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Drug

Decitabine

Approved · EMA
Emerging researchLate-stage developmentRising momentum
Also known as 5 aza 2 desoxycytidine, 5 azadeoxycytidine, 5-aza-2'-deoxycytidine, 5-azadeoxycytidine+4 more

5 aza 2 desoxycytidine, 5 azadeoxycytidine, 5-aza-2'-deoxycytidine, 5-azadeoxycytidine, DAC, Dacogen, Inqovi, Decitabina.

RxNorm15657ChEMBLCHEMBL1201129UNII776B62CQ27
6
Research papers
40
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Decitabine and Umbilical Cord Blood for Poor Graft Function Post Allogenic Hematopoietic Stem Cell Transplantation

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

Phase I Decitabine Dose-Tolerance in Surgically Resectable HPV-Negative Head and Neck Cancer

Clinical trial2026-07-15Results expected Q4 2027 · ClinicalTrials.gov

A Phase 1 Study of Oral Cedazuridine and Decitabine Combination (ASTX727, NSC# 820631) and Filgrastim as Maintenance Therapy Post-Hematopoietic Stem Cell Transplant in Children With High-Risk Acute Myeloid Leukemia

Clinical trial2026-07-07Results expected Q1 2027 · ClinicalTrials.gov

Low Dose Decitabine for Poor Graft Function Post Allogenic Hematopoietic Stem Cell Transplantation

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies

Clinical trial2026-06-12Results expected Q2 2027 · ClinicalTrials.gov

A Phase 1B Study of KRT-232 (AMG-232) in Combination With Decitabine and Venetoclax in Acute Myeloid Leukemia

Clinical trial2026-06-11Results expected Q2 2027 · ClinicalTrials.gov

A Study Comparing the Efficacy and Safety of Genotype-guided R-CHOP-X Versus R-CHOP in Patients With Diffuse Large B-Cell Lymphoma

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

Results of a randomized phase 3 study of oral sapacitabine in elderly patients with newly diagnosed acute myeloid leukemia (SEAMLESS).

Research2021-08-23Cancer

Low-dose decitabine for refractory prolonged isolated thrombocytopenia after HCT: a randomized multicenter trial.

Research2021-03-01Blood advances

Low-dose decitabine promotes megakaryocyte maturation and platelet production in healthy controls and immune thrombocytopenia.

Research2015-01-08Thrombosis and haemostasis

Approval: Dacogen (EMA)

Regulatory2012-09-20EMA

Epigenetic resensitization to platinum in ovarian cancer.

Research2012-05-01Cancer research

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Decitabine
Aliases & brands
5 aza 2 desoxycytidine5 azadeoxycytidine5-aza-2'-deoxycytidine5-azadeoxycytidineDACDacogenInqoviDecitabina
RxNorm CUI
15657
ChEMBL ID
CHEMBL1201129
UNII
776B62CQ27
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2012-09-20
Latest approval
2012-09-20
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2012-09-20Approval
Approval: Dacogen (EMA)
Indication: Treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organization (WHO) classification, who are not… Show full indication

Treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction chemotherapy.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

192 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
192
registered trials across all phases
LATEST COMPLETION 2026
40
Active studies
29
Recruiting
41
Late-stage (III+)
79
Completed
73
Discontinued
PHASE DISTRIBUTIONn = 192
Early Phase 13Phase 161Phase 1 / 232Phase 255Phase 2 / 312Phase 321Phase 45Phase N / A3

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Single-arm Clinical Study Evaluating the Safety and Efficacy of Decitabine in the Treatment of X-linked MAGT1 Deficiency With Increased Susceptibility to EBV Infection and N-linked Glycosylation Defect (XMEN) Patients

Not yet recruitingPH IVChildren's Hospital of Fudan Universityn=62028

A Prospective, Randomized, Controlled Trial of Decitabine Versus Conventional Chemotherapy for Maintenance Therapy of Patients With Acute Myeloid Leukemia With t(8;21)

Unknown statusPH IVThe First Hospital of Jilin Universityn=1802024

A Randomized, Controlled, Multi-center Collaborative Phase Ⅳ Study to Evaluate the Safety and Efficacy of Decitabine in Myelodysplastic Syndrome

Unknown statusPH IVCttqn=2402015

Decitabine for Myelodysplastic Syndromes and Acute Myeloid Leukemia Before Allogeneic Hematopoietic Cell Transplantation

Unknown statusPH IVThe First Affiliated Hospital of Soochow Universityn=302014

A Randomized, Open-label, Parallel-Group Study Comparing the Efficacy and Safety of DACOGEN (Decitabine) for Injection and VIDAZA (Azacitidine) for Injection In Subjects With Intermediate or High Risk Myelodysplastic Syndromes (MDS)

