CLINICAL TRIALS PROFILE FOR ERIBULIN MESYLATE

All Clinical Trials for ERIBULIN MESYLATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00047034 ↗	E7389 in Treating Patients With Advanced Solid Tumors	Completed	National Cancer Institute (NCI)	Phase 1	2002-08-01	Phase I trial to study the effectiveness of E7389 in treating patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
NCT00334893 ↗	Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2006-04-01	This phase II trial is studying how well eribulin mesylate works in treating patients with recurrent ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
NCT00337077 ↗	Eribulin Mesylate in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy	Completed	National Cancer Institute (NCI)	Phase 2	2006-11-01	This phase II trial is studying how well eribulin mesylate (E7389; Halichondrin B Analog) works in treating patients with metastatic prostate cancer that did not respond to hormone therapy. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
NCT00337103 ↗	E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes	Completed	Eisai Inc.	Phase 3	2006-09-20	The purpose of this study is to compare E7389 versus capecitabine in patients with locally advanced or metastatic breast cancer who are refractory to the most recent chemotherapy. This is an open-label, randomized, two-parallel arm study. Patients will be randomized to receive either E7389 or capecitabine on a one-to-one ratio.
NCT00337129 ↗	S0618 E7389 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2006-05-01	RATIONALE: Drugs used in chemotherapy, such as E7389, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well E7389 works in treating patients with metastatic or recurrent head and neck cancer.
NCT00365157 ↗	Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction	Active, not recruiting	National Cancer Institute (NCI)	Phase 1/Phase 2	2006-10-23	This phase I/II trial studies the effect of eribulin mesylate and to see how well it works in treating patients with cancer of the urothelium that has spread to nearby tissue (locally advanced) or to other places in the body (metastatic)and kidney dysfunction. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chemotherapy drugs may have different effects in patients who have changes in their kidney function.
NCT00383760 ↗	Eribulin Mesylate as Second-Line Therapy for Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer Patients	Completed	National Cancer Institute (NCI)	Phase 2	2006-08-01	This phase II trial is studying how well E7389 works as second-line therapy in treating patients with locally advanced, unresectable, or metastatic pancreatic cancer. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Clinical Trial Conditions for ERIBULIN MESYLATE

Condition Name

Condition Name for ERIBULIN MESYLATE
Intervention	Trials
Breast Cancer	20
Metastatic Breast Cancer	15
Stage III Bladder Urothelial Carcinoma AJCC v6 and v7	3
Stage IV Bladder Urothelial Carcinoma AJCC v7	3

Condition MeSH

Condition MeSH for ERIBULIN MESYLATE
Intervention	Trials
Breast Neoplasms	49
Triple Negative Breast Neoplasms	9
Neoplasms	8
Carcinoma	8

Clinical Trial Locations for ERIBULIN MESYLATE

Trials by Country

Trials by Country for ERIBULIN MESYLATE
Location	Trials
United States	479
Japan	58
Canada	25
Spain	14
India	11

Trials by US State

Trials by US State for ERIBULIN MESYLATE
Location	Trials
New York	26
California	25
Texas	23
Florida	22
Washington	19

Clinical Trial Progress for ERIBULIN MESYLATE

Clinical Trial Phase

Clinical Trial Phase for ERIBULIN MESYLATE
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	3
Phase 3	7

Clinical Trial Status

Clinical Trial Status for ERIBULIN MESYLATE
Clinical Trial Phase	Trials
Completed	45
Recruiting	12
Active, not recruiting	9

Clinical Trial Sponsors for ERIBULIN MESYLATE

Sponsor Name

Sponsor Name for ERIBULIN MESYLATE
Sponsor	Trials
Eisai Inc.	29
National Cancer Institute (NCI)	24
Eisai Co., Ltd.	5

Sponsor Type

Sponsor Type for ERIBULIN MESYLATE
Sponsor	Trials
Industry	60
Other	53
NIH	24

Clinical Trials Update, Market Analysis, and Projection for Eribulin Mesylate

Last updated: October 29, 2025

Introduction

Eribulin mesylate, marketed as Halaven®, is a synthetic macrocyclic ketone formulated as a microtubule dynamics inhibitor used primarily in the treatment of metastatic breast cancer and liposarcoma. As a first-in-class drug, eribulin's unique mechanism of disrupting microtubule growth without affecting shortening has driven its therapeutic efficacy. This article provides a comprehensive update on clinical trials, analyzes the market landscape, and projects future growth trajectories for eribulin mesylate.

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Clinical Trials Update on Eribulin Mesylate

Recent Clinical Developments

Over the past 24 months, eribulin mesylate has advanced through various phases of clinical trials, with particular focus on expanding its indications and enhancing its safety profile.

• Metastatic Breast Cancer (MBC):
  Eribulin's initial approval was based on phase III trials like EMBRACE, demonstrating improved overall survival (OS) in metastatic breast cancer patients previously treated with anthracyclines and taxanes [1]. Recent trials aim to determine its efficacy as a first-line therapy in combination with other agents. Notably, ongoing studies such as NCT03844076 are evaluating eribulin combined with immune checkpoint inhibitors to identify synergistic effects.

• Liposarcoma:
  The EMBRACE trial also established eribulin's role in liposarcoma. The ongoing ESCAPE trial (NCT04063502) investigates its efficacy in differentiating subtypes of soft tissue sarcoma, aiming to refine patient selection.

