DANYELZA

(Naxitamab)

Phase 2Monoclonal antibody

BBTG International Inc.

DANYELZA is one of 110 small molecule programs targeting Neuroblastoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

109

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

NeuroblastomaRecruiting

Triple-Negative Breast CancerActive, not recruiting

Breast CancerActive, not recruiting

Metastatic Triple-Negative Breast CancerRecruiting

NeuroblastomaPhase 2

Recruiting

Triple-Negative Breast CancerPhase 1/Phase 2

Active, not recruiting

Breast CancerPhase 1/Phase 2

Active, not recruiting

Metastatic Triple-Negative Breast CancerPreclinical

Recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Tykerb

GSK

Preclinical

80 2

DANYELZA

BBTG International Inc.

Phase 2

1 3

Prolia

Amgen

Preclinical

14 4

DATROWAY

Daiichi Sankyo

Preclinical

4 5

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 6

Acupan

YYonsei University

Preclinical

1 7

Nubain

AAultman Health Foundation

Preclinical

1 8

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 9

Paracetamol

GSK

Preclinical

1 10

Apatinib Mesylate

BBukwang Pharmaceutical

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 1/2Recruiting

Breast Cancer

NCT06026657

Q3 2027

Post-ApprovalNot yet recruiting

Neuroblastoma

NCT06047535

Q4 2027

Phase 1Recruiting

Neuroblastoma

NCT07027748

Q3 2028

Phase 2Recruiting

Efficacy and Safety

NCT05968768

Clinical

Trials by Indication[1]

Neuroblastoma6 trials

Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Combined With Isotretinoin for Maintenance Treatment of Patients With High-Risk Neuroblastoma in First Complete Response.

Not yet recruiting·SSciClone Pharmaceuticals·Phase 4·NCT06047535·62 enrolled

Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma

Recruiting·GGiselle Sholler·Phase 2·NCT06540963·98 enrolled

Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma

Recruiting·SSteven DuBois, MD·Phase 1·NCT07027748·18 enrolled

Show 3 more trials

Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission.

Withdrawn·YY-mAbs Therapeutics·Phase 2·NCT04909515

Quadruple Immunotherapy for Neuroblastoma

Recruiting·HHong Kong Children's Hospital·Phase 2·NCT05754684·29 enrolled

A Phase II Study of Naxitamab Added to Induction Therapy for Subjects With Newly Diagnosed High-Risk Neuroblastoma

Recruiting·GGiselle Sholler·Phase 2·NCT05489887·93 enrolled

Efficacy and Safety1 trial

To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma (Butterfly)

Recruiting·AAnna Raciborska·Phase 2·NCT05968768·24 enrolled

Breast Cancer1 trial

Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells With or Without Naxitamab (Danyelza) for the Treatment of Patients With Metastatic, GD2 Expressing, HER2 Negative Breast Cancer

Recruiting·MMargaret Gatti-Mays·Phase 1/2·NCT06026657·42 enrolled

Metastatic Triple-negative Breast Cancer1 trial

Phase I/II Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT07011654·31 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 25, 2020

DANYELZA

BLA BLA761171

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for Naxitamab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Naxitamab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Naxitamab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761171). U.S. Food & Drug Administration.
[5]
SEC EDGAR — BTG International Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 2[1]
Company: BBTG International Inc.

DANYELZA

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q4 2027

Q3 2028

Trials by Indication[1]

Neuroblastoma6 trials

Efficacy and Safety1 trial

Breast Cancer1 trial

Metastatic Triple-negative Breast Cancer1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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