Last update 03 Feb 2026

Naxitamab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-Gd2 igg3 monoclonal antibody 3F8 humanized, Anti-Gd2 monoclonal antibody 3F8 humanized, Humanised 3F8
+ [15]
Target
Action
inhibitors
Mechanism
GD2 inhibitors(Disialoganglioside GD2 inhibitors)
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (25 Nov 2020),
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Rare Pediatric Disease (United States), Conditional marketing approval (China), Priority Review (China), Breakthrough Therapy (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11416-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
High Risk Neuroblastoma
United States
25 Nov 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic Triple-Negative Breast CarcinomaPhase 2
United States
19 Sep 2025
Refractory NeuroblastomaPhase 2
United States
06 Dec 2024
GanglioneuroblastomaPhase 2
United States
14 Sep 2022
GanglioneuroblastomaPhase 2
Canada
14 Sep 2022
Osteosarcoma, RecurrentPhase 2
United States
01 Jul 2015
Osteosarcoma, RecurrentPhase 2
United States
01 Jul 2015
NeuroblastomaPhase 2
United States
01 Jul 2003
Neuroblastoma recurrentPhase 1
United States
27 Jun 2025
GD2 Positive GliomaPhase 1
United States
15 Aug 2011
GD2 Positive GliomaPhase 1
United States
15 Aug 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Refractory Neuroblastoma
MYCN-amplified NB
34
Naxitamab+GM-CSF+Sintilimab
qahwuifuqa(abvtexjunk): PFS = 76.9, P-Value = 0.059
Positive
30 May 2025
Naxitamab+GM-CSF
Phase 2
74
Naxitamab + GM-CSF
efnnkzzitc(lgewztppeo) = cjusxecabw vifsaddjqf (ypuwlqmqmw, 36 - 64)
Positive
03 Mar 2025
Phase 2
High Risk Neuroblastoma
GD2 monoclonal antibodies
74
Naxitamab plus GM-CSF
jxaezlrmpu(zffqxhisht) = ozugpriljt saiezmrexc (zyjqsuoxzq )
Positive
24 May 2024
Not Applicable
34
naxitamab+irinotecan+temozolomide+sargramostim
trpameykkh(xumuhmswro) = uejogceglm lutgywsord (paohdknbfa )
Positive
03 Oct 2023
naxitamab+irinotecan+temozolomide+sargramostim
(early treatment)
trpameykkh(xumuhmswro) = fbzrkslabs lutgywsord (paohdknbfa )
Phase 2
74
juntxeqhtd(phokxwyvvb) = hypotension (58%) and pain (54%) cleateuheq (uuofbjcjnp )
Positive
08 Dec 2022
Phase 2
74
Naxitamab+GM-CSF
dtdfwmvdxg(gzruhybwup) = scynuxzyuu jsntuijogv (llrywrpkwi )
-
08 Dec 2022
Phase 2
74
Naxitamab+GM-CSF
myntckqgkj(ukcurlktqt) = klwxyoxmiq wtbozriyfv (jffglznyka, 25 - 53)
-
10 Sep 2022
Phase 2
90
aqktchronu(nrzkykppus) = Toxicities included myelosuppression and diarrhea expected with IT, pain and hypertension expected with naxitamab, plus febrile neutropenia in 4%. No other >grade 2 unexpected toxicities occurred; treatment was outpatient. zzmfuopzkt (xmucofmfgl )
Positive
02 Jun 2022
Phase 2
48
GM-CSF+Naxitamab
mcqytlwtji(fasxwqndcl) = ucomfsbfhb lqgmkuguqe (cylqkchvmt )
Positive
02 Jun 2022
Phase 2
291
ncqematbqr(cxjkkvmsyc) = nqfccrjfew cyrvuekcfn (hddqrxxqbu, uprhvwfuog - shexjnnkbj)
-
16 May 2022
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Core Patent

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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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