Drug · Small Molecule

Daunorubicin

CI-DRUG-00000182Explore in graph →NCIt C62091 CHEMBL178 CIViC Approved

Regulatory

Approvals (9)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

emaRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	—	Vyxeos liposomal is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).	approved	Aug 23, 2018	ema

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 19 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	58	36	87	249	9	CA, EU, US	Dec 31, 1971	1986-11
Leukemia	Phase4	Phase 4	55	33	79	232	0	—	—	1986-11
Non-Hodgkin Lymphoma	Phase4	Phase 4	7	6	5	16	0	—	—	1993-03
Malignant Central Nervous System Neoplasm	Phase3	Phase 3	1	1	2	2	0	—

Curated evidence

Clinical evidence (15)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–15 of 15 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
DNMT3A R8821
Daunorubicin	Acute Myeloid Leukemia

Clinical trials

Trials with this intervention (252)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 252 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT05554393	Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)	recruiting	Phase 2	153	National Cancer Institute (NCI)NIH	3	Sep 28, 2026	clinicaltrials
NCT06124157	A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)

Molecule

Record

Kind: Small Molecule
Mechanism: DNA topoisomerase II alpha inhibitor; DNA inhibitor
Targets: 1 gene
UNII: UD984I04LZ
Aliases: 5,12-Naphthacenedione, 8-acetyl-10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-, (8S-cis)-, (8S-cis)-8-Acetyl-10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione, CERUBIDINE, DAUNOMYCIN, Daunorrubicina, Daunorubicin, Daunorubicina, Daunorubicin component of vyxeos, Daunorubicine, Daunorubicin Hydrochloride, DAUNORUBICIN HYDROCHLORIDE, Daunoxome, DAUNOXOME LIPOSOMAL -, DNR, Epirubicin hydrochloride impurity, daunorubicin-, FI 6339, Leukaemomycin C, L-lyxo-Hexopyranoside, 3beta-acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-metldioxo-1a-naphthacenyl 3-amino-2,3,6-trideoxy-,alpha-, NSC-83142, RP 13057, Rubidomycin, RUBOMYCIN C, Valrubicin impurity, daunorubicin, VYXEOS

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (17)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01DB02

FLT3 D835V1
Daunorubicin + SunitinibCombination	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	accepted	EID3010 SU11248 + Daunorubicin has a synergic effect on Murine Ba/F3 cells with FLT3 D835V mutation. (Combination Index = 0.82 for ED50, Combination Index = 0.72 for ED75, Combination Index = 0.64 for ED90) PMID 15304385 · Yee et al., 2004 · Open in CIViC	civic

FLT3 D835V1

Daunorubicin + SunitinibCombination

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID3010

SU11248 + Daunorubicin has a synergic effect on Murine Ba/F3 cells with FLT3 D835V mutation. (Combination Index = 0.82 for ED50, Combination Index = 0.72 for ED75, Combination Index = 0.64 for ED90)

PMID 15304385 · Yee et al., 2004 · Open in CIViC

civic

FLT3 ITD1
Daunorubicin	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Resistance	3	accepted	EID130 Ba/F3 cells with both FLT3-ITD and TKD mutations on the same allele have more resistance to daunorubicin than cells with FLT3-ITD alone. PMID 15626738 · Bagrintseva et al., 2005 · Open in CIViC	civic

FLT3 ITD1

Daunorubicin

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Resistance

accepted

EID130

Ba/F3 cells with both FLT3-ITD and TKD mutations on the same allele have more resistance to daunorubicin than cells with FLT3-ITD alone.

