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.
Background
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/11 | Phase 2 | Not yet recruiting | Vandana Abramson | ||
2025/05/13 | Phase 3 | Not yet recruiting | |||
2025/05/11 | Phase 2 | Recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2025/03/06 | Phase 2 | Recruiting | |||
2025/02/17 | Phase 2 | Withdrawn | |||
2025/01/28 | Phase 2 | Recruiting | |||
2024/11/21 | Phase 1 | Not yet recruiting | Hansoh BioMedical R&D Company | ||
2024/11/18 | Phase 2 | Not yet recruiting | Peking University Shenzhen Hospital | ||
2024/06/24 | Phase 2 | Not yet recruiting | |||
2024/05/08 | Phase 2 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Pharmacia & Upjohn Company LLC | 0009-5091 | INTRAVENOUS | 2 mg in 1 mL | 8/27/2020 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9203 | INTRAVENOUS | 2 mg in 1 mL | 12/13/2018 | |
| Pharmacia & Upjohn Company LLC | 0009-5093 | INTRAVENOUS | 2 mg in 1 mL | 8/27/2020 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9202 | INTRAVENOUS | 2 mg in 1 mL | 12/13/2018 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| PHARMORUBICIN CS INJECTION 10 mg/5 ml | SIN10098P | INJECTION | 10 mg/5 ml | 9/25/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Epirubicin Hydrochloride Injection | 国药准字H20213437 | 化学药品 | 注射剂 | 6/1/2021 | |
| Epirubicin Hydrochloride Injection | 国药准字H20041211 | 化学药品 | 注射剂 | 6/3/2020 | |
| Epirubicin Hydrochloride Injection | 国药准字HJ20181178 | 化学药品 | 注射剂 | 10/18/2022 | |
| Epirubicin Hydrochloride Injection | 国药准字HJ20181179 | 化学药品 | 注射剂 | 10/18/2022 | |
| Epirubicin Hydrochloride Injection | 国药准字H20213436 | 化学药品 | 注射剂 | 6/1/2021 | |
| Epirubicin Hydrochloride for Injection | 国药准字H20000497 | 化学药品 | 注射剂 | 8/13/2020 | |
| Epirubicin Hydrochloride for Injection | 国药准字H20233195 | 化学药品 | 注射剂 | 2/14/2023 | |
| Epirubicin Hydrochloride for Injection | 国药准字H20000496 | 化学药品 | 注射剂 | 8/13/2020 | |
| Epirubicin Hydrochloride for Injection | 国药准字H20183145 | 化学药品 | 注射剂 | 12/20/2022 | |
| Epirubicin Hydrochloride for Injection | 国药准字H20143165 | 化学药品 | 注射剂 | 5/28/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ACCORD EPIRUBICIN HYDROCHLORIDE SOLUTION FOR INJECTION OR INFUSION 10MG/5ML | N/A | N/A | N/A | 8/3/2018 | |
| EPISINDAN SOLN FOR INJ 10MG/5ML | N/A | N/A | N/A | 4/23/2010 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Hospira Epirubicin Hydrochloride Injection 100 mg/50 mL vial | 146109 | Medicine | A | 10/17/2007 | |
| Hospira Epirubicin Hydrochloride Injection 200 mg/100 mL vial | 143955 | Medicine | A | 8/29/2007 | |
| EPIRUBICIN ACCORD epirubicin hydrochloride 200mg/100mL concentrated injection vial | 227997 | Medicine | A | 10/9/2014 | |
| Hospira Epirubicin Hydrochloride Injection 10 mg/5 mL single dose vial | 209288 | Medicine | A | 5/8/2013 | |
| Epirubicin hydrochloride injection 10 mg in 5 mL (11) | 332709 | Medicine | A | 3/27/2020 | |
| Epirubicin hydrochloride injection 10 mg in 5 mL (3) | 309305 | Medicine | A | 9/14/2018 | |
| Epirubicin Injection 10 mg/5 mL (14) | 406167 | Medicine | A | 3/14/2023 | |
| PHARMORUBICIN RD (RAPID DISSOLUTION) epirubicin hydrochloride 50mg powder for injection vial | 40220 | Medicine | A | 10/30/1992 | |
| Epirubicin hydrochloride injection 50 mg in 25 mL (3) | 309450 | Medicine | A | 9/19/2018 | |
| Epirubicin Hydrochloride Injection 50 mg/25 mL (6) | 309661 | Medicine | A | 9/26/2018 |