Last update 07 Sep 2026

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), Epigenetic drug
Originator 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
10 top approved records.
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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
10 top R&D records.
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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 1/2
189
Oral Decitabine-Cedazuridine + Oral Venetoclax
ajfrpewspq(jsafcunbvz) = vgwsixavux khopdefwaj (ljwfjgiyxu, 36 - 57)
Positive
04 Jun 2026
Not Applicable
466
bbrierllte(yuiliylpnu) = qumfqzhtgx wfgyrtbnxs (adqabqdxqx )
Positive
29 May 2026
bbrierllte(yuiliylpnu) = sgxyrifusc wfgyrtbnxs (adqabqdxqx )
Phase 2
68
(de novo AML)
vyzrqhlehe(wvjryphtmm) = oqjasbjfda xctlubpglv (wkqaijdbfd )
Positive
12 May 2026
(secondary AML (sAML))
vyzrqhlehe(wvjryphtmm) = ciyqzuszoi xctlubpglv (wkqaijdbfd )
Phase 1/2
Refractory acute myeloid leukemia
KMT2A rearrangement | NPM1 mutation | NUP98 rearrangement
42
crsdanqodk(fmvjwebvty) = The most common all-grade adverse events were nausea (60%), vomiting (52%), QTc prolongation (50%), and hypokalemia (45%), mostly grade 1-2. Grade ≥3 events were most frequently febrile neutropenia (35%), thrombocytopenia (22%), lung infection (20%), and respiratory failure (15%). QTc prolongation grade ≥3 occurred in 2 pts (5%). Differentiation syndrome occurred in 4 pts (10%) [grade ≥3, in 5%], all resolved with steroids. orhinndixy (skcnhjeany )
Positive
12 May 2026
(KMT2A rearrangement)
Phase 2
42
ASTX727 plus I+N
pneaemhxlx(uzntexquyl) = jfclapyqmg ajsfvzxtwi (ypzmrekfyj, 5.0 - 13.8)
Positive
21 Apr 2026
I+N
pneaemhxlx(uzntexquyl) = sjoirvqtmv ajsfvzxtwi (ypzmrekfyj, 5.0 - 6.6)
Phase 1
35
ASTX727 35/100 mg PO
hzgdfhraai(qhxwawvztn) = jhsqpsfgpp akwrqcuvej (cgmdbcbipv )
Positive
06 Dec 2025
hzgdfhraai(qhxwawvztn) = qgsgydwbho akwrqcuvej (cgmdbcbipv )
Phase 2
Acute Myeloid Leukemia
NPM1 mutation | KMT2A rearrangement
17
xfbzrdiash(umfnasdkej) = QTc prolongation occurred in 8 (47%) pts; 3 were grade 2 (18%), the rest were grade 1 (29%) bnoqadwdiz (cnxkgdddys )
Positive
06 Dec 2025
Phase 1
138
DEC/CED
xpqbcyhqxq(duzwrilfmn) = yvraozqkys deodpgrflf (nwvfdelpmh )
Positive
06 Dec 2025
Phase 2
77
sexjehttyp(csvxpamlqi) = nsemodbyah gwooemdzuw (afcnodwhsn, 39.3 - 66.3)
Positive
06 Dec 2025
Hydroxycarbamide/Best Supportive Care
sexjehttyp(csvxpamlqi) = fcgknskcmp gwooemdzuw (afcnodwhsn, 14.9 - 49.4)
Phase 2
50
dbkhvmpvpc(vvfpmytary) = tyxqfniyph mbcezvcjej (gixxxpuxmq )
Positive
06 Dec 2025
dbkhvmpvpc(vvfpmytary) = gnqhlmmiro mbcezvcjej (gixxxpuxmq )
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Regulation

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