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capecitabine

Trade name: xeloda

Small moleculeapproved

Approved

Apr 30, 1998

Capecitabine, sold under the brand name Xeloda among others, is an anticancer medication used to treat breast cancer, gastric cancer and colorectal cancer. For breast cancer it is often used together with docetaxel. It is taken by mouth. — Wikipedia

Clinical trial activity

1,967 trials · 862 clinical orgs · 18 marketing orgs

Phase 1
395
Phase 2
1582
Phase 3
489
Phase 4
35

Earliest trial started Jan 1, 1997 (NCT01225523)

Timeline

1990s

  1. Jan 1, 1997

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1998

    Roche — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 1998

    Roche — Earliest Phase 3 Sponsor(trial)

  4. Apr 30, 1998

    Roche — Earliest FDA Approval

  5. Apr 30, 1998

    Roche — NDA Organization

  6. Apr 30, 1998

    Roche — Marketing Organization

  7. Apr 30, 1998

    CheplaPharm — Marketing Organization

  8. Apr 30, 1998

    CheplaPharm — NDA Secondary Org

2010s

  1. Sep 16, 2013

    Teva — Marketing Organization

  2. Aug 8, 2014

    Rising Pharmaceuticals — Marketing Organization

  3. Aug 8, 2014

    Mylan — Marketing Organization

  4. Apr 23, 2015

    Accord Research — Marketing Organization

  5. Jul 14, 2016

    West-Ward Pharmaceutical — Marketing Organization

  6. Jul 14, 2016

    Hikma — Marketing Organization

  7. Dec 12, 2016

    Shilpa Medicare Ltd. — Marketing Organization

  8. Feb 28, 2017

    Amneal Pharmaceuticals — Marketing Organization

  9. Nov 27, 2017

    Alkem Labs Ltd — Marketing Organization

  10. Apr 17, 2018

    Eugia Pharma — Marketing Organization

  11. Jul 2, 2018

    MSN Laboratories — Marketing Organization

  12. Jun 21, 2019

    Sun Pharmaceuticals — Marketing Organization

2020s

  1. Apr 27, 2020

    Reliance Life Sciences Pvt. Ltd — Marketing Organization

  2. Dec 4, 2020

    Dr. Reddy's Laboratories — Marketing Organization

  3. Oct 23, 2023

    TEYRO LABS — Marketing Organization

  4. Mar 5, 2024

    Hetero Labs Ltd — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedApr 30, 1998

Chemistry & pharmacology

Loading structure…

SMILES

CCCCCOC(=O)Nc1nc(=O)n([C@@H]2O[C@H](C)[C@@H](O)[C@H]2O)cc1F
Mol. weight
359.35 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warningProdrug

Sources

Also known as

  • (1-(5-deoxy-beta-d-ribofuranosyl)-5-fluoro-1,2-dihydro-2-oxo-4-pyrimidinyl)-carbamic acid pentyl ester
  • (1-(5-deoxy-beta-d-ribofuranosyl)-5-fluoro-1,2-dihydro-2-oxo-4-pyrimidinyl)-carbamic acid pentyl ester
  • capacitabine
  • capecitabin
  • capecitabin
  • capecitabina
  • capecitabina
  • capecitabine
  • capecitabine
  • capecitabine
  • capecitabine
  • capecitabine
  • capecitabine
  • capecitabine
  • capecitabine
  • capecitabine
  • capecitabine
  • capecitabine
  • capecitabine
  • capecitabine=
  • capecitabine=
  • capecitabinum
  • capecitabinum
  • capecitibine
  • capecytabine
  • capiibine
  • captabin
  • kd018
  • pentyl 1-(5-deoxy-beta-d-ribofuranosyl)-5-fluoro-1,2-dihydro-2-oxo-4-pyrimidinecarbamate
  • pentyl 1-(5-deoxy-beta-d-ribofuranosyl)-5-fluoro-1,2-dihydro-2-oxo-4-pyrimidinecarbamate
  • pentyl [1-(5-deoxy-beta-d-ribofuranosyl)-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl]carbamate
  • pentyl [1-(5-deoxy-beta-d-ribofuranosyl)-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl]carbamate
  • pseudomonas aeruginosa
  • ro-091978000
  • ro-091978000
  • sar439281
  • xeloda
  • xeloda
  • xeloda
  • xeloda
  • xeloda

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07281768Phase 2Mar 31, 2026Johns Hopkins University, Regeneron
NCT07221149Phase 2/Phase 3 (Phase 3)Mar 9, 2026Biontech, Bristol-Myers Squibb
NCT07221357Phase 2/Phase 3 (Phase 3)Mar 4, 2026Biontech, Bristol-Myers Squibb
NCT07266025Phase 2Jan 30, 2026Fudan University
NCT07243938Phase 2Jan 15, 2026Huazhong University of Science and Technology
NCT07254962Phase 2Jan 1, 2026McGill University, Technion University
NCT07291401Phase 2Jan 1, 2026Xiamen University
NCT07113275Phase 3Jan 1, 2026Huazhong University of Science and Technology
NCT07239466Phase 2Jan 1, 2026Huazhong University of Science and Technology
NCT07229846Phase 2Dec 31, 2025Harbin Medical University
NCT07296666Phase 2Dec 31, 2025Fudan University
NCT07265674Phase 3Dec 31, 2025J-Pharma Co., Ltd., Memorial Sloan-Kettering Cancer Center
NCT07222215Phase 2Dec 31, 2025Harvard University, Johns Hopkins University, Menarini Group, Pipeline Therapeutics, Inc., Translational Breast Cancer Research Consortium
NCT07251062Phase 2/Phase 3 (Phase 3)Dec 30, 2025Shijiazhuang Pharma Group (CSPC)
NCT07277842Phase 3Dec 29, 2025Sun Yat-Sen University
NCT07309419Phase 2/Phase 3 (Phase 3)Dec 22, 2025Fudan University
NCT07297030Phase 2Dec 20, 2025Sun Yat-Sen University
NCT07283367Phase 1/Phase 2 (Phase 2)Dec 19, 2025Jiangsu Hansoh Pharmaceutical Co., Ltd.
NCT07238569Phase 3Dec 1, 2025Sun Yat-Sen University
NCT07233850Phase 2Nov 30, 2025Sunshine Lake Pharma Co., Ltd.
Showing 20 of 1,967 trials
Page 1 / 99

Organizations

Research & Development (862)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
RocheFor profit1828341998
National Cancer Institute (NCI)Government1716241998
Fudan UniversityAcademic/Hospital1119542006
Sun Yat-Sen UniversityAcademic/Hospital1069032008
Chinese Academy of Medical SciencesAcademic/Hospital825952008
SanofiFor profit591342000
Zhejiang UniversityAcademic/Hospital433332010
University of Texas at HoustonAcademic/Hospital423042001
Jiao Tong UniversityAcademic/Hospital352251997
MerckFor profit352332004
GenentechFor profit33542002
NovartisFor profit311252002
AstraZenecaFor profit291832004
Peking UniversityAcademic/Hospital291942007
Bristol-Myers SquibbFor profit28942003
Harvard UniversityAcademic/Hospital272542001
People's Liberation Army of ChinaGovernment261742004
PfizerFor profit251142002
Huazhong University of Science and TechnologyAcademic/Hospital241442013
Nanjing Medical UniversityAcademic/Hospital241842012
862 organizations
Page 1 / 44

Marketing (26)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGApr 23, 2015
Alkem Labs LtdFor profitMKTGNov 27, 2017
Amneal PharmaceuticalsFor profitMKTGFeb 28, 2017
CheplaPharmFor profitMKTGApr 30, 1998
CheplaPharmFor profitNDA2Apr 30, 1998
Dr. Reddy's LaboratoriesFor profitSYNDec 4, 2020
Dr. Reddy's LaboratoriesFor profitMKTGDec 4, 2020
Eugia PharmaFor profitMKTGApr 17, 2018
Hetero Labs LtdFor profitMKTGMar 5, 2024
HikmaFor profitMKTGJul 14, 2016
HikmaFor profitSYNJul 14, 2016
MSN LaboratoriesFor profitSYNJul 2, 2018
MSN LaboratoriesFor profitMKTGJul 2, 2018
MylanFor profitMKTGAug 8, 2014
MylanFor profitSYNAug 8, 2014
Reliance Life Sciences Pvt. LtdFor profitMKTGApr 27, 2020
Rising PharmaceuticalsFor profitSYNAug 8, 2014
Rising PharmaceuticalsFor profitMKTGAug 8, 2014
RocheFor profitNDAApr 30, 1998
RocheFor profitMKTGApr 30, 1998
Shilpa Medicare Ltd.For profitMKTGDec 12, 2016
Shilpa Medicare Ltd.For profitMKTGDec 12, 2016
Sun PharmaceuticalsFor profitMKTGJun 21, 2019
TEYRO LABSFor profitMKTGOct 23, 2023
TevaFor profitMKTGSep 16, 2013
West-Ward PharmaceuticalFor profitMKTGJul 14, 2016