PMID 15626738 · Bagrintseva et al., 2005 · Open in CIViC

civic

NPM1 EXON 11 MUTATION1
Daunorubicin	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	2	accepted	EID147 Young patients (18-60) with NPM1 mutations had improved overall survival following high-dose versus standard dose daunorubicin (p=0.01) in univariate analysis. However, the adjusted p-value for multip… (full text at CIViC) PMID 22417203 · Patel et al., 2012 · Open in CIViC	civic

NPM1 EXON 11 MUTATION1

Daunorubicin

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID147

Young patients (18-60) with NPM1 mutations had improved overall survival following high-dose versus standard dose daunorubicin (p=0.01) in univariate analysis. However, the adjusted p-value for multip… (full text at CIViC)

PMID 22417203 · Patel et al., 2012 · Open in CIViC

civic

NPM1 W288FS1
Cytarabine + Daunorubicin + EtoposideCombination	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	E	Supports Sensitivity Response	3	accepted	EID153 NPM1 mutation (Type A, W288fs) causes cytoplasmic localization of NPM when transfected into a non-hematopoietic cell line (293T cells). Cytoplasmic localization of NPM in AML patients was associated w… (full text at CIViC) PMID 15659725 · Falini et al., 2005 · Open in CIViC	civic

NPM1 W288FS1

Cytarabine + Daunorubicin + EtoposideCombination

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID153

NPM1 mutation (Type A, W288fs) causes cytoplasmic localization of NPM when transfected into a non-hematopoietic cell line (293T cells). Cytoplasmic localization of NPM in AML patients was associated w… (full text at CIViC)

PMID 15659725 · Falini et al., 2005 · Open in CIViC

civic

WT1 Exon 7 Mutation1
Cytarabine + DaunorubicinCombination	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	B	Supports Resistance	3	accepted	EID139 WT1 mutations were associated with an inferior response to induction chemotherapy with a higher rate of resistant disease in young (15-60+, median 45) patients with cytogenetically normal AML. PMID 18591546 · Virappane et al., 2008 · Open in CIViC	civic

WT1 Exon 7 Mutation1

Cytarabine + DaunorubicinCombination

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Resistance

accepted

EID139

WT1 mutations were associated with an inferior response to induction chemotherapy with a higher rate of resistant disease in young (15-60+, median 45) patients with cytogenetically normal AML.

PMID 18591546 · Virappane et al., 2008 · Open in CIViC

civic

IKZF1 Deletion1
Cytarabine + Daunorubicin + Fludarabine + Imatinib + MethotrexateCombination	B Lymphoblastic Leukemia/LymphomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID7366 This prospective study reports on the prognosis of patients with B-ALL and an IKZF1 deletion and the impact of intensification of treatment in this subgroup. In 50 patients from the MS2003 cohort, th… (full text at CIViC) PMID 30044693 · Yeoh et al., 2018 · Open in CIViC	civic

IKZF1 Deletion1

Cytarabine + Daunorubicin + Fludarabine + Imatinib + MethotrexateCombination

B Lymphoblastic Leukemia/LymphomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID7366

This prospective study reports on the prognosis of patients with B-ALL and an IKZF1 deletion and the impact of intensification of treatment in this subgroup. In 50 patients from the MS2003 cohort, th… (full text at CIViC)

PMID 30044693 · Yeoh et al., 2018 · Open in CIViC

civic

PRPS1 A190T1
Asparaginase + Cytarabine + Daunorubicin + MethotrexateSubstitutes	B Lymphoblastic Leukemia/LymphomaCURATED_BROADER	Predictive	D	Does Not Support Resistance	3	accepted	EID7928 Lentiviral-mediated overexpression of PRPS1 A190T in Reh cells resulted no difference in response to Methotrexate, Cytarabine, Daunorubicin, or L-Asparginase compared to empty vector and wildtype PRPS… (full text at CIViC) PMID 25962120 · Li et al., 2015 · Open in CIViC	civic

PRPS1 A190T1

Asparaginase + Cytarabine + Daunorubicin + MethotrexateSubstitutes

B Lymphoblastic Leukemia/LymphomaCURATED_BROADER

Predictive

Does Not Support Resistance

accepted

EID7928

Lentiviral-mediated overexpression of PRPS1 A190T in Reh cells resulted no difference in response to Methotrexate, Cytarabine, Daunorubicin, or L-Asparginase compared to empty vector and wildtype PRPS… (full text at CIViC)

