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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 13 indications[4].[1]

Zinecard is one of 333 small molecule programs targeting Breast Cancer. It is currently in Approved.

13

Indications

28

Total Trials

10

Active Trials

332

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Breast CancerActive, not recruiting

Multiple SclerosisApproved

Abnormal Cardiovascular System MorphologyApproved

Hematologic MalignanciesRecruiting

Pleuropulmonary BlastomaRecruiting

ChemotherapyTerminated

Newly DiagnosedRecruiting

LymphomaRecruiting

NeuroblastomaActive, not recruiting

Ewing SarcomaCompleted

Breast CancerApproved

Active, not recruiting

Multiple SclerosisApproved

Approved

Abnormal Cardiovascular System MorphologyApproved

Approved

Hematologic MalignanciesPhase 1

Recruiting

Pleuropulmonary BlastomaPhase 3

Recruiting

ChemotherapyPreclinical

Terminated

Newly DiagnosedPhase 2

Recruiting

LymphomaPhase 3

Recruiting

NeuroblastomaPhase 2

Active, not recruiting

Ewing SarcomaPhase 3

Completed

Showing 10 of 13 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Zinecard

Adenocard

Lexiscan

Zolymbus

Blenoxane

Bristol-Myers Squibb

MS Contin

HHikma Pharmaceuticals LLC

Sporanox

SSebela Pharmaceuticals Development LLC

Acupan

YYonsei University

Chantix

PPrism Pharmaceuticals

Paracetamol

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

Timeline

Expected Milestones

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

Pleuropulmonary Blastoma

NCT06647953

Q2 2030

Phase 2Active, not recruiting

Rhabdomyosarcoma

NCT01871766

Clinical

Trials by Indication[1]

Soft Tissue Sarcoma3 trials

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

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

Ewing sarcoma2 trials

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

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

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

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

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

Efficacy1 trial

Efficacy of TopotectTM (Dexrazoxane) for Accidental Extravasation of Anthracyclines

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

19 more indications

Childhood Acute Lymphoblastic Leukemia1 trial

Treatment of Childhood Acute Lymphoblastic Leukemia

Terminated·—·Phase 3·NCT00165087·491 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

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

Chemotherapy1 trial

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

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

Acute Lymphoblastic Leukemia1 trial

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

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

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

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

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

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

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

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

Pleuropulmonary Blastoma1 trial

Prospective Treatment of Types I, II and III Pleuropulmonary Blastoma (PPB)

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

Diffuse Large B-cell Lymphoma(DLBCL)1 trial

A Randomized Study of Dexrazoxane or Liposomal Doxorubicin in Newly Diagnosed Diffuse Large B-cell Lymphoma at High Risk for Heart Failure Events: the CARDIOPROTECT Trial

Recruiting·BBeth Israel Deaconess Medical Center·Phase 2·NCT07654426·60 enrolled

Acute Lymphoblastic Leukemia, Pediatric1 trial

Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents

Active, not recruiting·DDana-Farber Cancer Institute·Phase 3·NCT03020030·560 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 — 28 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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