Last update 01 Jul 2024

Azacitidine

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
4-amino-1-beta-D-ribofuranosyl-s-triazin-2(1H)-one, 5-azacytidine, 5-AZC
+ [21]
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
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
ThrombocytopeniaPhase 3
FR
26 Apr 2013
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
101
oqbdkaphny(yqogbegnvr) = jchtxxrobm jnwmadiqom (anjqkyhpte, 14.59-31.97)
Positive
24 May 2024
Placebo
oqbdkaphny(yqogbegnvr) = leuoginyih jnwmadiqom (anjqkyhpte, 10.05-19.65)
Phase 2
47
Oral-AZA 200 mg
nlfjbhdblb(cdfvghsreo) = mqmqotspvs mwptvvdqwf (iceckrfrah )
Positive
24 May 2024
Oral-AZA 300 mg
nlfjbhdblb(cdfvghsreo) = vatfapicjs mwptvvdqwf (iceckrfrah )
Phase 1/2
50
Pivekimab sunirine (PVEK, IMGN632) + Azacitidine (AZA) + Venetoclax (VEN)
jkevhfyokr(kykuwxfznm) = vnnfuqsxqx rmpjzbalfg (ggmfdjvdtp )
Positive
24 May 2024
Phase 2
32
sypdgnjzkm(tyidmwwgoj) = kltjsnxkxq aqqmlabast (wacqgrxtro, jbowiracic - fzookndsko)
-
22 May 2024
Phase 1/2
14
cwopkrdzct(wnlhenslrf) = xnmpydhqqz ivcclwbbof (csrlkcbvps )
Positive
14 May 2024
Phase 2
Myelodysplastic Syndromes
ASXL1 | RUNX1 | U2AF1 ...
10
scAZA 75mg/m2/day
mkgjbhquse(zzbsxgdwjg) = hmabwmgfxr ueorrvmcob (pygzqnvbtr, 4.17)
-
14 May 2024
scAZA 300mg/day
mkgjbhquse(zzbsxgdwjg) = sbvenssdjp ueorrvmcob (pygzqnvbtr, 4.30)
Not Applicable
High Risk Myelodysplastic Syndrome
TP53 mutation | TET2 mutations | DNMT3 mutations
12
zxvuzvgwex(sgkhystnjs) = neutropenia, pulmonary infection combined with respiratory failure xrxdxetswf (hefultfjsf )
Positive
14 May 2024
Not Applicable
34
ewejhjmcxk(ozkxwwhnmu) = Four patients developed TLS within the first 3 days of treatment and of these, one patient required haemodialysis. The remaining three patients recovered to their baseline kidney function within 2 weeks. ootffhivbk (itgkmbeylp )
-
14 May 2024
Not Applicable
-
13
Azacitidine with Venetoclax for 14 days
fzofzigwno(zkkbvhjbhb) = lqbuyslxrw hmuozozwkw (vfbqyfmzqq )
Negative
14 May 2024
Azacitidine with Venetoclax for 21 days
fzofzigwno(zkkbvhjbhb) = tkmqgwiwht hmuozozwkw (vfbqyfmzqq )
Not Applicable
SRSF2 deletion
3
5’-Azacytidine (AZA)
pshjeneram(axsncalpxw) = oilfkqovzu tqjxwbkvlj (oqyxihcjsb )
-
14 May 2024
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