Drugs / Lenvatinib
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Lenvatinib

Small molecule targets FGFR1, FLT1, FLT4, KDR, KIT, PDGFRA, RET via inhibition

Developed for
hepatocellular carcinoma · biliary tract cancer · intrahepatic cholangiocarcinoma · renal cell carcinoma · cancer · non-small cell lung carcinoma · clear cell renal carcinoma · gastric cancer
+124 more · melanoma · endometrial cancer · thyroid cancer · cholangiocarcinoma · esophageal squamous cell carcinoma · portal vein thrombosis · differentiated thyroid carcinoma · liver cancer · refractory malignant neoplasm · thyroid gland undifferentiated (anaplastic) carcinoma · breast cancer · head and neck squamous cell carcinoma · neoplasm · small cell lung carcinoma · colorectal cancer · endometrial carcinoma · mucosal melanoma · poorly differentiated thyroid gland carcinoma · adenocarcinoma · adenoid cystic carcinoma · biliary tract neoplasm · cervical cancer · gastroesophageal adenocarcinoma · gastroesophageal junction adenocarcinoma · lymphoma · metastatic malignant neoplasm in the brain · neuroendocrine neoplasm · ovarian cancer · renal cell adenocarcinoma · triple-negative breast carcinoma · bone cancer · cancer of unknown primary site · castration-resistant prostate carcinoma · childhood malignant neoplasm · colorectal neoplasm · endometrium neoplasm · fallopian tube carcinoma · gallbladder cancer · gastric adenocarcinoma · gastrointestinal stromal tumor · glioblastoma · hepatoblastoma · kidney cancer · malignant epithelial tumor of ovary · malignant pancreatic neoplasm · malignant pleural mesothelioma · metastatic melanoma · neuroendocrine carcinoma · osteosarcoma · ovarian carcinoma · pancreatic ductal adenocarcinoma · primary peritoneal carcinoma · salivary gland adenoid cystic carcinoma · skin squamous cell carcinoma · squamous cell carcinoma · thymic carcinoma · thyroid gland papillary carcinoma · uveal melanoma · vulva cancer · adrenal cortex carcinoma · anal squamous cell carcinoma · breast neoplasm · carcinoid tumor · carcinoma · central nervous system cancer · central nervous system neoplasm · cervical carcinoma · classic Kaposi sarcoma · colon carcinoma · columnar cell variant thyroid gland papillary carcinoma · cutaneous melanoma · cutaneous neuroendocrine carcinoma · digestive system cancer · digestive system neoplasm · endometrium adenocarcinoma · esophageal adenocarcinoma · fallopian tube serous adenocarcinoma · female reproductive organ cancer · female reproductive system disorder · follicular variant thyroid gland papillary carcinoma · gastric carcinoma · gastroesophageal cancer · glioma · head and neck cancer · hematopoietic and lymphoid cell neoplasm · hormone receptor-positive breast cancer · leiomyosarcoma · liposarcoma · male reproductive organ cancer · malignant adrenal gland pheochromocytoma · malignant endocrine neoplasm · malignant soft tissue neoplasm · malignant tumor of meninges · malignant urinary system neoplasm · metastatic neoplasm · metastatic prostate carcinoma · ovarian clear cell adenocarcinoma · ovarian serous adenocarcinoma · pancreatic neuroendocrine tumor · parathyroid gland carcinoma · penile cancer · primary peritoneal serous adenocarcinoma · rectum adenocarcinoma · recurrent respiratory papillomatosis · respiratory system cancer · RET fusion positive cancer · salivary gland cancer · salivary gland carcinoma · sarcoma · skin angiosarcoma · soft tissue sarcoma · tall cell variant thyroid gland papillary carcinoma · thymoma type B3 · thyroid gland carcinoma · thyroid gland follicular carcinoma · thyroid gland squamous cell carcinoma · thyroid Hurthle cell carcinoma · thyroid tumor · transitional cell neoplasm · urothelial carcinoma · uterine carcinosarcoma · wet macular degeneration · breast carcinoma · non-small cell squamous lung carcinoma
Investigated by
Eisai Inc. · Merck Sharp & Dohme LLC · Sun Yat-sen University · Fudan University · Peking Union Medical College Hospital · Tianjin Medical University Cancer Institute and Hospital
+335 more · Shanghai Zhongshan Hospital · National Cancer Institute (NCI) · RenJi Hospital · Tongji Hospital · M.D. Anderson Cancer Center · Second Affiliated Hospital of Guangzhou Medical University · West China Hospital · Memorial Sloan Kettering Cancer Center · Asan Medical Center · AstraZeneca · The First Affiliated Hospital with Nanjing Medical University · Zhejiang Cancer Hospital · Akeso · Chen Xiaoping · H. Lee Moffitt Cancer Center and Research Institute · Nanfang Hospital, Southern Medical University · National University Hospital, Singapore · Shanghai Junshi Bioscience Co., Ltd. · Shi Ming · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Zhejiang University · BeiGene · Chinese PLA General Hospital · Eastern Hepatobiliary Surgery Hospital · Emory University · First Affiliated Hospital Xi'an Jiaotong University · Fujian Medical University · Guangxi Medical University · Guangzhou No.12 People's Hospital · Henan Cancer Hospital · National Cancer Center Hospital East · National Taiwan University Hospital · Ruijin Hospital · Second Affiliated Hospital, School of Medicine, Zhejiang University · Seoul National University Bundang Hospital · The First Affiliated Hospital of Zhengzhou University · The Netherlands Cancer Institute · Tianjin Medical University Second Hospital · University of Texas Southwestern Medical Center · Yonsei University · 3D Medicines (Sichuan) Co., Ltd. · Academic and Community Cancer Research United · Affiliated Hospital of Guangdong Medical University · Akeso Pharmaceuticals, Inc. · Amgen · Anhui Provincial Hospital · Assistance Publique - Hôpitaux de Paris · Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. · Bristol-Myers Squibb · Cancer Hospital of Guangxi Medical University · Centre Leon Berard · Chang Gung Memorial Hospital · Changhai Hospital · Chinese Cooperative Group of Liver Cancer · City of Hope Medical Center · Eisai Inc. · First Affiliated Hospital of Guangxi Medical University · First Affiliated Hospital, Sun Yat-Sen University · First Hospital of China Medical University · First People's Hospital of Foshan · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Fujian Cancer Hospital · Geneplus-Beijing Co. Ltd. · Guangdong Provincial People's Hospital · Gustave Roussy, Cancer Campus, Grand Paris · Harbin Medical University · Hunan Province Tumor Hospital · Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Jiangsu HengRui Medicine Co., Ltd. · Jinling Hospital, China · Kaiping Central Hospital · Liaoning Cancer Hospital & Institute · Melanoma Institute Australia · all 341 on the full record