TerminatedPH IVEisai Inc.n=262011

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase Ib/II Study Evaluating Navitoclax After Failure of Hypomethylating Agent and Venetoclax for Treatment of Relapsed or Refractory High-Risk Myelodysplastic Syndrome

CompletedPH IThomas Jefferson Universityn=62026

A Phase I Study of Pevonedistat (TAK-924) and Decitabine Combination Therapy in High Risk Acute Myeloid Leukemia

CompletedPH ICity of Hope Medical Centern=122026

A Phase 1 Open-label, Multi-center Study of the Safety, Pharmacokinetics (PK), and Anti-tumor Activity of LYT- 200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS)

CompletedPH IPureTechn=1012025

A Phase II Study of the Impact of Clinicogenetic Risk-Stratified Management on Outcomes of Acute Myeloid Leukemia in Older Patients

CompletedPH IIUniversity of Nebraskan=752024

A Phase IB Rescue Study With Oral Decitabine (AStX727) and Durvalumab (MEDI4736) Combination Therapy in Recurrent and/or Metastatic Head and Neck Cancer Patients Who Have Progressed on Anti-PD-1, Anti-PD-L1, or Anti-CTLA-4 Monotherapy

CompletedPH IMassachusetts General Hospitaln=132024

Phase II Randomized Study of Lower Doses of Decitabine (DAC; 20 mg/m2 IV Daily for 3 Days Every Month) Versus Azacitidine (AZA; 75 mg/m2 SC/IV Daily for 3 Days Every Month) Versus Azacitidine (AZA; 75 mg/m2 SC/IV Daily for 5 Days Every Month) in MDS Patients With Low and Intermediate-1 Risk Disease Transfusion-Dependent Versus Best Supportive Care (BSC) in MDS Patients With Low and Intermediate-1 Risk Disease Transfusion-Independent

CompletedPH IIM.D. Anderson Cancer Centern=1852024

Research activity

6 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20102021
Most influential

Epigenetic resensitization to platinum in ovarian cancer.

Cancer research · 2012 · 313 cites

A phase 1 and pharmacodynamic study of decitabine in combination with carboplatin in patients with recurrent, platinum-resistant, epithelial ovarian cancer.

Cancer · 2010 · 139 cites

Low-dose decitabine promotes megakaryocyte maturation and platelet production in healthy controls and immune thrombocytopenia.

Thrombosis and haemostasis · 2015 · 43 cites

The effect of decitabine on megakaryocyte maturation and platelet release.

Thrombosis and haemostasis · 2011 · 32 cites

Low-dose decitabine for refractory prolonged isolated thrombocytopenia after HCT: a randomized multicenter trial.

Blood advances · 2021 · 18 cites

Results of a randomized phase 3 study of oral sapacitabine in elderly patients with newly diagnosed acute myeloid leukemia (SEAMLESS).

Cancer · 2021 · 6 cites
Recent papers

Low-dose decitabine for refractory prolonged isolated thrombocytopenia after HCT: a randomized multicenter trial.

Blood advances · 2021 · 18 cites

Results of a randomized phase 3 study of oral sapacitabine in elderly patients with newly diagnosed acute myeloid leukemia (SEAMLESS).

Cancer · 2021 · 6 cites

Low-dose decitabine promotes megakaryocyte maturation and platelet production in healthy controls and immune thrombocytopenia.

Thrombosis and haemostasis · 2015 · 43 cites

Epigenetic resensitization to platinum in ovarian cancer.

Cancer research · 2012 · 313 cites

The effect of decitabine on megakaryocyte maturation and platelet release.

Thrombosis and haemostasis · 2011 · 32 cites

A phase 1 and pharmacodynamic study of decitabine in combination with carboplatin in patients with recurrent, platinum-resistant, epithelial ovarian cancer.

Cancer · 2010 · 139 cites
Major research themes4
Arabinonucleosides1Leukemia, Myeloid, Acute1Myelodysplastic Syndromes1Thrombocytopenia1
Journals, researchers & institutions
Top journals
  • Cancer2
  • Thrombosis and haemostasis2
  • Blood advances1
  • Cancer research1
Leading researchers
  • Fang F2
  • Li L2
  • Nephew KP2
  • Schilder J2
  • Shen C2
  • Altman JK1
  • Arellano ML1
  • Arnold A1
Leading institutions
free-text, unnormalised
  • Abramson Cancer Center1
  • Children's Hospital of Soochow University1
  • Cleveland Clinic1
  • Dartmouth-Hitchcock Medical Center1
  • David Geffen School of Medicine at the University of California1
  • Duke University Medical Center1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.