Dexrazoxane

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

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
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	2024/10/18	NCT06647953	Phase 3	Recruiting	Children's Oncology Group
CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients	2024/02/16	NCT06262438	Phase 2	Recruiting	Princess Maxima Center for Pediatric Oncology
Prevention of Anthracycline-Induced Cardiac Dysfunction With Dexrazoxane in Patients With Diffuse Large-B Cell Lymphoma	2024/01/23	NCT06220032	Phase 3	Recruiting	Stichting Hemato-Oncologie voor Volwassenen Nederland
Study of DPPG2-TSL-DOX Combined with Hyperthermia in Soft Tissue Sarcoma	2023/05/15	NCT05858710	Phase 1	Active, not recruiting	Thermosome GmbH
Venetoclax Basket Trial for High Risk Hematologic Malignancies	2022/03/23	NCT05292664	Phase 1	Recruiting	Andrew E. Place, MD
Use of the Cardioprotectant Dexrazoxane During Congenital Heart Surgery	2021/08/09	NCT04997291	Phase 1	UNKNOWN	University of Texas at Austin
A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations	2020/03/03	NCT04293562	Phase 3	Recruiting	Children's Oncology Group
Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane	2019/04/29	NCT03930680	Phase 1	Completed	University of Arkansas
Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma	2018/12/26	NCT03786783	Phase 2	Active, not recruiting	National Cancer Institute (NCI)
OlaReDo - Olaratumab and Rechallenge With Doxorubicin in Soft Tissue Sarcoma Patients	2018/10/05	NCT03698227	Phase 2	Terminated	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

FDA Drug Approvals

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

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Savene	CNX Therapeutics Ireland Limited,5th Floor Rear,Connaught House,1 Burlington Road,Dublin 4,Dublin,Ireland	Authorised	7/27/2006

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
Dexrazoxane for Injection	南京正大天晴制药有限公司	国药准字H20223884	化学药品	注射剂	11/30/2022
Dexrazoxane for Injection	GLAND PHARMA LIMITED	国药准字HJ20233122	化学药品	注射剂	2/7/2023
Dexrazoxane for Injection	扬子江药业集团有限公司	国药准字H20234637	化学药品	注射剂	12/13/2023
Dexrazoxane for Injection	南京海润医药有限公司	国药准字H20213177	化学药品	注射剂	3/16/2021
Dexrazoxane for Injection	江苏奥赛康药业有限公司	国药准字H20217024	化学药品	注射剂	3/12/2021
Dexrazoxane for Injection	中润药业有限公司	国药准字H20233114	化学药品	注射剂	1/31/2023
Dexrazoxane for Injection	石药集团欧意药业有限公司	国药准字H20244665	化学药品	注射剂	8/20/2024
Dexrazoxane for Injection	石药集团欧意药业有限公司	国药准字H20244666	化学药品	注射剂	8/20/2024
Dexrazoxane for Injection	江苏奥赛康药业有限公司	国药准字H20061157	化学药品	注射剂	1/14/2021

PPB Drug Approvals

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

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
DEXRAZOXANE-REACH dexrazoxane 250 mg powder for injection for infusion vial	428033	Reach Pharmaceuticals Pty Ltd	Medicine	A	3/24/2025
DEXRAZOXANE-REACH dexrazoxane 500 mg powder for injection for infusion vial	428034	Reach Pharmaceuticals Pty Ltd	Medicine	A	3/24/2025

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