TheraRadar
Data updated: May 26, 2026

HALAVEN (eribulin mesylate)

Trial Activity: Declining 7 active trials
Oncology Approved 2010-11-15

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

Source: FDA Label • EISAI INC
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How HALAVEN Works

Eribulin is a microtubule inhibitor that specifically inhibits the growth phase of microtubules without affecting the shortening phase, sequestering tubulin into nonproductive aggregates. This mechanism induces a G2/M cell-cycle block and disrupts mitotic spindles, leading to apoptotic cell death. Beyond its antimitotic activity, eribulin has been shown to decrease cancer cell migration and invasiveness and promote vascular remodeling, which increases tumor perfusion and reduces hypoxia in the tumor core.

Source: FDA Label

Development Insights

Eisai Inc. conducting 14 trials (31%)
107 indications explored (Broad Platform)
→ breast cancer (9 trials)
→ metastatic breast cancer (7 trials)
→ anatomic stage iv breast cancer ajcc v8 (3 trials)
3
Indications
--
Phase 3 Trials
3
Priority Reviews
15
Years on Market

Details

Status
Prescription
First Approved
2010-11-15
Patent Cliff
2027

Pro Metrics

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Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

EISAI INC
Active Ingredient: ERIBULIN MESYLATE

HALAVEN Approval History

2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
17 FDA actions from 2010 to 2022 · 2 indication expansions
Sep 2022 SUPPL Priority
Efficacy
FDA Letter Label
Sep 2021 SUPPL
Label · Labeling
FDA Letter Label
Feb 2021 SUPPL
Label · Labeling
FDA Letter

What HALAVEN Treats

2 indications

HALAVEN is approved for 2 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Metastatic Breast Cancer
  • Liposarcoma
Source: FDA Label

HALAVEN 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 HALAVEN

3 of 7

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

ERIBULIN MESYLATE
ERIBULIN MESYLATE
2 shared
LONG GROVE PHARMS
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
📋

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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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.

HALAVEN FDA Label Details

Indications & Usage

FDA Label (PDF)

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

View full patent landscape →
2 OB patents · 1 families · 61 international docs across 15 countries

HALAVEN Patents & Exclusivity

Latest Patent: Jul 2027
Exclusivity: Mar 2026

Patents (2 active)

USRE46965*PED Expires Jul 8, 2027
USRE46965 Expires Jan 8, 2027

Exclusivity

M-280 Until Sep 2025
PED Until Mar 2026
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for HALAVEN

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2027
  • • 2 active patents

Trial Analysis

  • • 45 total trials
  • • Stage: Declining

Competitive Landscape

  • • 7 similar drugs
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA201532 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment