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BG00002 (natalizumab)
BG00002 (natalizumab) is a Monoclonal antibody (integrin antagonist) Biologic drug developed by Biogen. It is currently FDA-approved for Relapsing-remitting multiple sclerosis, Crohn's disease. Also known as: Tysabri, Tysabri®.
Natalizumab is a monoclonal antibody that blocks the α4β1 integrin on immune cells, preventing their migration across the blood-brain barrier into the central nervous system.
Natalizumab is a monoclonal antibody that blocks the α4β1 integrin on immune cells, preventing their migration across the blood-brain barrier into the central nervous system. Used for Relapsing-remitting multiple sclerosis, Crohn's disease.
At a glance
| Generic name | BG00002 (natalizumab) |
|---|---|
| Also known as | Tysabri, Tysabri® |
| Sponsor | Biogen |
| Drug class | Monoclonal antibody (integrin antagonist) |
| Target | α4β1 integrin |
| Modality | Biologic |
| Therapeutic area | Immunology / Neurology |
| Phase | FDA-approved |
Mechanism of action
By binding to α4β1 integrin, natalizumab inhibits the adhesion and transmigration of lymphocytes across the blood-brain barrier and into inflamed tissues. This reduces the infiltration of immune cells into the brain and spinal cord, thereby decreasing inflammation and demyelination in multiple sclerosis. The drug effectively reduces relapse rates and slows disease progression in relapsing-remitting MS.
Approved indications
- Relapsing-remitting multiple sclerosis
- Crohn's disease
Common side effects
- Progressive multifocal leukoencephalopathy (PML)
- Infusion reactions
- Headache
- Fatigue
- Arthralgia
- Infections
Key clinical trials
- 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 (PHASE3)
- 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
- Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
- A Study to Investigate the Radiological Onset of Action After Treatment Initiation With Subcutaneous (SC) Natalizumab in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) (PHASE4)
- 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 (PHASE3)
- CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring
- Natalizumab Subcutaneous Immunogenicity and Safety Study (PHASE2)
- Tysabri Observational Program
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BG00002 (natalizumab) CI brief — competitive landscape report
- BG00002 (natalizumab) updates RSS · CI watch RSS
- Biogen portfolio CI
Frequently asked questions about BG00002 (natalizumab)
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Related
- Drug class: All Monoclonal antibody (integrin antagonist) drugs
- Target: All drugs targeting α4β1 integrin
- Manufacturer: Biogen — full pipeline
- Therapeutic area: All drugs in Immunology / Neurology
- Indication: Drugs for Relapsing-remitting multiple sclerosis
- Indication: Drugs for Crohn's disease
- Also known as: Tysabri, Tysabri®
- Compare: BG00002 (natalizumab) vs similar drugs
- Pricing: BG00002 (natalizumab) cost, discount & access