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clofarabine

Trade name: clolar

Small moleculeapprovedOrphan Drug FDAFast Track FDA

Approved

Dec 28, 2004

Clofarabine is a anti-cancer drug which was approved by FDA for the treatment of pediatric patients with relapsed or refractory acute lymphoblastic leukemia. After crossing the cell membrane the drug is rapidly metabolized by deoxycytidine kinase to diphosphate and triphosphate metabolites and these metabolites reversibly inhibit hRNR by binding to alpha subunit. Also the triphosphate is incorporated to DNA where it acts as a chain terminator. — NCATS

Clinical trial activity

170 trials · 114 clinical orgs · 19 marketing orgs

Phase 1
72
Phase 2
122
Phase 3
10
Phase 4
0

Earliest trial started Feb 1, 1999 (NCT00028418)

Timeline

1990s

  1. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Jan 1, 2002

    Genzyme — Earliest Phase 2 Sponsor(trial)

  2. Feb 7, 2002

    Orphan Drug Designation

  3. Dec 28, 2004

    Genzyme — Earliest FDA Approval

  4. Dec 28, 2004

    Genzyme — NDA Organization

  5. Jan 1, 2006

    Genzyme — Earliest Phase 3 Sponsor(trial)

2010s

  1. Mar 4, 2016

    Zydus Discovery DMCC — Marketing Organization

  2. May 9, 2017

    Abon Pharmaceuticals — Marketing Organization

  3. Nov 6, 2017

    Amneal Pharmaceuticals — Marketing Organization

  4. Nov 6, 2017

    Dr. Reddy's Laboratories — Marketing Organization

  5. Nov 6, 2017

    Mylan — Marketing Organization

  6. Nov 6, 2017

    PHARMOBEDIENT — Marketing Organization

  7. Dec 6, 2017

    MSN Laboratories — Marketing Organization

  8. Sep 14, 2018

    Ingenus Pharmaceuticals — Marketing Organization

  9. Sep 14, 2018

    Novast Labs — Marketing Organization

  10. Oct 31, 2018

    Gland Pharma Ltd — Marketing Organization

  11. Oct 31, 2018

    Fosun — Marketing Organization

  12. Dec 27, 2018

    Hospira — Marketing Organization

  13. Dec 27, 2018

    Pfizer — Marketing Organization

  14. Feb 22, 2019

    Accord Research — Marketing Organization

2020s

  1. Oct 23, 2020

    Meitheal — Marketing Organization

  2. Oct 23, 2020

    Eu Yan Sang — Marketing Organization

  3. Oct 3, 2022

    Eugia Pharma — Marketing Organization

  4. Jan 3, 2025

    ScinoPharm Taiwan — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedFast trackDec 28, 2004

Chemistry & pharmacology

Loading structure…

SMILES

NC1=NC(Cl)=NC2=C1N=CN2[C@@H]3O[C@H](CO)[C@@H](O)[C@@H]3F
Mol. weight
303.677 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

Prodrug

Sources

Also known as

  • 2-chloro-2'-arabino-fluoro-2'-deoxyadenosine
  • 2-chloro-2'-fluoroarabino-2'-deoxyadenosine
  • 2-chloro-9-(2-deoxy-2-fluoroarabinofuranosyl)adenine
  • 2-chloro-9-(2-deoxy-2-fluoro-beta-d-arabinofuranosyl)adenine
  • 2-chloro-9-(2-deoxy-2-fluoro-beta-d-arabinofuranosyl)adenine
  • 2-chloro-9-(2'-deoxy-2'-fluoro-beta-d-arabinofuranosyl)adenine
  • 2-chloro-9-(2'-deoxy-2'-fluoro-beta-d-arabinofuranosyl)adenine
  • 2-chloro-9-(2-deoxy-2-fluoro-beta-d-arbinofuranosyl)adenine
  • (2r,3r,4s,5r)-5-(6-amino-2-chloropurin-9-yl)-4-fluoro-2-(hydroxymethyl)oxolan-3-ol
  • (2r,3r,4s,5r)-5-(6-amino-2-chloropurin-9-yl)-4-fluoro-2-(hydroxymethyl)oxolan-3-ol
  • cafda
  • cafda
  • cl-f-ara-a
  • cl-f-ara-a
  • cl-f-ara-a
  • clofarabin
  • clofarabin
  • clofarabina
  • clofarabina
  • clofarabine
  • clofarabine
  • clofarabine
  • clofarabine
  • clofarabine
  • clofarabine
  • clofarabine
  • clofarabine
  • clofarabine
  • clofarabine
  • clofarabine
  • clofarabine
  • clofarabinum
  • clofarabinum
  • clofarex
  • clofarex
  • clofarex
  • clofarex
  • clolar
  • clolar
  • clolar
  • clolar
  • cloloar
  • evoltra
  • evoltra
  • evoltra
  • evoltra

