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cabazitaxel

Trade name: jevtana kit

Small moleculeapproved

Approved

Jun 17, 2010

Cabazitaxel (JEVTANA®) is an antineoplastic agent belonging to the taxane class and is used to treat people with prostate cancer that has progressed despite treatment with docetaxel. It is prepared by semi-synthesis with a precursor extracted from yew needles (10-deacetylbaccatin III). Cabazitaxel (JEVTANA®) is a microtubule inhibitor. It binds to tubulin and promotes its assembly into microtubules while simultaneously inhibiting disassembly. This leads to the stabilization of microtubules, which results in the inhibition of mitotic and interphase cellular functions. The cell is then unable to progress further into the cell cycle, being stalled at metaphase, thus triggering apoptosis of the cancer cell. — NCATS

Clinical trial activity

115 trials · 153 clinical orgs · 12 marketing orgs

Phase 1
29
Phase 2
91
Phase 3
17
Phase 4
4

Earliest trial started Oct 1, 1999 (NCT01755390)

Timeline

1990s

  1. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Jan 1, 2007

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jun 17, 2010

    Sanofi-Aventis — Earliest FDA Approval

  2. Jun 17, 2010

    Sanofi-Aventis — NDA Organization

  3. Jan 1, 2011

    Earliest Phase 2 Sponsor(trial)

  4. Jun 25, 2015

    Accord Research — NDA Secondary Org

  5. Mar 2, 2017

    Sandoz — NDA Secondary Org

  6. Jan 17, 2018

    Actavis — NDA Secondary Org

  7. Jan 17, 2018

    Allergan PLC (2015) — NDA Secondary Org

  8. Jul 11, 2018

    Apotex — Marketing Organization

  9. Nov 22, 2019

    Fresenius — Marketing Organization

  10. Nov 22, 2019

    Fresenius — NDA Secondary Org

2020s

  1. Dec 29, 2021

    Accord Research — Marketing Organization

  2. Jun 23, 2022

    Esteve Labs — Marketing Organization

  3. Jan 5, 2023

    Sandoz — Marketing Organization

  4. Jan 5, 2023

    Novartis — NDA Secondary Org

  5. Feb 10, 2023

    Dr. Reddy's Laboratories — Marketing Organization

  6. Mar 22, 2023

    BPI — Marketing Organization

  7. Jul 5, 2023

    Mylan — Marketing Organization

  8. Mar 14, 2024

    Actavis — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewJun 17, 2010

Chemistry & pharmacology

Loading structure…

SMILES

CO[C@H]1C[C@H]2OC[C@@]2(OC(C)=O)[C@H]3[C@H](OC(=O)C4=CC=CC=C4)[C@]5(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)C6=CC=CC=C6)C(C)=C([C@@H](OC)C(=O)[C@]13C)C5(C)C
Mol. weight
835.9324 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

  • 4-acetoxy-13-((3-((tert-butoxycarbonyl)amino)-2-hydroxy-3-phenylpropanoyl)oxy)-1-hydroxy-7,10-dimethoxy-9-oxo-5,20-epoxytax-11-en-2-yl benzoate
  • cabacitaxel
  • cabazitaxel
  • cabazitaxel
  • cabazitaxel
  • cabazitaxel
  • cabazitaxel
  • cabazitaxel
  • cabazitaxel
  • cabazitaxel
  • cabazitaxel
  • cabazitaxel
  • cabazitaxel
  • cabazitaxel
  • cabazitaxel acetonate
  • cabazitaxel acetone
  • cabazitaxel, docetaxel, mitoxantrone or satraplatin
  • cabazitaxelum
  • cabazitaxelum
  • javtana
  • jevtana
  • jevtana
  • jevtana
  • jevtana
  • jevtana
  • jevtana kit
  • jevtana kit
  • rpr-116258a
  • taxoid xrp6258
  • taxoid xrp6258
  • txd258
  • txd258
  • txd258
  • txd 258
  • txd-258
  • xrp6258
  • xrp6258
  • xrp6258
  • xrp-6258
  • xrp-6258
  • xrp-6258

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07213674Phase 3Nov 1, 2025Amgen
NCT06890832Phase 2May 31, 2025Jina Pharmaceuticals, Inc.
NCT06738303Phase 2Mar 15, 2025Case Western Reserve University
NCT06691984Phase 3Jan 31, 2025Amgen
NCT06470243Phase 3Dec 12, 2024National Cancer Institute (NCI), SWOG Cancer Research Network
NCT06632977Phase 2Oct 13, 2024National Cancer Institute (NCI)
NCT06353386Phase 1/Phase 2 (Phase 2)May 20, 2024Merck, Orion Corporation
NCT06085729Phase 1/Phase 2 (Phase 2)Mar 1, 2024University of Texas at Houston
NCT06434935Early Phase 1 (Phase 1)Nov 7, 2023Vascudyne, Inc.
NCT05762536Phase 2Oct 19, 2023Erasmus University Rotterdam
NCT05563558Phase 2Nov 1, 2022Autonomous University of Madrid, Fundacion Oncosur, Hospital General Universitario de Castellón, Hospital Universitario Lucus Augusti, Universidad Complutense de Madrid, University of Barcelona, University of Cantabria
NCT05340374Phase 1/Phase 2 (Phase 2)Jul 14, 2022Peter MacCallum Cancer Centre
NCT04643418Phase 1/Phase 2 (Phase 2)Nov 30, 2021MegaPro Biomedical Co. Ltd.
NCT05005728Phase 2Oct 22, 2021Xencor
NCT04709276Phase 2Jun 7, 2021Bristol-Myers Squibb, Duke University
NCT04622761Phase 2Jan 15, 2021University of Liverpool
NCT04592237Phase 2Nov 30, 2020University of Texas at Houston
NCT04495179Phase 2Aug 4, 2020AstraZeneca, Harvard University, Parexel
NCT03934840Phase 2Jun 30, 2019University of Minnesota
NCT03764540Phase 2Apr 1, 2019Genzyme, University of Montreal
Showing 20 of 115 trials
Page 1 / 6

Organizations

Research & Development (153)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
SanofiFor profit572241999
University of Texas at HoustonAcademic/Hospital7622012
National Cancer Institute (NCI)Government5122012
Oregon Health and Science UniversityAcademic/Hospital4132010
Erasmus University RotterdamAcademic/Hospital3312016
Institut Gustave RoussyAcademic/Hospital3222013
Karolinska InstituteAcademic/Hospital3222012
Thomas Jefferson UniversityAcademic/Hospital3222011
UNICANCERAcademic/Hospital3322012
University of BristolAcademic/Hospital3312012
University of ParisAcademic/Hospital3012010
AmgenFor profit2212025
AstraZenecaFor profit2112017
Bristol-Myers SquibbFor profit2012016
Brown UniversityAcademic/Hospital2212011
Case Western Reserve UniversityAcademic/Hospital2212013
Cornell UniversityAcademic/Hospital2212012
Hellenic Cooperative Oncology GroupAcademic/Hospital2212012
Hospital Universitario Lucus AugustiAcademic/Hospital2022013
Icahn School of Medicine at Mount SinaiAcademic/Hospital2222011
153 organizations
Page 1 / 8

Marketing (17)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGDec 29, 2021
Accord ResearchFor profitNDA2Jun 25, 2015
ActavisFor profitNDA2Jan 17, 2018
ActavisFor profitMKTGMar 14, 2024
Allergan PLC (2015)For profitNDA2Jan 17, 2018
ApotexFor profitMKTGJul 11, 2018
ApotexFor profitSYNFeb 10, 2023
BPIFor profitMKTGMar 22, 2023
Dr. Reddy's LaboratoriesFor profitMKTGFeb 10, 2023
Esteve LabsFor profitMKTGJun 23, 2022
FreseniusFor profitMKTGNov 22, 2019
FreseniusFor profitNDA2Nov 22, 2019
MylanFor profitMKTGJul 5, 2023
NovartisFor profitNDA2Jan 5, 2023
SandozFor profitNDA2Mar 2, 2017
SandozFor profitMKTGJan 5, 2023
Sanofi-AventisFor profitNDAJun 17, 2010