Regulatory milestones approvals, filings & regulatory actions · 23 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed clear cell papillary renal cell carcinoma 1 milestone
Filed US (FDA) LENVIMA clear cell papillary renal cell carcinoma 2026-02-28

“the U.S. FDA has accepted for review two supplemental New Drug Applications for WELIREG plus LENVIMA in certain previously treated patients with advanced RCC” merck.com ↗

Filed endometrial carcinoma 1 milestone
Filed US (FDA) LENVIMA endometrial carcinoma 2019-06-17

“Following submission on June 17, this is an accelerated approval reviewed under the FDA’s Real-Time Oncology Review (RTOR) pilot program” merck.com ↗

Filed hepatocellular carcinoma 5 milestones
Filed Other Lenvima hepatocellular carcinoma 2017-12-06

“announced that it has submitted an application for its in-house discovered and developed anticancer agent lenvatinib mesylate (product names: Lenvima® / Kisplyx®, product name...” eisai.com ↗

“Eisai submitted applications for an additional indication for lenvatinib for the treatment of HCC in Japan (June 2017), the United States and Europe (July 2017), China (October...” eisai.com ↗

“Eisai has submitted applications for an indication covering hepatocellular carcinoma in Japan (June 2017), the United States and Europe (July 2017), China (October 2017),...” eisai.com ↗

“Eisai submitted applications for an additional indication for Lenvima for the treatment of HCC in Japan (June 2017), the United States and Europe (July 2017), and China (October 2017).” eisai.com ↗

“Eisai has submitted applications for lenvatinib for the treatment of HCC in Japan (June 2017), the United States and Europe (July 2017), China (October 2017), Taiwan (December 2017)” eisai.com ↗

“Eisai has submitted applications for an indication covering hepatocellular carcinoma in China (October 2017), Taiwan (December 2017), and other countries.” eisai.com ↗

“Eisai has submitted applications for an indication covering hepatocellular carcinoma in China (October 2017), Taiwan (December 2017) and other countries.” eisai.com ↗

“An application seeking approval of LENVIMA for use in the treatment of unresectable HCC was submitted in South Korea in March 2018.” eisai.com ↗

“Eisai has submitted applications for an indication covering hepatocellular carcinoma in Taiwan (December 2017)” eisai.com ↗

Filed China (NMPA) Lenvima hepatocellular carcinoma —

“the China Food and Drug Administration (CFDA) has accepted for review a New Drug Application (NDA) submitted for Eisai's in-house discovered and developed anticancer agent...” eisai.com ↗

“Eisai submitted applications for an additional indication for lenvatinib for the treatment of HCC in Japan (June 2017), the United States and Europe (July 2017), China (October 2017)” eisai.com ↗

“Eisai has submitted applications for an indication covering hepatocellular carcinoma in Japan (June 2017), the United States and Europe (July 2017), China (October 2017)” eisai.com ↗

“Eisai has submitted applications for lenvatinib for the treatment of HCC in Japan (June 2017), the United States and Europe (July 2017), China (October 2017)” eisai.com ↗

“Eisai has submitted applications for an indication covering hepatocellular carcinoma in China (October 2017), Taiwan (December 2017), and other countries.” eisai.com ↗

“Eisai has submitted applications for an indication covering hepatocellular carcinoma in China (October 2017)” eisai.com ↗

“In China, the application of LENVIMA was submitted in October 2017” eisai.com ↗

Filed US (FDA) Lenvima hepatocellular carcinoma —

“the application submitted for an additional indication of its in-house discovered and developed anticancer agent Lenvima® (generic name: lenvatinib mesylate) for the treatment...” eisai.com ↗

“Eisai submitted applications for an additional indication for lenvatinib for the treatment of HCC in Japan (June 2017), the United States and Europe (July 2017).” eisai.com ↗

“Eisai submitted applications for an additional indication for lenvatinib for the treatment of HCC in Japan (June 2017), the United States” eisai.com ↗

“Eisai has submitted applications for an indication covering hepatocellular carcinoma in Japan (June 2017), the United States” eisai.com ↗

“Eisai has submitted applications for lenvatinib for the treatment of HCC in Japan (June 2017), the United States” eisai.com ↗

Filed Japan (PMDA) Lenvima hepatocellular carcinoma —

“Eisai submitted applications for an additional indication for lenvatinib for the treatment of HCC in Japan (June 2017)” eisai.com ↗

“Eisai submitted applications for an additional indication for lenvatinib for the treatment of HCC in Japan (June 2017)” eisai.com ↗

“Eisai has submitted applications for an indication covering hepatocellular carcinoma in Japan (June 2017)” eisai.com ↗

“Eisai has submitted applications for lenvatinib for the treatment of HCC in Japan (June 2017)” eisai.com ↗

Filed EU (EMA) Lenvima hepatocellular carcinoma —

“Eisai submitted applications for an additional indication for lenvatinib for the treatment of HCC in Japan (June 2017), the United States and Europe (July 2017).” eisai.com ↗

“Eisai submitted applications for an additional indication for lenvatinib for the treatment of HCC in Japan (June 2017), the United States and Europe (July 2017)” eisai.com ↗

“Eisai has submitted applications for an indication covering hepatocellular carcinoma in Japan (June 2017), the United States and Europe (July 2017)” eisai.com ↗

“Eisai has submitted applications for lenvatinib for the treatment of HCC in Japan (June 2017), the United States and Europe (July 2017)” eisai.com ↗

“Eisai has submitted applications for an indication covering hepatocellular carcinoma in Europe (July 2017)” eisai.com ↗

Filed renal cell adenocarcinoma 3 milestones
Filed Japan (PMDA) LENVIMA renal cell adenocarcinoma 2026-03-27

“an application for LENVIMA ® (lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, has been submitted in Japan” eisai.com ↗

Filed EU (EMA) — renal cell adenocarcinoma 2016-01-12

“has submitted a new application to the European Medicines Agency (EMA) for its in-house developed novel anticancer agent lenvatinib mesylate” eisai.com ↗

Filed US (FDA) LENVIMA renal cell adenocarcinoma —

“FDA accepted supplemental applications for WELIREG plus Lenvima in certain previously treated patients with advanced RCC, based on the Phase 3 LITESPARK-011 trial” merck.com ↗

“FDA has accepted two supplemental New Drug Applications (sNDA) for review based on Phase 3 LITESPARK-011 trial evaluating WELIREG in combination with LENVIMA” eisai.com ↗

Filed thymic mucoepidermoid carcinoma 1 milestone
Filed Japan (PMDA) LENVIMA thymic mucoepidermoid carcinoma 2020-07-30

“Eisai has submitted an application in Japan for the additional indication of treatment of unresectable thymic carcinoma for multiple receptor tyrosine kinase inhibitor LENVIMA” eisai.com ↗

Filed thyroid cancer, nonmedullary, 1 1 milestone
Filed Japan (PMDA) — thyroid cancer, nonmedullary, 1 2014-06-26

“has submitted its first marketing authorization application for its novel in-house developed anticancer agent lenvatinib mesylate (“lenvatinib”) for the treatment of thyroid...” eisai.com ↗

“An application seeking marketing approval of lenvatinib for the indication of thyroid cancer was submitted in Japan on June 26, 2014.” eisai.com ↗

“the first application for marketing authorization of lenvatinib in the world was submitted in Japan in June 2014.” eisai.com ↗

