Drugs / Dinutuximab
Dinutuximab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Unituxin | — | 2015-08-14 | europa.eu ↗ |
| Approved | US (FDA) | UNITUXIN | — | 2015-03-10 | fda.gov ↗ |
Trials 47
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 115 trials | ||||||
| Phase 1 | NCT07688252 | Jul 2026 → Dec 2032 expected | neuroblastoma | Chang Gung Memorial Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT06839703 | Mar 2025 → Mar 2027 expected | sarcoma | Prof. Dr. Dirk Reinhardt | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06485947 | Jan 2025 → Jul 2030 expected | neuroblastoma | Princess Maxima Center for Pediatric Oncology | Recruiting | No outcome recorded |
| Phase 1 | NCT05373901 | Jun 2022 → Jun 2023 | neuroblastoma | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT05272371 | Dec 2021 → Sep 2026 overdue | neuroblastoma | Jagiellonian University | Recruiting | No outcome recorded |
| Phase 1 | NCT04751383 | Aug 2021 → Sep 2024 | neuroblastoma, osteosarcoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT02573896 | Jan 2019 → Dec 2026 expected | neuroblastoma | New Approaches to Neuroblastoma Therapy Consortium | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03332667 | Sep 2018 → Feb 2024 | neuroblastoma | New Approaches to Neuroblastoma Therapy Consortium | Completed | No outcome recorded |
| Phase 1 | NCT02914405 | May 2018 → Jun 2025 overdue | neuroblastoma | University Hospital Southampton NHS Foundation Trust | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02130869 | Oct 2014 → Dec 2017 | lymphoma, neuroblastoma | St. Jude Children's Research Hospital | Completed | No outcome recorded |
| Phase 1 | NCT01711554 | Feb 2013 → Sep 2018 overdue | neuroblastoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT01576692 | Apr 2012 → Oct 2014 | neuroblastoma | St. Jude Children's Research Hospital | Completed | No outcome recorded |
| Phase 1 | NCT00743496 | Oct 2008 → Apr 2014 | Ewing sarcoma, melanoma, neuroblastoma, osteosarcoma | St. Jude Children's Research Hospital | Completed | No outcome recorded |
| Phase 1 | NCT01704872 | Jul 2005 → Feb 2006 | neuroblastoma | St. Anna Children's Cancer Research | Completed | No outcome recorded |
| Phase 1 | NCT00005576 | Jan 2001 → Mar 2002 | neuroblastoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1/26 trials | ||||||
| Phase 1/2 | NCT07853105 | Oct 2026 → Feb 2031 expected | Ewing sarcoma, bone cancer, osteosarcoma | University Hospital, Strasbourg, France | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07334301 | Nov 2024 → Dec 2030 expected | neuroblastoma | University of Birmingham | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04211675 | Sep 2022 → Dec 2026 expected | neuroblastoma | Nationwide Children's Hospital | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04238819 | Nov 2020 → Mar 2024 | refractory malignant neoplasm | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1/2 | NCT01592045 | Aug 2012 → Jun 2014 | neuroblastoma | United Therapeutics | Completed | No outcome recorded |
| Phase 1/2 | NCT01701479 | Jan 2012 → Dec 2020 | neuroblastoma | St. Anna Children's Cancer Research | Unknown | No outcome recorded |
| Phase 215 trials · 3 met primary | ||||||
| Phase 2 | NCT07261241 | Jul 2026 → Jul 2030 expected | neuroblastoma | New Approaches to Neuroblastoma Therapy Consortium | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07318831 | Jan 2026 → Dec 2028 expected | neuroblastoma | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05558280 | Nov 2023 → Dec 2025 | pediatric osteosarcoma | Prof. Franca Fagioli | Suspended | No outcome recorded |
| Phase 2 | NCT05421897 | Nov 2022 → Nov 2028 expected | neuroblastoma | Children's Hospital Los Angeles | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05754684 | Jan 2022 → Dec 2025 overdue | neuroblastoma | Hong Kong Children's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05080790 | Nov 2021 → Jan 2025 | leiomyosarcoma | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Completed | No outcome recorded |
