Drug · Small Molecule

Nelarabine

CI-DRUG-00000401Explore in graph →NCIt C1704 CHEMBL1201112 CIViC Approved

Regulatory

Approvals (4)

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

openfdaRegulatory2 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2019-07-31 (see label)	approved	Jul 31, 2019	openfda
US FDA	—	ARRANON is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. ARRANON is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. ( 1 )	approved	Oct 28, 2005	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 15 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 3	6	3	6	30	4	CA, EU, US	Oct 28, 2005	1997-06
Leukemia	Phase3	Phase 3	6	3	5	26	0	—	—	1997-06
Non-Hodgkin Lymphoma	Phase3	Phase 3	3	2	4	14	0	—	—	1997-06

Computedclinicaltrials

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
NT5C2 D407A1
Arabinosylguanine + Nelarabine

Clinical trials

Trials with this intervention (32)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–32 of 32 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
NCT06390319	Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)	recruiting	Phase 2	100	St. Jude Children's Research HospitalOTHER	1	Aug 10, 2026	clinicaltrials
NCT07072585	Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL)

Molecule

Record

Kind: Small Molecule
Mechanism: DNA inhibitor
UNII: 60158CV180
Aliases: 2-Amino, 6-Methoxypurine Arabinoside, 2-Amino-9-beta-D-arabinofuranosyl-6-methoxy-9H-purine, 506U, 506U78, Arranon, ARRANON, Atriance, Attriance, Compound 506U78, GW-506U78, GW506U78, MAY, Nelarabina, Nelarabine, Nelzarabine, NSC-686673, NSC-755985, NSC-759876

Data updated 18 hours agoSource updated unknown

Identifiers

Codes (4)

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

System	Code	Label
ATC (WHO)	L01BB07	NELARABINE
DIN (Health Canada)	02299925	ATRIANCE
DPD drug code	78527

NT5C2 R367Q2
Arabinosylguanine + NelarabineSubstitutes	T Acute Lymphoblastic LeukemiaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	4	rejected	EID634 CCRF-CEM and CUTLL1 T-ALL cell lines expressing NT5C2 mutant proteins (R367Q, R359Q or D407A) observed in relapsed T-ALL patients showed no difference in sensitivity to nelarabine or arabinosylguanine… (full text at CIViC) PMID 23377281 · Tzoneva et al., 2013 · Open in CIViC	civic
〃	T Acute Lymphoblastic LeukemiaCURATED_BROADER	Predictive	D	Does Not Support Resistance	4	accepted	EID633 CCRF-CEM and CUTLL1 T-ALL cell lines expressing NT5C2 mutant proteins (K359Q, R367Q or D407A) observed in relapsed T-ALL patients showed no difference in sensitivity to nelarabine or arabinosylguanine… (full text at CIViC) PMID 23377281 · Tzoneva et al., 2013 · Open in CIViC	civic