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Dexrazoxane

Generic Name
Dexrazoxane
Brand Names
Savene, Totect, Zinecard
Drug Type
Small Molecule
Chemical Formula
C11H16N4O4
CAS Number
24584-09-6
Unique Ingredient Identifier
048L81261F

Overview

An antimitotic agent with immunosuppressive properties. Dexrazoxane, the (+)-enantiomorph of razoxane, provides cardioprotection against anthracycline toxicity. It appears to inhibit formation of a toxic iron-anthracycline complex. [PubChem] The Food and Drug Administration has designated dexrazoxane as an orphan drug for use in the prevention or reduction in the incidence and severity of anthracycline-induced cardiomyopathy.

Indication

For reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin hydrochloride dose of 300 mg/m^2 and would benefit from continued doxorubicin therapy. Also approved for the treatment of extravasation from intravenous anthracyclines.

Associated Conditions

  • Doxorubicin Induced Cardiomyopathy
  • Drug Extravasation

Research Report

Published: Aug 12, 2025

Dexrazoxane (DB00380): A Comprehensive Monograph on its Cardioprotective and Chemoprotective Roles in Oncology

Section 1: Introduction to Dexrazoxane

Executive Summary

Dexrazoxane (DrugBank ID: DB00380) is a unique, systemically administered cytoprotective agent belonging to the bisdioxopiperazine class of compounds.[1] It occupies a distinct niche in modern oncology, primarily defined by its dual, yet highly specific, roles in mitigating the toxicities of anthracycline chemotherapy. First, it serves as a cardioprotective agent, administered to reduce the incidence and severity of cumulative, dose-dependent cardiomyopathy, a major source of long-term morbidity and mortality in cancer survivors treated with drugs like doxorubicin.[4] Second, it functions as a targeted chemoprotective agent, acting as the only approved antidote for the treatment of severe local tissue damage (extravasation) that can occur when intravenous anthracyclines leak from the vein into surrounding tissues.[7] Marketed under brand names including Zinecard®, Totect®, and Cardioxane®, Dexrazoxane addresses critical unmet needs that arise directly from the use of one of the most effective and widely used classes of anticancer drugs.[4]

The Central Clinical Problem

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/10/18
Phase 3
Recruiting
2024/02/16
Phase 2
Recruiting
Princess Maxima Center for Pediatric Oncology
2024/01/23
Phase 3
Recruiting
Stichting Hemato-Oncologie voor Volwassenen Nederland
2023/05/15
Phase 1
Completed
2022/03/23
Phase 1
Active, not recruiting
Andrew E. Place, MD
2021/08/09
Phase 1
UNKNOWN
2020/03/03
Phase 3
Recruiting
2019/04/29
Phase 1
Completed
2018/12/26
Phase 2
Active, not recruiting
2018/10/05
Phase 2
Terminated
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Almaject, Inc.
72611-716
INTRAVENOUS
500 mg in 50 mL
12/1/2016
Gland Pharma Limited
68083-388
INTRAVENOUS
250 mg in 25 mL
6/23/2025
Fosun Pharma USA Inc.
72266-101
INTRAVENOUS
500 mg in 50 mL
6/13/2022
Hikma Pharmaceuticals USA Inc.
0143-9248
INTRAVENOUS
10 mg in 1 mL
12/13/2018
Breckenridge Pharmaceutical, Inc.
51991-942
INTRAVENOUS
500 mg in 50 mL
2/10/2021
Gland Pharma Limited
68083-195
INTRAVENOUS
500 mg in 50 mL
6/23/2025
Novadoz Pharmaceuticals LLC
72205-247
INTRAVENOUS
250 mg in 25 mL
4/9/2025
Almaject, Inc.
72611-716
INTRAVENOUS
500 mg in 50 mL
12/1/2016
Fosun Pharma USA Inc.
72266-235
INTRAVENOUS
250 mg in 25 mL
6/13/2022
Clinigen Healthcare Ltd
76310-002
INTRAVENOUS
500 mg in 1 1
7/14/2017

EMA Drug Approvals

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
DEXRAZOXANE FOR INJECTION
Juno Pharmaceuticals Corp.
02544091
Powder For Solution - Intravenous
500 MG / VIAL
N/A
ZINECARD
02153440
Powder For Solution - Intravenous
500 MG / VIAL
12/31/1995
ZINECARD
02153432
Powder For Solution - Intravenous
250 MG / VIAL
12/31/1995
DEXRAZOXANE FOR INJECTION
hikma canada limited
02557649
Powder For Solution - Intravenous
250 MG / VIAL
N/A
DEXRAZOXANE FOR INJECTION
Juno Pharmaceuticals Corp.
02544083
Powder For Solution - Intravenous
250 MG / VIAL
N/A

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
CARDIOXANE 500 mg POLVO PARA SOLUCION PARA PERFUSION
67673
POLVO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
SAVENE 20 mg/ml POLVO PARA CONCENTRADO Y DISOLVENTE PARA SOLUCION PARA PERFUSION
06350001
POLVO Y DISOLVENTE PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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