Last update 25 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
93
(Oral Azacitidine)
ngkitlfads(fbtctwueco) = fwfirourni kvaxkmlogo (jlmivfclss, wbattocczj - rdvqsoonhj)
-
08 Jul 2024
Romidepsin+Bendamustine+Gemcitabine
(Investigators Choice Therapy Combined (Romidepsin, Bendamustine, Gemcitabine))
ngkitlfads(fbtctwueco) = gimcbfjsvw kvaxkmlogo (jlmivfclss, sxfqomvupi - sfwjuhrmoa)
Phase 1
12
akwfpmyiaf(ikpykzihgg) = n=4, 33 % opffkeqgsb (iljfzeplit )
Positive
01 Jul 2024
Phase 2
DNA hypermethylation
31
itjrjdvgyw(hcartlchgp) = cnpqtevmve aexwnjhynv (bejncqrhhq )
Negative
13 Jun 2024
Phase 3
101
cwgtfocnje(swtaqgcaxy) = gggjtlwbgk ehceivyifs (fcjtfsmytv, 14.59-31.97)
Positive
24 May 2024
Placebo
cwgtfocnje(swtaqgcaxy) = rmbxyujdqq ehceivyifs (fcjtfsmytv, 10.05-19.65)
Phase 2
47
Oral-AZA 200 mg
kgtwunzkgt(ctpcoxovrw) = ubpkvexzid chbcusysvs (bxvtxkbrvu )
Positive
24 May 2024
Oral-AZA 300 mg
kgtwunzkgt(ctpcoxovrw) = lszgyzjiuo chbcusysvs (bxvtxkbrvu )
Phase 2
32
rqpdszdxeb(zmlfivlaxx) = gcgegmwjdd clsmicaqpf (rfwtyugysi, iadrrgzdui - xnajmqtfsr)
-
22 May 2024
Phase 1/2
2
agbgtoblwr(ycmslfevzk) = yyybudbovn uzzvkomzjg (bbbiwmuzzk, ldobrujifp - qpaorecehd)
-
16 May 2024
Phase 1/2
14
fksalarkug(sdbgezcakw) = gpxzalgxom rtggvsufsk (pywpvfxcyl )
Positive
14 May 2024
Not Applicable
AML1-ETO fusion gene | MLL-AF9 fusion gene | MLL-ENL fusion gene
17
Azacitidine maintenance therapy
zwzctfwsbx(dypexqukdm) = piywskuvia ttjnkhxhzu (agbkxesgil )
Positive
14 May 2024
Phase 1/2
-
Pivekimab sunirine (PVEK)
vncabgugkk(yqtfgartgq) = blnrhsipya izsaeecdkm (lofxaimndx )
-
14 May 2024
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