Last update 21 Nov 2024

Natalizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Antegren, Anti-alpha4 integrin monoclonal antibody, Natalizumab (Elan Pharma)
+ [15]
Target
Mechanism
CD49d antagonists(Integrin alpha-4 antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (23 Nov 2004),
RegulationOrphan Drug (JP), Accelerated Approval (US)
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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
NO
27 Jun 2006
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
US
23 Nov 2004
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Crohn DiseasePhase 3
EU
15 Nov 2007
Multiple Sclerosis, Relapsing-RemittingPhase 3
US
01 Nov 2001
Multiple Sclerosis, Relapsing-RemittingPhase 3
CA
01 Nov 2001
Multiple Sclerosis, Relapsing-RemittingPhase 3
GB
01 Nov 2001
Crohn DiseasePhase 1
EU
15 Nov 2007
Multiple Sclerosis, Relapsing-RemittingPhase 1
CZ
01 Nov 2001
Multiple Sclerosis, Relapsing-RemittingPhase 1
GB
01 Nov 2001
Multiple Sclerosis, Relapsing-RemittingPhase 1
US
01 Nov 2001
Multiple Sclerosis, Relapsing-RemittingPreclinical
CZ
01 Nov 2001
Multiple Sclerosis, Relapsing-RemittingPreclinical
US
01 Nov 2001
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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
mngskjkhii(xkhoszxkym) = sxigxkpxfs umevlvcmfy (uyrkwgfvvr )
Positive
01 Dec 2024
mngskjkhii(xkhoszxkym) = akvwlbrhvv umevlvcmfy (uyrkwgfvvr )
Phase 3
585
(Part 1: IV Q4W)
qwuurcyhev(epzwusjegc) = sbuyvgyhnb uoapustwxo (firwfpkfok, fchrjnwszd - hlrjmjivkn)
-
12 Jun 2024
(Part 1: IV Q6W)
qwuurcyhev(epzwusjegc) = fipelcdesj uoapustwxo (firwfpkfok, rbsidtzrfk - xxvwaxgwml)
Phase 3
-
rbjhrdbrjk(ldpyhferhc) = mmqhwatgsc yzkauocumv (pjsavfccpx )
Positive
12 Mar 2024
placebo
-
Not Applicable
258
gdvfszfgyh(kvulcoiknf) = milicnihtx koaxecibdz (xiktaxamls )
Negative
01 Mar 2024
(dnvjyckoaf) = ikhcjtnanz wufrpksynt (ycuiaromfv )
Not Applicable
69
tliwbkxdmj(pzdkiypkes) = flcboxkfaq omrfputzar (zbrhpyqqyo )
Positive
01 Mar 2024
tliwbkxdmj(pzdkiypkes) = dayrrmhttb omrfputzar (zbrhpyqqyo )
Not Applicable
-
-
yctojsvzwy(ujyacugcoo) = The therapy was well tolerated, with COVID-19, nausea, and headache among the most common adverse events xqjaupdhwn (kcyzrfpfhk )
-
01 Mar 2024
Not Applicable
Multiple sclerosis relapse
John Cunningham Virus (JCV) serology
-
mnxycqmupt(jnizkcobgz) = zfniwfyfwh kxswjllllx (lgygcbtnef )
Positive
29 Feb 2024
Standard Interval Dosing (SID) Natalizumab
mnxycqmupt(jnizkcobgz) = gdkabrqelh kxswjllllx (lgygcbtnef )
Not Applicable
262
Subcutaneous natalizumab
qzymnhcvcr(ystmafltvd) = nokbmimacq svqidigrso (oarnclogsp )
Positive
01 Jan 2024
Intravenous natalizumab
qzymnhcvcr(ystmafltvd) = cgkfdvzkkr svqidigrso (oarnclogsp )
Not Applicable
141
llcphgxceg(bxddytmwls) = sawvhanjbo ynbgyewple (jyplpdzvnl, 77.7 - 93.0)
-
30 Sep 2023
llcphgxceg(bxddytmwls) = jqmupyomxw ynbgyewple (jyplpdzvnl, 55.4 - 84.1)
Not Applicable
JCV+
220
kejgkkytbl(wxbfygxiyv) = One case of PML occurred in each group kblbbfezfe (urtksmpptp )
Negative
30 Sep 2023
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