CDEK
← All drugs Report issue

eribulin

Trade name: halaven

Small moleculeapproved

Approved

Nov 15, 2010

ERIBULIN MESYLATE (HALAVEN®) is a microtubule dynamics inhibitor. It is a synthetic analog of halichondrin B, a product isolated from the marine sponge Halichondria okadai. ERIBULIN MESYLATE (HALAVEN®) inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates. It exerts its effects via a tubulin-based antimitotic mechanism leading to G2/M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after the prolonged mitotic blockage. ERIBULIN MESYLATE (HALAVEN®) is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. It is also indicated for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. — NCATS

Clinical trial activity

205 trials · 150 clinical orgs · 5 marketing orgs

Phase 1
60
Phase 2
161
Phase 3
43
Phase 4
4

Earliest trial started Aug 1, 2002 (NCT00047034)

Timeline

2000s

  1. Jan 1, 2002

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2004

    Eisai — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2006

    Eisai — Earliest Phase 3 Sponsor(trial)

2010s

  1. Nov 15, 2010

    Eisai — Earliest FDA Approval

  2. Nov 15, 2010

    Eisai — NDA Organization

2020s

  1. Apr 5, 2024

    Gland Pharma Ltd — Marketing Organization

  2. Jun 28, 2024

    Qingfeng Pharmaceutical Group — Marketing Organization

  3. Jul 18, 2024

    LONG GROVE PHARMS — Marketing Organization

  4. Oct 1, 2024

    Baxalta — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewNov 15, 2010

Chemistry & pharmacology

Loading structure…

SMILES

C=C1C[C@@H]2CC[C@@]34C[C@H]5O[C@H]6[C@@H](O3)[C@H]3O[C@H](CC[C@@H]3O[C@H]6[C@H]5O4)CC(=O)C[C@@H]3[C@@H](OC)[C@@H](C[C@H](O)CN)O[C@H]3C[C@H]3O[C@@H](CC[C@@H]1O2)C[C@@H](C)C3=C
Mol. weight
729.91 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

  • 2-(3-amino-2-hydroxypropyl)hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)11,15-18,21-24,28-triepoxy-7,9-ethano-12,15-methano-9h,15h-furo(3,2-i)furo(2',3'-5,6)pyrano(4,3-b)(1,4)dioxacyclopentacosin-5-(4h)-one
  • b 1793
  • b-1793
  • b 1939
  • b-1939
  • e7389
  • e7389
  • e7389
  • e7389
  • e 7389
  • e-7389
  • er086526
  • er 086526
  • er-086526
  • er-86526
  • eribulin
  • eribulin
  • eribulin
  • eribulin
  • eribulin
  • eribulin
  • eribulin
  • eribulin
  • eribulin
  • eribulin
  • eribulin (as mesylate)
  • eribulin mesilate
  • eribulin mesilate
  • eribulin mesylate
  • eribulin mesylate
  • eribulin mesylate
  • eribulin mesylate
  • eribulin mesylate
  • eribulin mesylate
  • eribulin mesylate
  • eribulin mesylate
  • eribulin monomethanesulfonate
  • halaven
  • halaven
  • halaven
  • halaven
  • halaven
  • halaven
  • nsc707389
  • nsc 707389
  • nsc-707389

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07255612Phase 2Nov 4, 2026Sun Yat-Sen University
NCT06981806Phase 1Jan 31, 2026Cedars-Sinai Medical Center
NCT07265674Phase 3Dec 31, 2025J-Pharma Co., Ltd., Memorial Sloan-Kettering Cancer Center
NCT07078604Phase 2Dec 1, 2025Kuni Foundation, University of Washington
NCT07173751Phase 3Oct 30, 2025Biontech, Bristol-Myers Squibb
NCT06957431Phase 1Oct 22, 2025Exelixis, Washington University in St. Louis
NCT07205185Phase 2Oct 1, 2025Fudan University
NCT06875128Phase 2Sep 30, 2025Delcath Systems
NCT07088263Phase 3Aug 4, 2025Sun Yat-Sen University
NCT06942234Phase 1/Phase 2 (Phase 2)Jun 1, 2025Alphamab Co., Ltd.
NCT06957886Phase 3May 15, 2025Baili Pharmaceutical Group
NCT07007559Phase 1/Phase 2 (Phase 2)Apr 28, 2025ALX Oncology
NCT06590558Phase 1Nov 8, 2024National Cancer Institute (NCI), Ohio State University
NCT06435429Phase 3Aug 13, 2024Jazz Pharmaceuticals
NCT06519370Phase 3Aug 9, 2024Fudan University, Shanghai Zhangjiang Biotechnology Limited Company
NCT06533722Phase 2Aug 4, 2024Sun Yat-Sen University
NCT06539559Phase 2Aug 1, 2024Chinese Academy of Medical Sciences
NCT06383767Phase 3Jul 11, 2024Chinese Academy of Medical Sciences
NCT06387628Phase 2Jul 10, 2024Fudan University
NCT06263231Phase 3Jun 28, 2024Intensity Therapeutics, Johns Hopkins University, Premier Research Group
Showing 20 of 205 trials
Page 1 / 11

Organizations

Research & Development (150)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
EisaiFor profit694552003
National Cancer Institute (NCI)Government201542002
Fudan UniversityAcademic/Hospital13922020
Sun Yat-Sen UniversityAcademic/Hospital11922020
City of Hope National Medical CenterAcademic/Hospital8232002
Harvard UniversityAcademic/Hospital7712013
Chinese Academy of Medical SciencesAcademic/Hospital6422020
MedSIRAcademic/Hospital6612013
University of Texas at HoustonAcademic/Hospital6622012
AstraZenecaFor profit5232014
MerckFor profit5122015
GenentechFor profit4012013
University of WashingtonAcademic/Hospital4322012
Baili Pharmaceutical GroupFor profit3312024
Daiichi SankyoFor profit3112018
Nanjing Medical UniversityAcademic/Hospital3222021
University of KentuckyAcademic/Hospital3022006
University of Texas, San AntonioAcademic/Hospital3312015
University of TorontoAcademic/Hospital3032006
Alphamab Co., Ltd.For profit2222023
150 organizations
Page 1 / 8

Marketing (5)

OrganizationOrg typeRelationshipDate
BaxaltaFor profitMKTGOct 1, 2024
EisaiFor profitNDANov 15, 2010
Gland Pharma LtdFor profitMKTGApr 5, 2024
LONG GROVE PHARMSFor profitMKTGJul 18, 2024
Qingfeng Pharmaceutical GroupFor profitMKTGJun 28, 2024