CLINICAL TRIALS PROFILE FOR LENVATINIB MESYLATE

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.
NCT02592356 ↗	Effect of Cabozantinib S-Malate or Lenvatinib Mesylate on Weight and Body Composition in Patients With Metastatic Endocrine Cancer	Active, not recruiting	M.D. Anderson Cancer Center	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.
NCT02788708 ↗	Lenvatinib and Weekly Paclitaxel for Patients With Recurrent Endometrial or Ovarian Cancer	Active, not recruiting	Eisai Inc.	Phase 1	2016-05-27	This phase I trial studies the side effects and best dose of lenvatinib mesylate when given together with paclitaxel in treating patients with endometrial, ovarian, fallopian tube, or primary peritoneal cancer that has come back or grown. Lenvatinib mesylate may stop the growth of tumor cells by blocking a protein needed for cell growth and may block the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as paclitaxel, 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. Giving lenvatinib mesylate and paclitaxel together may work better in treating patients with endometrial, ovarian, fallopian tube, or primary peritoneal cancer.
NCT02788708 ↗	Lenvatinib and Weekly Paclitaxel for Patients With Recurrent Endometrial or Ovarian Cancer	Active, not recruiting	Floor Backes	Phase 1	2016-05-27	This phase I trial studies the side effects and best dose of lenvatinib mesylate when given together with paclitaxel in treating patients with endometrial, ovarian, fallopian tube, or primary peritoneal cancer that has come back or grown. Lenvatinib mesylate may stop the growth of tumor cells by blocking a protein needed for cell growth and may block the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as paclitaxel, 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. Giving lenvatinib mesylate and paclitaxel together may work better in treating patients with endometrial, ovarian, fallopian tube, or primary peritoneal cancer.

Clinical Trial Conditions for lenvatinib mesylate

Condition Name

Condition Name for lenvatinib mesylate
Intervention	Trials
Kidney Cancer	1
Stage IIB Pancreatic Cancer AJCC v8	1
Stage IVC Thyroid Gland Papillary Carcinoma AJCC v7	1
Pathologic Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8	1

Condition MeSH

Condition MeSH for lenvatinib mesylate
Intervention	Trials
Carcinoma	5
Thyroid Diseases	3
Thyroid Neoplasms	3
Adenocarcinoma	2

Clinical Trial Locations for lenvatinib mesylate

Trials by Country

Trials by Country for lenvatinib mesylate
Location	Trials
China	19
United States	18
Japan	6
France	2
Korea, Republic of	2

Trials by US State

Trials by US State for lenvatinib mesylate
Location	Trials
California	4
Ohio	2
Texas	2
New York	2
Michigan	2

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

Clinical Trial Status

Clinical Trial Status for lenvatinib mesylate
Clinical Trial Phase	Trials
Recruiting	5
Active, not recruiting	3
Completed	3

Clinical Trial Sponsors for lenvatinib mesylate

Sponsor Name

Sponsor Name for lenvatinib mesylate
Sponsor	Trials
National Cancer Institute (NCI)	4
Eisai Co., Ltd.	2
Eisai Inc.	2

Sponsor Type

Sponsor Type for lenvatinib mesylate
Sponsor	Trials
Other	12
Industry	6
NIH	4

Lenvatinib Mesylate: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

Introduction

Lenvatinib Mesylate, commercially known as Lenvima, is an oral multi-kinase inhibitor developed by Eisai Co., Ltd. Approved by the FDA in 2015, it primarily targets thyroid cancers but has expanded into other oncologic indications. As the oncology drug landscape evolves rapidly, understanding Lenvatinib’s clinical development trajectory, market dynamics, and future growth potential is crucial for stakeholders.

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Clinical Trials Update

Approved Indications and Ongoing Studies

Lenvatinib received accelerated approval for differentiated thyroid carcinoma (DTC) resistant to radioactive iodine, and later received full approvals for hepatocellular carcinoma (HCC), renal cell carcinoma (RCC), and endometrial carcinoma [1]. Its mechanism involves inhibiting multiple receptor tyrosine kinases involved in tumor angiogenesis and proliferation, including VEGFR1-3, FGFR1-4, PDGFRα, RET, and KIT.

Ongoing clinical trials focus on expanding indications and optimizing combination therapies:

• Thyroid Cancer: Phase III trials confirm Lenvatinib's efficacy in radioiodine-refractory differentiated thyroid cancer (RR-DTC), showing significant progression-free survival (PFS) benefits [2]. Further studies are exploring its role in medullary thyroid cancer (MTC).

• Lenvatinib in Hepatocellular Carcinoma (HCC): The REFLECT trial, a pivotal phase III study, demonstrated non-inferiority to sorafenib, leading to its approval. Additional trials assess efficacy in earlier disease stages and in combination with immunotherapies.

• Renal Cell Carcinoma (RCC): Lenvatinib combined with pembrolizumab (Keytruda) received FDA approval for advanced RCC after demonstrating improved overall survival (OS) and PFS over standard treatments in phase III studies [3].

• Endometrial Carcinoma: The phase III Study 309/KEYNOTE-775 assessed Lenvatinib plus pembrolizumab in advanced endometrial carcinoma, showing notable improvements in PFS and OS compared to chemotherapy.

Emerging Trials and Future Potential

Research explores Lenvatinib's potential in:

• Combination with Immunotherapy: Multiple phase I/II trials combine Lenvatinib with immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab) across different cancers, aiming to leverage anti-angiogenic effects to enhance immune response [4].

