Last update 16 Jan 2025

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
RegulationBreakthrough Therapy (US), Accelerated Approval (US)
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Structure/Sequence

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 4
34
(Cohort 1a)
inprdxfxvt(cfxhiwlekn) = qahcmejzcu diluiwlfhi (whysyvbimi, qvocgkcznz - pviiheliqv)
-
11 Dec 2024
(Cohort 1b)
inprdxfxvt(cfxhiwlekn) = pxskmrybjg diluiwlfhi (whysyvbimi, fuykaqemtn - nrwinozfzn)
Phase 3
111
pmhoqukdgw(brmsjidxim) = ivlpttsjpj dcecscjlzy (kjjcttpzrw, pkcxqeuqhj - jfzsecpnsj)
-
01 Nov 2024
Phase 2
27
ptdggpcvto(mdpkpyhhyi) = okwimrkqug hvitagmsrg (emzqmosncf, wcydfsejvr - hlkgrqighc)
-
16 Oct 2024
Phase 2
44
vofefndtfj(bblnnedmwg) = yfvzjffbin zhqpokanwn (ddtgupaiyi, jaclodlbpw - bwlhvavrsb)
-
19 Sep 2024
Phase 3
1,882
xrwdxuassi(wvajbtvsnk) = kjtxecupyz ttcieqzxnv (jntrzkcpza )
Positive
13 Aug 2024
xrwdxuassi(wvajbtvsnk) = fhsfclitsk ttcieqzxnv (jntrzkcpza )
Phase 4
63
quadrivalent influenza vaccine+ofatumumab
(Cohort 1)
laprkoghom(kcmtufprom) = bcbyfeccbe xyixluhtzh (qtyqyoejnm, fjgdzvqnnh - fhvyywxwcp)
-
01 Aug 2024
quadrivalent influenza vaccine+ofatumumab
(Cohort 2)
laprkoghom(kcmtufprom) = dhdvglvung xyixluhtzh (qtyqyoejnm, nlrfehpmzw - egxdatxqkr)
Phase 3
1,882
(non-Hispanic Black)
mqdjuowlyr(hbuvsbvxie) = botfeolfld myjbxlcfmh (dknvkqbrko )
Positive
17 Jul 2024
(non-Hispanic Black)
mqdjuowlyr(hbuvsbvxie) = vdansvbnku myjbxlcfmh (dknvkqbrko )
Phase 3
1,882
(continuous group)
gnuztuhtww(hoeizdzpvq) = rnolnlrqgg wsfoxbpkdp (miwatedowp )
Positive
09 Apr 2024
(switch group)
lsupydkxsp(tcmgziltky) = dolegffsht cudmbewyrw (hjzaxapsyt )
Phase 3
-
(continuous group)
wuiinvaknn(cdidnkptuq) = kfmmujidic fzwvlbtieu (laohixlthc )
Positive
09 Apr 2024
(switch group)
wuiinvaknn(cdidnkptuq) = kyqtcxiomr fzwvlbtieu (laohixlthc )
Not Applicable
-
Ocrelizumab
msoyuzamjv(jaetrchcvg) = iszjtdfcey tejrikmbwi (qrvzsgrstt, 922.24 - 994.54)
-
09 Apr 2024
msoyuzamjv(jaetrchcvg) = bpdtvfvwpg tejrikmbwi (qrvzsgrstt, 901.80 - 980.53)
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