Data updated: May 26, 2026
CERUBIDINE (daunorubicin hydrochloride)
Oncology
Approved 1979-12-19
4
Indications
--
Phase 3 Trials
2
Priority Reviews
46
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1979-12-19
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
CERUBIDINE Approval History
1980
1981
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
19 FDA actions from 1979 to 2000 · 1 indication expansions
Dec 2000 SUPPL
Mfg · Manufacturing (CMC)
Nov 1999 SUPPL
Mfg · Manufacturing (CMC)
Oct 1999 SUPPL
Label · Labeling
Feb 1999 SUPPL
Label
Sep 1998 SUPPL
Mfg
Jun 1995 SUPPL
Mfg
Feb 1995 ORIGINAL
Update
Sep 1994 SUPPL Priority
Mfg
Apr 1993 SUPPL Priority
Label
Mar 1992 SUPPL Priority
Label
Mar 1987 SUPPL Priority
Efficacy
Dec 1982 SUPPL Priority
Label
Feb 1980 SUPPL Priority
Label
Feb 1980 ORIGINAL
Update
Dec 1979 ORIGINAL Priority
New Drug
What CERUBIDINE Treats
4 FDA approvalsOriginally approved for its first indication in 1979 . Covers 4 distinct patient populations.
- Other (4)
Other
(4 approvals)- • Approved indication (Dec 1979) Priority
- • Approved indication (Feb 1980)
- • Approved indication (Mar 1987) Priority
- • Approved indication (Feb 1995)
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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 |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
CERUBIDINE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.