DEXRAZOXANE HYDROCHLORIDE

Post-LOE

dexrazoxane

Hikma

ANDAINJECTIONINJECTABLE

Approved

Oct 2011

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

DEXRAZOXANE HYDROCHLORIDE (dexrazoxane) by Hikma is understood. Approved for breast cancer. First approved in 2011.

Drug data last refreshed 21h ago

Mechanism of Action

understood. Dexrazoxane is a cyclic derivative of EDTA that penetrates cell membranes. Results of laboratory studies suggest that dexrazoxane is converted intracellularly to a ring-opened chelating agent that interferes with iron-mediated free radical generation thought to be responsible, in part,…

Indications (1)

breast cancer

Clinical Trials (3)

NCT00548704Phase 2/3Completed

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

Started Apr 2002

57 enrolled

Extravasation

NCT00548561Phase 2/3Completed

Efficacy of TopotectTM (Dexrazoxane) for Accidental Extravasation of Anthracyclines

Started Jun 2001

23 enrolled

Anthracycline Extravasation

NCT01596088Phase 1/2Completed

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

2 enrolled

Extravasations of Anthracycline Anti-cancer Agents

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.