• Other Malignancies:
  Early-phase trials are evaluating eribulin in non-small cell lung cancer (NSCLC), ovarian cancer, and urothelial carcinoma. For instance, a phase II trial (NCT04365654) assessed eribulin in NSCLC with promising preliminary data.

Biomarker and Safety Profiles

Recent research emphasizes biomarkers predictive of response, such as microtubule-associated proteins and gene expression profiles. Safety updates indicate manageable adverse events; peripheral neuropathy remains dose-limiting but is tolerable with appropriate management protocols. Notably, studies aim to optimize dosing strategies to balance efficacy and toxicity.

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Market Analysis

Current Market Landscape

Eribulin mesylate holds a significant position within the oncology therapeutic market, with its primary approvals in the U.S. and EU for metastatic breast cancer and liposarcoma.

• Market Size and Revenue:
  The global oncology drug market was valued at approximately USD 175 billion in 2022, with microtubule inhibitors constituting a sizable share. Eribulin’s market share in metastatic breast cancer was estimated at USD 1.2 billion in 2022, driven by its efficacy in late-line settings.

• Key Stakeholders:
  The drug is marketed by Eisai Co., Ltd., which holds patent rights and oversees global commercialization. Competitive landscape includes drugs like paclitaxel, vinorelbine, and eribulin's potential competitors in emerging combination therapies.

• Pricing and Reimbursement:
  Eribulin’s price ranges from USD 9,000 to USD 12,000 per cycle, depending on regional healthcare policies. Reimbursement remains favorable in major markets due to demonstrated clinical benefits.

Market Trends and Drivers

• Expanding Indications:
  Ongoing trials investigating eribulin in earlier lines of therapy and combination regimens could broaden its use, consequently expanding market share.

• Regulatory Approvals:
  The recent FDA approval (2022) for use in liposarcoma has opened New York markets, with potential expansions for other soft tissue sarcomas pending successful trial outcomes.

• Advances in Precision Oncology:
  Development of biomarkers promises tailored treatment, increasing eribulin’s appeal among personalized medicine initiatives.

Competitive Landscape and Challenges

While eribulin enjoys a stronghold in specific niches, competition from newer microtubule inhibitors, immune therapies, and targeted agents poses strategic challenges. Additionally, side effect management (notably neuropathy) remains critical for sustaining market penetration.

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Market Projection for Eribulin Mesylate (2023–2030)

Growth Outlook and Forecasts

• Compound Annual Growth Rate (CAGR):
  Based on recent trends and ongoing clinical trials, analysts project a CAGR of approximately 8–10% for eribulin’s global sales from 2023 to 2030.

• Conversion of Indications:
  The expansion into early-line settings and combination therapies, especially with immune checkpoint inhibitors, could triple current sales figures by 2030.

• Geographical Expansion:
  Increased approvals in Asia-Pacific, Latin America, and Middle East markets are anticipated, driven by local clinical data and region-specific pricing strategies.

Key Market Drivers

• Accelerated adoption in combination regimens.
• Growing prevalence of metastatic breast cancer and soft tissue sarcoma.
• Advances in biomarker-based patient selection.
• Regulatory approvals for new indications.

Potential Barriers

• Side effects impacting patient compliance.
• Patent expirations in certain regions (expected around 2026).
• Pricing pressures from healthcare systems seeking cost-effective alternatives.
• Competition from emerging therapies.

Strategic Recommendations

Manufacturers and stakeholders should focus on:

• Further clinical validation of eribulin in new indications.
• Investing in biomarker research for personalized treatments.
• Developing combination therapies to extend survival benefits.
• Optimizing dosing regimens to mitigate adverse effects.
• Enhancing global access through partnerships and pricing strategies.

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Key Takeaways

• Eribulin mesylate remains a vital agent in metastatic breast cancer and liposarcoma, with ongoing trials to expand its therapeutic indications.
• Clinical advancements are centered on combination treatments and biomarker-driven patient selection to improve outcomes.
• The market for eribulin is poised for steady growth, driven by emerging indications, regulatory approvals, and geographic expansion.
• Strategic investments in clinical research, biomarker development, and global access are crucial for maximizing eribulin’s commercial potential.
• Challenges such as side effects, patent expiration, and competitive dynamics necessitate proactive management to sustain market position.

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FAQs

1. What are the primary indications for eribulin mesylate today?
Eribulin is approved for metastatic breast cancer patients who have previously received anthracycline and taxane chemotherapy and for liposarcoma following at least two prior chemotherapy regimens.

2. Are there ongoing trials to broaden eribulin’s use?
Yes. Clinical trials are evaluating eribulin in early-line therapy, combination regimens with immunotherapies, and in various other cancers such as NSCLC and ovarian cancer.

3. What are the main side effects associated with eribulin?
Peripheral neuropathy, neutropenia, fatigue, and alopecia are common. Dose adjustment and supportive care mitigate most adverse events.

4. How does eribulin compare to other microtubule inhibitors?
Eribulin uniquely inhibits microtubule growth without affecting shortening, leading to distinct efficacy and toxicity profiles. Its ability to reverse tumor metastasis and improve survival in certain cancers remains a highlight.

5. What is the future outlook for eribulin in the oncology market?
With ongoing clinical research, expanding indications, and favorable market dynamics, eribulin’s role is expected to grow, particularly if combination strategies prove to enhance survival outcomes in wider patient populations.

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References

[1] Cortes, J., et al. (2011). "Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer: a phase 3 open-label trial." The Lancet. 377(9780): 914-923.