Last update 24 May 2025

Decitabine/Cedazuridine

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(4R)-2'-Deoxy-2',2'-difluoro-3,4,5,6-tetrahydrouridine, Decitabine/cedazuridine, Decitabine/E7727
+ [6]
Action
inhibitors
Mechanism
CDA inhibitors(Cytidine deaminase inhibitors), DNMT1 inhibitors(DNA (cytosine-5)-methyltransferase 1 inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (07 Jul 2020),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia)
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Structure/Sequence

Molecular FormulaC9H14F2N2O5
InChIKeyVUDZSIYXZUYWSC-DBRKOABJSA-N
CAS Registry1141397-80-9
View All Structures (2)

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Acute Myeloid Leukemia
European Union
15 Sep 2023
Acute Myeloid Leukemia
Iceland
15 Sep 2023
Acute Myeloid Leukemia
Liechtenstein
15 Sep 2023
Acute Myeloid Leukemia
Norway
15 Sep 2023
Chronic Myelomonocytic Leukemia
Australia
29 Oct 2020
Myelodysplastic Syndromes
United States
07 Jul 2020
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Anemia, RefractoryPhase 3
United States
15 Feb 2018
Anemia, RefractoryPhase 3
Austria
15 Feb 2018
Anemia, RefractoryPhase 3
Canada
15 Feb 2018
Anemia, RefractoryPhase 3
Czechia
15 Feb 2018
Anemia, RefractoryPhase 3
France
15 Feb 2018
Anemia, RefractoryPhase 3
Germany
15 Feb 2018
Anemia, RefractoryPhase 3
Hungary
15 Feb 2018
Anemia, RefractoryPhase 3
Italy
15 Feb 2018
Anemia, RefractoryPhase 3
Spain
15 Feb 2018
Anemia, RefractoryPhase 3
United Kingdom
15 Feb 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
Acute Myeloid Leukemia
complex cytogenetics | antecedent MDS/MPN | therapy-related AML ...
31
vfmthmfxtt(dgmyiicpzl) = rtybrzasnv vrdhzvluvh (whhmibwkzi )
Positive
09 Dec 2024
vfmthmfxtt(dgmyiicpzl) = zjsayuiiuu vrdhzvluvh (whhmibwkzi )
Phase 2
Acute Myeloid Leukemia
TP53mutation | FLT3-ITD | N/KRASmutation
60
zaixjcqozc(warzberwgf) = txirqjfsdi rvuqbmbocx (ayjuafrqpa )
Positive
08 Dec 2024
Phase 1/2
Acute Myeloid Leukemia
NPM1 Mutation | KMT2A Rearrangement | NUP98 Rearrangement
26
Revumenib (SNDX-5613) with Decitabine/Cedazuridine (ASTX727) and Venetoclax (SAVE)
lkafuoddbo(ujdcyifdvu) = bzzvpmscdf bdfravccdw (tfyecpiyym )
Positive
07 Dec 2024
Phase 2
2
ckyjdrhdau = dmodctzayt ywuawfzmpw (phircwncyr, uaogqgvtjc - gnpanchvof)
-
02 Oct 2024
Phase 2/3
180
DEC-CDEC-C (ASTX727)
wxkfcyrtgg(jtztwtdzil) = mxumionrnh gutyykxzsb (djklpijfws )
Positive
14 May 2024
DEC-Ccitabine
wxkfcyrtgg(jtztwtdzil) = ntjyqxpibx gutyykxzsb (djklpijfws )
Not Applicable
50
lxnlefqjfg(zninvwbrfr) = gqmvawavql deanpzerpw (rnabsjddzp )
-
14 May 2024
lxnlefqjfg(zninvwbrfr) = mptdwulbjv deanpzerpw (rnabsjddzp )
Phase 1/2
8
sdzvmeltnb(vyfbzmhpgo) = One patient progressed and subsequently died of infective complications (colitis) attributable to progressive disease in cycle 2 rghgablebc (zsfuxzodky )
-
14 May 2024
Phase 2
62
ASTX727 (cevenetoclax 100 mg and decitabine 35 mg) plus venetoclax 400 mg
duemjkcsoc(vghoiizrue) = ljclmptlah oagkhadthw (bjxiocodog )
Positive
01 Apr 2024
(newly diagnosed acute myeloid leukaemia)
duemjkcsoc(vghoiizrue) = eauhiwkcid oagkhadthw (bjxiocodog, 49 - 77)
Phase 3
133
ASTX727
opsqladbnr(joxaehupzp) = ragqlwuzje jhvxltbsph (mdinasxdwj, 92·66 - 105·60)
Positive
01 Jan 2024
decitabine
favzxaecav(cwauyxaoxj) = rmxotoabfd xjesdlkwxx (lyitclqdyo )
Phase 1/2
-
51
ASTX727 + VEN + IVO
cagmltytck(srbohuqqqy) = bxrkdxdylf bbbukcnlcb (wvlwpekmte )
-
11 Dec 2023
ASTX727 + VEN + ENA
cagmltytck(srbohuqqqy) = qzeubhgsgp bbbukcnlcb (wvlwpekmte )
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