| Phase 2 | NCT04385277 | Dec 2020 → Jun 2023 overdue | neuroblastoma, nodular ganglioneuroblastoma | Children's Oncology Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02484443 | Feb 2016 → Mar 2020 | lung cancer, osteosarcoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT02641782 | Nov 2015 → Dec 2016 | neuroblastoma | University of Cologne | Terminated | No outcome recorded |
| Phase 2 | NCT02743429 | Mar 2015 → Dec 2023 | neuroblastoma | University Medicine Greifswald | Unknown | No outcome recorded |
| Phase 2 | NCT02169609 | Nov 2014 → Dec 2016 | neuroblastoma | Fundació Sant Joan de Déu | Completed | No outcome recorded |
| Phase 2 | NCT01857934 | Jul 2013 → Oct 2021 | neuroblastoma | St. Jude Children's Research Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02308527 | Jul 2013 → Aug 2021 | neuroblastoma | University of Birmingham | Completed | Met primary |
| Phase 2 | NCT01767194 | Feb 2013 → Jun 2018 | ganglioneuroblastoma, neuroblastoma | National Cancer Institute (NCI) | Completed | Met primary |
| Phase 2 | NCT02258815 | Aug 2010 → Nov 2018 | neuroblastoma | University Children's Hospital Tuebingen | Completed | Met primary |
| Phase 2/32 trials · 1 missed | ||||||
| Phase 2/3 | NCT07549321 | Mar 2026 → Mar 2031 expected | neuroblastoma | Renaissance Pharma Ltd. | Recruiting | No outcome recorded |
| Phase 2/3 | NCT03098030 | Jun 2017 → Jan 2020 | small cell lung carcinoma | United Therapeutics | Completed | Missed primary |
| Phase 39 trials · 1 met primary | ||||||
| Phase 3 | NCT07375563 | Nov 2025 → Dec 2026 expected | ganglioneuroblastoma, neuroblastoma | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Recruiting | No outcome recorded |
| Phase 3 | NCT06172296 | Apr 2024 → Dec 2029 expected | neuroblastoma, nodular ganglioneuroblastoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 3 | NCT06071897 | Sep 2023 → Sep 2026 overdue | ganglioneuroblastoma, neuroblastoma | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Recruiting | No outcome recorded |
| Phase 3 | NCT06669013 | May 2021 → Sep 2025 overdue | alveolar rhabdomyosarcoma, bone sarcoma, embryonal rhabdomyosarcoma | N.N. Petrov National Medical Research Center of Oncology | Recruiting | No outcome recorded |
| Phase 3 | NCT04221035 | Nov 2019 → Nov 2026 expected | neuroblastoma | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT01041638 | Dec 2009 → Dec 2013 | neuroblastoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 3 | NCT01704716 | Feb 2002 → Sep 2021 overdue | neuroblastoma | St. Anna Children's Cancer Research | Recruiting | Mixed |
| Phase 3 | NCT00030719 | Dec 2001 → ? | neuroblastoma | University of Leicester | Unknown | Met primary |
| Phase 3 | NCT00026312 | Oct 2001 → Jan 2012 | neuroblastoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Comparator or background therapy8 trials | ||||||
| Phase 1 | NCT06995872 Background | Oct 2025 → Jun 2028 expected | neuroblastoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT05400603 Background | Nov 2023 → Dec 2026 expected | neuroblastoma, osteosarcoma | Emory University | Recruiting | No outcome recorded |
| Phase 1 | NCT05608148 Background | Oct 2022 → Aug 2027 expected | childhood malignant neoplasm, neuroblastoma | Kyushu University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07437963 Background | Oct 2026 → Sep 2029 expected | ganglioneuroblastoma, neuroblastoma | National Cancer Institute (NCI) | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07085338 Background | Nov 2025 → Feb 2028 expected | neuroblastoma | St. Jude Children's Research Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06450041 Background | Dec 2024 → Dec 2028 expected | neuroblastoma | New Approaches to Neuroblastoma Therapy Consortium | Recruiting | No outcome recorded |
