Epirubicin
Ellence, Epirubicin (epirubicin) is a small molecule pharmaceutical. Epirubicin was first approved as Ellence on 1999-09-15. It is used to treat breast neoplasms in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
Ellence, Epirubicin (discontinued: Epirubicin)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ellence | New Drug Application | 2025-07-30 |
| epirubicin hydrochloride | ANDA | 2021-01-14 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| breast neoplasms | EFO_0003869 | D001943 | C50 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9178 | Injection, epirubicin hcl, 2 mg |
Clinical
Clinical Trials
664 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 26 | 195 | 137 | 17 | 37 | 386 |
| Triple negative breast neoplasms | D064726 | — | — | 4 | 45 | 20 | 2 | 5 | 70 |
| Carcinoma | D002277 | — | C80.0 | 5 | 21 | 13 | 3 | 13 | 50 |
| Lymphoma | D008223 | — | C85.9 | 7 | 30 | 12 | 6 | 3 | 50 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 4 | 15 | 10 | 2 | 17 | 43 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 6 | 14 | 10 | 3 | 14 | 41 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 1 | 15 | 6 | 2 | 1 | 23 |
| B-cell lymphoma | D016393 | — | — | 1 | 10 | 5 | 4 | 1 | 20 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | 6 | 6 | 1 | 6 | 19 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 5 | 8 | 7 | 1 | — | 18 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 6 | 28 | 15 | — | 4 | 47 |
| Neoplasms | D009369 | — | C80 | 10 | 16 | 4 | — | — | 25 |
| Adenocarcinoma | D000230 | — | — | 3 | 17 | 7 | — | 3 | 25 |
| Esophageal neoplasms | D004938 | — | C15 | 5 | 15 | 4 | — | 3 | 23 |
| Inflammatory breast neoplasms | D058922 | — | — | 2 | 9 | 5 | — | — | 15 |
| Recurrence | D012008 | — | — | 2 | 7 | 2 | — | 3 | 13 |
| Sarcoma | D012509 | — | — | 4 | 5 | 4 | — | — | 11 |
| Leukemia | D007938 | — | C95 | 3 | 4 | 4 | — | — | 9 |
| Ductal carcinoma breast | D018270 | — | — | 1 | 1 | 5 | — | — | 7 |
| Lung neoplasms | D008175 | — | C34.90 | — | 3 | 3 | — | 1 | 7 |
Show 51 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Transitional cell carcinoma | D002295 | — | — | — | 4 | — | — | 1 | 5 |
| Germ cell and embryonal neoplasms | D009373 | — | — | — | 4 | — | — | — | 4 |
| Myelodysplastic syndromes | D009190 | — | D46 | 3 | 1 | — | — | — | 3 |
| Prostatic neoplasms | D011471 | — | C61 | 2 | 1 | — | — | — | 3 |
| Chemotherapy-induced febrile neutropenia | D064146 | — | — | — | 3 | — | — | — | 3 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 1 | 1 | — | — | — | 2 |
| Colorectal neoplasms | D015179 | — | — | — | 1 | — | — | 1 | 2 |
| Bile duct neoplasms | D001650 | — | — | 2 | 1 | — | — | — | 2 |
| Cholangiocarcinoma | D018281 | — | C22.1 | 2 | 1 | — | — | — | 2 |
| Syndrome | D013577 | — | — | 1 | 1 | — | — | — | 2 |
Show 39 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | — | C92.0 | 2 | — | — | — | — | 2 |
| Hematologic neoplasms | D019337 | — | — | 1 | — | — | — | — | 1 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 1 | — | — | — | — | 1 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 1 | — | — | — | — | 1 |
| Primary myelofibrosis | D055728 | — | D47.4 | 1 | — | — | — | — | 1 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 1 | — | — | — | — | 1 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | 1 | — | — | — | — | 1 |
| Anemia | D000740 | EFO_0004272 | D64.9 | 1 | — | — | — | — | 1 |
| Leukemia myeloid chronic atypical bcr-abl negative | D054438 | — | C92.2 | 1 | — | — | — | — | 1 |
| Myelodysplastic-myeloproliferative diseases | D054437 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alopecia areata | D000506 | EFO_0004192 | L63 | — | — | — | — | 2 | 2 |
| Alopecia | D000505 | — | L64 | — | — | — | — | 2 | 2 |
| Biliary tract neoplasms | D001661 | — | C24.9 | — | — | — | — | 1 | 1 |
| Female genital neoplasms | D005833 | — | — | — | — | — | — | 1 | 1 |
| Radiofrequency ablation | D000078703 | — | — | — | — | — | — | 1 | 1 |
| Prognosis | D011379 | — | — | — | — | — | — | 1 | 1 |
| Signet ring cell carcinoma | D018279 | — | — | — | — | — | — | 1 | 1 |
| Esophageal and gastric varices | D004932 | EFO_0009545 | I85 | — | — | — | — | 1 | 1 |
| Peripheral nervous system diseases | D010523 | — | G64 | — | — | — | — | 1 | 1 |
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Epirubicin |
| INN | epirubicin |
| Description | 4'-epidoxorubicin is an anthracycline that is the 4'-epi-isomer of doxorubicin. It has a role as an EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor, an antineoplastic agent and an antimicrobial agent. It is an anthracycline, a deoxy hexoside, an anthracycline antibiotic, an aminoglycoside, a monosaccharide derivative, a member of p-quinones, a primary alpha-hydroxy ketone and a tertiary alpha-hydroxy ketone. It is functionally related to a doxorubicin. It is a conjugate acid of a 4'-epidoxorubicinium. |
| Classification | Small molecule |
| Drug class | antineoplastic antibiotics (daunorubicin type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)C[C@@](O)(C(=O)CO)C[C@@H]3O[C@H]1C[C@H](N)[C@@H](O)[C@H](C)O1 |
Identifiers
| PDB | — |
| CAS-ID | 56420-45-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL417 |
| ChEBI ID | 47898 |
| PubChem CID | 41867 |
| DrugBank | DB00445 |
| UNII ID | 3Z8479ZZ5X (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Ellence, Epirubicin hydrochloride
Adverse Events
Top Adverse Reactions
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22,734 adverse events reported
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