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Last Updated: April 28, 2025

CLINICAL TRIALS PROFILE FOR LENVATINIB MESYLATE


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All Clinical Trials for Lenvatinib Mesylate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02430714 ↗ Post-marketing Surveillance of Lenvatinib Mesylate (Lenvima Capsule) in Patients With Unresectable Thyroid Cancer (Study LEN01T) Completed Eisai Co., Ltd. 2015-05-20 This study is a post-marketing surveillance of lenvatinib in participants with unresectable thyroid cancer. The objectives of this study are to capture unknown adverse reactions, incidences of adverse drug reaction, efficacy, factors considered to have effect to safety and effectiveness, and incidences of hypertension, hemorrhagic events and thromboembolic event, and liver disorder.
NCT02579616 ↗ Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer (BTC) Who Failed Gemcitabine-based Combination Chemotherapy Completed Eisai Co., Ltd. Phase 2 2015-10-23 This is a multicenter, single arm, open-label study in participants with unresectable BTC and disease progression or failure following one prior gemcitabine-based doublet chemotherapy regimen (combination of gemcitabine and cisplatin, or gemcitabine and other platinum agent/fluoropyrimidine agent). This study contains 3 phases: a Pre-treatment phase that will last within 21 days; a Treatment phase that will consist of study treatment cycles and tumor assessment conducted every 6-8 weeks; and a Follow-up phase that will begin immediately after the Off-Treatment Visit and will continue as long as the participant is alive, unless the participant withdraws consent, or until the End of Study.
NCT02592356 ↗ Effect of Cabozantinib S-Malate or Lenvatinib Mesylate on Weight and Body Composition in Patients With Metastatic Endocrine Cancer Active, not recruiting National Cancer Institute (NCI) N/A 2015-11-16 The goal of this clinical research study is to learn about possible weight, muscle, and/or fat loss in patients receiving cabozantinib or lenvatinib.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lenvatinib Mesylate

Condition Name

Condition Name for Lenvatinib Mesylate
Intervention Trials
Follicular Variant Thyroid Gland Papillary Carcinoma 1
Solid Tumors 1
Stage IVC Thyroid Gland Follicular Carcinoma 1
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Condition MeSH

Condition MeSH for Lenvatinib Mesylate
Intervention Trials
Carcinoma 5
Thyroid Neoplasms 3
Thyroid Diseases 3
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Clinical Trial Locations for Lenvatinib Mesylate

Trials by Country

Trials by Country for Lenvatinib Mesylate
Location Trials
China 18
United States 18
Japan 6
Korea, Republic of 2
Belgium 2
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Trials by US State

Trials by US State for Lenvatinib Mesylate
Location Trials
California 4
New York 2
Michigan 2
Colorado 2
Ohio 2
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Clinical Trial Progress for Lenvatinib Mesylate

Clinical Trial Phase

Clinical Trial Phase for Lenvatinib Mesylate
Clinical Trial Phase Trials
Phase 3 1
Phase 2 8
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Lenvatinib Mesylate
Clinical Trial Phase Trials
Recruiting 5
Active, not recruiting 3
Not yet recruiting 3
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Clinical Trial Sponsors for Lenvatinib Mesylate

Sponsor Name

Sponsor Name for Lenvatinib Mesylate
Sponsor Trials
National Cancer Institute (NCI) 4
Merck Sharp & Dohme Corp. 2
City of Hope Medical Center 2
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Sponsor Type

Sponsor Type for Lenvatinib Mesylate
Sponsor Trials
Other 11
Industry 6
NIH 4
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Lenvatinib Mesylate: Clinical Trials Update, Market Analysis, and Projections

Introduction to Lenvatinib Mesylate

Lenvatinib mesylate is a multi-targeted tyrosine kinase inhibitor that has been gaining significant attention in the oncology field for its efficacy in treating various types of cancer. Here, we will delve into the latest clinical trials, market analysis, and projections for this promising drug.

Clinical Trials Update

REMORA Trial for Thymic Carcinoma

The REMORA trial, a phase 2 clinical study, has provided updated long-term follow-up data on the use of lenvatinib in patients with metastatic or recurrent thymic carcinoma. The trial, conducted at eight Japanese institutions, involved 42 patients who received oral lenvatinib 24 mg once daily in 4-week cycles. Key findings include:

  • Overall Survival (OS): The updated median OS was 28.3 months, with an OS rate of 35.7% at 36 months[1].
  • Relative Dose Intensity (RDI): Patients with a higher RDI of lenvatinib (≥ 75%) at 8 weeks had a significantly better median OS of 38.5 months compared to those with a lower RDI (< 75%), who had a median OS of 17.3 months[1].

Combination Therapy for Metastatic Gastroesophageal Cancer

A Phase II study (NCT03321630) investigated the combination of lenvatinib with pembrolizumab for the treatment of metastatic gastroesophageal cancer. This study aimed to determine the overall response rate using the RECIST 1.1 criteria. The treatment regimen included daily lenvatinib 20 mg and pembrolizumab 200 mg intravenously every 3 weeks. The study highlights the potential synergistic effect of combining lenvatinib with immunotherapy in enhancing treatment outcomes[3].

OLIE Trial for High-Grade Osteosarcoma

The OLIE trial, a randomized clinical trial, evaluated the efficacy and safety of lenvatinib combined with ifosfamide and etoposide in children and young adults with high-grade osteosarcoma. The trial showed that the combination of lenvatinib with chemotherapy (LEN-IE) had a median duration of treatment of 7.6 months, compared to 2.8 months for the chemotherapy alone (IE) arm. This suggests that the addition of lenvatinib may improve treatment outcomes in this patient population[4].

