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Data updated: Jun 28, 2026

CERUBIDINE (daunorubicin hydrochloride) · Pfizer

Oncology Approved 1979-12-19

CERUBIDINE is FDA-approved to treat 2 conditions (same as DAUNORUBICIN HYDROCHLORIDE).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
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

Companies

Pfizer Sanofi Hikma
Active Ingredient: DAUNORUBICIN HYDROCHLORIDE

CERUBIDINE Approval History

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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

What CERUBIDINE Treats

2 indications

CERUBIDINE is approved for 2 conditions since its original approval in 1979. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Acute Nonlymphocytic Leukemia
  • Acute Lymphocytic Leukemia

Same approved indications as DAUNORUBICIN HYDROCHLORIDE (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

44 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 completed 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 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 active not 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 completed 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
NCT07636564 S2507 NCI-2026-03381, S2507 Ph 2 not yet recruiting Testing Blinatumomab With or Without Revumenib in Patients With B-cell Acute Lymphoblastic Leukemia With a Genetic Change Requiring More Treatment
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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

Indications & Usage

CERUBIDINE is FDA-approved to treat 2 conditions — same approved indications as DAUNORUBICIN HYDROCHLORIDE.

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Data Sources

FDA Approval: NDA050484 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.