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.

health-canada-dpdRegulatory23 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as CYTARABINE INJECTION (DIN 02515296) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 21, 2022	health-canada-dpd

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 2 days 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 1,001–1,008 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
NCT00187122	Treatment for Patients With Stage III or IV Non-Hodgkin Lymphoma	completed	N/A	42	St. Jude Children's Research HospitalOTHER	1	Apr 23, 2008	clinicaltrials
NCT00129168	Zosuquidar in Combination With Daunorubicin and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia (AML)	completed

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