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Unituxin

(Dinutuximab)

Phase 3Monoclonal antibody

United Therapeutics

Dinutuximab is used to treat a type of childhood cancer called neuroblastoma. It works by helping the immune system recognize and destroy cancer cells.[1] Unituxin is currently being investigated across 7 indications[3], with its most advanced program in Phase 3.[1]

Unituxin is one of 145 biologic programs targeting Leiomyosarcoma. It is currently in Phase 3.

7

Indications

20

Total Trials

11

Active Trials

144

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

LeiomyosarcomaActive, not recruiting

OsteosarcomaActive, not recruiting

NeuroblastomaUnknown

Small Cell Lung CancerActive, not recruiting

High-Risk NeuroblastomaCompleted

Ganglioneuroblastoma, NodularRecruiting

Recurrent GanglioneuroblastomaNot yet recruiting

LeiomyosarcomaPhase 2

Active, not recruiting

OsteosarcomaPhase 2

Active, not recruiting

NeuroblastomaPreclinical

Unknown

Small Cell Lung CancerPhase 2

Active, not recruiting

High-Risk NeuroblastomaPhase 3

Completed

Ganglioneuroblastoma, NodularPhase 3

Recruiting

Recurrent GanglioneuroblastomaPreclinical

Not yet recruiting

Competition

Competitive Landscape

598 competitors in Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Keytruda

Opdivo

Bristol-Myers Squibb

Yervoy

Bristol-Myers Squibb

Taxotere

Beyfortus

Ellence

Lazcluze

Johnson & Johnson

Rybrevant

Johnson & Johnson

Unituxin

United Therapeutics

Mesnex

BBaxter Healthcare Corporation

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Active, not recruiting

Neuroblastoma

NCT03786783

Q4 2026

Phase 1Active, not recruiting

Neuroblastoma

NCT02573896

Q1 2027

Phase 1Active, not recruiting

Neuroblastoma

NCT01711554

Q3 2027

Phase 2Active, not recruiting

Neuroblastoma

NCT04385277

Clinical

Trials by Indication[1]

Neuroblastoma10 trials

Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma

Active, not recruiting·CChildren's Oncology Group·Phase 2·NCT03794349·94 enrolled

Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT01711554·27 enrolled

Post-Marketing Assessment of Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients

Terminated· United Therapeutics logo

United Therapeutics··NCT02693171·13 enrolled

Show 7 more trials

Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL)

Active, not recruiting·CChildren's Oncology Group·Phase 2·NCT04385277·41 enrolled

A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma

Completed· Eli Lilly logo

Eli Lilly·Phase 1/2·NCT04238819·47 enrolled

Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)

Recruiting·CChildren's Oncology Group·Phase 3·NCT03126916·750 enrolled

Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03786783·42 enrolled

Immunotherapy of Relapsed Refractory Neuroblastoma With Expanded NK Cells

Active, not recruiting·NNew Approaches to Neuroblastoma Therapy Consortium·Phase 1·NCT02573896·13 enrolled

Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01767194·73 enrolled

Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT00026312·1,449 enrolled

Temozolomide2 trials

NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab

Recruiting·NNationwide Children's Hospital·Phase 1/2·NCT04211675·31 enrolled

NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial

Recruiting·NNew Approaches to Neuroblastoma Therapy Consortium·Phase 2·NCT06450041·62 enrolled

High-Risk Neuroblastoma2 trials

Phase 1 Trial of Hu5F9-G4 (Magrolimab) Combined With Dinutuximab in Children and Young Adults With Relapsed and Refractory Neuroblastoma or Relapsed Osteosarcoma

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT04751383·12 enrolled

A Comprehensive Safety Trial of Chimeric Antibody 14.18 (Ch14.18) With GM-CSF, IL-2 and Isotretinoin in High-Risk Neuroblastoma Patients Following Myeloablative Therapy

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT01041638·105 enrolled

Randomized1 trial

NANT 2021-02: Randomized MIBG With Vorinostat/Dinutuximab/Vorinostat + Dinutuximab

Not yet recruiting·NNew Approaches to Neuroblastoma Therapy Consortium·Phase 2·NCT07261241·118 enrolled

Small Cell Lung Cancer1 trial

Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer

Completed· United Therapeutics logo

United Therapeutics·Phase 2/3·NCT03098030·483 enrolled

4 more indications

Osteosarcoma1 trial

Dinutuximab in Combination With Sargramostim in Treating Patients With Recurrent Osteosarcoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT02484443·41 enrolled

Ganglioneuroblastoma, Nodular1 trial

A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma

Recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT06172296·478 enrolled

Recurrent Ganglioneuroblastoma1 trial

Phase 1/2 Study of Dinutuximab/Cyclophosphamide/Topotecan/Sargramostim (GM-CSF) With or Without Iberdomide in Children With Relapsed, Refractory, or Progressive Neuroblastoma Following Prior Chemoimmunotherapy

Not yet recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT07437963·76 enrolled

Unspecified1 trial

MIBG With Dinutuximab +/- Vorinostat

Completed·NNew Approaches to Neuroblastoma Therapy Consortium·Phase 1·NCT03332667·45 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 10, 2015

UNITUXIN

BLA BLA125516

Sources

References

[1]
ClinicalTrials.gov — 20 trial records for Dinutuximab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Dinutuximab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Dinutuximab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA125516). U.S. Food & Drug Administration.
[5]
SEC EDGAR — United Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: United Therapeutics

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