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lurbinectedin

Trade name: Zepzelca

Small moleculeapprovedOrphan Drug FDA

Approved

Jun 15, 2020

Lurbinectedin, sold under the brand name Zepzelca, is a medication used for the treatment of small cell lung cancer. — Wikipedia

Clinical trial activity

55 trials · 46 clinical orgs · 1 marketing orgs

Phase 1
30
Phase 2
35
Phase 3
7
Phase 4
0

Earliest trial started Mar 1, 2009 (NCT00877474)

Timeline

2000s

  1. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2012

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2015

    Earliest Phase 3 Sponsor(trial)

  3. Aug 1, 2018

    Orphan Drug Designation

2020s

  1. Jun 15, 2020

    Jazz Pharmaceuticals — Earliest FDA Approval

  2. Jun 15, 2020

    Jazz Pharmaceuticals — Marketing Organization

  3. Jun 15, 2020

    Jazz Pharmaceuticals — NDA Secondary Org

  4. Jun 15, 2020

    Jazz Pharmaceuticals — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

  • DNAINHIBITOR

    DNA inhibitor

  • DNANEGATIVE MODULATOR

    DNA negative modulator

    Alkylating drug. Binds guanine residues in the minor groove of DNA and forms adducts that bend DNA and affects DNA binding proteins. Ultimately leads to cell death.

Approval history

  • approvedPriority reviewAcceleratedJun 15, 2020

Chemistry & pharmacology

Loading structure…

SMILES

COc1ccc2[nH]c3c(c2c1)CCN[C@]31CS[C@@H]2c3c(OC(C)=O)c(C)c4c(c3[C@H](COC1=O)N1[C@@H]2[C@H]2c3c(cc(C)c(OC)c3O)C[C@@H]([C@@H]1O)N2C)OCO4
Mol. weight
784.89 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

Sources

Also known as

  • lurbinectedin
  • lurbinectedin
  • lurbinectedin
  • pm01183
  • pm01183
  • pm01183
  • pm 01183
  • pm-01183

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07141771Phase 1/Phase 2 (Phase 2)Dec 31, 2025Chinese Academy of Medical Sciences
NCT07258147Phase 2Dec 25, 2025Sichuan University
NCT07155174Phase 2/Phase 3 (Phase 3)Dec 6, 2025AbbVie
NCT07153055Phase 1/Phase 2 (Phase 2)Nov 30, 2025Indiana University, Jazz Pharmaceuticals
NCT07121478Phase 2Sep 23, 2025National Cancer Center, Korea, Seoul National University, Sungkyunkwan University, The National Cancer Center, Yonsei University
NCT06681220Phase 2Jan 1, 2025Department of Veteran Affairs
NCT06217536Phase 1/Phase 2 (Phase 2)Oct 31, 2024Jazz Pharmaceuticals, University of California, San Francisco
NCT06496048Phase 3Aug 31, 2024Jilin Provincial Tumor Hospital, Luye Pharma
NCT06497530Phase 2Aug 31, 2024Guangzhou Medical University
NCT06501976Phase 2Jul 31, 2024Chinese Academy of Medical Sciences
NCT06228066Phase 2Jun 13, 2024National Cancer Institute (NCI)
NCT06385548Phase 1/Phase 2 (Phase 2)May 31, 2024Universidad Autonoma de Barcelona
NCT06088290Phase 2/Phase 3 (Phase 3)Sep 21, 2023PharmaMar
NCT05918640Phase 1/Phase 2 (Phase 2)Jul 27, 2023Jazz Pharmaceuticals, Stand Up To Cancer, University of Pennsylvania
NCT05876715Phase 1/Phase 2 (Phase 2)Jun 7, 2023Sarcoma Oncology Research Center, LLC
NCT05636111Phase 1May 31, 2023Jazz Pharmaceuticals, University of Texas at Houston
NCT05734066Phase 1/Phase 2 (Phase 2)May 23, 2023Jazz Pharmaceuticals
NCT05572476Phase 2Apr 30, 2023AstraZeneca, Institut Bergonié, PharmaMar
NCT05800587Phase 2Feb 22, 2023Temple University
NCT05574504Phase 2Jan 31, 2023Advent Health, Jazz Pharmaceuticals
Showing 20 of 55 trials
Page 1 / 3

Organizations

Research & Development (46)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
PharmaMarFor profit252142009
Jazz PharmaceuticalsFor profit12232020
National Cancer Institute (NCI)Government4222021
AstraZenecaFor profit2012015
Chinese Academy of Medical SciencesAcademic/Hospital2212024
Harvard UniversityAcademic/Hospital2212015
Jilin Provincial Tumor HospitalAcademic/Hospital2022020
Luye PharmaFor profit2222020
Universidad Autonoma de BarcelonaAcademic/Hospital2122009
University of Texas at HoustonAcademic/Hospital2222021
AbbVieFor profit1112025
Advent HealthAcademic/Hospital1112023
ASO SS Antonio e Biagio e C Arrigo Alessandria, ItalyAcademic/Hospital1012017
Bristol-Myers SquibbFor profit1012020
Cantonal Hospital WinterthurAcademic/Hospital1012017
Department of Veteran AffairsGovernment1112025
Emory UniversityAcademic/Hospital1112022
Fundacion Instituto Valenciano de OncologiaAcademic/Hospital1112015
Fundacion OncosurAcademic/Hospital1112019
G1 Therapeutics, Inc.For profit1012022
46 organizations
Page 1 / 3

Marketing (3)

OrganizationOrg typeRelationshipDate
Jazz PharmaceuticalsFor profitMKTGJun 15, 2020
Jazz PharmaceuticalsFor profitNDA2Jun 15, 2020
Jazz PharmaceuticalsFor profitNDAJun 15, 2020