Drug · Small Molecule

Decitabine

CI-DRUG-00000183Explore in graph →NCIt C981 CHEMBL1201129 CIViC Approved

Regulatory

Approvals (6)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

emaRegulatory2 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	Acute Myeloid Leukemia	Inaqovi is indicated as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy. Inaqovi in combination with venetoclax is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy.	approved	Sep 15, 2023	ema

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 17 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	70	35	35	285	6	CA, EU, US	Sep 20, 2012	1995-08
Leukemia	Approved	Phase 4	50	25	24	197	2	EU	Sep 20, 2012	1995-08
Non-Hodgkin Lymphoma	Phase4	Phase 4	4	2	2	18	0	—	—	2004-02
Malignant Ovarian Neoplasm	Phase2	Phase 2	4	1	0	7	0	—

Curated evidence

Clinical evidence (4)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–4 of 4 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
DNMT3A Mutation1
Decitabine	Acute Myeloid Leukemia

Clinical trials

Trials with this intervention (287)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 151–200 of 287 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT01720225	Decitabine Versus Azacitidine in Myelodysplastic Syndrome Patients With Low and Intermediate-1 Risk	completed	Phase 2	113	M.D. Anderson Cancer CenterOTHER	1	Dec 24, 2020	clinicaltrials
NCT03530085	Dec+Flu+Bu Conditioning Regimen for Elderly AML in CR Undergoing Allo-HSCT	unknown	Phase 2 / Phase 3

Molecule

Record

Kind: Small Molecule
Mechanism: DNA (cytosine-5)-methyltransferase 3A inhibitor; DNA (cytosine-5)-methyltransferase 1 inhibitor; DNA inhibitor
Targets: 2 genes
UNII: 776B62CQ27
Aliases: 2'-Deoxy-5-azacytidine, 4-Amino-1-(2-deoxy-beta-D-erythro-pentofuranosyl)-1,3,5-triazin-2(1H)-one, 5-Aza-2'deoxycytidine, 5-Aza-2'-deoxycytidine, 5-Azadeoxycytidine, DAC, Dacogen, Decitabina, Decitabine, Decitabine component of astx-727, Decitabine component of astx727, Decitabine component of inqovi, Decitabine For Injection, DEMYLOCAN, Deoxyazacytidine, Dezocitidine, Inaqovi, INQOVI, NSC-127716

Data updated 20 hours agoSource updated unknown

Identifiers

Codes (10)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01BC08	DECITABINE
ATC (WHO)	L01BC58