NDAINJECTIONINJECTABLEPriority Review
Approved
Sep 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
11
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ELLENCE (epirubicin hydrochloride) is a small-molecule anthracycline chemotherapy agent administered intravenously for the treatment of breast cancer. It functions as a DNA-damaging agent that intercalates into DNA and inhibits topoisomerase II, inducing apoptosis in rapidly dividing tumor cells. The drug is primarily used in adjuvant and neoadjuvant settings for early-stage and metastatic breast cancer.
LOE Approaching
Product is in late lifecycle stage with moderate competitive pressure (30/100), suggesting defensive rather than growth-oriented commercial strategies and potential team consolidation.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (11)
Evaluation of Maternal & Newborn Health Simulation Lab Centers of Excellence in Nepal
Started May 2024
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
Immunosuppression Management in Renal Transplant Recipients With Transplant Excellence Based on TruGraf Test
Started Jun 2021
75 enrolled
Kidney Transplant RejectionImmunosuppression
Strados System at Center of Excellence
Started Sep 2020
30 enrolled
CopdAsthmaCovid19
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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.