Drug · Small Molecule

Cytarabine

CI-DRUG-00000168Explore in graph →NCIt C408 CHEMBL803 CIViC Approved

Regulatory

Approvals (23)

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

openfdaRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection (preservative free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia.	approved	Jun 4, 1990	openfda

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 18 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	197	105	198	1,004	23	CA, EU, US	Jun 4, 1990	1986-11
Leukemia	Phase4	Phase 4	151	83	151	766	0	—	—	1986-11
Non-Hodgkin Lymphoma	Phase4	Phase 4	35	16	21	124	0	—	—	1993-03
Hodgkin Lymphoma	Phase3	Phase 3	5	4	2	20	0	—	—

Curated evidence

Clinical evidence (17)

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

civicCuratedShowing 1–17 of 17 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
FLT3 D835V1
Cytarabine + Sunitinib

Clinical trials

Trials with this intervention (1,008)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 801–850 of 1,008 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
NCT00028899	Monoclonal Antibody Plus Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes	completed	Phase 1	47	Children's Oncology GroupNETWORK	3	Feb 20, 2014	clinicaltrials
NCT00070174	Gemtuzumab Ozogamicin in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia Undergoing Remission Induction and Intensification Therapy

Molecule

Record

Kind: Small Molecule
Mechanism: DNA inhibitor; RNA inhibitor; DNA polymerase (alpha/delta/epsilon) inhibitor
Targets: 11 genes
UNII: 04079A1RDZ
Aliases: 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 4-Amino-1-beta-D-arabinofuranosyl-2(1H)-pyrimidinone, AJ-CYTARABINE, Alexan, Alexan 100, Arabine, Arabinocytosine, Arabinofuranosylcytosine, Arabinosyl cytosine, Arabinosylcytosine, Ara-C, ARA-cell, Ara-cytidine, Aracytidine, Aracytin, Aracytine, .beta.-Cytosine Arabinoside, CHX-3311, Citarabina, Cytarabine, Cytarabine component of vyxeos, CYTARABINE INJECTION, MYLAN STD., Cytarabine liposome, CYTARABINE-PWS, Cytarabinoside, Cytarabinum, Cytarbel, Cytosar … (+20)

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (44)

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

System	Code	Label
ATC (WHO)	L01BC01	CYTARABINE
ATC (WHO)

NPM1 W288FS1
Cytarabine + Daunorubicin + EtoposideCombination	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	E	Supports Sensitivity Response	3	accepted	EID153 NPM1 mutation (Type A, W288fs) causes cytoplasmic localization of NPM when transfected into a non-hematopoietic cell line (293T cells). Cytoplasmic localization of NPM in AML patients was associated w… (full text at CIViC) PMID 15659725 · Falini et al., 2005 · Open in CIViC	civic

NPM1 W288FS1

Cytarabine + Daunorubicin + EtoposideCombination

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID153

NPM1 mutation (Type A, W288fs) causes cytoplasmic localization of NPM when transfected into a non-hematopoietic cell line (293T cells). Cytoplasmic localization of NPM in AML patients was associated w… (full text at CIViC)

PMID 15659725 · Falini et al., 2005 · Open in CIViC