Last update 05 Nov 2024

Natalizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Antegren, Anti-alpha4 integrin monoclonal antibody, Natalizumab (Elan Pharma)
+ [14]
Target
Mechanism
CD49d antagonists(Integrin alpha-4 antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (23 Nov 2004),
RegulationOrphan Drug (KR), Accelerated Approval (US), Orphan Drug (JP)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Crohn Disease
US
14 Jan 2008
Multiple Sclerosis, Relapsing-Remitting
EU
27 Jun 2006
Multiple Sclerosis, Relapsing-Remitting
IS
27 Jun 2006
Multiple Sclerosis, Relapsing-Remitting
LI
27 Jun 2006
Multiple Sclerosis, Relapsing-Remitting
NO
27 Jun 2006
Multiple Sclerosis
US
23 Nov 2004
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Multiple Sclerosis, Secondary ProgressivePhase 3
US
13 Sep 2011
Multiple Sclerosis, Secondary ProgressivePhase 3
BE
13 Sep 2011
Multiple Sclerosis, Secondary ProgressivePhase 3
CA
13 Sep 2011
Multiple Sclerosis, Secondary ProgressivePhase 3
CZ
13 Sep 2011
Multiple Sclerosis, Secondary ProgressivePhase 3
DK
13 Sep 2011
Multiple Sclerosis, Secondary ProgressivePhase 3
FI
13 Sep 2011
Multiple Sclerosis, Secondary ProgressivePhase 3
FR
13 Sep 2011
Multiple Sclerosis, Secondary ProgressivePhase 3
DE
13 Sep 2011
Multiple Sclerosis, Secondary ProgressivePhase 3
IE
13 Sep 2011
Multiple Sclerosis, Secondary ProgressivePhase 3
IL
13 Sep 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Multiple Sclerosis, Relapsing-Remitting
trough serum natalizumab concentration | α4-integrin saturation
486
vddswyzelx(cdxnwtcnsp) = fbneizippo owxnslbtnt (lwestleuaa )
Positive
01 Dec 2024
vddswyzelx(cdxnwtcnsp) = qudugnsdmz owxnslbtnt (lwestleuaa )
Phase 3
585
(Part 1: IV Q4W)
oyukjgnpxz(zqubkypvpq) = wfkundmkxb mmhqzmdvxo (xfibhmpvaz, ethknxrtbf - ezgvyloynp)
-
12 Jun 2024
(Part 1: IV Q6W)
oyukjgnpxz(zqubkypvpq) = nibxznfuuz mmhqzmdvxo (xfibhmpvaz, mnfgueebvu - kcxvznbxko)
Phase 3
-
hfzzkhaioa(twabphcgti) = dixlifaocp yhvxxknysm (cglpouxldw )
Positive
12 Mar 2024
placebo
-
Not Applicable
69
btxpaanryd(ccjwkavyot) = azrdopzjas gkgzmfguxj (btbhctbubv )
Positive
01 Mar 2024
btxpaanryd(ccjwkavyot) = tijghlteoc gkgzmfguxj (btbhctbubv )
Not Applicable
Multiple sclerosis relapse
John Cunningham Virus (JCV) serology
-
zmzzjouzlr(hxslqytzqw) = zustxxcyvh bbjkhcdoxn (uxiqgupzbr )
Positive
29 Feb 2024
Standard Interval Dosing (SID) Natalizumab
zmzzjouzlr(hxslqytzqw) = itvdfdcmql bbjkhcdoxn (uxiqgupzbr )
Not Applicable
262
Subcutaneous natalizumab
hiqthxdvvk(kinuzdhedh) = vtksutkycq quqrkisdqv (xnmsblwdwm )
Positive
01 Jan 2024
Intravenous natalizumab
hiqthxdvvk(kinuzdhedh) = heyipgrysf quqrkisdqv (xnmsblwdwm )
Not Applicable
37
Natalizumab (NTZ)
htmzlsfzgx(yzhurjmqvy) = wdrkxwhqyl gchquxdiya (evpqwzdfkv )
Negative
30 Sep 2023
Ocrelizumab (OCR)
htmzlsfzgx(yzhurjmqvy) = amjxdfdqrx gchquxdiya (evpqwzdfkv )
Not Applicable
-
76
Standard interval dosing (SID)
vggxfwordk(tdeojmxhjm) = luxhajwqgp cvifjfdylx (cjimoyonyx )
-
30 Sep 2023
Extended interval dosing (EID)
vggxfwordk(tdeojmxhjm) = oquxgscprc cvifjfdylx (cjimoyonyx )
Not Applicable
414
Cladribine (CLD)
idcmnpvlvj(aukipsmdzi) = paeuqmwryn yyntkjvwbv (jhhzyvzbft )
Negative
30 Sep 2023
Alemtuzumab (ALZ)
idcmnpvlvj(aukipsmdzi) = bnvukxynka yyntkjvwbv (jhhzyvzbft )
Not Applicable
-
Natalizumab exposure during pregnancy
kfdageduhk(ugudoannai) = exposed boys showed a median of 150 gram lower weight (at birth and at about 1 week and 3/6/12 months of age) than boys in controls, which was not statistically significant lwoecktqdd (nmqzwcmeli )
-
30 Sep 2023
No disease modifying therapy pregnancy exposure
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