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decitabine

Trade name: dacogen

Small moleculeapprovedOrphan Drug FDAFast Track FDA

Approved

May 2, 2006

Decitabine was first synthesized by Pliml and Sorm in the Institute of Organic Chemistry, Czechoslovak Academy of Sciences in 1964. Later, the drug was approved by FDA for the treatment of myelodysplastic syndromes in patients with cancer. Upon administration the decitabine is metabolized to the active phosphorylated metabolite which is incorporated into DNA and thus inhibits DNA methyltransferase (decitabine deplete DNMT1). — NCATS

Clinical trial activity

423 trials · 239 clinical orgs · 31 marketing orgs

Phase 1
196
Phase 2
269
Phase 3
55
Phase 4
7

Earliest trial started Jul 1, 1994 (NCT00002831)

Timeline

1990s

  1. Jan 1, 1994

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1998

    Earliest Phase 2 Sponsor(trial)

  3. Mar 8, 1999

    Orphan Drug Designation

2000s

  1. Jan 1, 2001

    Earliest Phase 3 Sponsor(trial)

  2. May 2, 2006

    MGI Pharma — Earliest FDA Approval

  3. May 2, 2006

    MGI Pharma — NDA Organization

  4. May 2, 2006

    Otsuka — NDA Secondary Org

2010s

  1. Jul 11, 2013

    Dr. Reddy's Laboratories — Marketing Organization

  2. Jan 23, 2014

    Sun Pharmaceuticals — NDA Secondary Org

  3. Jan 23, 2014

    Sun Pharmaceuticals — Marketing Organization

  4. Aug 28, 2014

    Sandoz — Marketing Organization

  5. Aug 28, 2014

    Novartis — Marketing Organization

  6. Feb 27, 2017

    Accord Research — Marketing Organization

  7. May 31, 2017

    Pharmasciences — Marketing Organization

  8. May 31, 2017

    Ferring — Marketing Organization

  9. Sep 22, 2017

    Chemi SpA — Marketing Organization

  10. Sep 22, 2017

    Italfarmaco — Marketing Organization

  11. Nov 16, 2017

    Cipla — Marketing Organization

  12. Mar 16, 2018

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  13. Mar 16, 2018

    Nichi-Iko Pharmaceutical Co., Ltd. — Marketing Organization

  14. Nov 9, 2018

    Lupin — Marketing Organization

  15. Apr 9, 2019

    Wockhardt — Marketing Organization

  16. Aug 28, 2019

    MSN Laboratories — Marketing Organization

  17. Sep 16, 2019

    Novast Labs — Marketing Organization

  18. Sep 16, 2019

    Ingenus Pharmaceuticals — Marketing Organization

2020s

  1. Jul 7, 2020

    Taiho Pharmaceutical — NDA Secondary Org

  2. Nov 23, 2020

    Apotex — Marketing Organization

  3. Nov 23, 2020

    Gland Pharma Ltd — Marketing Organization

  4. Nov 23, 2020

    Fosun — Marketing Organization

  5. Dec 7, 2020

    Nivagen Pharmaceuticals Inc. — Marketing Organization

  6. Apr 12, 2021

    Qilu Pharmaceutical Co., Ltd. — Marketing Organization

  7. Jul 2, 2021

    Meitheal — Marketing Organization

  8. Sep 20, 2021

    Eugia Pharma — Marketing Organization

  9. Nov 19, 2021

    Zydus Discovery DMCC — Marketing Organization

  10. Apr 15, 2022

    Jiangsu Hansoh Pharmaceutical Co., Ltd. — Marketing Organization

  11. May 10, 2024

    Hetero Labs Ltd — Marketing Organization

  12. Dec 19, 2025

    Reliance Life Sciences Pvt. Ltd — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • inqovi

    with cedazuridine

    Also known as decitabine and cedazuridine

Approval history

  • approvedFast trackMay 2, 2006

Chemistry & pharmacology

Loading structure…

SMILES

NC1=NC(=O)N(C=N1)[C@H]2C[C@H](O)[C@@H](CO)O2
Mol. weight
228.2053 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Sources

Also known as

  • 2'-deoxy-5-azacytidine
  • 4-amino-1-(2-deoxy-beta-d-erythro-pentofuranosyl)-s-triazin-2(1h)-one
  • 4-amino-1-(2-deoxy-beta-d-erythro-pentofuranosyl)-s-triazin-2(1h)-one
  • 5-aza-2'-deoxycytidine
  • 5-aza-2'-deoxycytidine
  • 5-aza-2'-deoxycytidine
  • 5-aza-2'-deoxycytidine
  • 5-azadeoxycytidine
  • 5-azadeoxycytidine
  • 5-azadeoxycytidine
  • 5-aza-deoxycytidine
  • 5-aza-deoxycytidine
  • 5-deoxyazacytidine
  • azadc
  • azadc
  • azadc compound
  • dac
  • dac
  • dacogen
  • dacogen
  • dacogen
  • dacogen
  • dacogen
  • dacogen
  • decitabine
  • decitabine
  • decitabine
  • decitabine
  • decitabine
  • decitabine
  • decitabine
  • decitabine
  • decitabine
  • decitabine
  • decitabine
  • decitabine mesilate
  • decitabine mesylate
  • decitabine mesylate
  • decitabine mesylate
  • decitabine mesylate
  • decitabine mesylate
  • decitabine mesylate
  • decitabine plus modified bucy
  • dezocitidine
  • dezocitidine
  • dezocitidine
  • jnj-30979754
  • jnj-30979754
  • nsc 127716
  • nsc-127716

