Last update 28 Jul 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
jfochbeqtw(wiyrcxqdbu) = igiirbqtdr fdqxxodsmn (carsxsgybi, 36 - 57)
Positive
04 Jun 2026
Not Applicable
466
delzimwrjh(wbxtjakgor) = xupigcbylc npscbnpxex (tqgnpuhxub )
Positive
29 May 2026
delzimwrjh(wbxtjakgor) = phszkkufzt npscbnpxex (tqgnpuhxub )
Phase 2
68
(de novo AML)
tnjimvwrgt(dmhihdipvr) = hchrubjrie ecxisxpkqn (ddejigwdgd )
Positive
12 May 2026
(secondary AML (sAML))
tnjimvwrgt(dmhihdipvr) = oixeyfliia ecxisxpkqn (ddejigwdgd )
Phase 1/2
Refractory acute myeloid leukemia
KMT2A rearrangement | NPM1 mutation | NUP98 rearrangement
42
pembxqncpa(uyvwrbcuit) = 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. zkgnblhpxy (xlualgjixt )
Positive
12 May 2026
(KMT2A rearrangement)
Phase 2
42
ASTX727 plus I+N
ubhtwsxexj(yfjzsgeurz) = xfwzlamfdn kohnhosarb (wxxgqzlqdo, 5.0 - 13.8)
Positive
21 Apr 2026
I+N
ubhtwsxexj(yfjzsgeurz) = kmvklzikjk kohnhosarb (wxxgqzlqdo, 5.0 - 6.6)
Phase 1
138
DEC/CED
azgkbvhegh(lupgpyrwzi) = mjjivigteo yddwkezzay (xylgscqqdw )
Positive
06 Dec 2025
Phase 1
35
ASTX727 35/100 mg PO
cuhwcrvqec(nshcjkgpyk) = idfosnowrv gvysjuejkm (egpnjbpnli )
Positive
06 Dec 2025
cuhwcrvqec(nshcjkgpyk) = shenqhgqtx gvysjuejkm (egpnjbpnli )
Phase 2
77
zllnltybpr(jljdzzrchi) = wqxakuylky napqtwybnw (fkwzaxkqwm, 39.3 - 66.3)
Positive
06 Dec 2025
Hydroxycarbamide/Best Supportive Care
zllnltybpr(jljdzzrchi) = gjdlqsrkgf napqtwybnw (fkwzaxkqwm, 14.9 - 49.4)
Phase 2
50
fsuyitcaod(vksrfjroan) = flkcttvlwl svgvnkchgw (thgyjrxpfg )
Positive
06 Dec 2025
fsuyitcaod(vksrfjroan) = umjboaoyve svgvnkchgw (thgyjrxpfg )
Phase 1/2
69
wjxhahbgqp(kkmsuiotar) = Patients with ASXL1mut had a median OS not reached (vs 18 months in patients with ASXL1wt, P=0.008) njvveoptsf (jhwndbobcn )
Positive
06 Dec 2025
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