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nelarabine

Trade name: arranon

Small moleculeapprovedOrphan Drug FDAFast Track FDA

Approved

Oct 28, 2005

Arranon is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. It is a purine nucleoside analog converted to its corresponding arabinosylguanine nucleotide triphosphate (araGTP), resulting in inhibition of DNA synthesis and cytotoxicity. Administration of nelarabine in combination with adenosine deaminase inhibitors, such 195 as pentostatin, is not recommended. The most common (≥20%) adverse reactions were: anemia, thrombocytopenia, neutropenia, nausea, diarrhea, vomiting, constipation, fatigue, pyrexia, cough, and dyspnea — NCATS

Clinical trial activity

29 trials · 23 clinical orgs · 14 marketing orgs

Phase 1
7
Phase 2
22
Phase 3
6
Phase 4
0

Earliest trial started Jun 1, 1997 (NCT00002970)

Timeline

1990s

  1. Jan 1, 1997

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Aug 10, 2004

    Orphan Drug Designation

  2. Oct 28, 2005

    GlaxoSmithKline — Earliest FDA Approval

  3. Oct 28, 2005

    Novartis — NDA Secondary Org

  4. Oct 28, 2005

    Novartis — Marketing Organization

  5. Oct 28, 2005

    GlaxoSmithKline — NDA Organization

  6. Oct 28, 2005

    Sandoz — Marketing Organization

  7. Jan 1, 2007

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Nov 17, 2021

    Zydus Discovery DMCC — Marketing Organization

  2. Dec 22, 2022

    Dr. Reddy's Laboratories — Marketing Organization

  3. Jan 10, 2023

    KINDOS — Marketing Organization

  4. Jan 10, 2023

    Meitheal — Marketing Organization

  5. Mar 3, 2023

    SHORLA — Marketing Organization

  6. Apr 4, 2023

    Amneal Pharmaceuticals — Marketing Organization

  7. Jun 2, 2023

    Nexus Pharmaceuticals — Marketing Organization

  8. Jan 3, 2024

    Gland Pharma Ltd — Marketing Organization

  9. Aug 1, 2024

    Alembic — Marketing Organization

  10. Sep 5, 2024

    X Gen Pharmaceuticals — Marketing Organization

  11. Sep 13, 2024

    MSN Laboratories — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • DNAINHIBITOR

    DNA inhibitor

Approval history

  • approvedPriority reviewAcceleratedFast trackOct 28, 2005

Chemistry & pharmacology

Loading structure…

SMILES

COC1=NC(N)=NC2=C1N=CN2[C@@H]3O[C@H](CO)[C@@H](O)[C@@H]3O
Mol. weight
297.2673 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warningProdrug

