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Zinecard

(Dexrazoxane)

ApprovedSmall molecule

Dexrazoxane is used to protect the heart from damage caused by certain chemotherapy drugs used to treat cancer, and to treat extravasation (leakage of chemotherapy drugs outside the vein).[2] Zinecard is currently approved and in use across 15 indications[4].[1]

Zinecard is one of 358 small molecule programs targeting Childhood Acute Lymphoblastic Leukemia. It is currently in Approved.

15

Indications

27

Total Trials

9

Active Trials

357

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Childhood Acute Lymphoblastic LeukemiaActive, not recruiting

LymphomaActive, not recruiting

OsteosarcomaActive, not recruiting

NeuroblastomaActive, not recruiting

Abnormal Cardiovascular System MorphologyApproved

Liver CancerActive, not recruiting

Ewing SarcomaActive, not recruiting

Acute Lymphoblastic LeukemiaActive, not recruiting

Breast CancerActive, not recruiting

Acute Myeloid LeukemiaActive, not recruiting

Childhood Acute Lymphoblastic LeukemiaPhase 3

Active, not recruiting

LymphomaPhase 3

Active, not recruiting

OsteosarcomaPhase 1

Active, not recruiting

NeuroblastomaPhase 2

Active, not recruiting

Abnormal Cardiovascular System MorphologyApproved

Approved

Liver CancerPhase 3

Active, not recruiting

Ewing SarcomaPhase 3

Active, not recruiting

Acute Lymphoblastic LeukemiaPhase 3

Active, not recruiting

Breast CancerApproved

Active, not recruiting

Acute Myeloid LeukemiaPhase 2

Active, not recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Zinecard

Tykerb

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Megace

Bristol-Myers Squibb

Adenocard

Recentin

NNational Cancer Institute (NCI)

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Acupan

YYonsei University

Chantix

PPrism Pharmaceuticals

Avastin

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

Timeline

Expected Milestones

Q3 2026

Phase 2Active, not recruiting

Neuroblastoma

NCT03786783

Q2 2027

Phase 2Active, not recruiting

Ewing Sarcoma

NCT01864109

Phase 2Active, not recruiting

Acute Myeloid Leukemia

NCT03164057

Q4 2028

Phase 3Recruiting

Lymphoma

NCT06220032

Q1 2029

Phase 3Recruiting

Chemotherapy

NCT06647953

Clinical

Trials by Indication[1]

Soft Tissue Sarcoma3 trials

OlaReDo - Olaratumab and Rechallenge With Doxorubicin in Soft Tissue Sarcoma Patients

Terminated·IInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest·Phase 2·NCT03698227·2 enrolled

Doxorubicin With Upfront Dexrazoxane for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma

Completed·WWashington University School of Medicine·Phase 2·NCT02584309·73 enrolled

Study of DPPG2-TSL-DOX Combined With Hyperthermia in Soft Tissue Sarcoma

Completed·TThermosome GmbH·Phase 1·NCT05858710·8 enrolled

Chemotherapy2 trials

Doxorubicin With Cisplatin, High-Dose Methotrexate, and Additional Risk-Adapted Outpatient Chemotherapy

Terminated·MM.D. Anderson Cancer Center·N/A·NCT00673179·7 enrolled

Testing a Standardized Approach to Surgery and Chemotherapy for Type I Pleuropulmonary Blastoma or the Addition of an Anti-cancer Drug, Topotecan, to the Usual Treatment for Types II and III Pleuropulmonary Blastoma

Recruiting·CChildren's Oncology Group·Phase 3·NCT06647953·110 enrolled

Surgery2 trials

Use of the Cardioprotectant Dexrazoxane During Congenital Heart Surgery: Proposal for Pilot Investigation

