UNITUXIN (dinutuximab)
UNITUXIN is indicated for the treatment of Neuroblastoma.
How UNITUXIN Works
Dinutuximab targets and binds to the glycolipid GD2, which is expressed on the surface of neuroblastoma cells and normal cells of neuroectodermal origin. Once bound to the cell surface, the antibody induces cell lysis of the GD2-expressing cells. This therapeutic effect is achieved through two immune processes: antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).
Development Insights
Details
- Status
- Prescription
- First Approved
- 2015-03-10
- Patent Cliff
- 2022
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
UNITUXIN Approval History
What UNITUXIN Treats
1 indicationsUNITUXIN is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Neuroblastoma
UNITUXIN Boxed Warning
SERIOUS INFUSION REACTIONS AND NEUROTOXICITY WARNING: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY See full prescribing information for complete boxed warning. Infusion Reactions: Life-threatening infusion adverse reactions occur with Unituxin. Administer required prehydration and premedication. Immediately interrupt for severe infusion reactions and permanently discontinue for anaphylaxis [see Dosage and Administration (2.2 , 2.3) and Warnings and Precautions (5.1) ] . Neurotoxicity: Unituxin c...
WARNING: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY WARNING: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY See full prescribing information for complete boxed warning. Infusion Reactions: Life-threatening infusion adverse reactions occur with Unituxin. Administer required prehydration and premedication. Immediately interrupt for severe infusion reactions and permanently discontinue for anaphylaxis [see Dosage and Administration (2.2 , 2.3) and Warnings and Precautions (5.1) ] . Neurotoxicity: Unituxin causes severe neuropathic pain. Administer intravenous opioid prior to, during, and for 2 hours following completion of the Unituxin infusion. Severe peripheral sensory neuropathy ranged from 2% to 9% in patients with neuroblastoma. Severe peripheral motor neuropathy has also been reported. Discontinue for severe unresponsive pain, severe sensory neuropathy, and moderate to severe peripheral motor neuropathy [see Dosage and Administration (2.2 , 2.3) and Warnings and Precautions (5.2) ] . Infusion Reactions Serious and potentially life-threatening infusion reactions occurred in 26% of patients treated with Unituxin. Administer required prehydration and premedication including antihistamines prior to each Unituxin infusion. Monitor patients closely for signs and symptoms of an infusion reaction during and for at least four hours following completion of each Unituxin infusion. Immediately interrupt Unituxin for severe infusion reactions and permanently discontinue Unituxin for anaphylaxis ( 2.2, 2.3, 5.1 ). Neurotoxicity Unituxin causes serious neurologic adverse reactions including severe neuropathic pain and peripheral neuropathy. Severe neuropathic pain occurs in the majority of patients. Administer intravenous opioid prior to, during, and for 2 hours following completion of the Unituxin infusion. In clinical studies of patients with high-risk neuroblastoma, Grade 3 peripheral sensory neuropathy occurred in 2% to 9% of patients. In clinical studies of Unituxin and re
UNITUXIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06172296 | NCI-2023-08530 NCI-2023-08530, ANBL2131 | Ph 3 | recruiting | Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma |
| NCT07437963 | NCI-2026-01050 NCI-2026-01050, ANBL2421 | Ph 1, Ph 2 | not yet recruiting | Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse |
| NCT01711554 | NCI-2012-02011 NCI-2012-02011, CDR0000741991 | Ph 1 | active not recruiting | Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma |
| NCT03786783 results posted | NCI-2018-03732 NCI-2018-03732, ANBL17P1 | Ph 2 | active not recruiting | Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma |
| NCT06450041 | NANT 2021-01 | Ph 2 | recruiting | NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial |
| NCT02573896 | NANT 2013-01 | Ph 1 | active not recruiting | Immunotherapy of Relapsed Refractory Neuroblastoma With Expanded NK Cells |
| NCT04238819 results posted | 16950 I3Y-MC-JPCS, 2019-002931-27 | Ph 1, Ph 2 | completed | A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma |
| NCT03126916 | ANBL1531 NCI-2016-01734, ANBL1531 | Ph 3 | recruiting | Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) |
| NCT03794349 results posted | ANBL1821 NCI-2018-03377, ANBL1821 | Ph 2 | active not recruiting | Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma |
| NCT04751383 results posted | NCI-2021-00913 NCI-2021-00913, PED-CITN-03 | Ph 1 | completed | Testing the Combination of Two Immunotherapy Drugs (Magrolimab and Dinutuximab) in Patients With Relapsed or Refractory Neuroblastoma or Relapsed Osteosarcoma |
| NCT07261241 | NANT 2021-02 | Ph 2 | not yet recruiting | NANT 2021-02: Randomized MIBG With Vorinostat/Dinutuximab/Vorinostat + Dinutuximab |
| NCT04385277 results posted | ANBL19P1 NCI-2020-02950, ANBL19P1 | Ph 2 | active not recruiting | Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL) |
| NCT04211675 STING | STUDY00000476 | Ph 1, Ph 2 | recruiting | NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab |
| NCT03332667 results posted | NANT2017-01 2P01CA217959 | Ph 1 | completed | MIBG With Dinutuximab +/- Vorinostat |
| NCT02484443 results posted | NCI-2015-01001 NCI-2015-01001, AOST1421 | Ph 2 | completed | Dinutuximab in Combination With Sargramostim in Treating Patients With Recurrent Osteosarcoma |
| NCT01767194 results posted | NCI-2012-03125 NCI-2012-03125, CDR0000745188 | Ph 2 | completed | Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma |
| NCT01041638 results posted | NCI-2011-01997 NCI-2011-01997, COG-ANBL0931 | Ph 3 | completed | Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma |
| NCT03098030 results posted | DIV-SCLC-301 | Ph 2, Ph 3 | completed | Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
UNITUXIN FDA Label Details
Indications & Usage
FDA Label (PDF)UNITUXIN is indicated for the treatment of Neuroblastoma.
WARNING: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY WARNING: SERIOUS INFUSION REACTIONS AND NEUROTOXICITY See full prescribing information for complete boxed warning. Infusion Reactions: Life-threatening infusion adverse reactions occur with Unituxin. Administer required prehydration and premedica...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment