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fludarabine

Trade name: fludara

Small moleculeapprovedOrphan Drug FDA

Approved

Apr 18, 1991

Fludarabine or fludarabine phosphate is a chemotherapy drug used in the treatment of hematological malignancies (cancers of blood cells such as leukemias and lymphomas). It is a purine analog, which interferes with DNA synthesis. Fludarabine phosphate is a fluorinated nucleotide analog of the antiviral agent vidarabine, 9-β-D-arabinofuranosyladenine (ara-A), that is relatively resistant to deamination by adenosine deaminase. Fludarabine (marketed as fludarabine phosphate under the trade name Fludara) is a chemotherapy drug used in the treatment of hematological malignancies. Fludarabine phosphate is rapidly dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-ATP. This metabolite appears to act by inhibiting DNA polymerase alpha, ribonucleotide reductase and DNA primase, thus inhibiting DNA synthesis. The mechanism of action of this antimetabolite is not completely characterized and may be multi-faceted. — NCATS

Clinical trial activity

1,606 trials · 560 clinical orgs · 15 marketing orgs

Phase 1
753
Phase 2
987
Phase 3
137
Phase 4
19

Earliest trial started Jan 1, 1994 (NCT00140569)

Timeline

1980s

  1. Apr 18, 1989

    Orphan Drug Designation

1990s

  1. Apr 18, 1991

    Genzyme — Earliest FDA Approval

  2. Apr 18, 1991

    Genzyme — NDA Secondary Org

  3. Apr 18, 1991

    Genzyme — NDA Organization

  4. Jan 1, 1994

    Earliest Phase 2 Sponsor(trial)

  5. Jan 1, 1994

    Earliest Phase 3 Sponsor(trial)

  6. Jan 1, 1995

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Aug 28, 2003

    Custopharm Inc — Marketing Organization

  2. Aug 28, 2003

    Hikma — Marketing Organization

  3. Apr 28, 2004

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  4. Apr 6, 2007

    Hospira — Marketing Organization

  5. Sep 21, 2007

    Sandoz — NDA Secondary Org

  6. Sep 21, 2007

    Novartis — NDA Secondary Org

  7. Oct 15, 2007

    Fresenius — Marketing Organization

  8. Dec 18, 2008

    Sanofi-Aventis — NDA Secondary Org

2010s

  1. Sep 27, 2010

    Areva Med LLC — Marketing Organization

  2. Dec 21, 2011

    Mylan — Marketing Organization

  3. Dec 21, 2011

    Rising Pharmaceuticals — Marketing Organization

  4. Dec 21, 2011

    EXTROVIS — Marketing Organization

  5. Feb 28, 2017

    Actavis — Marketing Organization

  6. Feb 28, 2017

    Allergan PLC (2015) — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewApr 18, 1991

Chemistry & pharmacology

Loading structure…

SMILES

NC1=NC(F)=NC2=C1N=CN2[C@@H]3O[C@H](CO)[C@@H](O)[C@@H]3O
Mol. weight
285.2318 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Black box warningProdrug

Sources

Also known as

  • 2-f-araa
  • 2-f-araa
  • 2-f-ara-amp
  • 2-f-ara-amp
  • 2-fluoroadenine arabinoside
  • 2-fluoro ara-a
  • 2-fluoro ara-a
  • 9-beta-d-arabinofuranosyl-2-fluoroadenine
  • 9 beta-d-arabinofuranosyl-2-fluoroadenine monophosphate
  • 9h-purin-6-amine, 2-fluoro-9-(5-o-phosphono-beta-d-arabinofuranosyl)-
  • 9h-purin-6-amine, 9-beta-d-arabinofuranosyl-2-fluoro-
  • beneflur
  • beneflur
  • f-ara-a
  • faraamp
  • f-ara-amp
  • fludara
  • fludara
  • fludara
  • fludara
  • fludara
  • fludara
  • fludarabine
  • fludarabine
  • fludarabine
  • fludarabine
  • fludarabine
  • fludarabine
  • fludarabine
  • fludarabine 5'-monophosphate
  • fludarabine 5'-monophosphate
  • fludarabine 5'-monophosphate
  • fludarabine 5'-monophosphate
  • fludarabine 5'-monophosphate
  • fludarabine 5'-monophosphate
  • fludarabine monophosphate
  • fludarabine phosphate
  • fludarabine phosphate
  • fludarabine phosphate
  • fludarabine phosphate
  • fludarabine phosphate
  • fludarabine phosphate
  • fludarabine phosphate
  • fludarabine phosphate (fludara)
  • fludura
  • flu-id
  • fluoro-ara-amp
  • fp253
  • npc 16
  • npc-16
  • npc-16
  • npc16 cpd
  • nsc 312887
  • nsc-312887
  • oforta
  • oforta