PMID 25962120 · Li et al., 2015 · Open in CIViC

civic

PRPS1 D183E1
Asparaginase + Cytarabine + Daunorubicin + MethotrexateSubstitutes	B Lymphoblastic Leukemia/LymphomaCURATED_BROADER	Predictive	D	Does Not Support Resistance	3	accepted	EID7927 Lentiviral-mediated overexpression of PRPS1 D183E in Reh cells resulted no difference in response to Methotrexate, Cytarabine, Daunorubicin, or L-Asparginase compared to empty vector and wildtype PRPS… (full text at CIViC) PMID 25962120 · Li et al., 2015 · Open in CIViC	civic

PRPS1 D183E1

Asparaginase + Cytarabine + Daunorubicin + MethotrexateSubstitutes

B Lymphoblastic Leukemia/LymphomaCURATED_BROADER

Predictive

Does Not Support Resistance

accepted

EID7927

Lentiviral-mediated overexpression of PRPS1 D183E in Reh cells resulted no difference in response to Methotrexate, Cytarabine, Daunorubicin, or L-Asparginase compared to empty vector and wildtype PRPS… (full text at CIViC)

PMID 25962120 · Li et al., 2015 · Open in CIViC

civic

PRPS1 K176N1
Asparaginase + Cytarabine + Daunorubicin + MethotrexateSubstitutes	B Lymphoblastic Leukemia/LymphomaCURATED_BROADER	Predictive	D	Does Not Support Resistance	3	accepted	EID7926 Lentiviral-mediated overexpression of PRPS1 K176N in Reh cells resulted no difference in response to Methotrexate, Cytarabine, Daunorubicin, or L-Asparginase compared to empty vector and wildtype PRPS… (full text at CIViC) PMID 25962120 · Li et al., 2015 · Open in CIViC	civic

PRPS1 K176N1

Asparaginase + Cytarabine + Daunorubicin + MethotrexateSubstitutes

B Lymphoblastic Leukemia/LymphomaCURATED_BROADER

Predictive

Does Not Support Resistance

accepted

EID7926

Lentiviral-mediated overexpression of PRPS1 K176N in Reh cells resulted no difference in response to Methotrexate, Cytarabine, Daunorubicin, or L-Asparginase compared to empty vector and wildtype PRPS… (full text at CIViC)

PMID 25962120 · Li et al., 2015 · Open in CIViC

civic

PRPS1 L191F1
Asparaginase + Daunorubicin + MethotrexateSubstitutes	B Lymphoblastic Leukemia/LymphomaCURATED_BROADER	Predictive	D	Does Not Support Resistance	3	accepted	EID7923 Lentiviral-mediated overexpression of PRPS1 L191F in Reh cells resulted no difference in response to Methotrexate, Daunorubicin, or L-Asparginase compared to empty vector and wildtype PRPS1 overexpres… (full text at CIViC) PMID 25962120 · Li et al., 2015 · Open in CIViC	civic

PRPS1 L191F1

Asparaginase + Daunorubicin + MethotrexateSubstitutes

B Lymphoblastic Leukemia/LymphomaCURATED_BROADER

Predictive

Does Not Support Resistance

accepted

EID7923

Lentiviral-mediated overexpression of PRPS1 L191F in Reh cells resulted no difference in response to Methotrexate, Daunorubicin, or L-Asparginase compared to empty vector and wildtype PRPS1 overexpres… (full text at CIViC)

PMID 25962120 · Li et al., 2015 · Open in CIViC

civic

PRPS1 N144S1
Asparaginase + Daunorubicin + MethotrexateSubstitutes	B Lymphoblastic Leukemia/LymphomaCURATED_BROADER	Predictive	D	Does Not Support Resistance	3	accepted	EID7930 Lentiviral-mediated overexpression of PRPS1 N144S in Reh cells resulted no difference in response to Methotrexate, Daunorubicin, or L-Asparginase compared to empty vector and wildtype PRPS1 overexpres… (full text at CIViC) PMID 25962120 · Li et al., 2015 · Open in CIViC	civic

