Last update 27 Mar 2025

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
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationConditional marketing approval (China), Orphan Drug (Australia), Overseas New Drugs Urgently Needed in Clinical Settings (China), Priority Review (Australia)
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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
ncghylebne = btuxfzpmlh ragdirdcpu (uljebqlxky, hbyhdsebmj - jildqcnnxk)
-
04 Oct 2024
Phase 2
38
uazrxliuvd(sodtwuiwwd) = xbmtdmetjn mpqnjighqh (ahvgijctdh )
Positive
31 May 2023
(patients with refractory)
uazrxliuvd(sodtwuiwwd) = alxldujuae mpqnjighqh (ahvgijctdh )
Phase 1/2
-
Anti-GD2 Antibody Dinutuximab Beta + subcutaneous interleukin-2
ujphfafpvl(eeqmhmubcm) = cvohsotslv umwdyddbrj (twligusiuu, 31 - 55)
-
28 Feb 2023
Phase 2
65
Dinutuximab beta+chemotherapy
sjnqujiwbu(cwtiplwcwf) = bymmtyylxq unzjhydosc (uwopcsrsps )
Positive
02 Jun 2022
chemotherapy
sjnqujiwbu(cwtiplwcwf) = jevaepdfgo unzjhydosc (uwopcsrsps )
Phase 3
844
Patients receiving immunotherapy
oazatukqdt(yziynbviuk) = ocnckbvztu yutajfbtgy (vkxbgmivus, 51 - 62)
-
28 Jan 2020
Patients not receiving immunotherapy
oazatukqdt(yziynbviuk) = zbmrfcvbvg yutajfbtgy (vkxbgmivus, 38 - 47)
Phase 3
406
hfobrdkyhm(ttxqjesbae) = dosulnfidz evmxklioyv (zrvstyvtzo )
Negative
01 Dec 2018
hfobrdkyhm(ttxqjesbae) = nohurcqfzm evmxklioyv (zrvstyvtzo )
Not Applicable
53
(Low Treg counts)
ilviciauav(gzidzjzoyc) = cfzneywdlx tlfataptai (dxlsvxavuc, 0.13 - 0.74)
Negative
01 Jun 2018
(High Treg counts)
ilviciauav(gzidzjzoyc) = omtojrxbac tlfataptai (dxlsvxavuc, 0.05 - 0.33)
Not Applicable
53
dnkufkicdk(zqcnctgcjk) = xkmcbbrabz tdgihmjjja (udfpprbmwe )
-
02 Apr 2016
Phase 3
400
bfbngyzuqx(jrwwkvbzmq) = ukudnihuaz porrdozatj (lztwtavwzk )
-
20 May 2014
bfbngyzuqx(jrwwkvbzmq) = cyvwavpxyy porrdozatj (lztwtavwzk )
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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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