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trabectedin

Trade name: yondelis

Small moleculeapprovedOrphan Drug FDA

Approved

Oct 23, 2015

Trabectedin (ET-743) is a marine alkaloid isolated from the Caribbean tunicate Ecteinascidia turbinata. Trabectedin was approved for the treatment of liposarcoma or leiomyosarcoma (USA and Europe) and ovarian cancer (only in Europe). Trabectedin exerts its anti-cancer action by binding guanine residues in the minor groove of DNA. The binding prevents DNA from interacting with transcription factors and the reparation system and results in perturbation of the cell cycle and eventual cell death. — NCATS

Clinical trial activity

87 trials · 76 clinical orgs · 4 marketing orgs

Phase 1
21
Phase 2
63
Phase 3
19
Phase 4
1

Earliest trial started Feb 1, 1996 (NCT00002904)

Timeline

1990s

  1. Jan 1, 1996

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Oct 1, 2000

    PharmaMar — IND Organization

  2. Oct 1, 2000

    PharmaMar — IND Organization

  3. Sep 30, 2004

    Orphan Drug Designation

  4. Jan 1, 2005

    Johnson and Johnson — Earliest Phase 3 Sponsor(trial)

2010s

  1. Oct 23, 2015

    Johnson and Johnson — Earliest FDA Approval

  2. Oct 23, 2015

    Johnson and Johnson — NDA Secondary Org

  3. Oct 23, 2015

    Johnson and Johnson — NDA Organization

2020s

  1. Aug 10, 2022

    Natco Pharma — Marketing Organization

  2. May 1, 2026

    Apotex — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • DNADISRUPTING AGENT

    DNA disrupting agent

Approval history

  • approvedPriority reviewOct 23, 2015

Chemistry & pharmacology

Loading structure…

SMILES

[H][C@@]12[C@@H]3SC[C@]4(NCCC5=C4C=C(OC)C(O)=C5)C(=O)OC[C@H](N1[C@@H](O)[C@@H]6CC7=C([C@H]2N6C)C(O)=C(OC)C(C)=C7)C8=C9OCOC9=C(C)C(OC(C)=O)=C38
Mol. weight
761.837 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • ecteinascidin
  • ecteinascidin 743
  • ecteinascidin 743
  • ecteinascidin 743
  • ecteinascidin 743
  • ecteinascidin 743
  • ecteinascidine
  • et 743
  • et 743
  • et-743
  • et-743
  • et-743
  • et-743
  • nsc 684766
  • trabectedin
  • trabectedin
  • trabectedin
  • trabectedin
  • trabectedin
  • trabectedin
  • trabectedin
  • trabectedin
  • trabectedin
  • trabectedin
  • trabectedin
  • trabectedin
  • yondelis
  • yondelis
  • yondelis
  • yondelis
  • yondelis
  • yondelis

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07076186Phase 2Dec 1, 2025University of Texas at Houston
NCT06524583Phase 2Oct 31, 2024Aix-University of Marseille, Institut Bergonié, Ligue contre le cancer, France, National Research Agency, France, PharmaMar, UNICANCER, University of Toulouse
NCT06263231Phase 3Jun 28, 2024Intensity Therapeutics, Johns Hopkins University, Premier Research Group
NCT05432791Phase 2/Phase 3 (Phase 3)Mar 30, 2023National Cancer Institute (NCI)
NCT05633381Phase 2/Phase 3 (Phase 3)Dec 9, 2022National Cancer Institute (NCI)
NCT05597917Phase 3Oct 26, 2021Anturec Pharmaceuticals GmbH, University of Munster
NCT04979442Phase 3Jul 14, 2021Rain Therapeutics Inc.
NCT05131386Phase 2May 28, 2021Autonomous University of Madrid, Grupo Espanol de Investigacion en Sarcomas, Hospital General Universitario Gregorio Marañon, Universidad Autonoma de Barcelona, Universidad Autonoma de Madrid, Universidad Complutense de Madrid, University of Barcelona, University of Las Palmas de Gran Canaria
NCT04794127Phase 2Apr 24, 2021Humanitas University, Mario Negri Institute, University of Milan
NCT04535271Phase 2Dec 8, 2020Sarcoma Oncology Research Center, LLC
NCT04383119Phase 2Sep 1, 2020Campus Biomedico of Rome, Italian Sarcoma Group, PharmaMar
NCT04305548Phase 2Sep 1, 2020Italian Sarcoma Group, PharmaMar, University of Milan
NCT04076579Phase 2Oct 31, 2019AstraZeneca, Janssen Pharmaceutica NV, University of Michigan
NCT04067115Phase 1Oct 31, 2019Janssen Pharmaceutica NV, National Cancer Institute (NCI), National Institutes of Health (NIH), Sarcoma Alliance for Research through Collaboration, University of Pennsylvania
NCT04008238N/ASep 30, 2019Institut Bergonié
NCT03838744Phase 2Aug 31, 2019AstraZeneca, Fondazione del Piemonte IRCCS di Candiolo, Italian Sarcoma Group, PharmaMar
NCT03690739Phase 3Aug 9, 2019AGO Germany
NCT03884972Phase 1Jun 18, 2019National Cancer Institute (NCI), University of Texas at Houston
NCT03886311Phase 2May 15, 2019Sarcoma Oncology Research Center, LLC
NCT03773510Phase 3Feb 28, 2019Italian Sarcoma Group, PharmaMar, University of Milan
Showing 20 of 87 trials
Page 1 / 5

Organizations

Research & Development (76)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
PharmaMarFor profit33142001
Johnson and JohnsonFor profit191842002
National Cancer Institute (NCI)Government14531999
Italian Sarcoma GroupAcademic/Hospital10932011
Mario Negri InstituteAcademic/Hospital7532010
University of MilanAcademic/Hospital7222011
AstraZenecaFor profit5022014
European Organisation for Research and Treatment of CancerAcademic/Hospital5531996
Grupo Espanol de Investigacion en SarcomasAcademic/Hospital5432009
Institut BergoniéAcademic/Hospital5342011
Institut Gustave RoussyAcademic/Hospital4321999
Janssen Pharmaceutica NVFor profit4022018
Cornell UniversityAcademic/Hospital3211999
Sarcoma Oncology Research Center, LLCAcademic/Hospital3312017
University of WashingtonAcademic/Hospital3222016
Vita-Salute University of Milano. ItalyAcademic/Hospital3112011
Bristol-Myers SquibbFor profit2012017
Chao Family Comprehensive Cancer CenterAcademic/Hospital2012007
Gynecologic Oncology GroupAcademic/Hospital2212007
Harvard UniversityAcademic/Hospital2122002
76 organizations
Page 1 / 4

Marketing (5)

OrganizationOrg typeRelationshipDate
ApotexFor profitMKTGMay 1, 2026
Johnson and JohnsonFor profitNDA2Oct 23, 2015
Johnson and JohnsonFor profitNDAOct 23, 2015
Natco PharmaFor profitMKTGAug 10, 2022
PharmaMarFor profitINDOct 1, 2000