MedPath

Doxorubicin

Generic Name
Doxorubicin
Brand Names
Adriamycin, Doxil, Myocet, Caelyx pegylated liposomal, Zolsketil pegylated liposomal, Myocet liposomal (previously Myocet), Celdoxome pegylated liposomal
Drug Type
Small Molecule
Chemical Formula
C27H29NO11
CAS Number
23214-92-8
Unique Ingredient Identifier
80168379AG

Overview

Doxorubicin is a cytotoxic anthracycline antibiotic isolated from cultures of Streptomyces peucetius var. caesius along side with daunorubicin, another cytotoxic agent, in 1970. Although they both have aglyconic and sugar moieties, doxorubicin's side chain terminates with a primary alcohol group compared to the methyl group of daunorubicin. Although its detailed molecular mechanisms have yet to be understood, doxorubicin is generally thought to exert its effect through DNA intercalation, which eventually leads to DNA damage and the generation of reactive oxygen species. Thanks to its efficacy and broad effect, doxorubicin was approved by the FDA in 1974 to treat a variety of cancer, including but not limited to breast, lung, gastric, ovarian, thyroid, non-Hodgkin’s and Hodgkin’s lymphoma, multiple myeloma, sarcoma, and pediatric cancers. However, one of the major side effects of doxorubicin is cardiotoxicity, which excludes patients with poor heart function and requires treatment termination once the maximally tolerated cumulative dose is reached.

Background

Doxorubicin is a cytotoxic anthracycline antibiotic isolated from cultures of Streptomyces peucetius var. caesius along side with daunorubicin, another cytotoxic agent, in 1970. Although they both have aglyconic and sugar moieties, doxorubicin's side chain terminates with a primary alcohol group compared to the methyl group of daunorubicin. Although its detailed molecular mechanisms have yet to be understood, doxorubicin is generally thought to exert its effect through DNA intercalation, which eventually leads to DNA damage and the generation of reactive oxygen species. Thanks to its efficacy and broad effect, doxorubicin was approved by the FDA in 1974 to treat a variety of cancer, including but not limited to breast, lung, gastric, ovarian, thyroid, non-Hodgkin’s and Hodgkin’s lymphoma, multiple myeloma, sarcoma, and pediatric cancers. However, one of the major side effects of doxorubicin is cardiotoxicity, which excludes patients with poor heart function and requires treatment termination once the maximally tolerated cumulative dose is reached.

Indication

Doxorubicin is indicated for the treatment of neoplastic conditions like acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin and non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms’ tumor, metastatic neuroblastoma, metastatic soft tissue and bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, and metastatic bronchogenic carcinoma. Doxorubicin is also indicated for use as a component of adjuvant therapy in women with evidence of axillary lymph node involvement following resection of primary breast cancer. For the liposomal formulation, doxorubicin is indicated for the treatment of ovarian cancer that has progressed or recurred after platinum-based chemotherapy, AIDS-Related Kaposi's Sarcoma after the failure of prior systemic chemotherapy or intolerance to such therapy, and multiple myeloma in combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy.

Associated Conditions

  • AIDS-related Kaposi's Sarcoma
  • Acute Lymphoblastic Leukemia (ALL)
  • Acute Myeloid Leukemia
  • Advanced Endometrial Cancer
  • Advanced Ovarian Cancer
  • Breast Cancer
  • Hodgkin's Lymphoma
  • Metastatic Bone Sarcomas
  • Metastatic Breast Cancer
  • Metastatic Soft Tissue Sarcoma
  • Metastatic Thyroid Cancer
  • Metastatic Urothelial Cancer
  • Multiple Myeloma (MM)
  • Mycosis Fungoides (MF)
  • Non-Hodgkin's Lymphoma (NHL)
  • Sezary Syndrome
  • Waldenström's Macroglobulinemia (WM)
  • Advanced Thymoma
  • Advanced uterine sarcoma
  • Metastatic Bronchogenic Carcinoma
  • Metastatic Gastric carcinoma
  • Metastatic Neuroblastoma
  • Metastatic Ovarian carcinoma
  • Metastatic Wilms' tumor

