TheraRadar
Data updated: May 26, 2026

ERIBULIN MESYLATE

Oncology Approved 2024-04-05

Eribulin mesylate helps patients with metastatic breast cancer who have already received at least two prior chemotherapy regimens, including an anthracycline and a taxane. It is also used for individuals with liposarcoma that is unresectable or has spread after previous treatment with an anthracycline-containing regimen. This medication provides a therapeutic option for those managing advanced stages of these specific cancers.

Source: FDA Label • LONG GROVE PHARMS
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How ERIBULIN MESYLATE Works

This drug works by blocking the growth phase of microtubules and trapping tubulin, which prevents cancer cells from dividing properly. This disruption leads to a block in the cell cycle and eventually causes the cancer cells to die. Additionally, it may help by decreasing the ability of cancer cells to migrate and by improving blood flow to the center of tumors.

Source: FDA Label
9
Indications
--
Phase 3 Trials
2
Years on Market

Details

Status
Prescription
First Approved
2024-04-05
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

LONG GROVE PHARMS JIANGXI KVVIT PHARM GLENMARK PHARMS Dr. Reddy's GLAND XGEN PHARMS Novartis Baxter CHIA TAI TIANQING
Active Ingredient: ERIBULIN MESYLATE

ERIBULIN MESYLATE Approval History

2025
2026
Original
New Indication
New Form
Label Update
9 FDA actions from 2024 to 2026
Mar 2026 ORIGINAL
Update
Aug 2025 ORIGINAL
Update
Jul 2025 ORIGINAL
Update

What ERIBULIN MESYLATE Treats

2 indications

ERIBULIN MESYLATE is approved for 2 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Metastatic Breast Cancer
  • Liposarcoma
Source: FDA Label

ERIBULIN MESYLATE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

3

Same target(s) AND same indication — head-to-head.

DOCIVYX
AVYXA HOLDINGS
2022 5 indic.
KADCYLA
Roche
2013 1 indic.

MoA expansion candidates

8

Same target(s), different indications — where else is this mechanism being explored?

BLENREP
GSK
2025 1 indic.
EMRELIS
AbbVie
2025 1 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

BONCRESA
AMNEAL PHARMS
2025 3 indic.
CONJUGATED ESTROGENS
NOVAST LABS
2025 6 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to ERIBULIN MESYLATE

3 of 7

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

HALAVEN
ERIBULIN MESYLATE
2 shared
EISAI INC
Shared indications:
Metastatic Breast CancerLiposarcoma
GEMCITABINE HYDROCHLORIDE
GEMCITABINE HYDROCHLORIDE
1 shared
Teva
Shared indications:
Metastatic breast cancer
PERJETA
PERTUZUMAB
1 shared
Roche
Shared indications:
Metastatic Breast Cancer
View all 7 similar drugs Pro
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Clinical Trial Registry

