CLINICAL TRIALS PROFILE FOR HALAVEN

All Clinical Trials for HALAVEN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00410553 ↗	Eribulin Mesylate and Gemcitabine Hydrochloride in Treating Patients With Metastatic Solid Tumors or Solid Tumors That Cannot be Removed by Surgery	Completed	National Cancer Institute (NCI)	Phase 1	2006-11-14	This phase I trial is studying the side effects and best dose of eribulin mesylate and gemcitabine hydrochloride in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as eribulin mesylate and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
NCT01372579 ↗	Carboplatin and Eribulin Mesylate in Triple Negative Breast Cancer Patients	Unknown status	Eisai Inc.	Phase 2	2011-08-01	This phase II trial studies how well giving eribulin mesylate and carboplatin together before surgery works in treating patients with stage I-III triple-negative breast cancer. Drugs used in chemotherapy, such as eribulin mesylate and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
NCT01372579 ↗	Carboplatin and Eribulin Mesylate in Triple Negative Breast Cancer Patients	Unknown status	Northwestern University	Phase 2	2011-08-01	This phase II trial studies how well giving eribulin mesylate and carboplatin together before surgery works in treating patients with stage I-III triple-negative breast cancer. Drugs used in chemotherapy, such as eribulin mesylate and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
NCT01388647 ↗	Study of Neoadjuvant Carboplatin, Eribulin and Trastuzumab for Operable HER2 Positive Breast Cancer	Terminated	Eisai Inc.	Phase 1/Phase 2	2011-08-01	This study will evaluate the safety and efficacy of eribulin in combination with carboplatin and trastuzumab in the neoadjuvant setting in subjects who are human epidermal growth factor receptor (HER)2 positive and are clinically stage IIA to IIIB. The study regimen will be administered every 3 weeks for a total of 6 cycles followed by definitive surgery.
NCT01388647 ↗	Study of Neoadjuvant Carboplatin, Eribulin and Trastuzumab for Operable HER2 Positive Breast Cancer	Terminated	Vector Oncology	Phase 1/Phase 2	2011-08-01	This study will evaluate the safety and efficacy of eribulin in combination with carboplatin and trastuzumab in the neoadjuvant setting in subjects who are human epidermal growth factor receptor (HER)2 positive and are clinically stage IIA to IIIB. The study regimen will be administered every 3 weeks for a total of 6 cycles followed by definitive surgery.
NCT01401959 ↗	Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy	Completed	Eisai Inc.	Phase 2	2011-09-23	The investigators propose to evaluate eribulin as adjuvant therapy in breast cancer patients who have residual invasive disease in breast or lymph node tissue following standard neoadjuvant chemotherapy and surgery regimen. Three cohorts of patients will be evaluated separately based on tumor type: triple-negative, hormone-receptor-positive/HER2-negative, and HER2-positive breast cancers.

Clinical Trial Conditions for HALAVEN

Condition Name

Condition Name for HALAVEN
Intervention	Trials
Breast Cancer	16
Metastatic Breast Cancer	12
Stage III Urethral Cancer	3
Stage IV Bladder Urothelial Carcinoma AJCC v7	3

Condition MeSH

Condition MeSH for HALAVEN
Intervention	Trials
Breast Neoplasms	45
Carcinoma	8
Triple Negative Breast Neoplasms	8
Carcinoma, Transitional Cell	5

Clinical Trial Locations for HALAVEN

Trials by Country

Trials by Country for HALAVEN
Location	Trials
United States	250
Spain	13
Canada	11
India	10
China	5

Trials by US State

Trials by US State for HALAVEN
Location	Trials
Florida	14
Texas	13
Missouri	11
Georgia	10
California	10

Clinical Trial Progress for HALAVEN

Clinical Trial Phase

Clinical Trial Phase for HALAVEN
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	7
Phase 2	36

Clinical Trial Status

Clinical Trial Status for HALAVEN
Clinical Trial Phase	Trials
Completed	19
Recruiting	15
Active, not recruiting	10

Clinical Trial Sponsors for HALAVEN

Sponsor Name

Sponsor Name for HALAVEN
Sponsor	Trials
Eisai Inc.	18
National Cancer Institute (NCI)	11
Dana-Farber Cancer Institute	6

Sponsor Type

Sponsor Type for HALAVEN
Sponsor	Trials
Other	61
Industry	41
NIH	11

Clinical Trials Update, Market Analysis, and Projection for Halaven (Eribulin Mesylate)

Last updated: October 28, 2025

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Introduction

Halaven (eribulin mesylate), developed by Eisai Co., Ltd., is a synthetic macrocyclic halichondrin class anticancer agent approved primarily for metastatic breast cancer and liposarcoma. Since its initial approval, ongoing clinical trials and evolving market dynamics are shaping its future trajectory. This analysis provides a comprehensive update on Halaven’s clinical development, examines current market conditions, and projects future growth based on recent data.

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Clinical Trials Update

Regulatory Approvals and Indications

Initially approved by the U.S. Food and Drug Administration (FDA) in 2010 for metastatic breast cancer resistant to multiple prior therapies, Halaven’s indications have expanded. In 2016, the FDA approved it for metastatic liposarcoma post-anthracycline chemotherapy. These approvals established Halaven as a second-line therapy for specific soft tissue sarcomas and advanced breast cancer.

Ongoing and Recent Clinical Trials

1. Breast Cancer

• Phase III Trials: Current research continues to explore Halaven's utility in early-stage and combination therapy settings. Notably, trials such as NCT03677919 are evaluating Halaven in HER2-positive breast cancer, assessing its potential to improve progression-free survival when combined with other targeted agents.

• Adjuvant and Neoadjuvant Settings: Several phase II/III studies are assessing the efficacy of Halaven in neoadjuvant treatment. A notable trial, NCT03646829, is evaluating its use with checkpoint inhibitors to enhance immune response in triple-negative breast cancer.

2. Liposarcoma and Other Soft Tissue Sarcomas

• Expanded Use Studies: Trials like NCT04722449 are investigating Halaven’s role in other sarcoma subtypes, including leiomyosarcoma and synovial sarcoma, leveraging its proven activity in liposarcoma.

• Combination Therapies: There is increasing interest in combining Halaven with immune checkpoint inhibitors, such as pembrolizumab, to augment anti-tumor activity, as seen in early-phase trials (NCT04693434).

3. Non-Oncology Indications

Although primarily focused on oncology, preclinical studies are exploring Halaven's potential in other therapeutic areas, such as neurodegenerative diseases, but these are early-stage with limited clinical data.

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Market Analysis

Current Market Position

As of 2023, Halaven remains a vital agent in the niche of soft tissue sarcomas and metastatic breast cancer. Its global sales are estimated at approximately $450 million annually, with the United States contributing roughly 70% of revenue. The drug benefits from patent exclusivity until 2030, ensuring market protection over the near term.

Market Share and Competitive Landscape

Halaven faces competition from other chemotherapeutics, immunotherapies, and targeted agents. In metastatic breast cancer, agents like Kadcyla (ado-trastuzumab emtansine), Lynparza (olaparib), and immunotherapies limit Halaven’s market dominance, often used in combination or specific patient subsets.

For soft tissue sarcomas, Pazopanib (Votrient) and trabectedin have alternative mechanisms, yet Halaven’s efficacy in liposarcoma provides a competitive edge in second-line therapy.

Key Market Drivers

• Unmet Medical Needs: Limited effective options for heavily pretreated metastatic breast cancer and liposarcoma sustain demand.

• Regulatory Pathways: Ongoing trials could lead to label expansions, broadening the patient population.

• Geographical Expansion: Growth in emerging markets, particularly Asia-Pacific, driven by increasing cancer prevalence and healthcare infrastructure improvements.

Market Challenges

• Pricing and Reimbursement: High treatment costs and variable reimbursement policies pose barriers.

• Safety Profile: Myelosuppression and neuropathy restrict prolonged use in some patients.

• Market Penetration: Competition from emerging therapies, including immuno-oncology agents, may erode market share.

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Future Market Projection

Growth Outlook (2023-2030)

Based on clinical trial progression, regulatory activities, and market trends, Halaven’s global sales are projected to grow modestly at a compounded annual growth rate (CAGR) of approximately 4% over the next seven years, reaching an estimated $560 million by 2030.

Factors Influencing Growth

• Possible Indication Expansion: Positive results from ongoing trials could lead to new approvals, increasing the addressable market.

• Combination Therapy Potential: Demonstrated synergistic effects with immunotherapies could enhance sales.

• Generic Entry: Patent expirations around 2030 may introduce generics, likely resulting in price reductions and market share shifts.

• Geographical Expansion: Penetration into emerging markets could contribute to sales growth, especially where affordable treatment options are prioritized.

• Healthcare Policy and Reimbursement: Adoption will depend heavily on evolving healthcare policies and cost-effectiveness assessments.

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Strategic Implications

Eisai’s focus on clinical development and possible label expansion positions Halaven for continued relevance, especially if trials demonstrate superiority or additive benefit in combination therapies. Strategic collaborations with pharmaceutical companies developing immunotherapies could further solidify Halaven’s position.

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Key Takeaways

• Ongoing phase II/III trials seek to expand Halaven’s indications, especially in combination with immune checkpoint inhibitors across various cancers.
• Market revenue remains stable with potential for moderate growth driven by clinical expansion and geographical penetration.
• Competition from targeted therapies and immunotherapies necessitates strategic positioning and potential combination approaches.
• Patent protections persist until 2030, but impending patent cliffs could influence pricing and market dynamics.
• Investment in biomarker research and personalized medicine approaches could optimize patient selection, improving outcomes and commercial viability.

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FAQs

1. What are the primary approved indications for Halaven?
Halaven is approved for metastatic breast cancer resistant to multiple therapies and for liposarcoma after anthracycline chemotherapy.

2. Are there ongoing clinical trials that could expand Halaven’s uses?
Yes, multiple trials are investigating its role in early-stage breast cancer, combination therapies, and other sarcoma subtypes, potentially leading to label expansions.

3. How does Halaven compare to other agents in soft tissue sarcoma?
Halaven demonstrates notable efficacy in liposarcoma and offers an alternative to agents like Pazopanib, with ongoing studies seeking to solidify its role.

4. What factors threaten Halaven’s market share?
Emerging therapies, generic competition post-patent expiry, and challenges related to reimbursement and safety could impact market share.

5. What is the outlook for Halaven’s sales over the next decade?
Modest growth is expected, driven by clinical advancements, geographic expansion, and potential label extensions, with sales possibly reaching $560 million by 2030.

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References

1. FDA approvals and label information: [FDA Database]
2. ClinicalTrials.gov entries for Halaven trials: [ClinicalTrials.gov]
3. Eisai official reports and presentations: [Eisai Corporation]
4. Market data and forecasts: IQVIA, EvaluatePharma
5. Industry analyses and peer-reviewed articles: [Journal Literature]