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/06/30
Not Applicable
Not yet recruiting
2025/06/25
Phase 1
Not yet recruiting
2025/06/24
Phase 2
Not yet recruiting
2025/06/15
Phase 2
Not yet recruiting
Michael Spinner, MD
2025/06/11
Phase 2
Not yet recruiting
Vandana Abramson
2025/06/03
Phase 2
Not yet recruiting
2025/05/22
Phase 2
Recruiting
National Medical Research Radiological Centre of the Ministry of Health of Russia
2025/05/21
Phase 2
Not yet recruiting
National Health Research Institutes, Taiwan
2025/05/18
Phase 1
Recruiting
2025/05/13
Phase 3
Not yet recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Baxter Healthcare Company
0338-0080
INTRAVENOUS
2 mg in 1 mL
5/31/2022
Baxter Healthcare Corporation
0338-0080
INTRAVENOUS
2 mg in 1 mL
5/31/2022
Hikma Pharmaceuticals USA Inc.
0143-9089
INTRAVENOUS
2 mg in 1 mL
1/16/2024
Gland Pharma Limited
68083-248
INTRAVENOUS
2 mg in 1 mL
5/15/2023
NorthStar RxLLC
72603-103
INTRAVENOUS
2 mg in 1 mL
7/12/2022
Hikma Pharmaceuticals USA Inc.
0143-9085
INTRAVENOUS
2 mg in 1 mL
1/16/2024
Athenex Pharmaceutical Division, LLC.
70860-208
INTRAVENOUS
2 mg in 1 mL
10/20/2017
BluePoint Laboratories
68001-345
INTRAVENOUS
2 mg in 1 mL
9/28/2022
Hikma Pharmaceuticals USA Inc.
0143-9087
INTRAVENOUS
2 mg in 1 mL
1/16/2024
NorthStar RxLLC
72603-200
INTRAVENOUS
2 mg in 1 mL
7/12/2022

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
DOXORUBICIN ADVAGEN CONCENTRATE FOR SOLUTION FOR INFUSION 2MG/ML
SIN16420P
INJECTION, SOLUTION, CONCENTRATE
2.0 mg/ml
1/25/2022
ADRIM – DOXORUBICIN HYDROCHLORIDE INJECTION USP 2MG/ML
SIN16081P
INJECTION, SOLUTION
2 mg/ml
1/15/2021
CAELYX CONCENTRATE FOR INFUSION 2 mg/ml
SIN10426P
INJECTION
2.00 mg/ml
11/16/1998
DOXORUBICIN-TEVA CONCENTRATE FOR SOLUTION FOR INFUSION 2 MG/ML
SIN14969P
INJECTION, SOLUTION, CONCENTRATE
2mg/ml
3/21/2016
DOXOCCORD CONCENTRATE FOR SOLUTION FOR INFUSION 2 MG/ML
SIN16284P
INFUSION, SOLUTION CONCENTRATE
2 mg/ml
7/23/2021
K. U. DOXORUBICIN HCL FOR INJECTION 10 mg/vial
SIN10992P
INJECTION, POWDER, FOR SOLUTION
10 mg/vial
6/26/1999
K. U. DOXORUBICIN HCL FOR INJECTION 50 mg/vial
SIN10991P
INJECTION, POWDER, FOR SOLUTION
50 mg/vial
6/26/1999
CHEMODOX CONCENTRATE FOR INFUSION 2MG/ML
SIN16102P
INJECTION, SOLUTION
2MG/ML
2/9/2021
ADRIAMYCIN CS INJECTION 2 mg/ml
SIN10566P
INJECTION
2 mg/ml
12/18/1998
DOXABIN INJECTION 2MG/ML
Mylan Laboratories Limited [OTL]
SIN14262P
INJECTION, SOLUTION
2mg/ml
10/30/2012

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Doxorubicin Hydrochloride for Injection
国药准字H20013334
化学药品
注射剂
8/13/2020
Doxorubicin Hydrochloride for Injection
国药准字H14023879
化学药品
注射剂
9/3/2020
Doxorubicin Hydrochloride for Injection
国药准字H33021980
化学药品
注射剂
6/3/2020
Doxorubicin Hydrochloride for Injection
国药准字H44024359
化学药品
注射剂(冻干)
9/17/2019
Doxorubicin Hydrochloride for Injection
国药准字H33021981
化学药品
注射剂
6/3/2020
Doxorubicin Hydrochloride for Injection
国药准字H14023143
化学药品
注射剂
8/25/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.
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