• Other Tumors: Studies investigate its efficacy in gastric, pancreatic, and lung cancers, reflecting its broad kinase inhibition profile.

• Biomarker-driven Strategies: Efforts focus on identifying predictive biomarkers for response, aligning with personalized medicine trends.

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Market Analysis

Current Market Position

Lenvatinib’s global sales reached approximately $1.55 billion in 2022, asserting its position as an important multi-indication oncology therapy [5]. Its primary markets include the U.S., Europe, Japan, and emerging economies.

Key Drivers

• Multiple Approved Indications: Expanding indications in thyroid, liver, kidney, and endometrial cancers bolster revenue streams.
• Combination Therapies: The approval of Lenvatinib with pembrolizumab for RCC and endometrial carcinoma significantly enhances market potential by positioning it as part of combination regimens.
• Unmet Medical Needs: Lenvatinib addresses niche patient populations with resistant or advanced cancers, where treatment options are limited.

Competitive Landscape

Lenvatinib competes with other multikinase inhibitors such as sorafenib, sunitinib, axitinib, and newer agents like cabozantinib. Its differentiator lies in its broader kinase inhibition and proven efficacy in combination therapies, especially its synergy with immunotherapies.

Market Challenges

• Adverse Events: Common side effects, including hypertension, fatigue, diarrhea, and hepatotoxicity, may limit tolerability.
• Pricing and Reimbursement: Cost remains a hurdle in some markets, affecting adoption, particularly in low- and middle-income countries.
• Patent Expirations and Biosimilar Entry: Although biosimilars are less relevant for small molecules like Lenvatinib, patent cliffs for combination drugs could influence competitive dynamics.

Market Outlook and Projections

The global Lenvatinib market is expected to grow at a compound annual growth rate (CAGR) of around 6% through 2028, driven by approved indications’ expansion and pipeline developments. The incorporation into first-line therapy for RCC and potential future approvals in additional tumor types could catalyze growth beyond current estimates.

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Future Projections

Market Growth Drivers

• Pipeline Expansion: Anticipated FDA approvals in additional indications will diversify revenue streams.
• Combination Strategies: Synergistic regimens with PD-1/PD-L1 inhibitors anticipate higher adoption rates.
• Global Access Initiatives: Strategic partnerships and price negotiations aim to improve access in emerging markets.
• Personalized Medicine: Development of biomarker-driven treatment algorithms will optimize patient selection, improving outcomes and market penetration.

Potential Risks

• Regulatory Delays: Delays in ongoing trials could postpone new approvals.
• Competitive Innovations: Emergence of novel agents or next-generation kinase inhibitors may diminish Lenvatinib’s market share.
• Safety Profiles: Managing adverse events in broader populations remains a concern impacting prescribing patterns.

Long-term Outlook

By 2030, Lenvatinib’s annual sales are projected to surpass $2.5 billion, driven by expanded indications, combination treatments, and global access. Increased adoption worldwide will hinge on regulatory approvals in additional tumor types and effective management of side effects.

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Key Takeaways

• Robust Clinical Evidence: Lenvatinib’s proven efficacy in thyroid, liver, renal, and endometrial cancers sustains its pivotal role in oncology therapy.
• Pipeline and Combinations: Active trials with immunotherapies and biomarker-guided strategies will shape future expansion.
• Market Expansion: Its diversified indications and collaboration strategies position Lenvatinib for sustained growth, despite competition and safety considerations.
• Regulatory and Access Challenges: Navigating global regulatory landscapes and reimbursement policies remains essential for maximizing market penetration.
• Strategic Positioning: Lenvatinib’s broad kinase inhibition and combination potential make it a valuable asset in personalized cancer treatment landscapes.

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FAQs

1. What are the primary therapeutic indications for Lenvatinib Mesylate?
Lenvatinib is primarily approved for differentiated thyroid carcinoma resistant to radioactive iodine, unresectable hepatocellular carcinoma, advanced renal cell carcinoma, and advanced endometrial carcinoma, especially in combination with pembrolizumab.

2. How does Lenvatinib compare to other tyrosine kinase inhibitors in oncology?
Lenvatinib offers a broader kinase inhibition profile, targeting VEGFR1-3, FGFR1-4, and other pathways, which may translate into improved efficacy in some indications and synergy with immunotherapies, differentiating it from more selective agents.

3. What are the ongoing clinical trials that could redefine Lenvatinib’s market presence?
Key trials include combination studies with PD-1/PD-L1 inhibitors across various tumor types, and investigations into earlier lines of therapy and new indications like gastric and lung cancers.

4. What challenges could impede Lenvatinib’s future market growth?
Potential obstacles include emerging competitors, adverse event management, reimbursement hurdles, and delays in pivotal trial results.

5. What is the long-term outlook for Lenvatinib in cancer therapy?
With ongoing trials and expanding indications, Lenvatinib’s sales are expected to grow, potentially surpassing $2.5 billion annually by 2030, especially with successful integration into combination regimens and stringent patient selection.

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References

[1] US Food and Drug Administration. Lenvima Prescribing Information. 2015.

[2] Schlumberger M, et al. Lenvatinib vs. placebo in radioiodine-refractory differentiated thyroid cancer: a randomized clinical trial. Lancet. 2015.

[3] Motzer RJ, et al. Lenvatinib plus pembrolizumab in renal cell carcinoma. N Engl J Med. 2021.

[4] Hodi FS, et al. Lenvatinib combined with pembrolizumab in advanced solid tumors: phase I trial. J Clin Oncol. 2022.

[5] IQVIA. Pharmaceutical Market Data, 2022.