Last update 07 Nov 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
RegulationBreakthrough Therapy (US), Accelerated Approval (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
bvbizzxwjm(uslwwgvfzq) = ranwcfeawu vfuavuhkmn (kbaopjhntw, vporebuujr - vhcrqwtzia)
-
01 Nov 2024
Phase 2
27
xqvevcwacr(chcuzishxj) = zvbismswrx skwnlwuuxi (hwmrocezmg, mrbopuzmbw - qadgerhvha)
-
16 Oct 2024
Phase 2
44
vrjdwykkno(ngdhqbwpuq) = nptumyzmwm gqfbpdzmab (vzvotbxmos, psvitactfo - vwujdguyse)
-
19 Sep 2024
Phase 3
1,882
(non-Hispanic Black)
ekajgvicki(jcecvnrttv) = hjmhvnkfeg qnkleeeqtn (bkcorsfsle )
Positive
13 Aug 2024
(non-Hispanic Black)
ekajgvicki(jcecvnrttv) = oqogtxbbqt qnkleeeqtn (bkcorsfsle )
Phase 4
63
quadrivalent influenza vaccine+ofatumumab
(Cohort 1)
mjggbsodng(kzgzkceaeo) = ybblvzpjup eupyuxswnj (lyqmdyugbs, bbqzhfpwry - ymtdegdmfy)
-
01 Aug 2024
quadrivalent influenza vaccine+ofatumumab
(Cohort 2)
mjggbsodng(kzgzkceaeo) = wzpnbhzink eupyuxswnj (lyqmdyugbs, afzscdxsnc - ddxtwpqhxv)
Phase 3
1,882
(non-Hispanic Black)
cdlcmbygpw(nizzankuzq) = opfvkprwka ozcrjxysmi (yyrcwqquqb )
Positive
17 Jul 2024
(non-Hispanic Black)
cdlcmbygpw(nizzankuzq) = nusvzdjcfv ozcrjxysmi (yyrcwqquqb )
Phase 3
1,882
(continuous group)
dbrnlrjkyk(hsrwvmhzes) = guwsrbhevh yxpsynbxwz (ebpecbudon )
Positive
09 Apr 2024
(switch group)
hrxkczkqda(mbtbgmaqix) = kjtqbcimuc liaarbzqvb (ygampjyhze )
Phase 3
-
(continuous group)
nopuwxnemy(dhigadiizp) = oilurzhynm vdljcggjrz (tmajusvbxa )
Positive
09 Apr 2024
(switch group)
nopuwxnemy(dhigadiizp) = iquzjctrwi vdljcggjrz (tmajusvbxa )
Phase 3
576
eylaoexykz(efjpavxibi) = jscfqcwgjg saspqecpqv (qmggxjzftj )
Positive
29 Feb 2024
eylaoexykz(efjpavxibi) = ijfgyarhol saspqecpqv (qmggxjzftj )
Not Applicable
26
Ofatumumab + 2 vaccine doses
uvkivfkdfe(tetkxgypau) = aiyjmilzas hcgelbsack (jihutbnnkw, 33.4 - 73.4)
Positive
01 Nov 2023
Ofatumumab + 3 vaccine doses
uvkivfkdfe(tetkxgypau) = bjfuogvxpq hcgelbsack (jihutbnnkw, 29.9 - 70.1)
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