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06986382Phase 1/Phase 2 (Phase 2)Jul 31, 2025Stanford University
NCT07022834Phase 2Jun 1, 2025Sichuan University
NCT06252870Phase 2Jul 18, 2024University of Angers, University of Nantes, University of Western Brittany
NCT07034053Phase 1/Phase 2 (Phase 2)Oct 24, 2023Medical University of Vienna
NCT05917405Phase 2Sep 14, 2023University of Nantes
NCT05569512Phase 1/Phase 2 (Phase 2)Oct 6, 2022GlycoMimetics, Inc., Harvard University
NCT05477589Phase 3Jun 7, 2022University of Gothenburg, Utrecht University, Vastra Gotaland Region
NCT05065736Early Phase 1 (Phase 1)Mar 31, 2022Case Western Reserve University, University of Rochester
NCT04994808Phase 2Jan 1, 2022Medexus, University of Washington
NCT04989335Phase 2Aug 2, 2021Race Oncology Ltd, Tel Aviv University
NCT04644016Phase 2Nov 20, 2020Memorial Sloan-Kettering Cancer Center
NCT07156435Phase 1Nov 6, 2020Jazz Pharmaceuticals, Princess Maxima Center for Pediatric Oncology
NCT04220008Phase 2Jun 1, 2020National Cancer Institute (NCI), University of Texas at Houston
NCT04002115Phase 2Jul 31, 2019Pennsylvania State University
NCT03615105Phase 2Jul 25, 2018Memorial Sloan-Kettering Cancer Center
NCT03615144Phase 2Jul 23, 2018Memorial Sloan-Kettering Cancer Center
NCT03263767Phase 2Jan 31, 2018University of Nantes
NCT03136146Phase 2Jun 1, 2017University of Texas at Houston
NCT03096782Phase 2Jun 1, 2017Mesoblast, Inc., University of Texas at Houston
NCT02518750Phase 2Nov 23, 2016Novartis, Spectrum Pharmaceuticals, St. Jude Children's Hospital
Showing 20 of 170 trials
Page 1 / 9

Organizations

Research & Development (114)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GenzymeFor profit601532002
University of Texas at HoustonAcademic/Hospital333131999
National Cancer Institute (NCI)Government32442005
St. Jude Children's HospitalAcademic/Hospital111142005
University of WashingtonAcademic/Hospital9722006
Harvard UniversityAcademic/Hospital7722008
University of NantesAcademic/Hospital7622009
University of MinnesotaAcademic/Hospital5522006
Cornell UniversityAcademic/Hospital4422006
University of RochesterAcademic/Hospital4022006
Assisi FoundationAcademic/Hospital3022007
Baylor UniversityAcademic/Hospital3212005
City of Hope National Medical CenterAcademic/Hospital3222007
Gruppo Italiano Malattie EMatologiche dell'AdultoAcademic/Hospital3212008
Johns Hopkins UniversityAcademic/Hospital3212005
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital3312018
Northwestern UniversityAcademic/Hospital3222009
Ohio State UniversityAcademic/Hospital3022004
Pennsylvania State UniversityAcademic/Hospital3322007
University of Alabama, BirminghamAcademic/Hospital3122004
114 organizations
Page 1 / 6

Marketing (24)

OrganizationOrg typeRelationshipDate
Abon PharmaceuticalsFor profitMKTGMay 9, 2017
Accord ResearchFor profitMKTGFeb 22, 2019
Amneal PharmaceuticalsFor profitMKTGNov 6, 2017
Amneal PharmaceuticalsFor profitSYNNov 6, 2017
Dr. Reddy's LaboratoriesFor profitSYNNov 6, 2017
Dr. Reddy's LaboratoriesFor profitMKTGNov 6, 2017
Eu Yan SangFor profitMKTGOct 23, 2020
Eugia PharmaFor profitMKTGOct 3, 2022
FosunFor profitMKTGOct 31, 2018
GenzymeFor profitNDADec 28, 2004
Gland Pharma LtdFor profitMKTGOct 31, 2018
Gland Pharma LtdFor profitSYNOct 31, 2018
HospiraFor profitSYNDec 27, 2018
HospiraFor profitMKTGDec 27, 2018
Ingenus PharmaceuticalsFor profitMKTGSep 14, 2018
MSN LaboratoriesFor profitSYNDec 6, 2017
MSN LaboratoriesFor profitMKTGDec 6, 2017
MeithealFor profitMKTGOct 23, 2020
MylanFor profitMKTGNov 6, 2017
Novast LabsFor profitMKTGSep 14, 2018
PHARMOBEDIENTFor profitMKTGNov 6, 2017
PfizerFor profitMKTGDec 27, 2018
ScinoPharm TaiwanFor profitMKTGJan 3, 2025
Zydus Discovery DMCCFor profitMKTGMar 4, 2016