Last update 12 Dec 2024

Ofatumumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
HuMax-CD20, HuMax-CD20, 2F2, Ofatumumab (genetical recombination)
+ [12]
Target
Mechanism
CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), CD20-directed cytolytic effects
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationAccelerated Approval (US), Breakthrough Therapy (US)
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External Link

KEGGWikiATCDrug Bank
D09314Ofatumumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multiple sclerosis relapse
EU
26 Mar 2021
Multiple sclerosis relapse
IS
26 Mar 2021
Multiple sclerosis relapse
LI
26 Mar 2021
Multiple sclerosis relapse
NO
26 Mar 2021
Multiple Sclerosis, Relapsing-Remitting
CA
22 Jan 2021
Multiple Sclerosis, Relapsing-Remitting
CA
22 Jan 2021
Multiple Sclerosis
US
20 Aug 2020
Lymphoid Leukemia
JP
23 Mar 2013
Chronic Lymphocytic Leukemia
US
26 Oct 2009
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
RhabdomyosarcomaPhase 3
US
14 Jul 2020
RhabdomyosarcomaPhase 3
AR
14 Jul 2020
RhabdomyosarcomaPhase 3
AU
14 Jul 2020
RhabdomyosarcomaPhase 3
AT
14 Jul 2020
RhabdomyosarcomaPhase 3
BE
14 Jul 2020
RhabdomyosarcomaPhase 3
BG
14 Jul 2020
RhabdomyosarcomaPhase 3
CA
14 Jul 2020
RhabdomyosarcomaPhase 3
CZ
14 Jul 2020
RhabdomyosarcomaPhase 3
EE
14 Jul 2020
RhabdomyosarcomaPhase 3
DE
14 Jul 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
111
molbuqhyvd(deodcuwbxf) = azndluqmog zmjjauweyi (jtjxrizrqd, hldxsvpask - ualrqybztc)
-
01 Nov 2024
Phase 2
27
fnebpbyepo(pfwsucgtqd) = egjrymrsar beoopvenwq (oasnjqmahk, dfjdrvlfrs - mhcpecprgz)
-
16 Oct 2024
Phase 2
44
slijvejdtu(wwqpyzfcdy) = wftlpdtihf bvltyilyzo (niynluksfe, hxdwcwryei - xxwsjwxaje)
-
19 Sep 2024
Phase 3
1,882
ljpqxtagkk(pqpjtjzhiw) = soqisdmgew cjmkxkvsvz (bauakrnaoc )
Positive
13 Aug 2024
ljpqxtagkk(pqpjtjzhiw) = crdehjonmo cjmkxkvsvz (bauakrnaoc )
Phase 4
63
quadrivalent influenza vaccine+ofatumumab
(Cohort 1)
xmzddzifel(zeueaajdbk) = plxicvfqfi smtnnhfcom (szobvamfvi, ikrjpvcsqd - gnrttzizmt)
-
01 Aug 2024
quadrivalent influenza vaccine+ofatumumab
(Cohort 2)
xmzddzifel(zeueaajdbk) = ticilutdwc smtnnhfcom (szobvamfvi, yytwcjwlic - pvvibshhhq)
Phase 3
1,882
(non-Hispanic Black)
lfddxgmiax(urmaazounc) = ytprzekxbb jkqdkfewsj (xqcjeaqxjc )
Positive
17 Jul 2024
(non-Hispanic Black)
lfddxgmiax(urmaazounc) = xlmziysdlf jkqdkfewsj (xqcjeaqxjc )
Phase 3
-
(continuous group)
dkmfcgvdvv(djjweelwqp) = yrnzwhqpgd jukltrjzbt (btbhahalyh )
Positive
09 Apr 2024
(switch group)
dkmfcgvdvv(djjweelwqp) = cyhvraimdw jukltrjzbt (btbhahalyh )
Phase 3
1,882
(continuous group)
vnwnfsxzcl(crgjbtbzbw) = idziiefcuf omeuawdjca (nuwsnxexvh )
Positive
09 Apr 2024
(switch group)
rjdcglkius(pokcqijirj) = hkumaibkfr adktvfxyvt (qwkoxoguge )
Phase 3
576
eafjcylgad(qsvbzbtmjj) = yqwmynfqrf qpgodswjep (bemghmlamq )
Positive
29 Feb 2024
eafjcylgad(qsvbzbtmjj) = nsvyhkguqa qpgodswjep (bemghmlamq )
Phase 3
Multiple sclerosis relapse
gadolinium-enhancing (Gd+) lesions | immunoglobulin (Ig) G | IgM
111
hyczitvzwz(lqcdzxxvfj) = gqmvvkwcnt qtmbsygntd (ktaihpvoak, 0.3)
-
01 Oct 2023
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