42 trials
Trial Sponsor ID Phase Status Title
NCT04579224 NCI-2020-07651 NCI-2020-07651, S1937 Ph 3 active not recruiting Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer
NCT03237780 NCI-2017-01388 NCI-2017-01388, PHII-150 Ph 2 active not recruiting Atezolizumab With or Without Eribulin Mesylate in Treating Patients With Recurrent Locally Advanced or Metastatic Urothelial Cancer
NCT04345913 results posted NCI-2020-02319 NCI-2020-02319, 202010089 Ph 1, Ph 2 active not recruiting Testing the Addition of Copanlisib to Eribulin in Metastatic Triple Negative Breast Cancer
NCT03361436 STUDY00017190 NCI-2017-02120, STUDY00017190 Ph 1 active not recruiting Eribulin and Radiation Therapy in Treating Patients With Retroperitoneal Liposarcoma That Can Be Removed by Surgery
NCT05374512 D926PC00001 2023-509260-25, 2021-005223-21 Ph 3 active not recruiting A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02)
NCT05530057 ESPERO H-1905-141-1035 Ph 2 recruiting Eribulin With or Without Trastuzumab-biosimilar in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer
NCT01676818 results posted 5C-11-2 NCI-2012-01378 Ph 2 completed Eribulin Mesylate in Treating Patients With Advanced or Recurrent Cervical Cancer
NCT06590558 NCI-2024-05666 NCI-2024-05666, 10647 Ph 1 withdrawn Testing the Addition of an Investigational Anti-Cancer Drug, ASTX660 (Tolinapant), to a Usual Chemotherapy Treatment (Eribulin) for Treatment of Advanced Triple Negative Breast Cancer
NCT05041101 results posted 2021-0077 NCI-2021-09158, 2021-0077 Ph 1, Ph 2 terminated Grapiprant and Eribulin for the Treatment of Metastatic Inflammatory Breast Cancer
NCT05619913 EPOCH ANZGOG 1828/2021 Ph 2 recruiting EPOCH: Eribulin and Pembrolizumab in Ovarian/Uterine Carcinosarcoma
NCT02037529 results posted RU011201I NCI-2016-02048, RU011201I Ph 3 suspended Eribulin Mesylate or Paclitaxel as First- or Second-Line Therapy in Treating Patients With Recurrent Stage IIIC-IV Breast Cancer
NCT03051659 results posted 16-577 Ph 2 completed A Randomized Phase II Study Of Eribulin Mesylate With or Without Pembrolizumab For Metastatic Hormone Receptor Positive Breast Cancer
NCT01269346 results posted E7389-A001-208 Ph 2 completed Eribulin With Trastuzumab as First-line Therapy for Locally Recurrent or Metastatic HER2 Positive Breast Cancer
NCT01126736 results posted E7389-701 2009-016047-19 Ph 1, Ph 2 completed Eribulin Mesylate Administered in Combination With Pemetrexed Versus Pemetrexed Alone as Second Line Therapy in Patients With Stage IIIB or IV Nonsquamous Non Small Cell Lung Cancer
NCT01439282 results posted E7389-A001-212 Ph 2 completed Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer
NCT01268150 results posted E7389-A001-206 Ph 2 completed A Study of Single-Agent Eribulin Mesylate as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Negative Breast Cancer
NCT00879086 results posted E7389-G000-209 Ph 2 completed A Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Participants With Advanced Breast Cancer
NCT05206656 YYS-20200305 Ph 2 completed Safety and Efficacy of Eribullin or Eribulin Combined With Anlotinib in Metastatic Breast Cancer
NCT03579472 2017-0500 NCI-2018-01140, 2017-0500 Ph 1 terminated M7824 and Eribulin Mesylate in Treating Patients With Metastatic Triple Negative Breast Cancer
NCT03441360 results posted E7389-G000-223 Ph 2 completed Study to Assess Safety and Preliminary Activity of Eribulin Mesylate in Pediatric Participants With Relapsed/Refractory Rhabdomyosarcoma (RMS), Non-rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) and Ewing Sarcoma (EWS)
NCT02120469 results posted 14036 NCI-2014-00844, 14036 Ph 1 completed Eribulin Mesylate and Everolimus in Treating Patients With Triple-Negative Metastatic Breast Cancer
NCT03502681 results posted BTCRC-GU16-051 Ph 1 terminated A Study Combining Eribulin Mesylate With Avelumab in Cisplatin Ineligible Metastatic Urothelial Cell Cancer Patients
NCT02513472 ENHANCE-1 results posted E7389-M001-218 KEYNOTE-150 Ph 1, Ph 2 completed Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Combination With Pembrolizumab in Participants With Metastatic Triple-Negative Breast Cancer (mTNBC)
NCT02824575 2016-6488 Ph 1 terminated Rebastinib Plus Antitubulin Therapy With Paclitaxel or Eribulin in Metastatic Breast Cancer
NCT02864030 PAINTER01 Ph 4 completed PAINTER: Polymorphism And INcidence of Toxicity in ERibulin Treatment
NCT01323530 results posted E7389-E044-203 2009-011217-24 Ph 1, Ph 2 completed A Confirmation Study of Eribulin in Combination With Capecitabine
NCT02581839 results posted CASE7113 Ph 2 completed Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate
NCT01908101 results posted 8093 NCI-2013-01326, 8093 Ph 2 completed Eribulin Mesylate in Treating Patients With Previously Treated Metastatic Breast Cancer
NCT02753595 results posted E7389-M000-219 2015-004740-19 Ph 1, Ph 2 terminated Study of Eribulin Mesylate in Combination With PEGylated Recombinant Human Hyaluronidase (PEGPH20) Versus Eribulin Mesylate Alone in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, High-Hyaluronan (HA) Metastatic Breast Cancer (MBC)
NCT02097238 results posted NCI-2014-00621 NCI-2014-00621, COG-AOST1322 Ph 2 completed Eribulin Mesylate in Treating Patients With Recurrent or Refractory Osteosarcoma
NCT02082626 ERIBULIN 3812 Ph 1 terminated Study of Eribulin in Children With Cancer to Determine Safety
NCT02178241 results posted NCI-2014-01294 NCI-2014-01294, P9653_A02PAMDREVW01 Ph 2 completed Gemcitabine Hydrochloride and Eribulin Mesylate in Treating Patients With Bladder Cancer That is Advanced or Cannot Be Removed by Surgery
NCT03583944 E7389-M065-401 Ph 4 completed A Study to Evaluate Safety, Tolerability and Efficacy of Eribulin Mesylate in Treating Adult Females With Locally Advanced or Metastatic Breast Cancer
NCT01328249 results posted E7389-A001-210 Ph 2 completed Dose Dense Doxorubucin and Cyclophosphamide Followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast Cancer
NCT02171260 BOLD 113 results posted E7389-A001-113 (ADVL1314) Ph 1 completed This is a Phase 1 Study of Eribulin Mesylate in Pediatric Participants With Recurrent or Refractory Solid Tumors (Excluding [Central Nervous System] CNS), Including Lymphomas
NCT02481050 results posted E7389-M001-216 Ph 2 completed Study to Evaluate the Efficacy and Safety of Eribulin Mesylate Administered Biweekly (Q2W) for Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast Cancer
NCT01613768 results posted 7674 NCI-2012-00892 Ph 2 completed Eribulin Mesylate in Treating Patients With Recurrent or Metastatic Salivary Gland Cancer
NCT03002493 E7389-E044-111 Ph 1 completed To Assess the Effect of Rifampicin on the Pharmacokinetics of Eribulin Mesylate in Participants With Advanced Solid Tumors
NCT01961544 ESKIMO results posted EKI-CT-1301 Ph 4 completed Eribulin Mesylate Phase IV Clinical Trial in Korean Patients With Metastatic or Locally Advanced Breast Cancer
NCT01458249 results posted E7389-J081-217 Ph 2 completed An Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Previously Treated Subjects With Advanced or Metastatic Soft Tissue Sarcoma (Study E7389-J081-217)
NCT00965523 results posted E7389-J081-224 E7389-J081-221 Ph 2 completed Study of E7389 for Advanced or Metastatic Breast Cancer
NCT01106248 results posted E7389-E044-110 Ph 1 completed QT Interval Prolongation Study of Eribulin Mesylate (E7389) in Patients With Advanced Solid Tumors
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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

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Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ERIBULIN MESYLATE FDA Label Details

Indications & Usage

ERIBULIN MESYLATE is indicated for the treatment of Metastatic Breast Cancer; Liposarcoma.

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Data Sources

FDA Approval: ANDA214850 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.