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07159373Phase 3Mar 31, 2026Medicines Development for Global Health, Murdoch University, University of New South Wales
NCT07153497Phase 2Feb 26, 2026National Cancer Institute (NCI)
NCT07148947Phase 2Feb 1, 2026Swedish Orphan Biovitrum, University of Washington
NCT07216833Phase 1Jan 31, 2026Case Western Reserve University
NCT07283094Phase 1Jan 31, 2026Foghorn Therapeutics Inc., Yeshiva University
NCT07177079Phase 1Dec 31, 2025University of Iowa
NCT06997094Phase 1Dec 8, 2025Mayo Clinic
NCT07071155Early Phase 1 (Phase 1)Dec 5, 2025Johns Hopkins University
NCT07044544Phase 1Oct 31, 2025University of Alabama, Birmingham
NCT07012044Phase 1Oct 31, 2025National Cancer Institute (NCI)
NCT06928662Phase 1/Phase 2 (Phase 2)Sep 23, 2025University of Washington
NCT06930651Phase 1/Phase 2 (Phase 2)Sep 3, 2025University of Texas at Houston
NCT06923488Phase 1/Phase 2 (Phase 2)Aug 31, 2025West Virginia University
NCT07060001Phase 2Jul 31, 2025Methodist Cancer Center, Houston, Texas, The University of Texas, Dallas
NCT07052422Phase 2/Phase 3 (Phase 3)Jul 15, 2025Southern Medical University
NCT07238686Phase 2Jun 20, 2025People's Liberation Army of China
NCT07007767Phase 2Jun 15, 2025Huazhong University of Science and Technology
NCT06972641Phase 2/Phase 3 (Phase 3)Jun 10, 2025Jiao Tong University
NCT07006025Phase 1Jun 3, 2025EpiDestiny, Inc.
NCT06802523Phase 1Apr 30, 2025National Cancer Institute (NCI), Yale University
Showing 20 of 423 trials
Page 1 / 22

Organizations

Research & Development (239)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government824341994
University of Texas at HoustonAcademic/Hospital605131994
EisaiFor profit321142002
People's Liberation Army of ChinaGovernment262532012
Jiao Tong UniversityAcademic/Hospital201932011
Soochow UniversityAcademic/Hospital171742009
Ohio State UniversityAcademic/Hospital14632004
Southern Medical UniversityAcademic/Hospital141322016
Peking UniversityAcademic/Hospital13342017
Astex Pharmaceuticals, Inc.For profit12732001
Johnson and JohnsonFor profit12642008
Sun Yat-Sen UniversityAcademic/Hospital10022016
Harvard UniversityAcademic/Hospital9622014
NovartisFor profit9522009
University of WashingtonAcademic/Hospital9932012
Washington University in St. LouisAcademic/Hospital9822008
Chinese Academy of Medical SciencesAcademic/Hospital8422012
City of Hope National Medical CenterAcademic/Hospital8522017
State University of New York, BuffaloAcademic/Hospital8822009
University of RochesterAcademic/Hospital8322010
239 organizations
Page 1 / 12

Marketing (39)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGFeb 27, 2017
ApotexFor profitMKTGNov 23, 2020
Chemi SpAFor profitMKTGSep 22, 2017
CiplaFor profitMKTGNov 16, 2017
Dr. Reddy's LaboratoriesFor profitMKTGJul 11, 2013
Dr. Reddy's LaboratoriesFor profitSYNJul 11, 2013
Eugia PharmaFor profitMKTGSep 20, 2021
FerringFor profitMKTGMay 31, 2017
FosunFor profitMKTGNov 23, 2020
Gland Pharma LtdFor profitMKTGNov 23, 2020
Hetero Labs LtdFor profitMKTGMay 10, 2024
Ingenus PharmaceuticalsFor profitMKTGSep 16, 2019
ItalfarmacoFor profitMKTGSep 22, 2017
Jiangsu Hansoh Pharmaceutical Co., Ltd.For profitMKTGApr 15, 2022
LupinFor profitMKTGNov 9, 2018
LupinFor profitSYNNov 9, 2018
MGI PharmaFor profitNDAMay 2, 2006
MSN LaboratoriesFor profitSYNAug 28, 2019
MSN LaboratoriesFor profitMKTGAug 28, 2019
MeithealFor profitMKTGJul 2, 2021
Nichi-Iko Pharmaceutical Co., Ltd.For profitMKTGMar 16, 2018
Nivagen Pharmaceuticals Inc.For profitMKTGDec 7, 2020
NovartisFor profitMKTGAug 28, 2014
Novast LabsFor profitMKTGSep 16, 2019
OtsukaFor profitNDA2May 2, 2006
OtsukaFor profitSYNMay 2, 2006
PharmasciencesFor profitMKTGMay 31, 2017
Qilu Pharmaceutical Co., Ltd.For profitMKTGApr 12, 2021
Qilu Pharmaceutical Co., Ltd.For profitSYNApr 12, 2021
Reliance Life Sciences Pvt. LtdFor profitMKTGDec 19, 2025
Sagent Pharmaceuticals, Inc.For profitMKTGMar 16, 2018
Sagent Pharmaceuticals, Inc.For profitSYNMar 16, 2018
SandozFor profitMKTGAug 28, 2014
SandozFor profitSYNAug 28, 2014
Sun PharmaceuticalsFor profitNDA2Jan 23, 2014
Sun PharmaceuticalsFor profitMKTGJan 23, 2014
Taiho PharmaceuticalFor profitNDA2Jul 7, 2020
WockhardtFor profitMKTGApr 9, 2019
Zydus Discovery DMCCFor profitMKTGNov 19, 2021