- 2003-02-28
- Last Posted Date
- 2016-06-16
- Lead Sponsor
- Biogen
- Target Recruit Count
- 30
- Registration Number
- NCT00055367
- Locations
- 🇺🇸
The Children's Hospital, Boston, Massachusetts, United States
🇺🇸Johns Hopkins University School of Medicine, Baltimore, Maryland, United States
🇺🇸Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease
- Conditions
- Crohn's Disease
- First Posted Date
- 2002-04-04
- Last Posted Date
- 2016-06-16
- Lead Sponsor
- Biogen
- Registration Number
- NCT00032786
Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease
- Conditions
- Crohn's Disease
- First Posted Date
- 2002-04-04
- Last Posted Date
- 2016-06-16
- Lead Sponsor
- Biogen
- Target Recruit Count
- 905
- Registration Number
- NCT00032799
- Locations
- 🇺🇸
Elan Pharmaceuticals, San Diego, California, United States
Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Interventions
- Drug: Placebo
- First Posted Date
- 2002-02-18
- Last Posted Date
- 2009-06-18
- Lead Sponsor
- Biogen
- Target Recruit Count
- 1200
- Registration Number
- NCT00030966
- Locations
- 🇺🇸
Mercy Hospital Outpatient Pharmacy, Des Moines, Iowa, United States
🇺🇸University of Pittsburgh, Department of Neurology, Pittsburgh, Pennsylvania, United States
🇩🇪Asklepios Klinik Schildautal, Seesen/Harz, Germany
Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Interventions
- Drug: Placebo
- First Posted Date
- 2001-12-03
- Last Posted Date
- 2017-01-09
- Lead Sponsor
- Biogen
- Target Recruit Count
- 900
- Registration Number
- NCT00027300
- Locations
- 🇬🇧
Oldchurch Hospital, Essex, United Kingdom
🇧🇪National MS Centrum, Melsbroek, Belgium
🇺🇸University of Miami School of Medicine, Department of Neurology, Miami, Florida, United States
Drug Development Updates
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