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Epirubicin

Generic Name
Epirubicin
Brand Names
Ellence, Pharmorubicin PFS
Drug Type
Small Molecule
Chemical Formula
C27H29NO11
CAS Number
56420-45-2
Unique Ingredient Identifier
3Z8479ZZ5X

Overview

An anthracycline which is the 4'-epi-isomer of doxorubicin. The compound exerts its antitumor effects by interference with the synthesis and function of DNA.

Indication

For use as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer.

Associated Conditions

  • Breast Cancer
  • Breast Cancer, Stage II
  • Breast Cancer, Stage III
  • Colorectal Cancer
  • Hormone-Refractory Prostate Cancer
  • Neoplasm of Stomach
  • Non-Small Cell Lung Carcinoma
  • Ovarian Cancer
  • Papillary transitional cell carcinoma of bladder
  • Recurrent Superficial Bladder Cancer
  • Small Cell Lung Cancer (SCLC)
  • Soft Tissue Sarcoma
  • Carcinoma in situ of urinary bladder

Research Report

Published: Jul 17, 2025

Epirubicin (DB00445): A Comprehensive Monograph

Executive Summary

Epirubicin is a semisynthetic anthracycline antibiotic that serves as a cornerstone agent in modern oncologic practice.[1] Classified as a small molecule, it is primarily employed as a cytotoxic chemotherapy drug, most notably in the adjuvant treatment of breast cancer in patients with axillary node involvement following surgical resection.[1] Its core mechanism of action is multifaceted, centered on its function as a topoisomerase II inhibitor and a potent DNA intercalator. By forming a stable complex with DNA and inhibiting key enzymatic processes, Epirubicin effectively disrupts DNA and RNA synthesis, leading to the programmed death of rapidly proliferating cancer cells.[1]

A defining characteristic of Epirubicin is its unique stereochemistry; it is the 4'-epi-isomer of the widely used anthracycline, doxorubicin.[1] This specific spatial orientation of a hydroxyl group on the daunosamine sugar moiety fundamentally alters its metabolic profile and pharmacokinetic disposition, resulting in faster systemic clearance and a comparatively more favorable toxicity profile.[4] This structural modification is particularly associated with reduced cardiotoxicity, a major dose-limiting factor for the anthracycline class.[4]

Despite its improved safety profile relative to doxorubicin, Epirubicin therapy is associated with significant and predictable toxicities that require diligent management. The principal dose-limiting toxicities are acute, reversible myelosuppression, manifesting as severe neutropenia and leukopenia, and a cumulative, dose-dependent cardiotoxicity that can lead to potentially fatal congestive heart failure months to years after treatment completion.[5] Furthermore, a recognized long-term risk is the development of secondary malignancies, including acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS).[8]

Continue reading the full research report

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2017/09/05
Phase 2
Completed
2017/04/21
Phase 4
UNKNOWN
Zhejiang University
2017/01/30
Phase 3
Active, not recruiting
2017/01/19
Phase 2
Recruiting
Groupe Hospitalier Diaconesses Croix Saint-Simon
2017/01/16
Not Applicable
UNKNOWN
Hebei Medical University Fourth Hospital
2017/01/06
Phase 3
Completed
2016/12/30
Phase 3
UNKNOWN
Shi Yanxia
2016/12/08
Phase 1
UNKNOWN
2016/11/22
Phase 3
UNKNOWN
Shanghai Zhongshan Hospital
2016/10/31
Phase 2
UNKNOWN
Jinling Hospital, China

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