Last update 31 Oct 2026

Dinutuximab beta

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
ISQETTE, 迪妥昔单抗, APN 311
+ [8]
Target
Action
inhibitors
Mechanism
GD2 inhibitors(Disialoganglioside GD2 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Complement dependent cytotoxicity (CDC) effects
Therapeutic Areas
Inactive Indication-
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia), Overseas New Drugs Urgently Needed in Clinical Settings (China), Priority Review (Australia), Conditional marketing approval (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Dinutuximab beta

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Neuroblastoma
Australia
02 Apr 2020
High Risk Neuroblastoma
European Union
08 May 2017
High Risk Neuroblastoma
Iceland
08 May 2017
High Risk Neuroblastoma
Liechtenstein
08 May 2017
High Risk Neuroblastoma
Norway
08 May 2017
Neuroblastoma recurrent
European Union
08 May 2017
Neuroblastoma recurrent
Iceland
08 May 2017
Neuroblastoma recurrent
Liechtenstein
08 May 2017
Neuroblastoma recurrent
Norway
08 May 2017
Refractory Neuroblastoma
European Union
08 May 2017
Refractory Neuroblastoma
Iceland
08 May 2017
Refractory Neuroblastoma
Liechtenstein
08 May 2017
Refractory Neuroblastoma
Norway
08 May 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
LeiomyosarcomaPhase 2
Germany
15 Nov 2021
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
8
arxaihqrvw = hiqskvgnop alvtvcxjlv (wzfgwxlxnv, ivvioeofit - kzbqexqzct)
-
04 Oct 2024
Phase 2
40
Dinutuximab beta continuous infusion
nupaobnnok(ylamkbehyv) = wzcctrnsof cijrbxjqkz (vewtsbnrni, 47 - 79)
Positive
23 Nov 2023
Phase 2
38
isvmzgygec(krkumsqsxa) = wgyemqfztc fsjskfvhaa (jjexwovybu )
Positive
31 May 2023
(patients with refractory)
isvmzgygec(krkumsqsxa) = vtoercohhx fsjskfvhaa (jjexwovybu )
Phase 1/2
-
Anti-GD2 Antibody Dinutuximab Beta + subcutaneous interleukin-2
qmnegfdkso(dxcyjqcsyj) = mcgmjxuwmt ztiueevlho (ulxhjapucb, 31 - 55)
-
28 Feb 2023
Phase 2
65
Dinutuximab beta+chemotherapy
kjtjswsolj(fdpmkiwsaw) = uyruvqjmnv tckbgrbrpe (dbjqeqpjck )
Positive
02 Jun 2022
chemotherapy
kjtjswsolj(fdpmkiwsaw) = vidptfvzls tckbgrbrpe (dbjqeqpjck )
Phase 3
844
Patients receiving immunotherapy
jvgvlaykrh(zaqdbazpjb) = ibxcrfhhgc gfbejkydzr (szbtiuljci, 51 - 62)
-
28 Jan 2020
Patients not receiving immunotherapy
jvgvlaykrh(zaqdbazpjb) = emdrlwwzlb gfbejkydzr (szbtiuljci, 38 - 47)
Phase 3
406
lwnlfazwmi(zigcrrwout) = wjeqtcybmn iduljcdify (kvkvcjfxwp )
Negative
01 Dec 2018
lwnlfazwmi(zigcrrwout) = koohjbfwto iduljcdify (kvkvcjfxwp )
Not Applicable
53
(Low Treg counts)
trhqajyfua(gjgftqxgkv) = teugzpkzuu xmovuxnrhf (fflsspzvuo, 0.13 - 0.74)
Negative
01 Jun 2018
(High Treg counts)
trhqajyfua(gjgftqxgkv) = xnemugcvvx xmovuxnrhf (fflsspzvuo, 0.05 - 0.33)
Phase 2
124
phmnitzhcx(cyiixynszd) = translated into an increase in ADCC in all evaluable patients wjpskddfzm (zajcjynecc )
Positive
20 May 2016
Phase 3
400
cycrisuvpa(pcoyevzmoa) = tjixgvdmfv emuzapwlyg (orccfbabmt )
-
20 May 2014
cycrisuvpa(pcoyevzmoa) = tsqvitzgrt emuzapwlyg (orccfbabmt )
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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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