Overview
A very toxic anthracycline aminoglycoside antineoplastic isolated from Streptomyces peucetius and others, used in treatment of leukemia and other neoplasms.
Indication
For remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults. Daunorubicin is indicated in combination with cytarabine for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.
Associated Conditions
- Acute Lymphoblastic Leukaemias (ALL)
- Acute Myeloid Leukemia With Myelodysplasia-Related Changes
- Chronic Phase Chronic Myeloid Leukemia
- Ewing's Sarcoma
- Lymphoma, Diffuse
- Myeloblastic Leukemia
- Non-Hodgkin's Lymphoma (NHL)
- Treatment-Related Acute Myeloid Leukemia
- Wilms' tumor
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/08 | Not Applicable | Not yet recruiting | |||
2025/06/05 | Phase 3 | Not yet recruiting | |||
2025/04/09 | Phase 2 | Not yet recruiting | City of Hope Medical Center | ||
2025/04/09 | Phase 2 | Not yet recruiting | |||
2024/12/20 | Phase 3 | Recruiting | |||
2024/12/20 | Phase 2 | Recruiting | |||
2024/08/01 | Phase 2 | Recruiting | |||
2024/04/30 | Phase 2 | Recruiting | |||
2024/04/11 | Phase 3 | Recruiting | First Affiliated Hospital of Zhejiang University | ||
2024/03/19 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Hisun Pharmaceuticals USA, Inc. | 42658-021 | INTRAVENOUS | 5 mg in 1 mL | 1/1/2023 | |
| Hisun Pharmaceuticals USA, Inc. | 42658-021 | INTRAVENOUS | 5 mg in 1 mL | 2/9/2021 | |
| Hisun Pharmaceuticals USA, Inc. | 42658-019 | INTRAVENOUS | 5 mg in 1 mL | 2/9/2021 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9550 | INTRAVENOUS | 5 mg in 1 mL | 2/15/2024 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9551 | INTRAVENOUS | 5 mg in 1 mL | 2/15/2024 | |
| Jazz Pharmaceuticals, Inc. | 68727-745 | INTRAVENOUS | 44 mg in 20 mL | 8/3/2017 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/23/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| DAUNOCIN FOR INJECTION 20 mg/vial | SIN11002P | INJECTION, POWDER, FOR SOLUTION | 20 mg/vial | 6/29/1999 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Daunorubicin Hydrochloride for Injection | 国药准字H44024361 | 化学药品 | 注射剂(冻干) | 9/17/2019 | |
| Daunorubicin Hydrochloride for Injection | 国药准字H33020925 | 化学药品 | 注射剂 | 6/3/2020 | |
| Daunorubicin Hydrochloride for Injection | 国药准字H20083726 | 化学药品 | 注射剂 | 4/17/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PFIZER DAUNORUBICIN daunorubicin (as hydrochloride) 18.7 mg powder for injection vial | 399600 | Medicine | A | 9/1/2023 | |
| Pfizer (Australia) DAUNORUBICIN (as hydrochloride) 20mg/10mL injection vial | 12723 | Medicine | A | 8/13/1991 | |
| Daunorubicin Injection 20 mg in 10 mL (2) | 312170 | Medicine | A | 12/4/2018 | |
| VYXEOS daunorubicin (as hydrochloride) 44 mg and cytarabine 100 mg powder for injection vial | 363250 | Medicine | A | 6/3/2022 | |
| Daunorubicin Injection 20 mg/10 mL (1) | 283862 | Medicine | A | 12/20/2016 |
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