Terminated·—·Phase 1·NCT02519335·12 enrolled

Use of the Cardioprotectant Dexrazoxane During Congenital Heart Surgery

Unknown status·UUniversity of Texas at Austin·Phase 1·NCT04997291·12 enrolled

Ewing sarcoma2 trials

Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT01864109·83 enrolled

Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma

Completed·CChildren's Oncology Group·Phase 3·NCT01231906·642 enrolled

Acute Lymphoblastic Leukemia2 trials

Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents

Active, not recruiting·—·Phase 3·NCT03020030·560 enrolled

Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (IND 104224)

Terminated·TTherapeutic Advances in Childhood Leukemia Consortium·Phase 1·NCT00928200·1 enrolled

16 more indications

Childhood Acute Lymphoblastic Leukemia1 trial

Treatment of Childhood Acute Lymphoblastic Leukemia

Terminated·—·Phase 3·NCT00165087·491 enrolled

Osteosarcoma1 trial

A Study of Pre-Operative Treatment of Newly-Diagnosed, Surgically-Resectable Osteosarcoma With Doxorubicin, Ifosfamide, Etoposide, and Cisplatin With Early Metabolic Assessment of Response

Terminated·UUniversity of Chicago·Phase 1·NCT01258634·2 enrolled

Neuroblastoma1 trial

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

Heart Failure1 trial

Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane

Completed·UUniversity of Arkansas·Phase 1·NCT03930680·25 enrolled

Treatment1 trial

A Phase I/II Study of KDX-0811(Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents

Completed·KKissei Pharmaceutical Co., Ltd.·Phase 1/2·NCT01596088·2 enrolled

Lymphoma1 trial

Prevention of Anthracycline-Induced Cardiac Dysfunction With Dexrazoxane in Patients With Diffuse Large-B Cell Lymphoma

Recruiting·SStichting Hemato-Oncologie voor Volwassenen Nederland·Phase 3·NCT06220032·324 enrolled

Neoadjuvant Chemotherapy1 trial

Marched Pair Study Conventional Doxorubicin(DOX) Versus Pegylated Liposomal Doxorubicin(PLD) Neoadjuvant Chemotherapy

Unknown status·JJilin University·Phase 2·NCT02953184·160 enrolled

Efficacy1 trial

Efficacy of TopotectTM (Dexrazoxane) for Accidental Extravasation of Anthracyclines

Completed·VValerio Therapeutics·Phase 2/3·NCT00548561·23 enrolled

Newly Diagnosed1 trial

CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients

Recruiting·PPrincess Maxima Center for Pediatric Oncology·Phase 2·NCT06262438·60 enrolled

Clinical Trial1 trial

A Clinical Trial on Topotect® (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracyclines

Completed·VValerio Therapeutics·Phase 2/3·NCT00548704·57 enrolled

Ewing's Sarcoma1 trial

Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) in High Risk Ewing's Sarcoma Patients

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT00038142·46 enrolled

Acute Myeloid Leukemia1 trial

A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia

Active, not recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT03164057·206 enrolled

Rhabdomyosarcoma1 trial

Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy

Active, not recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT01871766·115 enrolled

Induction Chemotherapy1 trial

Everolimus With Multiagent Re-Induction Chemotherapy in Pediatric Patients With ALL

Completed·—·Phase 1·NCT01523977·22 enrolled

Hematologic Malignancies1 trial

Venetoclax Basket Trial for High Risk Hematologic Malignancies

Recruiting·—·Phase 1·NCT05292664·30 enrolled

Hepatoblastoma1 trial

Treatment of Children With All Stages of Hepatoblastoma With Temsirolimus (NSC#683864) Added to High Risk Stratum Treatment

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT00980460·236 enrolled

Regulatory

FDA Approval Timeline[5]

May 26, 1995

ZINECARD

NDA NDA020212

Sep 6, 2007

TOTECT

NDA NDA022025

Sources

References

[1]
ClinicalTrials.gov — 27 trial records for Dexrazoxane. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Zinecard drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Dexrazoxane compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Dexrazoxane. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022025). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: DNA Topoisomerase II Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer

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