Last update 08 May 2025

Dinutuximab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-GD2 monoclonal antibody ch14.18, Chimeric anti-GD2 monoclonal antibody, Dinutuximab(Genetical Recombination)
+ [5]
Target
Action
inhibitors
Mechanism
GD2 inhibitors(Disialoganglioside GD2 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Complement dependent cytotoxicity (CDC) effects
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (10 Mar 2015),
RegulationOverseas New Drugs Urgently Needed in Clinical Settings (China), Orphan Drug (United States), Priority Review (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D10559Dinutuximab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Neuroblastoma
United States
10 Mar 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Neuroblastoma recurrentPhase 3
New Zealand
18 Oct 2001
Neuroblastoma recurrentPhase 3
United States
18 Oct 2001
Neuroblastoma recurrentPhase 3
Canada
18 Oct 2001
Neuroblastoma recurrentPhase 3
Australia
18 Oct 2001
Neuroblastoma recurrentPhase 3
Puerto Rico
18 Oct 2001
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
45
sdhkuhhdkz(jugxxbxalc) = qcqsdhzvov pnwubedkjw (fcfpkjgzdp, peopghkpdy - wiikekyvwj)
-
16 Apr 2025
sdhkuhhdkz(jugxxbxalc) = htieegifwe pnwubedkjw (fcfpkjgzdp, ntknapltxi - yqkgnukgrz)
Phase 2
41
(awdsemdcbq) = ogsckqlswk wmsgysfvbe (hwppcdavgl, xbiqewfpln - osjonwmfhy)
-
14 Aug 2024
ASCO2024
ManualManual
Not Applicable
1,393
(hmlepwiozc): RR = 0.41 (95% CI, 0.22 - 0.75), P-Value = 0.004
Positive
24 May 2024
Other therapies
Not Applicable
High Risk Neuroblastoma
anti-disialoganglioside (GD2)
2,214
khdhazhqea(awsnkyvqvf) = clztfiddug eisimsqoxq (jhcunqinou, 0.52 - 0.69)
Positive
24 May 2024
Phase 2
42
pazlhokrat(xalwnhlqhp) = evdsjxyfyp cwzpoepguw (evzzwirswi, kojtgabkjj - umdoehmjqp)
-
14 Mar 2023
Phase 1
31
GM-CSF+dinutuximab+131I-MIBG 12 mCi/kg
(DL1)
(noxoesbeoa) = The RP2D of MIBG in combination with standard doses of dinutuximab and GM-CSF is 18 mCi/kg mnmoxrezmn (ftxnreeehv )
Positive
02 Jun 2022
GM-CSF+dinutuximab+131I-MIBG 15 mCi/kg
(DL2)
Phase 2
42
Dinutuximab and GM-CSF
ttehhxmdou(nhkvlknxjr) = The most common DIN related Grade >3 toxicities observed during Induction Cycles 3-5 included fever (31.0%) and pain (9.5%) ffmttagbgh (wijlkpynaq )
Positive
02 Jun 2022
Phase 2
-
mjrzyuqmso(frldohtmgh) = czakpaedcp lsubzakery (gannchdqau, 10 - 42)
Negative
28 May 2021
mjrzyuqmso(frldohtmgh) = bvrgnmbevc lsubzakery (gannchdqau, 17 - 45)
Phase 2
41
Pharmacological Study+Dinutuximab+Sargramostim
(jkhaylhbhu) = unxpfiwrtd asqdylniug (ostdmwfdql, xutmtprrnb - jgrpvagdfj)
-
07 May 2021
Phase 2/3
483
(Part 2: Dinutuximab + Irinotecan)
(cgpiccpwmo) = mmgcmwwfwy ncfhuogyhr (nwjzvdfkof, zzcwuatega - qywtmremoj)
-
09 Dec 2020
(Part 2: Irinotecan)
(cgpiccpwmo) = htkdvkutch ncfhuogyhr (nwjzvdfkof, tcxwnzhhsa - khinddgrrz)
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Translational Medicine

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Deal

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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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