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Natalizumab (Tysabri)
Natalizumab is a monoclonal antibody that blocks the α4β1 integrin on immune cells, preventing them from crossing the blood-brain barrier and entering the central nervous system.
Natalizumab blocks the α4β1 integrin on immune cells, preventing them from crossing the blood-brain barrier and entering the central nervous system. Used for Relapsing-remitting multiple sclerosis, Crohn's disease (moderate to severe).
At a glance
| Generic name | Natalizumab (Tysabri) |
|---|---|
| Sponsor | Cornerstone Health Care, PA |
| Drug class | Monoclonal antibody; integrin antagonist |
| Target | α4β1 integrin (VLA-4) |
| Modality | Small molecule |
| Therapeutic area | Immunology; Neurology; Gastroenterology |
| Phase | FDA-approved |
Mechanism of action
By binding to α4β1 integrin, natalizumab inhibits the adhesion and transmigration of lymphocytes across the blood-brain barrier, reducing immune cell infiltration into the brain and spinal cord. This mechanism reduces inflammation and demyelination in multiple sclerosis and decreases intestinal inflammation in Crohn's disease by preventing leukocyte trafficking to affected tissues.
Approved indications
- Relapsing-remitting multiple sclerosis
- Crohn's disease (moderate to severe)
Common side effects
- Progressive multifocal leukoencephalopathy (PML)
- Headache
- Fatigue
- Infusion reactions
- Arthralgia
- Urinary tract infection
Key clinical trials
- Evaluation of Early Changes Visible to the Diffusion MRI in Response to Two Years of Treatment With Tysabri in Patients With Multiple Sclerosis (PHASE4)
- Study of the Mechanisms of Action of Cladribine in Multiple Sclerosis (NA)
- Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation (AttackMS) (PHASE2)
- Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS) (PHASE3)
- Implication of 5-HT7 Receptor in Inflammatory Mechanisms in Multiple Sclerosis
- Cladribine Tablets After Treatment With Natalizumab (CLADRINA) (PHASE4)
- 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
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:
- Natalizumab (Tysabri) CI brief — competitive landscape report
- Natalizumab (Tysabri) updates RSS · CI watch RSS
- Cornerstone Health Care, PA portfolio CI