NDAINTRAVENOUSPOWDER
Approved
Sep 2006
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
3/8 — Basic
EPIRUBICIN HYDROCHLORIDE (epirubicin hydrochloride) by Pfizer is agent. First approved in 2006.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Epirubicin hydrochloride is an anthracycline chemotherapy agent administered intravenously as a powder for injection. It treats various cancers, particularly breast tumors, by intercalating into DNA and triggering topoisomerase II-mediated DNA cleavage. The drug also generates cytotoxic free radicals and inhibits DNA helicase, resulting in broad cytotoxic and antiproliferative effects across multiple tumor models.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), suggesting team consolidation and increased focus on lifecycle management and cost optimization.
Mechanism of Action
agent. Although it is known that anthracyclines can interfere with a number of biochemical and biological functions within eukaryotic cells, the precise mechanisms of epirubicin's cytotoxic and/or antiproliferative properties have not been completely elucidated. Epirubicin forms a complex with DNA…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
A Clinical Trial to Evaluate the Efficacy and Safety of Anotinib Hydrochloride Capsule Combined With Epirubicin Hydrochloride Versus Placebo Combined With Epirubicin Hydrochloride in First-line Treatment of Advanced Soft Tissue Sarcoma
Started Mar 2022
256 enrolled
Soft Tissue Sarcoma
A Phase 3 Study to Evaluate the Safety and Efficacy of APL-1202 as a Single-agent Oral Treatment Versus Intravesical Instillation of Epirubicin Hydrochloride in naïve Intermediate-risk NMIBC Patients
Started Sep 2021
800 enrolled
Non-muscle Invasive Bladder Cancer
Safety and Efficacy of APL-1202 in Combination With Epirubicin Hydrochloride Versus Epirubicin Hydrochloride Alone in Intermediate and High-risk Chemo-refractory Non-muscle Invasive Bladder Cancer (NMIBC) Patients
Started Mar 2017
359 enrolled
Non-muscle Invasive Bladder Cancer
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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.