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dinutuximab

Trade name: unituxin

mAbapprovedOrphan Drug FDA

Approved

Mar 10, 2015

Dinutuximab and dinutuximab beta are monoclonal antibodies used as a second-line treatment for children with high-risk neuroblastoma. Each antibody is made of both mouse and human components and targets glycolipid GD2, expressed on neuroblastoma cells and on normal cells of neuroectodermal origin, including the central nervous system and peripheral nerves. They differ in that dinutuximab is manufactured using mouse cells, and dinutuximab beta is manufactured using hamster cells. The dosing regime differs, and dinutuximab is given in combination with granulocyte-macrophage colony stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), while dinutuximab beta can be given alone. — Wikipedia

Clinical trial activity

41 trials · 40 clinical orgs · 1 marketing orgs

Phase 1
17
Phase 2
25
Phase 3
8
Phase 4
1

Earliest trial started Jan 1, 2001 (NCT00005576)

Timeline

2000s

  1. Jan 1, 2001

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2001

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Earliest Phase 2 Sponsor(trial)

  2. Dec 20, 2010

    Orphan Drug Designation

  3. Mar 10, 2015

    United Therapeutics — Earliest FDA Approval

  4. Mar 10, 2015

    United Therapeutics — Marketing Organization

  5. Mar 10, 2015

    United Therapeutics — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

  • Disialoganglioside GD2BINDING AGENT

    Disialoganglioside GD2 binding agent

  • Disialoganglioside GD2INHIBITOR

    Disialoganglioside GD2 inhibitor

    A mouse-human chimeric monoclonal IgG1 antibody produced in a mammalian cell line (CHO) by recombinant DNA technology

  • Disialoganglioside GD2Immunity, passive

    Disialoganglioside GD2 immunity, passive

Approval history

  • approvedMar 10, 2015

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • 14,18
  • ch14.18
  • ch14.18
  • ch14.18
  • ch14.18
  • ch14.18 monoclonal antibody
  • ch14.18-utc
  • ch14.18-utc
  • dinutuximab
  • dinutuximab
  • dinutuximab
  • dinutuximab
  • dinutuximab
  • dinutuximab
  • dinutuximab
  • dinutuximab
  • dinutuximab
  • dinutuximab
  • dinutuximab beta
  • dinutuximab beta
  • hu14.18k322a
  • mab ch14.18
  • monoclonal antibody ch14.18
  • monoclonal antibody ch14.18
  • monoclonal antibody ch14.18
  • unituxin
  • unituxin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07261241Phase 2Jul 31, 2026Jubilant DraxImage Inc., National Cancer Institute (NCI), United Therapeutics
NCT06995872Phase 1Oct 21, 2025National Cancer Institute (NCI)
NCT06839703Phase 1Mar 1, 2025German Society for Pediatric Oncology and Hematology GPOH gGmbH
NCT06450041Phase 2Nov 30, 2024National Cancer Institute (NCI), Ohio State University, United Therapeutics
NCT06485947Phase 1Jul 1, 2024EUSA, Princess Maxima Center for Pediatric Oncology
NCT06172296Phase 3Feb 14, 2024National Cancer Institute (NCI)
NCT05558280Phase 2Dec 15, 2022Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna, Città della Salute e della Scienza of Torino
NCT05400603Phase 1Nov 30, 2022Emory University
NCT05421897Phase 4Jul 31, 2022Children's Hospital Los Angeles, United Therapeutics
NCT05373901Phase 1Jun 7, 2022BeOne Medicines
NCT05754684Phase 2Jan 1, 2022Hong Kong Children's Hospital, The University of Hong Kong
NCT05080790Phase 2Nov 15, 2021EUSA, IKF Klinische Krebsforschung GmbH am Krankenhaus Nordwest
NCT06669013Phase 3May 20, 2021Government of Russia
NCT04751383Phase 1Apr 16, 2021Cancer Immunotherapy Trials Network, National Cancer Institute (NCI)
NCT04385277Phase 2Jan 20, 2021National Cancer Institute (NCI)
NCT04211675Phase 1/Phase 2 (Phase 2)Jan 31, 2020Ohio State University
NCT04221035Phase 3Nov 5, 2019Institut Gustave Roussy
NCT03794349Phase 2May 28, 2019National Cancer Institute (NCI)
NCT03786783Phase 2Jan 14, 2019National Cancer Institute (NCI)
NCT03332667Phase 1Sep 5, 2018Children's Hospital Los Angeles, Emory University, National Cancer Institute (NCI), United Therapeutics
Showing 20 of 41 trials
Page 1 / 3

Organizations

Research & Development (40)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government161632001
United TherapeuticsFor profit7242012
St. Anna KinderkrebsforschungAcademic/Hospital5332001
St. Jude Children's HospitalAcademic/Hospital3322008
University of GreifswaldAcademic/Hospital3122010
University of Southern CaliforniaAcademic/Hospital3022008
Children's Hospital Los AngelesAcademic/Hospital2122018
Emory UniversityAcademic/Hospital2112018
EUSAFor profit2022021
Institut Gustave RoussyAcademic/Hospital2122010
Medical University of ViennaAcademic/Hospital2022005
Ohio State UniversityAcademic/Hospital2112020
University of GenoaAcademic/Hospital2022005
University of LondonAcademic/Hospital2022010
University of TuebingenAcademic/Hospital2122008
University of WisconsinAcademic/Hospital2012008
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'AnnaAcademic/Hospital1112022
BeOne MedicinesFor profit1112022
Cancer Immunotherapy Trials NetworkAcademic/Hospital1012021
Città della Salute e della Scienza of TorinoAcademic/Hospital1012022
40 organizations
Page 1 / 2

Marketing (2)

OrganizationOrg typeRelationshipDate
United TherapeuticsFor profitMKTGMar 10, 2015
United TherapeuticsFor profitNDAMar 10, 2015