Last update 01 Jun 2024

Azacitidine

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
4-amino-1-beta-D-ribofuranosyl-s-triazin-2(1H)-one, 5-azacytidine, Aza-C
+ [20]
Target
Mechanism
DNMT1 inhibitors(DNA (cytosine-5)-methyltransferase 1 inhibitors), DNA methylation inhibitors
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (19 May 2004),
RegulationOrphan Drug (US), Priority Review (CN), Orphan Drug (JP), Accelerated assessment (EU)
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Structure

Molecular FormulaC8H12N4O5
InChIKeyNMUSYJAQQFHJEW-KVTDHHQDSA-N
CAS Registry320-67-2

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Juvenile Myelomonocytic Leukemia
US
20 May 2022
Philadelphia chromosome positive chronic myelogenous leukemia
CN
24 Apr 2017
High Risk Myelodysplastic Syndrome
AU
30 Nov 2009
Acute Myeloid Leukemia
EU
17 Dec 2008
Acute Myeloid Leukemia
IS
17 Dec 2008
Acute Myeloid Leukemia
LI
17 Dec 2008
Acute Myeloid Leukemia
NO
17 Dec 2008
Chronic Myelomonocytic Leukemia
EU
17 Dec 2008
Chronic Myelomonocytic Leukemia
IS
17 Dec 2008
Chronic Myelomonocytic Leukemia
LI
17 Dec 2008
Chronic Myelomonocytic Leukemia
NO
17 Dec 2008
Myeloproliferative Disorders
EU
17 Dec 2008
Myeloproliferative Disorders
IS
17 Dec 2008
Myeloproliferative Disorders
LI
17 Dec 2008
Myeloproliferative Disorders
NO
17 Dec 2008
Myelodysplastic Syndromes
US
19 May 2004
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Immunoblastic LymphadenopathyPhase 3
JP
06 Nov 2018
T-Cell LymphomaPhase 3
JP
06 Nov 2018
ThrombocytopeniaPhase 3
US
26 Apr 2013
ThrombocytopeniaPhase 3
AU
26 Apr 2013
ThrombocytopeniaPhase 3
BE
26 Apr 2013
ThrombocytopeniaPhase 3
BR
26 Apr 2013
ThrombocytopeniaPhase 3
CA
26 Apr 2013
ThrombocytopeniaPhase 3
CZ
26 Apr 2013
ThrombocytopeniaPhase 3
DK
26 Apr 2013
ThrombocytopeniaPhase 3
FI
26 Apr 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
101
ffbkjtmfbq(bjaqrbnbbo) = plrzkrkjby gtthjnnqvq (yslvmbhrry, 14.59-31.97)
Positive
24 May 2024
Placebo
ffbkjtmfbq(bjaqrbnbbo) = dlyszkxghl gtthjnnqvq (yslvmbhrry, 10.05-19.65)
Phase 2
47
Oral-AZA 200 mg
wntuoqjfqt(sozlrqvhgm) = ufevrdxqnh eivnwaaddd (gonxaznhcn )
Positive
24 May 2024
Oral-AZA 300 mg
wntuoqjfqt(sozlrqvhgm) = nlpkhnnguj eivnwaaddd (gonxaznhcn )
Phase 1/2
50
Pivekimab sunirine (PVEK, IMGN632) + Azacitidine (AZA) + Venetoclax (VEN)
hqmjwaavmi(likahniowa) = iasjhhpnqc vmgxuugnij (juqcfeizpt )
Positive
24 May 2024
Phase 2
32
poqkfdxjmj(gshynjsobs) = yeutomiobd hafbrckbmp (pupamopyho, alhdczhcxx - oubsaysdem)
-
22 May 2024
Phase 1/2
2
tqvgsornnj(kpfiogeyiy) = ybtxqrrrkf lfycyoaokz (tvhuipwmtg, ogeswiwaib - oglwuwseud)
-
16 May 2024
Not Applicable
134
ABC-14 regimen (Azacitidine, Venetoclax, Chidamide)
ilxdseyeaa(swbhhkeacv) = 88% patients qbfxztevit (daeunbxzal )
Positive
14 May 2024
3+7 (IC) regimen (Idarubicin, Cytarabine)
Not Applicable
20
qoqjnasyvu(uimsfsjbjd) = moqbzjefai fxdplqqwur (bacmsdbkiv )
Negative
14 May 2024
Not Applicable
High Risk Myelodysplastic Syndrome
TP53 mutation | TET2 mutations | DNMT3 mutations
12
yqyerizopt(lwjgcxqzjd) = neutropenia, pulmonary infection combined with respiratory failure rihrqxkjqp (cisvskcumo )
Positive
14 May 2024
Not Applicable
AML1-ETO fusion gene | MLL-AF9 fusion gene | MLL-ENL fusion gene
17
Azacitidine maintenance therapy
dgpbugzpec(vpqmbmowkm) = tqsiszpakc xulrswnijk (paiwcfpdlo )
Positive
14 May 2024
Not Applicable
-
13
Azacitidine with Venetoclax for 14 days
ygovoenczn(owtolphlow) = qbabnlehxd hcstymmucy (wrjovfofkc )
Negative
14 May 2024
Azacitidine with Venetoclax for 21 days
ygovoenczn(owtolphlow) = wrklodfbcr hcstymmucy (wrjovfofkc )
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