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gemcitabine

Trade name: gemzar

Small moleculeapproved

Approved

May 15, 1996

Gemcitabine is a nucleoside analog used as chemotherapy. It is marketed as Gemzar® by Eli Lilly and Company. Gemcitabine inhibits thymidylate synthetase, leading to inhibition of DNA synthesis and cell death. Gemcitabine is a prodrug so activity occurs as a result of intracellular conversion to two active metabolites, gemcitabine diphosphate and gemcitabine triphosphate by deoxycitidine kinase. Gemcitabine diphosphate also inhibits ribonucleotide reductase, the enzyme responsible for catalyzing synthesis of deoxynucleoside triphosphates required for DNA synthesis. Finally, Gemcitabine triphosphate (diflurorodeoxycytidine triphosphate) competes with endogenous deoxynucleoside triphosphates for incorporation into DNA. Gemcitabine is indicated for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy; metastatic ovarian cancer; inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer; and locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. — NCATS

Clinical trial activity

2,812 trials · 1,212 clinical orgs · 32 marketing orgs

Phase 1
749
Phase 2
2190
Phase 3
556
Phase 4
27

Earliest trial started Feb 1, 1995 (NCT00001431)

Timeline

1990s

  1. Jan 1, 1995

    Earliest Phase 1 Sponsor(trial)

  2. May 15, 1996

    Eli Lilly — Earliest FDA Approval

  3. May 15, 1996

    Eli Lilly — NDA Organization

  4. Jan 1, 1997

    Earliest Phase 2 Sponsor(trial)

  5. Jan 1, 1997

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Dec 8, 2009

    Teva — Marketing Organization

2010s

  1. Jan 19, 2010

    Eurohlth Intl Sarl — Marketing Organization

  2. Nov 15, 2010

    Hospira — NDA Secondary Org

  3. May 16, 2011

    Fresenius — Marketing Organization

  4. Jul 25, 2011

    Accord Research — NDA Secondary Org

  5. Jul 25, 2011

    Cipla — Marketing Organization

  6. Jul 25, 2011

    Dr. Reddy's Laboratories — Marketing Organization

  7. Jul 25, 2011

    Hospira — Marketing Organization

  8. Jul 25, 2011

    Mylan — Marketing Organization

  9. Jul 25, 2011

    Sun Pharmaceuticals — Marketing Organization

  10. Jul 25, 2011

    TEYRO LABS — Marketing Organization

  11. Jul 25, 2011

    Accord Research — Marketing Organization

  12. Jul 25, 2011

    PHARMOBEDIENT — Marketing Organization

  13. Sep 10, 2012

    Hameln Pharma GmbH — Marketing Organization

  14. Sep 11, 2012

    Emcure — Marketing Organization

  15. May 7, 2013

    Sankyo — Marketing Organization

  16. May 7, 2013

    Jiangsu Hansoh Pharmaceutical Co., Ltd. — Marketing Organization

  17. May 7, 2013

    Lutipold — Marketing Organization

  18. May 7, 2013

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  19. May 7, 2013

    Daiichi Sankyo — Marketing Organization

  20. Jan 5, 2016

    Gland Pharma Ltd — Marketing Organization

  21. Apr 11, 2016

    Actavis — Marketing Organization

  22. Apr 11, 2016

    Allergan PLC (2015) — Marketing Organization

  23. May 23, 2017

    Apotex — Marketing Organization

  24. Jul 16, 2018

    Sun Pharmaceuticals — NDA Secondary Org

  25. Jul 20, 2018

    Nichi-Iko Pharmaceutical Co., Ltd. — Marketing Organization

  26. Feb 14, 2019

    Ingenus Pharmaceuticals — Marketing Organization

  27. Feb 14, 2019

    Novast Labs — Marketing Organization

  28. Feb 22, 2019

    Shilpa Medicare Ltd. — Marketing Organization

2020s

  1. Dec 11, 2020

    Nanjing King-Friend — Marketing Organization

  2. Dec 11, 2020

    Meitheal — Marketing Organization

  3. Jun 25, 2021

    Hikma — Marketing Organization

  4. Jun 27, 2025

    AVYXA HOLDINGS — Marketing Organization

  5. Sep 9, 2025

    Johnson and Johnson — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewMay 15, 1996

Chemistry & pharmacology

Loading structure…

SMILES

Nc1ccn([C@@H]2O[C@H](CO)[C@@H](O)C2(F)F)c(=O)n1
Mol. weight
263.2 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

Sources

Also known as

  • 2',2'-dfdc
  • 2',2'-difluoro-2'-deoxycytidine
  • 2',2'-difluorodeoxycytidine
  • 2',2'-difluorodeoxycytidine
  • 2',2'-difluorodeoxycytidine
  • 2'-deoxy-2',2'-difluorocytidine
  • 2'-deoxy-2',2'-difluorocytidine
  • 2'-deoxy-2',2''-difluorocytidine-5'-o-monophosphate
  • 2'-deoxy-2'-difluorocytidine
  • 4-amino-1-((2r,4r,5r)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)-tetrahydrofuran-2-yl)pyrimidin-2(1h)-one
  • 4-amino-1-((2r,4r,5r)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)-tetrahydrofuran-2-yl)pyrimidin-2(1h)-one
  • ca-101
  • co-101
  • co-1.01
  • co-1.01
  • cp4126
  • cp 4126
  • cp-4126
  • cp-4126
  • cp-4126
  • cp-4126
  • dfdcyd
  • gamcitabine
  • gemcitabin
  • gemcitabin
  • gemcitabina
  • gemcitabina
  • gemcitabina
  • gemcitabine
  • gemcitabine
  • gemcitabine
  • gemcitabine
  • gemcitabine
  • gemcitabine
  • gemcitabine
  • gemcitabine
  • gemcitabine
  • gemcitabine
  • gemcitabine
  • gemcitabine, (alpha-d-threo-pentofuranosyl)-isomer
  • gemcitabine, (beta-d-threo-pentafuranosyl)-isomer
  • gemcitabine, (d-threo-pentafuranosyl)-isomer
  • gemcitabine elaidate
  • gemcitabine elaidate
  • gemcitabine elaidate
  • gemcitabine hcl
  • gemcitabine hcl
  • gemcitabine hcl
  • gemcitabine hydrochloride
  • gemcitabine hydrochloride
  • gemcitabine hydrochloride
  • gemcitabine hydrochloride
  • gemcitabine hydrochloride
  • gemcitabine - nabpaclitaxel
  • gemcitabinum
  • gemcitabinum
  • gemcitibine
  • gemcitibine
  • gemox
  • gemzar
  • gemzar
  • gemzar
  • gemzar
  • gemzar
  • ly 188011
  • ly-188011
  • ly-188011
  • ly-188011
  • ly2334737
  • ly2334737
  • oxaliplatin
  • urlc10 peptide

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07275216Phase 2Jul 1, 2026City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07283705Phase 2May 18, 2026Bristol-Myers Squibb, University of Texas at Houston
NCT07286266Phase 3Mar 3, 2026European Network for Gynaecological Oncological Trial, GlaxoSmithKline, GOG Foundation, Inc.
NCT07158489Phase 2Mar 1, 2026Swiss Cancer Institute
NCT07263360Phase 2Feb 1, 2026Tianjin Medical University
NCT07302841Phase 4Jan 20, 2026Tianjin Medical University
NCT06998940Phase 3Jan 6, 2026National Cancer Institute (NCI), SWOG Cancer Research Network
NCT07272109Phase 3Jan 1, 2026Fudan University
NCT07232875Phase 3Dec 31, 2025Hengrui Therapeutics, Inc.
NCT07238283Phase 3Dec 31, 2025Hengrui Therapeutics, Inc.
NCT07296341Phase 1/Phase 2 (Phase 2)Dec 31, 2025Hengrui Therapeutics, Inc.
NCT07259317Phase 2Dec 31, 2025Corcept Therapeutics
NCT07255404Phase 2Dec 31, 2025Biontech, Bristol-Myers Squibb
NCT07221253Phase 3Dec 31, 2025AstraZeneca
NCT07049055Phase 1/Phase 2 (Phase 2)Dec 31, 2025EnGeneIC Limited, Herbert Irving Comprehensive Cancer Center
NCT07235202Phase 1/Phase 2 (Phase 2)Dec 22, 2025Government of China
NCT07279584Phase 2Dec 20, 2025Jiao Tong University
NCT07277452Phase 2Dec 10, 2025Nanjing Medical University, Peking University
NCT07226856Phase 2Dec 1, 2025Mayo Clinic
NCT07033689Early Phase 1 (Phase 1)Dec 1, 2025SONIRE Therapeutics Inc., Stanford University
Showing 20 of 2,812 trials
Page 1 / 141

Organizations

Research & Development (1,212)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government41514941995
Eli LillyFor profit16610131997
Sun Yat-Sen UniversityAcademic/Hospital1079342008
Fudan UniversityAcademic/Hospital937442007
University of Texas at HoustonAcademic/Hospital836741998
RocheFor profit704842001
AstraZenecaFor profit683542000
CelgeneFor profit571332005
MerckFor profit552442006
GenentechFor profit52732000
Mayo ClinicAcademic/Hospital521641997
Cornell UniversityAcademic/Hospital513541997
SanofiFor profit472142001
Harvard UniversityAcademic/Hospital422741998
Bristol-Myers SquibbFor profit411532002
Chinese Academy of Medical SciencesAcademic/Hospital382442010
Jiao Tong UniversityAcademic/Hospital382742008
University of TorontoAcademic/Hospital361332000
Southwest Oncology GroupAcademic/Hospital322321998
NovartisFor profit30832004
1,212 organizations
Page 1 / 61

Marketing (43)

OrganizationOrg typeRelationshipDate
AVYXA HOLDINGSFor profitMKTGJun 27, 2025
Accord ResearchFor profitNDA2Jul 25, 2011
Accord ResearchFor profitMKTGJul 25, 2011
ActavisFor profitMKTGApr 11, 2016
ActavisFor profitSYNJul 25, 2011
Allergan PLC (2015)For profitMKTGApr 11, 2016
ApotexFor profitSYNMay 23, 2017
ApotexFor profitMKTGMay 23, 2017
CiplaFor profitMKTGJul 25, 2011
Daiichi SankyoFor profitMKTGMay 7, 2013
Dr. Reddy's LaboratoriesFor profitMKTGJul 25, 2011
Eli LillyFor profitNDAMay 15, 1996
EmcureFor profitMKTGSep 11, 2012
Eurohlth Intl SarlFor profitMKTGJan 19, 2010
FreseniusFor profitMKTGMay 16, 2011
Gland Pharma LtdFor profitMKTGJan 5, 2016
Gland Pharma LtdFor profitSYNJan 5, 2016
Hameln Pharma GmbHFor profitMKTGSep 10, 2012
HikmaFor profitMKTGJun 25, 2021
HikmaFor profitSYNMar 7, 2023
HospiraFor profitNDA2Nov 15, 2010
HospiraFor profitMKTGJul 25, 2011
Ingenus PharmaceuticalsFor profitMKTGFeb 14, 2019
Jiangsu Hansoh Pharmaceutical Co., Ltd.For profitMKTGMay 7, 2013
Johnson and JohnsonFor profitMKTGSep 9, 2025
LutipoldFor profitMKTGMay 7, 2013
MeithealFor profitMKTGDec 11, 2020
MylanFor profitMKTGJul 25, 2011
Nanjing King-FriendFor profitMKTGDec 11, 2020
Nichi-Iko Pharmaceutical Co., Ltd.For profitMKTGJul 20, 2018
Novast LabsFor profitMKTGFeb 14, 2019
PHARMOBEDIENTFor profitMKTGJul 25, 2011
Sagent Pharmaceuticals, Inc.For profitSYNJul 20, 2018
Sagent Pharmaceuticals, Inc.For profitMKTGMay 7, 2013
SankyoFor profitMKTGMay 7, 2013
Shilpa Medicare Ltd.For profitMKTGFeb 22, 2019
Shilpa Medicare Ltd.For profitMKTGFeb 22, 2019
Sun PharmaceuticalsFor profitSYNJul 16, 2018
Sun PharmaceuticalsFor profitNDA2Jul 16, 2018
Sun PharmaceuticalsFor profitMKTGJul 25, 2011
TEYRO LABSFor profitMKTGJul 25, 2011
TevaFor profitMKTGDec 8, 2009
TevaFor profitSYNJan 25, 2011