PRPS1 N144S1

Asparaginase + Daunorubicin + MethotrexateSubstitutes

B Lymphoblastic Leukemia/LymphomaCURATED_BROADER

Predictive

Does Not Support Resistance

accepted

EID7930

Lentiviral-mediated overexpression of PRPS1 N144S in Reh cells resulted no difference in response to Methotrexate, Daunorubicin, or L-Asparginase compared to empty vector and wildtype PRPS1 overexpres… (full text at CIViC)

PMID 25962120 · Li et al., 2015 · Open in CIViC

civic

PRPS1 S103N1
Asparaginase + Cytarabine + Daunorubicin + MethotrexateSubstitutes	B Lymphoblastic Leukemia/LymphomaCURATED_BROADER	Predictive	D	Does Not Support Resistance	3	accepted	EID7925 Lentiviral-mediated overexpression of PRPS1 S103N in Reh cells resulted no difference in response to Methotrexate, Cytarabine, Daunorubicin, or L-Asparginase compared to empty vector and wildtype PRPS… (full text at CIViC) PMID 25962120 · Li et al., 2015 · Open in CIViC	civic

PRPS1 S103N1

Asparaginase + Cytarabine + Daunorubicin + MethotrexateSubstitutes

B Lymphoblastic Leukemia/LymphomaCURATED_BROADER

Predictive

Does Not Support Resistance

accepted

EID7925

Lentiviral-mediated overexpression of PRPS1 S103N in Reh cells resulted no difference in response to Methotrexate, Cytarabine, Daunorubicin, or L-Asparginase compared to empty vector and wildtype PRPS… (full text at CIViC)

PMID 25962120 · Li et al., 2015 · Open in CIViC

civic

PRPS1 S103T1
Asparaginase + Cytarabine + Daunorubicin + MethotrexateSubstitutes	B Lymphoblastic Leukemia/LymphomaCURATED_BROADER	Predictive	D	Does Not Support Resistance	3	accepted	EID7924 Lentiviral-mediated overexpression of PRPS1 S103T in Reh cells resulted no difference in response to Methotrexate, Cytarabine, Daunorubicin, or L-Asparginase compared to empty vector and wildtype PRPS… (full text at CIViC) PMID 25962120 · Li et al., 2015 · Open in CIViC	civic

PRPS1 S103T1

Asparaginase + Cytarabine + Daunorubicin + MethotrexateSubstitutes

B Lymphoblastic Leukemia/LymphomaCURATED_BROADER

Predictive

Does Not Support Resistance

accepted

EID7924

Lentiviral-mediated overexpression of PRPS1 S103T in Reh cells resulted no difference in response to Methotrexate, Cytarabine, Daunorubicin, or L-Asparginase compared to empty vector and wildtype PRPS… (full text at CIViC)

PMID 25962120 · Li et al., 2015 · Open in CIViC

civic

PRPS1 T303S1
Asparaginase + Cytarabine + Daunorubicin + MethotrexateSubstitutes	B Lymphoblastic Leukemia/LymphomaCURATED_BROADER	Predictive	D	Does Not Support Resistance	3	accepted	EID7929 Lentiviral-mediated overexpression of PRPS1 T303S in Reh cells resulted no difference in response to Methotrexate, Cytarabine, Daunorubicin, or L-Asparginase compared to empty vector and wildtype PRPS… (full text at CIViC) PMID 25962120 · Li et al., 2015 · Open in CIViC	civic

PRPS1 T303S1

Asparaginase + Cytarabine + Daunorubicin + MethotrexateSubstitutes

B Lymphoblastic Leukemia/LymphomaCURATED_BROADER

Predictive

Does Not Support Resistance

accepted

EID7929

Lentiviral-mediated overexpression of PRPS1 T303S in Reh cells resulted no difference in response to Methotrexate, Cytarabine, Daunorubicin, or L-Asparginase compared to empty vector and wildtype PRPS… (full text at CIViC)

PMID 25962120 · Li et al., 2015 · Open in CIViC

civic