DAUNORUBICIN HYDROCHLORIDE
DAUNORUBICIN HYDROCHLORIDE is indicated for the treatment of Acute Nonlymphocytic Leukemia; Acute Lymphocytic Leukemia.
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1998-01-30
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DAUNORUBICIN HYDROCHLORIDE Approval History
What DAUNORUBICIN HYDROCHLORIDE Treats
2 indicationsDAUNORUBICIN HYDROCHLORIDE is approved for 2 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Nonlymphocytic Leukemia
- Acute Lymphocytic Leukemia
DAUNORUBICIN HYDROCHLORIDE Boxed Warning
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 ...
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.
DAUNORUBICIN HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in DAUNORUBICIN HYDROCHLORIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DAUNORUBICIN HYDROCHLORIDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to DAUNORUBICIN HYDROCHLORIDE
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
43 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05564390 | NCI-2022-07006 NCI-2022-07006, MYELOMATCH | Ph 2 | recruiting | MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) |
| NCT05554393 | NCI-2022-07534 NCI-2022-07534, AL.6 | Ph 2 | recruiting | Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial) |
| NCT05554406 | NCI-2022-07535 NCI-2022-07535, MM1YA-S01 | Ph 2 | recruiting | Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial) |
| NCT03150693 | A041501 NCI-2016-01981, U10CA180821 | Ph 3 | recruiting | Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia |
| NCT04293562 | AAML1831 NCI-2020-00546, AAML1831 | Ph 3 | recruiting | A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations |
| NCT03959085 | AALL1732 NCI-2019-02845, AALL1732 | Ph 3 | recruiting | Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy |
| NCT02112916 results posted | NCI-2014-00712 NCI-2014-00712, s14-01925 | Ph 3 | active not recruiting | Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma |
| NCT02883049 results posted | NCI-2011-03797 NCI-2011-03797, S12-01254 | Ph 3 | active not recruiting | Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations |
| NCT03007147 | AALL1631 NCI-2016-01588, AALL1631 | Ph 3 | active not recruiting | Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia |
| NCT02003222 results posted | NCI-2013-02229 NCI-2013-02229, ECOG-E1910 | Ph 3 | active not recruiting | Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia |
| NCT00558519 results posted | CALGB-10403 CALGB-10403, ECOG C10403 | Ph 2 | completed | Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia |
| NCT06917911 | NCI-2025-02426 NCI-2025-02426, MM1YA-A04 | Ph 2 | not yet recruiting | Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin, "7+3") for Core Binding Factor Acute Myeloid Leukemia (CBF-AML) to Improve Response (A MyeloMATCH Treatment Trial) |
| NCT01627041 | NCI-2012-01959 NCI-2012-01959, 1106011736 | Ph 2 | active not recruiting | Decitabine, Cytarabine, and Daunorubicin Hydrochloride in Treating Patients With Acute Myeloid Leukemia |
| NCT05955261 | AML23 NCI-2023-04138 | Ph 2 | suspended | A Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia |
| NCT04214249 results posted | NCI-2019-08626 NCI-2019-08626, 2000028858 | Ph 2 | active not recruiting | BLAST MRD AML-1: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Intensive Chemotherapy as Frontline Therapy in Patients With Acute Myeloid Leukemia |
| NCT02971397 results posted | IRB00040792 NCI-2016-01464, CCCWFU 22616 | Ph 1 | completed | Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia |
| NCT06918431 | 24442 NCI-2025-02184, 24442 | Ph 2 | recruiting | Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma |
| NCT02835222 | IRB00039092 NCI-2016-00951, CCCWFU 22316 | Ph 2 | active not recruiting | Selinexor With Combination With Induction/Consolidation Therapy in Acute Myeloid Leukemia Patients |
| NCT05157971 | 21134 NCI-2021-09185, 21134 | Ph 1 | recruiting | Venetoclax and a Pediatric-Inspired Regimen for the Treatment of Newly Diagnosed B Cell Acute Lymphoblastic Leukemia |
| NCT07072585 | AALL2331 NCI-2025-02230, AALL2331 | Ph 2, Ph 3 | not yet recruiting | Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL) |
| NCT01371981 results posted | NCI-2011-02670 NCI-2011-02670, CDR0000701850 | Ph 3 | active not recruiting | Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia |
