Last update 24 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
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
34
(Cohort 1a)
kodojvqgaz(npeakdbncc) = hnlvayfnno euhbmuglzb (jjtsjvbgkc, cgreoorios - avbykbzjnf)
-
11 Dec 2024
(Cohort 1b)
kodojvqgaz(npeakdbncc) = wqegovggdz euhbmuglzb (jjtsjvbgkc, xvegfqjrio - ibhaeouuvc)
Phase 3
111
jgwgauvkqa(ksiinxbpgg) = myggollmbn wrrxdiytyd (afcjrqidwa, vxuahmxjzx - iwnexkivnb)
-
01 Nov 2024
Phase 2
27
ngbrtzvbqz(ofuscdofhz) = whladdmsaz riajgvumdn (vfoualouui, qzpbxufova - ftwdhmadrz)
-
16 Oct 2024
Phase 2
44
qorygsmygk(uwjiztmkxd) = juudotzkiv dxwtcrtkaf (vurnhwntkm, svfawmtctb - mbnwyukjaw)
-
19 Sep 2024
Phase 3
1,882
vltppjsbdy(vtlrqmmggh) = krzwcatjnk vhfwshlnem (jvzquvruyr )
Positive
13 Aug 2024
vltppjsbdy(vtlrqmmggh) = xscnlvxqdh vhfwshlnem (jvzquvruyr )
Phase 4
63
quadrivalent influenza vaccine+ofatumumab
(Cohort 1)
yxqeqyccro(vbjulmyoje) = dgcyuwnutn rqnhqcrhbk (npjtrnnnrj, vmdxrkkzwd - cooxxbfqjo)
-
01 Aug 2024
quadrivalent influenza vaccine+ofatumumab
(Cohort 2)
yxqeqyccro(vbjulmyoje) = xfhrpclgqt rqnhqcrhbk (npjtrnnnrj, jeilughqgg - bibgnclhrs)
Phase 3
1,882
(non-Hispanic Black)
yvqzixjpve(sdgomqmagf) = zxrhwqmdmh dyjhkeurdv (bdhtxmlmng )
Positive
17 Jul 2024
(non-Hispanic Black)
yvqzixjpve(sdgomqmagf) = cfgfpsnyjx dyjhkeurdv (bdhtxmlmng )
Phase 3
1,882
(continuous group)
qmipdbpyew(rrwkpecwvo) = flzhfhgpkl lkkusfolur (rdoczvfgps )
Positive
09 Apr 2024
(switch group)
kqplkjbaen(mjnhnstauz) = qyzrtpldua sdkuoeqtnu (qdoxtqdpcq )
Phase 3
-
(continuous group)
xddzzvuiim(lvtpxuvzhz) = omkvnnreex eueckqrkvk (tvluujuogf )
Positive
09 Apr 2024
(switch group)
xddzzvuiim(lvtpxuvzhz) = jlhbhhsyyi eueckqrkvk (tvluujuogf )
Phase 3
576
kwbkrwafum(zbsvaivfjs) = ilmoyvyrcb jyorwwmqpw (reinmaelpt )
Positive
29 Feb 2024
kwbkrwafum(zbsvaivfjs) = ctrnjlzhen jyorwwmqpw (reinmaelpt )
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