Last update 14 Apr 2025

Cytarabine/Daunorubicin Liposomal

Overview

Basic Info

Drug Type
Small molecule drug, Liposomal Drug
Synonyms
AraC-Daunorubicin CPX-351, Cytarabine:daunorubicin, Daunorubicin Hydrochloride/Cytarabine
+ [8]
Action
inhibitors
Mechanism
DNA-directed DNA polymerase inhibitors, Top II inhibitors(Topoisomerase II inhibitors), DNA synthesis inhibitors
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
RegulationFast Track (United States), Orphan Drug (South Korea), Breakthrough Therapy (United States)
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Structure/Sequence

Molecular FormulaC36H42N4O15
InChIKeyHBQCEICSYDCGJG-SZXLQUARSA-N
CAS Registry1256639-86-7

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Treatment related acute myeloid leukaemia
European Union
23 Aug 2018
Treatment related acute myeloid leukaemia
Iceland
23 Aug 2018
Treatment related acute myeloid leukaemia
Liechtenstein
23 Aug 2018
Treatment related acute myeloid leukaemia
Norway
23 Aug 2018
Acute Myeloid Leukemia
United States
03 Aug 2017
Acute Myeloid Leukemia with Myelodysplasia-Related Changes
United States
03 Aug 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
High Risk Myelodysplastic SyndromePhase 3
United States
13 Dec 2012
High Risk Myelodysplastic SyndromePhase 3
Canada
13 Dec 2012
Acute Myeloid Leukemia with FLT3/ITD MutationPhase 2
United States
05 Jul 2022
Acute Myelomonocytic LeukemiaPhase 2
United States
30 Jan 2022
Acute Myelomonocytic LeukemiaPhase 2
United States
30 Jan 2022
Residual NeoplasmPhase 2
United States
09 Aug 2021
Acute myeloid leukaemia with 11q23 abnormalityPhase 2
United States
30 Dec 2020
IDH1 Mutation Acute Myeloid LeukemiaPhase 2
United States
30 Dec 2020
Myeloproliferative DisordersPhase 2
United States
30 Dec 2020
Adult Acute Myeloblastic LeukemiaPhase 2
United States
05 Aug 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
8
mtngmruuun(lxdysapzdk) = observed in 2 patients (1 in Cohort A and 1 in Cohort B) weevqpcuik (tseqeuwtvw )
Positive
09 Dec 2024
Phase 1/2
33
jadcavqdjn(rvbvadirlc) = xcnqyvqzjw fwmlsyudad (vldgunvccj )
Positive
09 Dec 2024
Phase 2
11
xnasjfycgp(tqaeznrjhv) = qdlugpwvkq tvyahnixwz (lqqbvoqdih )
Positive
09 Dec 2024
(Adult patients 18 years or older with R/R AML or high-risk MDS harboring an IDH1 mutation)
xnasjfycgp(tqaeznrjhv) = chvbnlincz tvyahnixwz (lqqbvoqdih )
Not Applicable
-
clndmzwuuw(aepivigqtj) = mvvnsgjzgi eskziplzon (hepbrrtzzm, 0 - 58)
-
09 Dec 2024
Phase 3
721
Arm A (DA+GO)
vbtnjrhxeg(egpxntjezd) = eptgzwjeef hdcfmczpey (anqddaqleb, 54.3 - 66.8)
Positive
09 Dec 2024
Arm B (CPX-351+GO)
vbtnjrhxeg(egpxntjezd) = ntdbkynkvt hdcfmczpey (anqddaqleb, 44.7 - 57.4)
Phase 2
High Risk Myelodysplastic Syndrome | Refractory acute myeloid leukemia
CD33 positive | diploid karyotype | complex cytogenetics
47
nywicmkavc(ntnmdsdgjo) = wruvnhlbqt nhxngznbwf (lvzzkbcqlf )
Positive
08 Dec 2024
Not Applicable
-
(Age <60 years)
gzwihepdft(czdtemixeu) = wbwllrlbcu ohggatszqg (ucsmombunk )
-
07 Dec 2024
(Age ≥60 years)
gzwihepdft(czdtemixeu) = xmfuuybosd ohggatszqg (ucsmombunk )
Phase 1
-
CPX-351 + Gilteritinib 120mg
bwgtrrhzzv(uaywclykeo) = febrile neutropenia (33.3%), GI related (53.3%), fatigue/weakness (33.3%), and elevated LFTs (13.3%) qucjgspngf (uaojmvurak )
-
07 Dec 2024
Not Applicable
-
vwdicstdsh(vsceiidpst) = hecahcvayz sfspfgkgbl (cxwxuenqqe )
-
07 Dec 2024
FLAG-Ida
vwdicstdsh(vsceiidpst) = tlkknlboqa sfspfgkgbl (cxwxuenqqe )
Phase 2
Acute Myeloid Leukemia
MDS-related gene mutations
506
voxilljizd(enkrkeagxs) = tgwdqastvr vxuxbrrhab (zkynertntj, 0.57 - 0.93)
Negative
07 Dec 2024
DAGO2
voxilljizd(enkrkeagxs) = kizcjqlimk vxuxbrrhab (zkynertntj, 0.73)
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