| NCT03900949 | OSU-21190 NCI-2019-01726 | Ph 1 | completed | Gentuzumab Ozogamicin and Midostaurin Combination With Standard Cytarabine and Danunorubi Midostaurin as a Novel Approach to Treating Patients With Newly Diagnosed FLT-3 Mutated Acute Myeloid Leukemia |
| NCT02521493 results posted | AAML1531 NCI-2015-00324, AAML1531 | Ph 3 | active not recruiting | Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome |
| NCT03724084 results posted | NCI-2018-02349 NCI-2018-02349, 10212 | Ph 1, Ph 2 | terminated | Pinometostat With Standard Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and MLL Gene Rearrangement |
| NCT02828358 results posted | NCI-2016-00973 NCI-2016-00973, s17-00488 | Ph 2 | completed | Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement |
| NCT01228331 | CDR0000686545 2009-012758-18 | Ph 2, Ph 3 | completed | Clofarabine or High-Dose Cytarabine and Pegaspargase in Children with ALL |
| NCT00557193 results posted | AALL0631 NCI-2009-00313, CDR0000573996 | Ph 3 | completed | Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia |
| NCT01806571 results posted | MC1284 NCI-2013-00469, 12-006178 | Ph 2 | completed | Daunorubicin Hydrochloride, Cytarabine, and Nilotinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia |
| NCT01256398 results posted | NCI-2011-02621 NCI-2011-02621, CALGB 10701/CTSU C10701 | Ph 2 | completed | Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia |
| NCT01238211 results posted | NCI-2011-02615 NCI-2011-02615, CDR0000688434 | Ph 2 | completed | Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia |
| NCT01253070 results posted | NCI-2011-02618 NCI-2011-02618, CDR0000689593 | Ph 2 | completed | Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia |
| NCT01117441 | AIEOP-BFM ALL 2009 | Ph 3 | completed | International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia |
| NCT00671034 results posted | AALL07P4 NCI-2009-00317, CDR0000594340 | Ph 3 | completed | Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia |
| NCT00866307 results posted | AALL08P1 NCI-2009-01169, CDR0000636174 | Ph 1 | completed | Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011) |
| NCT02029950 | NCI-2013-02426 NCI-2013-02426, J13128 | Ph 1 | completed | Pomalidomide After Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome |
| NCT00720109 results posted | NCI-2009-00312 NCI-2009-00312, AALL0622 | Ph 2, Ph 3 | completed | Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia |
| NCT02323607 | OSU-14169 NCI-2014-02436 | Ph 1 | completed | Pacritinib and Chemotherapy in Treating Patients With Acute Myeloid Leukemia and FLT3 Mutations |
| NCT01802333 results posted | NCI-2013-00490 NCI-2013-00490, S1203 | Ph 3 | completed | Cytarabine and Daunorubicin Hydrochloride or Idarubicin and Cytarabine With or Without Vorinostat in Treating Younger Patients With Previously Untreated Acute Myeloid Leukemia |
| NCT02472626 | IRB00033422 NCI-2015-00890, IRB00033422 | Ph 1, Ph 2 | withdrawn | 6,8-Bis(Benzylthio)Octanoic Acid, Cytarabine, and Daunorubicin Hydrochloride in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia |
| NCT01349972 results posted | NCI-2011-02587 NCI-2011-02587, JHOC-J1101 | Ph 2 | completed | Alvocidib, Cytarabine, and Mitoxantrone Hydrochloride or Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia |
| NCT00814164 results posted | CDR0000630678 RPCI-I-132208 | Ph 2 | terminated | Clofarabine and Daunorubicin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia |
| NCT00742625 results posted | NCI-2009-00443 NCI-2009-00443, CDR0000612758 | Ph 1, Ph 2 | completed | Bortezomib, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia |
| NCT00840684 | CDR0000634230 IPC-LAM-HR, IPC-2006-007 | Ph 1, Ph 2 | completed | Laromustine, Daunorubicin, and Cytarabine in Treating Patients With Acute Myeloid Leukemia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DAUNORUBICIN HYDROCHLORIDE FDA Label Details
Indications & Usage
DAUNORUBICIN HYDROCHLORIDE is indicated for the treatment of Acute Nonlymphocytic Leukemia; Acute Lymphocytic Leukemia.
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 i...
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Full clinical data, patents, trials, and competitive landscape for daunorubicin hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment