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Drug

Cytarabine

Approved · FDA
Emerging researchLate-stage developmentSteady momentum
Also known as 1-beta-D-Arabinofuranosylcytosine, 4-Amino-1-beta-D-arabinofuranosyl-2(1H)-pyrimidinone, Arabinosylcytosine, Aracytidine+11 more

1-beta-D-Arabinofuranosylcytosine, 4-Amino-1-beta-D-arabinofuranosyl-2(1H)-pyrimidinone, Arabinosylcytosine, Aracytidine, Citarabina, Cytosar, Cytosar-U, Cytosine arabinoside, Cytosine-1-beta-D-arabinofuranoside, DepoCyt, HiDAC, Tarabine PFS, Vyxeos, Cytarabin, Cytarabinum.

RxNorm3041ChEMBLCHEMBL803UNII04079A1RDZ
4
Research papers
42
Active clinical trials
20
Regulatory events
Latest activity
beta

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

A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7 + 3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who Are Considered High-Risk (Adverse) Acute Myeloid Leukemia As Determined by MYELOMATCH; A MYELOMATCH SubStudy

Clinical trial2026-07-31Results expected Q1 2027 · ClinicalTrials.gov

Label change: CYTARABINE (ANDA071868)

Regulatory2026-07-29FDA

A Phase 2 Study of SNDX-5613 in Combination With Chemotherapy for Patients With Relapsed or Refractory KMT2A-Rearranged Infant Leukemia

Clinical trial2026-07-16Results expected Q4 2027 · ClinicalTrials.gov

Phase 3 Open-label, Multicenter, Randomized Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation

Clinical trial2026-07-16Results posted · ClinicalTrials.gov

Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents

Clinical trial2026-07-16Results expected Q4 2026 · ClinicalTrials.gov

Label change: CYTARABINE (ANDA071868)

Regulatory2020-06-02FDA

Label change: CYTARABINE (ANDA071868)

Regulatory2019-01-15FDA

Label change: CYTARABINE (ANDA071868)

Regulatory2019-01-15FDA

Safety and pharmacokinetics of the antisense oligonucleotide (ASO) LY2181308 as a single-agent or in combination with idarubicin and cytarabine in patients with refractory or relapsed acute myeloid leukemia (AML).

Research2013-02-10Investigational new drugs

Clofarabine plus cytarabine compared with cytarabine alone in older patients with relapsed or refractory acute myelogenous leukemia: results from the CLASSIC I Trial.

Research2012-05-14Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Sequential cytarabine and alpha-particle immunotherapy with bismuth-213-lintuzumab (HuM195) for acute myeloid leukemia.

Research2010-09-21Clinical cancer research : an official journal of the American Association for Cancer Research

Phase II study of intermediate-dose cytarabine in patients with relapsed or refractory Ewing sarcoma: a report from the Children's Oncology Group.

Research2009-03-01Pediatric blood & cancer

Profile

Identifiers & mechanism

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

Canonical name
Cytarabine
Aliases & brands
1-beta-D-Arabinofuranosylcytosine4-Amino-1-beta-D-arabinofuranosyl-2(1H)-pyrimidinoneArabinosylcytosineAracytidineCitarabinaCytosarCytosar-UCytosine arabinosideCytosine-1-beta-D-arabinofuranosideDepoCytHiDACTarabine PFSVyxeosCytarabinCytarabinum
RxNorm CUI
3041
ChEMBL ID
CHEMBL803
UNII
04079A1RDZ
Regulatory jurisdictions
fda

Regulatory timeline

20 events

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
1990-06-04
Latest approval
2001-05-14
Authorities
FDA
Total events
20
fdaU.S. Food and Drug Administration· 20 events
2026-07-29Label change
Label change: CYTARABINE (ANDA071868)
Evidence ↗
2020-06-02Label change
Label change: CYTARABINE (ANDA071868)
Evidence ↗
2019-01-15Label change
Label change: CYTARABINE (ANDA071868)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

197 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
197
registered trials across all phases
LATEST COMPLETION 2026
42
Active studies
24
Recruiting
51
Late-stage (III+)
106
Completed
49
Discontinued
PHASE DISTRIBUTIONn = 197
Early Phase 13Phase 138Phase 1 / 231Phase 274Phase 2 / 34Phase 335Phase 48Phase N / A4

Late-stage studies

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

A Multicenter, Prospective, Randomized Controlled Study Comparing the Efficacy and Safety of CLAG(Cladribine, Cytarabine and G-CSF) Combined With Venetoclax and CLAG in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

Not yet recruitingPH IVNanfang Hospital, Southern Medical Universityn=1722025

EDOCH Alternating With DHAP Regimen Combined Rituximab or Not to Treat New Diagnosed Younger (Age≤65 Years) Mantle Cell Lymphoma in China: A Multicentre Phase III Trial

CompletedPH IVInstitute of Hematology & Blood Diseases Hospital, Chinan=552020

Ma-Spore ALL 2010 Study

Unknown statusPH IVNational University Hospital, Singaporen=5002018

German Multicenter Trial for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years With Rituximab for Improvement of Prognosis in CD20 Positive Standard Risk ALL (Amend 2)

CompletedPH IVJohann Wolfgang Goethe University Hospitaln=602009

PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

CompletedPH IVPETHEMA Foundationn=3742007

Recent completions

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

A Phase III Randomized Trial for Patients With De Novo AML Using Bortezomib and Sorafenib (NSC# 681239, NSC# 724772) for Patients With High Allelic Ratio FLT3/ITD

CompletedPH IIIKey trialNational Cancer Institute (NCI)n=1,6452026

A Trial of Atovaquone (Mepron®) Combined With Conventional Chemotherapy for de Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults (ATACC AML)

CompletedPH IBaylor College of Medicinen=262025

A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax Co-Administered With Low Dose Cytarabine Versus Low Dose Cytarabine in Treatment Naïve Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

CompletedPH IIIAbbVien=2112025

A Pilot Study of Acalabrutinib With Bendamustine / Rituximab Followed by Cytarabine / Rituximab for Untreated Mantle Cell Lymphoma

CompletedPH IIWashington University School of Medicinen=132025

A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; NSC#617807)

CompletedPH IIIChildren's Oncology Groupn=2182024

A Randomized Phase II/III Trial of "Novel Therapeutics" Versus Azacitidine in Newly Diagnosed Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS), Age 60 or Older LEAP: Less-Intense AML Platform Trial

CompletedPH II/IIINational Cancer Institute (NCI)n=762024

Research activity

4 papers

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

Publications over time
20092013
Most influential

Sequential cytarabine and alpha-particle immunotherapy with bismuth-213-lintuzumab (HuM195) for acute myeloid leukemia.

Clinical cancer research : an official journal of the American Association for Cancer Research · 2010 · 177 cites

Clofarabine plus cytarabine compared with cytarabine alone in older patients with relapsed or refractory acute myelogenous leukemia: results from the CLASSIC I Trial.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2012 · 133 cites

Phase II study of intermediate-dose cytarabine in patients with relapsed or refractory Ewing sarcoma: a report from the Children's Oncology Group.

Pediatric blood & cancer · 2009 · 51 cites

Safety and pharmacokinetics of the antisense oligonucleotide (ASO) LY2181308 as a single-agent or in combination with idarubicin and cytarabine in patients with refractory or relapsed acute myeloid leukemia (AML).

Investigational new drugs · 2013 · 42 cites
Recent papers

Safety and pharmacokinetics of the antisense oligonucleotide (ASO) LY2181308 as a single-agent or in combination with idarubicin and cytarabine in patients with refractory or relapsed acute myeloid leukemia (AML).

Investigational new drugs · 2013 · 42 cites

Clofarabine plus cytarabine compared with cytarabine alone in older patients with relapsed or refractory acute myelogenous leukemia: results from the CLASSIC I Trial.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2012 · 133 cites

Sequential cytarabine and alpha-particle immunotherapy with bismuth-213-lintuzumab (HuM195) for acute myeloid leukemia.

Clinical cancer research : an official journal of the American Association for Cancer Research · 2010 · 177 cites

Phase II study of intermediate-dose cytarabine in patients with relapsed or refractory Ewing sarcoma: a report from the Children's Oncology Group.

Pediatric blood & cancer · 2009 · 51 cites
Journals, researchers & institutions
Top journals
  • Clinical cancer research : an official journal of the American Association for Cancer Research1
  • Investigational new drugs1
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology1
  • Pediatric blood & cancer1
Leading researchers
  • Andre V1
  • Andreeff M1
  • Avigan D1
  • Brandt JT1
  • Callies S1
  • Chanel S1
  • Chen Z1
  • Collins R1
Leading institutions
free-text, unnormalised
  • Memorial Sloan-Kettering Cancer Center1
  • The University of Texas MD Anderson Cancer Center1
  • UCSF School of Medicine1
  • University of Michigan Comprehensive Cancer 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.