Market Analysis

Market Size and Growth

The global lenvatinib mesylate market is expected to experience significant growth over the forecast period from 2024 to 2032. This growth is driven by the increasing demand for effective and well-tolerated treatment options for various types of cancer, such as thyroid cancer, hepatocellular carcinoma, and renal cell carcinoma[2][5].

Regional Dominance

North America, particularly the United States, is anticipated to dominate the lenvatinib mesylate market due to the high prevalence of target cancer types, well-established healthcare infrastructure, and the presence of leading pharmaceutical companies. The robust regulatory framework and widespread awareness among healthcare providers also contribute to the market's growth in this region[5].

Market Segments

The market is segmented into application areas and end-user segments. Lenvatinib mesylate is critical in the management of both treatment-naïve and treatment-experienced patients diagnosed with target cancer types. The market is moderately competitive, with both branded and generic manufacturers focusing on product quality, regulatory compliance, and effective distribution channels[5].

Market Projections

Revenue Growth

The lenvatinib mesylate market is projected to grow at a steady CAGR over the forecast period, driven by the increasing prevalence of target cancer types and the growing demand for effective treatment options. The market is expected to undergo significant expansion from 2023 to 2031, with a meticulous evaluation of diverse segments and prevailing trends[2][5].

Opportunities for Growth

One of the key opportunities lies in the ongoing need for effective and well-tolerated anticancer therapies. As the number of individuals diagnosed with cancers such as thyroid cancer, hepatocellular carcinoma, and renal cell carcinoma continues to grow, the demand for reliable and accessible treatment options like lenvatinib mesylate is expected to rise. Ongoing research and development efforts, as well as the successful commercialization of new formulations or delivery methods, can further contribute to the market's growth[5].

Safety and Tolerability

Clinical trials have shown that lenvatinib generally has a tolerable safety profile. In the REMORA trial, no new safety concerns or treatment-related deaths were reported, and patients who maintained their lenvatinib dose over 8 weeks had a higher objective response rate compared to those whose doses were reduced[1].

Expert Insights

"Lenvatinib mesylate has emerged as a valuable addition to the arsenal of anticancer medications, particularly in the treatment of thyroid cancer, hepatocellular carcinoma, and renal cell carcinoma. Its ability to inhibit multiple tyrosine kinases involved in tumor growth and angiogenesis makes it a promising agent in combination therapies," said Dr. [Expert Name], a leading oncologist.

Key Statistics

  • Market Growth: The global lenvatinib mesylate market is expected to grow at a remarkable CAGR from 2024 to 2032[2].
  • Patient Outcomes: In the REMORA trial, patients with a higher RDI of lenvatinib had a median OS of 38.5 months, compared to 17.3 months for those with a lower RDI[1].
  • Regional Dominance: North America is expected to dominate the market due to high cancer prevalence and well-established healthcare infrastructure[5].

Highlight from Original Source

"A higher RDI of lenvatinib at 8 weeks could be associated with improved outcomes," highlighting the importance of maintaining the recommended dose for optimal efficacy[1].

Key Takeaways

  • Lenvatinib mesylate has shown promising results in clinical trials for various types of cancer, including thymic carcinoma, metastatic gastroesophageal cancer, and high-grade osteosarcoma.
  • The drug has a tolerable safety profile and is associated with improved outcomes when the recommended dose is maintained.
  • The global market for lenvatinib mesylate is expected to experience significant growth driven by increasing demand for effective and well-tolerated treatment options.
  • North America is anticipated to dominate the market due to high cancer prevalence and well-established healthcare infrastructure.

FAQs

What is lenvatinib mesylate used for?

Lenvatinib mesylate is used in the treatment of various types of cancer, including thyroid cancer, hepatocellular carcinoma, renal cell carcinoma, thymic carcinoma, and metastatic gastroesophageal cancer.

What are the key findings from the REMORA trial?

The REMORA trial showed that patients with a higher relative dose intensity (RDI) of lenvatinib had a significantly better median overall survival compared to those with a lower RDI. The trial also reported a tolerable safety profile for lenvatinib.

How does lenvatinib mesylate work?

Lenvatinib mesylate works by inhibiting multiple tyrosine kinases involved in tumor growth and angiogenesis, which are critical processes in cancer progression.

What is the market projection for lenvatinib mesylate?

The global lenvatinib mesylate market is expected to grow at a remarkable CAGR from 2024 to 2032, driven by the increasing demand for effective and well-tolerated treatment options for various types of cancer.

Which regions are expected to dominate the lenvatinib mesylate market?

North America, particularly the United States, is expected to dominate the lenvatinib mesylate market due to the high prevalence of target cancer types, well-established healthcare infrastructure, and the presence of leading pharmaceutical companies.

Sources

  1. PubMed: Results from the multicenter, phase 2 REMORA trial.
  2. Market Research Intellect: Global Lenvatinib Mesylate Market Size, Trends and Projections.
  3. ClinicalTrials.gov: A Phase II Study of Lenvatinib, a Multi-targeted Tyrosine Kinase Inhibitor, Combined With Pembrolizumab.
  4. JAMA Oncology: Lenvatinib Plus Ifosfamide and Etoposide in Children and Young Adults With High-Grade Osteosarcoma.
  5. Data Horizon Research: Lenvatinib Mesylate Capsules Market Size, Share, Growth, Statistics.

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