Sources

Also known as

  • 2-amino-6-methoxypurine arabinoside
  • 2-amino-9-beta-d-arabinofuranosyl-6-methoxy-9h-purine
  • 2-amino-9-beta-d-arabinofuranosyl-6-methoxy-9h-purine
  • 2-amino-9-beta-d-arabinofuranosyl-6-methoxy-9h-purine
  • 506u
  • 506u
  • 506u78
  • 506u78
  • 506u78
  • arranon
  • arranon
  • arranon
  • arranon
  • arranon
  • atriance
  • atriance
  • atriance
  • compound 506u78
  • glaxosmithkline brand of nelarabine
  • gw506u78
  • may
  • may
  • nelarabine
  • nelarabine
  • nelarabine
  • nelarabine
  • nelarabine
  • nelarabine
  • nelarabine
  • nelarabine
  • nelarabine
  • nelarabine
  • nelarabine
  • nelarabine
  • nelzarabine
  • nelzarabine
  • nelzarabine
  • nelzarabine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07072585Phase 2/Phase 3 (Phase 3)Mar 30, 2026National Cancer Institute (NCI)
NCT07294677Phase 1/Phase 2 (Phase 2)Mar 17, 2026University of Chicago
NCT06390319Phase 2Dec 31, 2024AbbVie, St. Jude Children's Hospital
NCT06210750Phase 2Aug 9, 2024National Cancer Institute (NCI), SWOG Cancer Research Network
NCT06434467Phase 3May 31, 2024Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
NCT03808610Phase 1/Phase 2 (Phase 2)Apr 3, 2019National Cancer Institute (NCI), University of Texas at Houston
NCT03328104Phase 1Jul 24, 2018Emory University
NCT03020030Phase 3Jan 1, 2017Baxalta, Harvard University
NCT02763384Phase 2Dec 2, 2016Washington University in St. Louis
NCT02518750Phase 2Nov 23, 2016Novartis, Spectrum Pharmaceuticals, St. Jude Children's Hospital
NCT02881086Phase 3Aug 1, 2016J. W. Goethe University
NCT02619630Phase 2Dec 1, 2015University of Paris
NCT00981799Phase 1/Phase 2 (Phase 2)Jun 1, 2010GlaxoSmithKline, Novartis, University of Southern California, University of Toronto
NCT01094860Phase 1Jun 1, 2010GlaxoSmithKline, University of Texas at Houston
NCT01085617Phase 3Jan 1, 2010University of London
NCT00501826Phase 2Jul 1, 2007Novartis, University of Texas at Houston
NCT00408005Phase 3Jan 22, 2007National Cancer Institute (NCI)
NCT00406757Phase 1Aug 1, 2006GlaxoSmithKline
NCT00684619Phase 2Jun 1, 2003J. W. Goethe University
NCT00016302N/AApr 1, 2001National Cancer Institute (NCI)
Showing 20 of 29 trials
Page 1 / 2

Organizations

Research & Development (23)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government141141997
University of Texas at HoustonAcademic/Hospital5322000
GlaxoSmithKlineFor profit4221999
NovartisFor profit3012007
Harvard UniversityAcademic/Hospital2121998
J. W. Goethe UniversityAcademic/Hospital2222003
Southwest Oncology GroupAcademic/Hospital2111998
Stanford UniversityAcademic/Hospital2011998
St. Jude Children's HospitalAcademic/Hospital2212016
University of ChicagoAcademic/Hospital2121999
AbbVieFor profit1012024
BaxaltaFor profit1012017
Cancer and Leukemia Group B (CALGB)Academic/Hospital1012000
Emory UniversityAcademic/Hospital1112018
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,LtdFor profit1112024
National Institutes of Health (NIH)Government1011999
Spectrum PharmaceuticalsFor profit1012016
SWOG Cancer Research NetworkAcademic/Hospital1012024
University of LondonAcademic/Hospital1112010
University of ParisAcademic/Hospital1112015
23 organizations
Page 1 / 2

Marketing (16)

OrganizationOrg typeRelationshipDate
AlembicFor profitMKTGAug 1, 2024
Amneal PharmaceuticalsFor profitMKTGApr 4, 2023
Dr. Reddy's LaboratoriesFor profitMKTGDec 22, 2022
Gland Pharma LtdFor profitMKTGJan 3, 2024
Gland Pharma LtdFor profitSYNJan 3, 2024
GlaxoSmithKlineFor profitNDAOct 28, 2005
KINDOSFor profitMKTGJan 10, 2023
MSN LaboratoriesFor profitMKTGSep 13, 2024
MeithealFor profitMKTGJan 10, 2023
Nexus PharmaceuticalsFor profitMKTGJun 2, 2023
NovartisFor profitNDA2Oct 28, 2005
NovartisFor profitMKTGOct 28, 2005
SHORLAFor profitMKTGMar 3, 2023
SandozFor profitMKTGOct 28, 2005
X Gen PharmaceuticalsFor profitMKTGSep 5, 2024
Zydus Discovery DMCCFor profitMKTGNov 17, 2021