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06996119Phase 1May 25, 2026City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07227571Phase 1May 1, 2026University of Washington
NCT07228624Phase 2May 1, 2026Incyte, University of Washington
NCT07137481Phase 2Feb 28, 2026University of Texas at Houston
NCT07164469Phase 2Feb 28, 2026Bellicum Pharmaceuticals, University of Texas at Houston
NCT07304154Phase 1Jan 31, 2026Gilead Sciences
NCT07288073Phase 2Jan 31, 2026Harvard University, Iovance
NCT07297667Phase 1Jan 31, 2026Canadian Cancer Trials Group, University of Calgary
NCT07157514Phase 2/Phase 3 (Phase 3)Jan 31, 2026Actinium Pharmaceuticals
NCT06815003Phase 2Jan 8, 2026City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07257419Phase 1Dec 31, 2025St. Jude Children's Hospital
NCT07052370Phase 1Dec 31, 2025St. Jude Children's Hospital
NCT07225439Phase 1Dec 31, 2025Case Western Reserve University, Incyte
NCT07228273Phase 2Dec 24, 2025OHSU Knight Cancer Institute, Oregon Health and Science University
NCT06954987Phase 2Dec 18, 2025National Cancer Institute (NCI)
NCT07259161Phase 2Dec 15, 2025China Academy of Chinese Medical Sciences
NCT07222735Phase 1Dec 5, 2025St. Jude Children's Hospital
NCT06904066Phase 1Dec 2, 2025National Cancer Institute (NCI)
NCT06961357Phase 1/Phase 2 (Phase 2)Dec 1, 2025University of South Florida
NCT06984341Phase 1Dec 1, 2025Genentech
Showing 20 of 1,606 trials
Page 1 / 81

Organizations

Research & Development (560)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government38212641994
University of Texas at HoustonAcademic/Hospital14614041994
University of WashingtonAcademic/Hospital12011541997
University of MinnesotaAcademic/Hospital656142000
National Heart, Lung, and Blood Institute (NHLBI)Government49941999
National Institutes of Health (NIH)Government471041997
Harvard UniversityAcademic/Hospital423241999
Baylor UniversityAcademic/Hospital403732000
St. Jude Children's HospitalAcademic/Hospital383641997
City of Hope National Medical CenterAcademic/Hospital363332001
Jiao Tong UniversityAcademic/Hospital302452011
People's Liberation Army of ChinaGovernment282442004
Gilead SciencesFor profit242242010
Cornell UniversityAcademic/Hospital232231998
Case Western Reserve UniversityAcademic/Hospital222131998
Johns Hopkins UniversityAcademic/Hospital221831999
RocheFor profit221542003
Peking UniversityAcademic/Hospital20752011
Bristol-Myers SquibbFor profit191042010
CelgeneFor profit19532007
560 organizations
Page 1 / 28

Marketing (18)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGFeb 28, 2017
ActavisFor profitSYNFeb 11, 2009
Allergan PLC (2015)For profitMKTGFeb 28, 2017
Areva Med LLCFor profitMKTGSep 27, 2010
Custopharm IncFor profitMKTGAug 28, 2003
EXTROVISFor profitMKTGDec 21, 2011
FreseniusFor profitMKTGOct 15, 2007
GenzymeFor profitNDA2Apr 18, 1991
GenzymeFor profitNDAApr 18, 1991
HikmaFor profitMKTGAug 28, 2003
HospiraFor profitMKTGApr 6, 2007
MylanFor profitMKTGDec 21, 2011
NovartisFor profitNDA2Sep 21, 2007
Rising PharmaceuticalsFor profitMKTGDec 21, 2011
Sagent Pharmaceuticals, Inc.For profitMKTGApr 28, 2004
Sagent Pharmaceuticals, Inc.For profitSYNApr 28, 2004
SandozFor profitNDA2Sep 21, 2007
Sanofi-AventisFor profitNDA2Dec 18, 2008