MedPath

Lenvatinib

Generic Name
Lenvatinib
Brand Names
Lenvima 10, Kisplyx, Lenvima
Drug Type
Small Molecule
Chemical Formula
C21H19ClN4O4
CAS Number
417716-92-8
Unique Ingredient Identifier
EE083865G2

Overview

Lenvatinib is a receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). Lenvatinib also inhibits other RTKs that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4; the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. These receptor tyrosine kinases (RTKs) located in the cell membrane play a central role in the activation of signal transduction pathways involved in the normal regulation of cellular processes, such as cell proliferation, migration, apoptosis and differentiation, and in pathogenic angiogenesis, lymphogenesis, tumour growth and cancer progression. In particular, VEGF has been identified as a crucial regulator of both physiologic and pathologic angiogenesis and increased expression of VEGF is associated with a poor prognosis in many types of cancers. Lenvatinib is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine (RAI)-refractory differentiated thyroid cancer. Most patients with thyroid cancer have a very good prognosis with treatment (98% 5 year survival rate) involving surgery and hormone therapy. However, for patients with RAI-refractory thyroid cancer, treatment options are limited and the prognosis is poor, leading to a push for the development of more targeted therapies such as lenvatinib.

Indication

Lenvatinib is indicated for the treatment of the following cancerous conditions: Differentiated Thyroid Cancer (DTC) Renal Cell Carcinoma (RCC) Hepatocellular Carcinoma (HCC) Endometrial Carcinoma

Associated Conditions

  • Advanced Renal Cell Carcinoma
  • Endometrial Carcinoma
  • Unresectable Hepatocellular Carcinoma (HCC)
  • Progressive, locally advanced radioactive iodine-refractory Differentiated Thyroid Cancer (DTC)
  • Progressive, metastatic radioactive iodine-refractory Differentiated Thyroid Cancer (DTC)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/08/20
Not Applicable
Not yet recruiting
2025/07/31
Not Applicable
Not yet recruiting
2025/07/30
Not Applicable
Not yet recruiting
2025/07/22
Not Applicable
Not yet recruiting
Wan-Guang Zhang
2025/07/17
Not Applicable
Recruiting
2025/07/02
Not Applicable
Recruiting
2025/06/10
Phase 2
Not yet recruiting
2025/06/10
Phase 2
Withdrawn
2025/06/08
Phase 4
Not yet recruiting
Fujian Medical University
2025/05/23
Phase 2
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Eisai Inc.
62856-704
ORAL
4 mg in 1 1
10/26/2023
Eisai Inc.
62856-720
ORAL
10 mg in 1 1
10/26/2023
Eisai Inc.
62856-712
ORAL
4 mg in 1 1
10/26/2023
Eisai Inc.
62856-710
ORAL
10 mg in 1 1
10/26/2023
Eisai Inc.
62856-708
ORAL
4 mg in 1 1
10/26/2023

EMA Drug Approvals

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
LENVIMA lenvatinib 4mg hard capsule blister pack
233425
Medicine
A
1/28/2016
LENVIMA lenvatinib 10mg hard capsule blister pack
233426
Medicine
A
1/28/2016

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
LENVIMA 4 MG CAPSULAS DURAS
1151002001
CÁPSULA DURA
Diagnóstico Hospitalario
Commercialized
LENVIMA 10 MG CAPSULAS DURAS
1151002002
CÁPSULA DURA
Diagnóstico Hospitalario
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.