| Phase 2 | NCT03794349 Background | Jul 2019 → Mar 2025 overdue | neuroblastoma | Children's Oncology Group | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03126916 Background | May 2018 → Sep 2030 expected | neuroblastoma, nodular ganglioneuroblastoma | Children's Oncology Group | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2021-08-17 | BeOne Medicines | Regulatory BeiGene and EUSA Pharma Announce China NMPA Approval of QARZIBA® (Dinutuximab Beta) for Patients with High-Risk Neuroblastoma beonemedicines.com ↗
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) and EUSA Pharma (UK), Ltd. today announced that the China National Medical Products Administration (NMPA) has granted QARZIBA® (dinutuximab beta) conditional approval for the treatment of high-risk neuroblastoma in patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with a history of relapsed or refractory (R/R) neuroblastoma with or without residual disease. |
| 2020-11-10 | BeOne Medicines | Regulatory EUSA Pharma and BeiGene Announce Acceptance of a Biologics License Application for QARZIBA®▼ (Dinutuximab Beta) in China beonemedicines.com ↗
EUSA Pharma (UK) Limited and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) today announced that the Biologics License Application (BLA) for QARZIBA®▼ (dinutuximab beta) was accepted by the China National Medical Products Administration (NMPA) and granted priority review. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-08-17 | BeOne Medicines | BeiGene and EUSA Pharma Announce China NMPA Approval of QARZIBA® (Dinutuximab Beta) for Patients with High-Risk Neuroblastoma beonemedicines.com ↗ |
| 2020-11-10 | BeOne Medicines | EUSA Pharma and BeiGene Announce Acceptance of a Biologics License Application for QARZIBA®▼ (Dinutuximab Beta) in China beonemedicines.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 56 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dinutuximab | “Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refractory Neuroblastoma” NCT06995872 ↗22“Dinutuximab: 17.5mg/m2/day on Day4-7 and Day36-39” NCT05608148 ↗ |
| Known as | APN311 | “APN311 (ch14.18/CHO) is manufactured in a Good Manufacturing Practice (GMP) compliant facility” NCT02914405 ↗ |
| Known as | ch14.18 | “Anti-ganglioside GD2 antibody ch14.18 is a monoclonal antibody specifically recognizing the target antigen GD2” NCT01704872 ↗ |
| Known as | ch14.18/CHO | “anti-GD2 МАB ch14.18/CHO (dinutuximab beta)” NCT06071897 ↗ |
| Known as | daretabart | “This multinational study aims to find out how effective and safe the treatment of a monoclonal anti-GD2 antibody hu14.18K322A (daretabart) is when used together with...” NCT07549321 ↗ |
| Known as | DIN | “the anti-GD2 antibody dinutuximab (DIN) and granulocyte macrophage colony stimulating factory (GM-CSF)” PMID 36822669 ↗ Feb 2023 |
| Known as | Dinutuximab-beta | “Dinutuximab-beta 10 mg/m²/day administered as a continuous intravenous infusion on Days 0-9 of Cycles 2-6.” NCT07688252 ↗17“Dinutuximab beta 10 mg/m2 i.v., days 5-9” NCT06071897 ↗ |
| Known as | Hu14.18K322A | “This multinational study aims to find out how effective and safe the treatment of a monoclonal anti-GD2 antibody hu14.18K322A (daretabart) is when used together with...” NCT07549321 ↗6“We report the results of a phase I trial to determine the maximum-tolerated dose (MTD), safety profile, and pharmacokinetics of hu14.18K322A, a humanized anti-GD2 mAb with a...” PMID 24711551 ↗ Apr 2014 “Phase I trial of a novel anti-GD2 monoclonal antibody, Hu14.18K322A, designed to decrease toxicity in children with refractory or recurrent neuroblastoma.” PMID 24711551 ↗ Apr 2014 “a humanized anti-GD2 antibody (HU14.18K322A)” NCT01576692 ↗ |
| Action | Deplete | “Monoclonal antibodies, such as Ch14.18, may find tumor cells and help kill them.” NCT01041638 ↗ |
| Modality | Monoclonal antibody | “ANTI-GD2 MONOCLONAL ANTIBODY (ch14.18)” NCT00005576 ↗ |
| Route | Intravenous | “Given IV” NCT00005576 ↗ |