Drug

Lenvatinib

Established medicine

ResearchActive indication expansion

Also known as Lenvima, Lenvima 20 mg daily-dose, Lenvima 8 mg daily-dose.

RxNorm1603296 ChEMBLCHEMBL1289601 ATCL01EX08UNIIEE083865G2

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Multicenter Phase 2 Trial of Lenvatinib in Patients With Unresectable or Metastatic Hepatocellular Carcinoma After Progression on First-line Atezolizumab Plus Bevacizumab

Clinical trial2026-11-01Primary completion · ClinicalTrials.gov

Lenvatinib Plus Iodine-125 Seed Brachytherapy Compared With Lenvatinib Alone for TACE-refractory Hepatocellular Carcinoma: a Single Center, Prospective, Randomized Control Trail

Clinical trial2026-10-31Primary completion · ClinicalTrials.gov

A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants Who Are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab

Clinical trial2026-10-29Results expected Q3 2043 · ClinicalTrials.gov

Pembrolizumab, Lenvatinib and IL-15 Superagonist N-803 in Combination With HER2 Targeting Autologous Dendritic Cell (AdHER2DC) Vaccine in Participants With Advanced or Metastatic Endometrial Cancer

Clinical trial2026-10-16Results expected Q4 2026 · ClinicalTrials.gov

Belzutifan Plus Lenvatinib Approved for Advanced ccRCC

Regulatory2026-09-28Regulatory news · Medscape Medical News

FDA approves belzutifan in combination with lenvatinib for advanced renal cell carcinoma with a clear cell component

Regulatory2026-09-24Regulatory news · FDA Drug Approvals

Indication expansion: LENVATINIB (NDA206947)

Regulatory2026-09-24FDA

[Articles] Durvalumab and tremelimumab, with or without lenvatinib, combined with transarterial chemoembolisation in participants with embolisation-eligible hepatocellular carcinoma (EMERALD-3): a global, randomised, open-label, sponsor-blinded, phase 3 study

Regulatory2026-09-01Regulatory news · The Lancet Oncology

Indication expansion: LENVATINIB (NDA206947)

Regulatory2025-01-29FDA

Label change: LENVATINIB (NDA206947)

Regulatory2024-11-20FDA

Indication expansion: LENVATINIB (NDA206947)

Regulatory2024-06-07FDA

Lenvatinib Plus Pembrolizumab Versus Standard of Care for Previously Treated Metastatic Colorectal Cancer: Final Analysis of the Randomized, Open-Label, Phase III LEAP-017 Study.

Research2024-06-04Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Lenvatinib

Aliases & brands

LenvimaLenvima 20 mg daily-doseLenvima 8 mg daily-dose

RxNorm CUI

1603296

ChEMBL ID

CHEMBL1289601

ATC codes

L01EX08

UNII

EE083865G2

Regulatory jurisdictions

fda

Regulatory timeline

25 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2015-02-13

Latest approval

2026-09-24

Authorities

FDA

Total events

fdaU.S. Food and Drug Administration· 25 events

2026-09-24Indication expansion

Indication expansion: LENVATINIB (NDA206947)

Evidence ↗

2025-01-29Indication expansion

Indication expansion: LENVATINIB (NDA206947)

Evidence ↗

2024-11-20Label change

Label change: LENVATINIB (NDA206947)

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

197 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

197

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 197

Early Phase 14Phase 124Phase 1 / 223Phase 2102Phase 2 / 35Phase 326Phase 41Phase N / A12

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Prospective Single Arm Post Marketing Phase IV Study to Assess the Safety and Efficacy of Lenvatinib in Subjects With Locally Recurrent or Metastatic, Progressive, Radioiodine Refractory Differentiated Thyroid Cancer

CompletedPH IVEisai Pharmaceuticals India Pvt. Ltdn=502025

A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants Who Are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab

RecruitingPH IIIKey trialMerck Sharp & Dohme LLCn=3,5002043

Phase III Double Blinded Trial of Immune-Based Therapy With a Live Biotherapeutic MO-03 or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma [BioFront Trial]

RecruitingPH IIISWOG Cancer Research Networkn=7182034

Tislelizumab Plus Lenvatinib as Neoadjuvant Therapy for Patients With Resectable HCC at High Risk of Recurrence: a Prospective, Multicenter, Randomized Controlled Phase III Study

Not yet recruitingPH IIITianjin Medical University Cancer Institute and Hospitaln=1982030

A Multicenter, Randomized, Open-Label Phase II/III Clinical Study on the Efficacy and Safety of LB1410 Plus Lenvatinib With or Without LB4330 Versus Investigator's Choice of Chemotherapy in Advanced Recurrent/Metastatic Cervical Cancer

Not yet recruitingPH II/IIIL & L Bio Co., Ltd., Ningbo, Chinan=1202028

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Pilot Study to Assess Changes in Tumor Biology Following Second-line Treatment With Pembrolizumab Plus Lenvatinib in Patients With Advanced Pancreatic Ductal Adenocarcinoma

CompletedPH IM.D. Anderson Cancer Centern=152026

A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (U03): Substudy 03A in First Line Metastatic Participants

CompletedPH I/IIMerck Sharp & Dohme LLCn=3932026

A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (KEYMAKER-U03): Substudy 03B in Second-Line Metastatic Participants

CompletedPH I/IIMerck Sharp & Dohme LLCn=2632026

A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination With Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants With Advanced Hepatocellular Carcinoma

CompletedPH IIIBristol-Myers Squibbn=7322026

A Pilot, Rapid Sequencing of First Line Cabozantinib, Ipilimumab and Nivolumab, and Lenvatinib and Everolimus in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma

CompletedPH IIcahn School of Medicine at Mount Sinain=102026

A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Chemotherapy Compared With Standard of Care as First-line Intervention in Participants With Metastatic Esophageal Carcinoma.

CompletedPH IIIMerck Sharp & Dohme LLCn=8632026

Research activity

6 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

2019–2024

Most influential

Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer.

The New England journal of medicine · 2022 · 708 cites

Lenvatinib plus anti-PD-1 antibody combination treatment activates CD8+ T cells through reduction of tumor-associated macrophage and activation of the interferon pathway.

PloS one · 2019 · 383 cites

Molecular targeted and immune checkpoint therapy for advanced hepatocellular carcinoma.

Journal of experimental & clinical cancer research : CR · 2019 · 162 cites

Phase 2 study of lenvatinib monotherapy as second-line treatment in unresectable biliary tract cancer: primary analysis results.

BMC cancer · 2020 · 76 cites

Lenvatinib Plus Pembrolizumab Versus Standard of Care for Previously Treated Metastatic Colorectal Cancer: Final Analysis of the Randomized, Open-Label, Phase III LEAP-017 Study.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024 · 69 cites

The more the merrier? Evidence and efficacy of immune checkpoint- and tyrosine kinase inhibitor combinations in advanced solid cancers.

Cancer treatment reviews · 2024 · 17 cites

Related diseases

2 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas

Liver Neoplasms3 Carcinoma, Hepatocellular2

Related drugs

6 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Pembrolizumab

Studied across 6 of the same disease areas as Lenvatinib in the shared literature.

6 shared diseases2 shared papers

Regorafenib

Studied across 3 of the same disease areas as Lenvatinib in the shared literature.

3 shared diseases2 shared papers

Axitinib

Studied across 4 of the same disease areas as Lenvatinib in the shared literature.

4 shared diseases1 shared paper

Cabozantinib

Studied across 4 of the same disease areas as Lenvatinib in the shared literature.

4 shared diseases1 shared paper

Sorafenib

Studied across 3 of the same disease areas as Lenvatinib in the shared literature.

3 shared diseases1 shared paper

Ramucirumab

Studied across 2 of the same disease areas as Lenvatinib in the shared literature.

2 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.