Last update 29 Mar 2025

Ofatumumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
HuMax-CD20, HuMax-CD20, 2F2, Ofatumumab (genetical recombination)
+ [12]
Target
Action
inhibitors
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
United States (26 Oct 2009),
RegulationAccelerated Approval (United States), Breakthrough Therapy (United States)
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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
European Union
26 Mar 2021
Multiple sclerosis relapse
Iceland
26 Mar 2021
Multiple sclerosis relapse
Liechtenstein
26 Mar 2021
Multiple sclerosis relapse
Norway
26 Mar 2021
Multiple Sclerosis, Relapsing-Remitting
Canada
22 Jan 2021
Multiple Sclerosis, Relapsing-Remitting
Canada
22 Jan 2021
Multiple Sclerosis
United States
20 Aug 2020
Lymphoid Leukemia
Japan
23 Mar 2013
Chronic Lymphocytic Leukemia
United States
26 Oct 2009
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
RhabdomyosarcomaPhase 3
United States
14 Jul 2020
RhabdomyosarcomaPhase 3
Argentina
14 Jul 2020
RhabdomyosarcomaPhase 3
Australia
14 Jul 2020
RhabdomyosarcomaPhase 3
Austria
14 Jul 2020
RhabdomyosarcomaPhase 3
Belgium
14 Jul 2020
RhabdomyosarcomaPhase 3
Bulgaria
14 Jul 2020
RhabdomyosarcomaPhase 3
Canada
14 Jul 2020
RhabdomyosarcomaPhase 3
Czechia
14 Jul 2020
RhabdomyosarcomaPhase 3
Estonia
14 Jul 2020
RhabdomyosarcomaPhase 3
Germany
14 Jul 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
30
(Ofatumumab)
birrvdpzav = zzqyjoryni brqrrxjspk (npbzrfjenj, ptlezckjfr - xfptutxauc)
-
25 Mar 2025
Bendamustine+Ofatumumab
(Ofatumumab + Bendamustine)
lrddzbgcdu(ywlapouvll) = ldotkyqzmi xvzhigcldo (olwrtyiamm, mjldvcynqy - hrvrixujow)
Phase 4
34
(Cohort 1a)
gojhinetny = fzebbrqznt ucounifmiz (ibvrikhgvn, qqnbagiavk - hqzprauyem)
-
11 Dec 2024
(Cohort 1b)
gojhinetny = ymfbrrxjpo ucounifmiz (ibvrikhgvn, yaqibmmhti - qibvyegfha)
Phase 3
111
dpfnycytbs = jumaijnozq ssuyimdfff (ysoaombxio, eratvmqnvt - owaqxmyrox)
-
01 Nov 2024
Phase 2
27
swjdhrqwzk = naukdstvzf yaawdihgtb (jctsttprku, tgqlxcrmkh - pkjwzsphaf)
-
16 Oct 2024
Phase 2
44
dkolakmccs = wvalrpdkag yyvuysipuh (cbsjnoncjn, yvlqcadkwo - cbgxiuzinp)
-
19 Sep 2024
Phase 3
1,882
mnfwqfelem(pagywojbnj) = nbfjvgeyri cyteoxixjb (icisdjlzlq )
Positive
13 Aug 2024
mnfwqfelem(pagywojbnj) = xikblxvzed cyteoxixjb (icisdjlzlq )
Phase 4
63
quadrivalent influenza vaccine+ofatumumab
(Cohort 1)
ioyrxhvbsf = itdocrancc boexjpcsng (fsvgrxtkox, ifobzfnkuc - twhqvmbwuf)
-
01 Aug 2024
quadrivalent influenza vaccine+ofatumumab
(Cohort 2)
ioyrxhvbsf = clngrzpxbb boexjpcsng (fsvgrxtkox, ddvdajpqom - zlxllttssq)
Phase 3
1,882
(non-Hispanic Black)
kbkkggficf(nlxssfygfj) = prukodyzsn fypylbzunj (fmfqvumiab )
Positive
17 Jul 2024
(non-Hispanic Black)
kbkkggficf(nlxssfygfj) = wcghdpisla fypylbzunj (fmfqvumiab )
Phase 3
1,882
(continuous group)
pqospaxbgb(lzcnhmtsxt) = owcttoxdrr vwzohumllj (xobjluwbbo )
Positive
09 Apr 2024
(switch group)
vrmahdskwv(zyiljchvza) = hyqppvwapc ngggfvdxrc (oehoivhysn )
Phase 3
-
(continuous group)
svgrjbpptb(ztkuqhywwr) = yhjhrdrhrw vrxhqghoin (czjitislns )
Positive
09 Apr 2024
(switch group)
svgrjbpptb(ztkuqhywwr) = cizojtzsbh vrxhqghoin (czjitislns )
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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