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Daunorubicin Hydrochloride (daunorubicin)
Daunorubicin Hydrochloride (generic name: daunorubicin) is a Anthracycline Topoisomerase Inhibitor drug developed by Meiji Seika Pharma Co., Ltd. It is currently FDA-approved (first approved 1979) for Acute lymphoid leukemia, Acute monocytic/monoblastic leukemia, Acute myeloid leukemia, disease.
At a glance
| Generic name | daunorubicin |
|---|---|
| Sponsor | Meiji Seika Pharma Co., Ltd |
| Drug class | Anthracycline Topoisomerase Inhibitor |
| Target | Histone deacetylase 6 |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1979 |
Approved indications
- Acute lymphoid leukemia
- Acute monocytic/monoblastic leukemia
- Acute myeloid leukemia, disease
- Acute promyelocytic leukemia, FAB M3
- Blast crisis of chronic myeloidleukemia
- Erythroleukemia, FAB M6
- Kaposi's sarcoma
Boxed warnings
- WARNINGS 1.Daunorubicin Hydrochloride Injection must be given into a rapidly flowing intravenous infusion. It must never be given by the intramuscular or subcutaneous route. Severe local tissue necrosis will occur if there is extravasation during administration. 2.Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure may occur either during therapy or months to years after termination of therapy. The incidence of myocardial toxicity increases after a total cumulative dose exceeding 400 to 550 mg/m 2 in adults, 300 mg/m 2 in children more than 2 years of age, or 10 mg/kg in children less than 2 years of age. 3.Severe myelosuppression occurs when used in therapeutic doses; this may lead to infection or hemorrhage. 4.It is recommended that daunorubicin hydrochloride be administered only by physicians who are experienced in leukemia chemotherapy and in facilities with laboratory and supportive resources adequate to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The physician and institution must be capable of responding rapidly and completely to severe hemorrhagic conditions and/or overwhelming infection. 5.Dosage should be reduced in patients with impaired hepatic or renal function.
Common side effects
- myelosuppression
- cardiotoxicity
- alopecia
- mucositis
- nausea
- vomiting
- diarrhea
- abdominal pain
- severe local tissue necrosis
- severe cellulitis
- thrombophlebitis
- painful induration
Key clinical trials
- Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial (PHASE2)
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma (PHASE3)
- Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (PHASE2)
- Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (PHASE2,PHASE3)
- A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) (PHASE3)
- A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (PHASE3)
- Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Daunorubicin Hydrochloride CI brief — competitive landscape report
- Daunorubicin Hydrochloride updates RSS · CI watch RSS
- Meiji Seika Pharma Co., Ltd portfolio CI
Frequently asked questions about Daunorubicin Hydrochloride
What is Daunorubicin Hydrochloride?
Daunorubicin Hydrochloride (daunorubicin) is a Anthracycline Topoisomerase Inhibitor drug developed by Meiji Seika Pharma Co., Ltd, indicated for Acute lymphoid leukemia, Acute monocytic/monoblastic leukemia, Acute myeloid leukemia, disease.
What is Daunorubicin Hydrochloride used for?
Daunorubicin Hydrochloride is indicated for Acute lymphoid leukemia, Acute monocytic/monoblastic leukemia, Acute myeloid leukemia, disease, Acute promyelocytic leukemia, FAB M3, Blast crisis of chronic myeloidleukemia.
Who makes Daunorubicin Hydrochloride?
Daunorubicin Hydrochloride is developed and marketed by Meiji Seika Pharma Co., Ltd (see full Meiji Seika Pharma Co., Ltd pipeline at /company/meiji-seika-pharma-co-ltd).
What is the generic name of Daunorubicin Hydrochloride?
daunorubicin is the generic (nonproprietary) name of Daunorubicin Hydrochloride.
What drug class is Daunorubicin Hydrochloride in?
Daunorubicin Hydrochloride belongs to the Anthracycline Topoisomerase Inhibitor class. See all Anthracycline Topoisomerase Inhibitor drugs at /class/anthracycline-topoisomerase-inhibitor.
When was Daunorubicin Hydrochloride approved?
Daunorubicin Hydrochloride was first approved on 1979.
What development phase is Daunorubicin Hydrochloride in?
Daunorubicin Hydrochloride is FDA-approved (marketed).
What are the side effects of Daunorubicin Hydrochloride?
Common side effects of Daunorubicin Hydrochloride include myelosuppression, cardiotoxicity, alopecia, mucositis, nausea, vomiting.
What does Daunorubicin Hydrochloride target?
Daunorubicin Hydrochloride targets Histone deacetylase 6 and is a Anthracycline Topoisomerase Inhibitor.
Related
- Drug class: All Anthracycline Topoisomerase Inhibitor drugs
- Target: All drugs targeting Histone deacetylase 6
- Manufacturer: Meiji Seika Pharma Co., Ltd — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Acute lymphoid leukemia
- Indication: Drugs for Acute monocytic/monoblastic leukemia
- Indication: Drugs for Acute myeloid leukemia, disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing