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vinorelbine

Trade name: navelbine

Small moleculeapproved

Approved

Dec 23, 1994

Vinorelbine (trade name Navelbine) is a semi-synthetic vinca-alkaloid with a broad spectrum of anti-tumour activity. Vinorelbine is a mitotic spindle poison that impairs chromosomal segregation during mitosis. It blocks cells at G2/M. Microtubules (derived from polymers of tubulin) are the principal target of vinorelbine. Vinorelbine was developed by Pierre Fabre under licence from the CNRS in France. NAVELBINE (vinorelbine tartrate) as a single agent or in combination is indicated for the first line treatment of non small cell lung cancer and advanced breast cancer. — NCATS

Clinical trial activity

478 trials · 462 clinical orgs · 14 marketing orgs

Phase 1
73
Phase 2
406
Phase 3
138
Phase 4
8

Earliest trial started Jul 1, 1992 (NCT00002498)

Timeline

1990s

  1. Jan 1, 1992

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 1993

    Earliest Phase 3 Sponsor(trial)

  3. Dec 23, 1994

    Pierre Fabre — Earliest FDA Approval

  4. Dec 23, 1994

    Pierre Fabre — NDA Organization

  5. Dec 23, 1994

    Pierre Fabre — NDA Secondary Org

  6. Jan 1, 1995

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Feb 3, 2003

    Teva — Marketing Organization

  2. Jun 10, 2003

    West-Ward Pharmaceutical — Marketing Organization

  3. Jun 10, 2003

    Hikma — Marketing Organization

  4. Apr 18, 2005

    Fresenius — Marketing Organization

  5. Jun 2, 2005

    Hospira — Marketing Organization

  6. Feb 13, 2008

    EBEWE Pharma — Marketing Organization

  7. Jul 22, 2009

    Actavis — Marketing Organization

2010s

  1. Aug 31, 2012

    Mylan — Marketing Organization

  2. Aug 31, 2012

    Rising Pharmaceuticals — Marketing Organization

  3. Sep 26, 2012

    Jiangsu Hansoh Pharmaceutical Co., Ltd. — Marketing Organization

  4. Sep 12, 2013

    Dr. Reddy's Laboratories — Marketing Organization

  5. Aug 5, 2019

    Novast Labs — Marketing Organization

  6. Aug 5, 2019

    Ingenus Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewDec 23, 1994

Chemistry & pharmacology

Loading structure…

SMILES

CCC1=C[C@@H]2CN(C1)Cc1c([nH]c3ccccc13)[C@@](C(=O)OC)(c1cc3c(cc1OC)N(C)[C@H]1[C@@](O)(C(=O)OC)[C@H](OC(C)=O)[C@]4(CC)C=CCN5CC[C@]31[C@@H]54)C2
Mol. weight
778.95 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • 5'-anhydrovinblastine
  • 5'-noranhydrovinblastine
  • 5'-noranhydrovinblastine
  • 5'-noranhydrovinblastine
  • 5'-nor-anhydrovinblastine
  • c'-norvincaleukoblastine, 3',4'-didehydro-4'-deoxy-
  • kw 2307
  • kw-2307
  • liposomal vinorelbine
  • navelbin
  • navelbine
  • navelbine
  • navelbine
  • navelbine
  • navelbine
  • navelbine
  • navelbine base
  • nor-5'-anhydrovinblastine
  • nor-5'-anhydrovinblastine
  • noranhydrovinblastine tartrate
  • vinorelbin
  • vinorelbin
  • vinorelbina
  • vinorelbina
  • vinorelbin ditartrate
  • vinorelbin ditartrate
  • vinorelbin ditartrate
  • vinorelbin ditartrate
  • vinorelbin ditartrate
  • vinorelbine
  • vinorelbine
  • vinorelbine
  • vinorelbine
  • vinorelbine
  • vinorelbine
  • vinorelbine
  • vinorelbine
  • vinorelbine
  • vinorelbine base
  • vinorelbine base
  • vinorelbine base
  • vinorelbine ditartarate
  • vinorelbine ditartarate
  • vinorelbine ditartrate
  • vinorelbine ditartrate
  • vinorelbine (ditartrate)
  • vinorelbine ditartrate salt hydrate
  • vinorelbine tartrate
  • vinorelbine tartrate
  • vinorelbine tartrate
  • vinorelbine tartrate
  • vinorelbine tartrate
  • vinorelbinum
  • vinorelbinum

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07214779Phase 3Dec 1, 2025ENGOT Foundation, GOG Foundation, Inc., Incyte
NCT07230626Phase 3Nov 20, 2025Shijiazhuang Pharma Group (CSPC)
NCT06908304Phase 3Nov 3, 2025Maia Biotechnology
NCT07021989Phase 2Oct 31, 2025Gateway for Cancer Research, University of California, San Francisco
NCT07137884Phase 2Oct 1, 2025Sun Yat-Sen University
NCT06875128Phase 2Sep 30, 2025Delcath Systems
NCT07152405Phase 3Sep 24, 2025Baili Pharmaceutical Group
NCT07165769Phase 2Sep 4, 2025China Academy of Chinese Medical Sciences
NCT07088263Phase 3Aug 4, 2025Sun Yat-Sen University
NCT06632327Phase 3May 30, 2025National Cancer Institute (NCI)
NCT07007559Phase 1/Phase 2 (Phase 2)Apr 28, 2025ALX Oncology
NCT06857747N/AMar 1, 2025Chinese Academy of Medical Sciences
NCT06839560Phase 2Mar 1, 2025Chinese Academy of Medical Sciences
NCT06692491Phase 2Jan 1, 2025Peking University
NCT06690840Phase 2Dec 31, 2024University of Milan
NCT06653972Phase 2Nov 1, 2024Chinese Academy of Medical Sciences
NCT06564844Phase 3Oct 28, 2024AstraZeneca, Daiichi Sankyo, Universidad Autonoma de Barcelona
NCT06714084N/AOct 8, 2024Akeso Pharmaceuticals, Inc., People's Hospital Of Yichang, Wuhan University
NCT06576635N/ASep 30, 2024University of Illinois at Chicago
NCT06435429Phase 3Aug 13, 2024Jazz Pharmaceuticals
Showing 20 of 478 trials
Page 1 / 24

Organizations

Research & Development (462)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government612241994
Fudan UniversityAcademic/Hospital261722005
Chinese Academy of Medical SciencesAcademic/Hospital231452005
Sun Yat-Sen UniversityAcademic/Hospital221732011
RocheFor profit201042002
Pierre FabreFor profit18332002
GlaxoSmithKlineFor profit13532000
Eli LillyFor profit11622004
GenentechFor profit11221999
Harvard UniversityAcademic/Hospital111032000
SanofiFor profit11242000
University of CreteAcademic/Hospital10132002
Boehringer IngelheimFor profit9632009
Hellenic Oncology Research GroupAcademic/Hospital9932002
Southwest Oncology GroupAcademic/Hospital9721994
University of WashingtonAcademic/Hospital9741994
Jiao Tong UniversityAcademic/Hospital8322014
Peking UniversityAcademic/Hospital8232005
AstraZenecaFor profit7522004
Cornell UniversityAcademic/Hospital7532001
462 organizations
Page 1 / 24

Marketing (17)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGJul 22, 2009
Dr. Reddy's LaboratoriesFor profitMKTGSep 12, 2013
Dr. Reddy's LaboratoriesFor profitSYNSep 12, 2013
EBEWE PharmaFor profitMKTGFeb 13, 2008
FreseniusFor profitMKTGApr 18, 2005
HikmaFor profitSYNJun 10, 2003
HikmaFor profitMKTGJun 10, 2003
HospiraFor profitMKTGJun 2, 2005
Ingenus PharmaceuticalsFor profitMKTGAug 5, 2019
Jiangsu Hansoh Pharmaceutical Co., Ltd.For profitMKTGSep 26, 2012
MylanFor profitMKTGAug 31, 2012
Novast LabsFor profitMKTGAug 5, 2019
Pierre FabreFor profitNDADec 23, 1994
Pierre FabreFor profitNDA2Dec 23, 1994
Rising PharmaceuticalsFor profitMKTGAug 31, 2012
TevaFor profitMKTGFeb 3, 2003
West-Ward PharmaceuticalFor profitMKTGJun 10, 2003