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

  • USTyruko|Tysabri · Approved2004-11-23 Source
  • EU/EEATysabri · Authorised2006-06-27 Source
  • EU/EEATyruko · Authorised · Biosimilar2023-09-22 Source

Safety communications

  • EMA referral · 2015-05-07

    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.

3,204 reports in total, 1,829 marked serious.

  • Fatigue449
  • Headache362
  • Multiple sclerosis relapse194
  • Multiple sclerosis180
  • Asthenia165
  • Nausea153
  • Influenza like illness147
  • Dizziness136
  • Pain132
  • Urinary tract infection129

Trials

Key trials

Large trials with a reported result on their main goal.

Running now

Other trials (62)

Completed small trials, dose-finding studies and trials in other diseases.

  • Natalizumab

    Terminated · Relapsing MS · stopped_other

  • Natalizumab, phase 4

    Terminated · Phase 4 · Relapsing MS · stopped_other

  • Natalizumab

    Completed · Relapsing MS · result_in_paper_unread

  • Natalizumab

    Status unknown · MS (type not specified) · no_result_found

  • Natalizumab

    Completed · Relapsing MS · no_result_found

  • SUPERNEXT

    Status unknown · Phase 4 · Relapsing MS · result_in_paper_unread

  • NEXT-MS

    Moved to EU CTIS registry · Phase 4 · Relapsing MS

  • Methylprednisolone, phase 4

    Status unknown · Phase 4 · Relapsing MS · no_result_found

  • Antelope

    Completed · Phase 3 · Relapsing MS · no_result_found

  • Natalizumab

    Completed · MS (type not specified) · no_result_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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