Natalizumab
How it works: Keeping immune cells out of the brain →
Tysabri
EU: Approved in the EU since 2006US: FDA approved 2004
- Molecule type
- Antibody
- Mechanism (ChEMBL)
- Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor
- Targets
- Integrin alpha-4/beta-1, Integrin alpha-4/beta-7
- Availability
- Authorised in all EU and EEA countries. Reimbursement is decided by each country.
Approvals
Safety communications
- EMA referral · 7 May 2015
Tysabri Source
Most-reported side effects (FDA reports)
Reports to the FDA's adverse event system (FAERS) show what people and doctors reported while taking the medicine. They do not prove the medicine caused it, and they are not rates.
3,273 reports in total, 1,884 marked serious.
- Fatigue458
- Headache363
- Multiple sclerosis relapse198
- Multiple sclerosis181
- Asthenia165
- Nausea154
- Influenza like illness147
- Dizziness137
- Pain132
- Urinary tract infection129
Trials
Key trials
Large trials with a reported result on their main goal.
- A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacody
Terminated · Phase 3 · Relapsing MS · Stopped: not working
- A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natal
Completed · Phase 3 · Relapsing MS · Missed its main goal
- A Clinical Study of the Efficacy of Natalizumab on Reducing Disability
Terminated · Phase 3 · Relapsing and progressive · Stopped: not working
- Natalizumab (BG00002, Tysabri) Study in Japanese Participants With Rel
Completed · Phase 2 / Phase 3 · Relapsing MS · Met its main goal
- Safety and Efficacy of Natalizumab in Combination With Avonex in the T
Completed · Phase 3 · Relapsing MS · Met its main goal
- Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclero
Completed · Phase 3 · Relapsing MS · Met its main goal
Running now
- Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
Recruiting · Relapsing MS · Still running
- A Study Utilising Data From European Union (EU) National Multiple Scle
Running, not recruiting · Relapsing MS · Still running
- Natalizumab for the Treatment of People With Inflammatory Demyelinatio
Recruiting · Phase 2 · Early (CIS/RIS) · Still running
- A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY
Running, not recruiting · Relapsing MS · Still running
- Reduce the number of natalizumab infusions in patients with multiple s
Ongoing · Phase 4 · MS (type not specified)
Other trials (63)
Completed small trials, dose-finding studies and trials in other diseases.
- A Study of End of Dose Phenomena in Subcutaneous Natalizumab Treated M
Terminated · Relapsing MS · Stopped
- A Study to Investigate the Radiological Onset of Action After Treatmen
Terminated · Phase 4 · Relapsing MS · Stopped
- A Study for Tysabri Participant Preference
Completed · Relapsing MS · Paper found, not read
- Analysis of MS Patients Who Have Had Greater Than 60 Infusions of Nata
Status unknown · MS (type not specified) · No results found
- Examining Effects of Tysabri on Cognitive Fatigue Using fMRI
Completed · Relapsing MS · No results found
- Personalized Extended Interval Dosing of Natalizumab in Relapsing Remi
Status unknown · Phase 4 · Relapsing MS · Paper found, not read
- Personalizing the treatment with natalizumab in patients with multiple
Moved to EU CTIS registry · Phase 4 · Relapsing MS
- Methylprednisolone During the Switch Between Natalizumab and Fingolimo
Status unknown · Phase 4 · Relapsing MS · No results found
- A study of biosimilar Natalizumab in comparision to Tysabri in Patient
Completed · Phase 3 · Relapsing MS · No results found
- TOPIK Study: A Study to Report Progressive Multifocal Leukoencephalopa
Completed · MS (type not specified) · No results found
For information only, not medical advice. Talk to your neurologist before changing treatment.
Hypotheses involving this medicine
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Lab studies
Lab studies in animals or cells. Results in animals often do not hold in people, and these studies never change the status of an idea.
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