Natalizumab
Approved · FDA / EMAAlso known as Anti-VLA4, Anti-alpha4 integrin, Natalizumab (Murine), Tyruko+3 more
Anti-VLA4, Anti-alpha4 integrin, Natalizumab (Murine), Tyruko, Tysabri, IMMUNOGLOBULIN G4 (HUMAN-MOUSE MONOCLONAL AN100226 4-CHAIN ANTI-HUMAN INTEGRIN 4), DISULFIDE WITH HUMAN-MOUSE MONOCLONAL AN100226 LIGHT CHAIN, DIMER, IMMUNOGLOBULIN G4 (HUMAN-MOUSE MONOCLONAL AN100226 4-CHAIN ANTI-HUMAN INTEGRIN 4), DISULPHIDE WITH HUMAN-MOUSE MONOCLONAL AN100226 LIGHT CHAIN, DIMER.
Recent clinical, regulatory, research and industry developments relating to this drug.
Supplemental approval: NATALIZUMAB-SZTN (BLA761322)
Supplemental approval: NATALIZUMAB-SZTN (BLA761322)
Label change: NATALIZUMAB-SZTN (BLA761322)
Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis
Approval: NATALIZUMAB-SZTN (BLA761322)
The Role of Inflammation in Brain and Cognitive Function in Mental Disorders
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups: Patients with… Show full indicationShow less
Tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods see sections 4.4 and 5.1) or Patients with rapidly evolving severe RRMS defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain Magnetic Resonance Imaging (MRI) or a significant increase in T2 lesion load as compared to a previous recent MRI.
Indication: Tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: Patients with… Show full indicationShow less
Tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: Patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods see sections 4.4 and 5.1) or Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
Recent completions
Trials that read out recently, adding to the completed evidence base.
- RxNorm (U.S. National Library of Medicine) — drug identity
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.