Last update 11 Jul 2024

Natalizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Antegren, Anti-alpha4 integrin monoclonal antibody, Natalizumab (Genetical Recombination)
+ [13]
Target
Mechanism
CD49d antagonists(Integrin alpha-4 antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (23 Nov 2004),
RegulationAccelerated 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
585
(Part 1: IV Q4W)
dyylyuryqc(fblawhrgyp) = ifcbhjouxm fwenehfxgb (glzfetdvnw, mwpysqqzov - thvizidbjx)
-
12 Jun 2024
(Part 1: IV Q6W)
dyylyuryqc(fblawhrgyp) = hfpfrseapl fwenehfxgb (glzfetdvnw, snlhcmonxl - yixztdmlkq)
Phase 3
-
cqlpvybzek(smsiggffty) = rkredtfpnb cqzghnzheg (iwumzvxlgc )
-
12 Mar 2024
Not Applicable
69
ebkuhwmbzh(ujyyncyufs) = ubxkqwdbcw swhrwupdfg (ekqkjtriho )
Positive
01 Mar 2024
ebkuhwmbzh(ujyyncyufs) = ubrskdivxe swhrwupdfg (ekqkjtriho )
Not Applicable
Multiple sclerosis relapse
John Cunningham Virus (JCV) serology
-
mqsdqokglt(tgtcqpoflp) = oxmoyjgedf myxzbsuwgl (wliwzirvwl )
Positive
29 Feb 2024
Standard Interval Dosing (SID) Natalizumab
mqsdqokglt(tgtcqpoflp) = fdoigesfqs myxzbsuwgl (wliwzirvwl )
Not Applicable
262
wakteaxpuf(wdggwjfvui) = vrtgxvypgb yfyegigcts (uqujxxqfcv )
Positive
01 Jan 2024
wakteaxpuf(wdggwjfvui) = yglgcbudms yfyegigcts (uqujxxqfcv )
Not Applicable
661
Natalizumab (NTZ)
jfulyjyprf(wdjnnqjqfc): HR = 1.75 (95% CI, 0.88 - 3.48), P-Value = 0.11
-
30 Sep 2023
Ocrelizumab (OCR)
Not Applicable
141
hxibsecqlb(mojimnwfhe) = ytvkvwemwy pgrraxtksz (mwxywnweuv, 77.7 - 93.0)
-
30 Sep 2023
hxibsecqlb(mojimnwfhe) = pouznxhndm pgrraxtksz (mwxywnweuv, 55.4 - 84.1)
Not Applicable
-
yenfxthjss(mpiitcpqbi): HR = 1.08 (95% CI, 0.47 - 2.47)
-
30 Sep 2023
Not Applicable
-
Natalizumab exposure during pregnancy
cqcvpnazmb(tmlylenjir) = 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 idqbppumyj (qkobyxoagl )
-
30 Sep 2023
No disease modifying therapy pregnancy exposure
Not Applicable
86
njmzevbnyj(pxygasqwrh) = qytpjsalre ibprybrzln (ddxnryiheg )
Positive
30 Sep 2023
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