Trials 508 · started per year

today
US approved 2015
EU approved 2015
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200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 09 trials
Phase 0 NCT07356466 May 2025 → Apr 2027 expected gastric cancer Fujian Medical University Enrolling by invitation No outcome recorded
Phase 0 NCT05553782 Nov 2023 → Apr 2029 expected head and neck squamous cell carcinoma, salivary gland adenoid cystic carcinoma Brigham and Women's Hospital Recruiting No outcome recorded
Phase 0 NCT05733715 May 2023 → Jun 2026 overdue renal cell carcinoma Abramson Cancer Center at Penn Medicine Recruiting No outcome recorded
Phase 0 NCT06321120 Mar 2023 → Apr 2024 — Hadassah Medical Organization Unknown No outcome recorded
Phase 0 NCT05188118 Feb 2023 → Feb 2025 renal cell carcinoma Icahn School of Medicine at Mount Sinai Completed No outcome recorded
Phase 0 NCT05411757 Jun 2022 → Jun 2023 liver cancer Shandong Public Health Clinical Center Unknown No outcome recorded
Phase 0 NCT05041153 Feb 2022 → Dec 2026 expected gastric adenocarcinoma, gastroesophageal junction adenocarcinoma M.D. Anderson Cancer Center Active not recruiting No outcome recorded
Phase 0 NCT05131698 Mar 2021 → Dec 2023 hepatocellular carcinoma Cancer Hospital of Guangxi Medical University Unknown No outcome recorded
Phase 0 NCT04974281 Jan 2021 → Dec 2022 hepatocellular carcinoma Fudan University Unknown No outcome recorded
Phase 145 trials
Phase 1 NCT06161558 Jul 2025 neoplasm National Cancer Institute (NCI) Withdrawn No outcome recorded Stop: Enrollment
Phase 1 NCT06462183 Aug 2024 → Dec 2027 expected adenoid cystic carcinoma, colorectal cancer Rgenta Therapeutics Inc Active not recruiting No outcome recorded
Phase 1 NCT06470256 Jun 2024 → Jun 2027 expected hepatocellular carcinoma Zhiyong Huang Recruiting No outcome recorded
Phase 1 NCT06463444 Jun 2024 → Jun 2025 hepatocellular carcinoma Chen Xiaoping Unknown No outcome recorded
Phase 1 NCT05803928 Jan → Nov 2024 overdue hepatocellular carcinoma Hua Li Recruiting No outcome recorded
Phase 1 NCT05767684 Jun 2023 → Mar 2025 refractory malignant neoplasm National Health Research Institutes, Taiwan Unknown No outcome recorded
Phase 1 NCT05603910 Apr 2023 → Apr 2027 expected endometrial carcinoma Aaron Wolfson Recruiting No outcome recorded
Phase 1 NCT05675462 Mar 2023 → Dec 2025 hepatocellular carcinoma Fudan University Unknown No outcome recorded
Phase 1 NCT05225116 Jan 2023 → Dec 2025 hepatocellular carcinoma Beijing Tsinghua Chang Gung Hospital Unknown No outcome recorded
Phase 1 NCT05533892 Sep 2022 → Aug 2024 hepatocellular carcinoma Wan-Guang Zhang Unknown No outcome recorded
Phase 1/250 trials · 1 met primary · 1 missed
Phase 1/2 NCT07540832 Sep 2026 → Sep 2028 expected hepatocellular carcinoma Zhejiang Haichang Biotech Co., Ltd. Not yet recruiting No outcome recorded
Phase 1/2 NCT07683949 Jun 2026 → Oct 2029 expected colorectal cancer Seoul National University Bundang Hospital Enrolling by invitation No outcome recorded
Phase 1/2 NCT07636798 Jun 2026 → Mar 2029 expected biliary tract cancer West China Hospital Recruiting No outcome recorded
Phase 1/2 NCT07482059 Feb → Jun 2026 overdue hepatocellular carcinoma West China Hospital Recruiting No outcome recorded
Phase 1/2 NCT07149090 Nov 2025 → Jul 2027 expected gastric adenocarcinoma Asan Medical Center Recruiting No outcome recorded
Phase 1/2 NCT07096609 Oct 2025 → Dec 2027 expected gastrointestinal stromal tumor Asan Medical Center Recruiting No outcome recorded
Phase 1/2 NCT07282184 Oct 2025 → Jun 2027 expected hepatocellular carcinoma Tongji Hospital Recruiting No outcome recorded
Phase 1/2 NCT06682780 Sep 2025 → Dec 2028 expected neoplasm LaNova Medicines Limited Recruiting No outcome recorded
Phase 1/2 NCT06409637 Jan 2025 → Dec 2027 expected hepatocellular carcinoma Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Not yet recruiting No outcome recorded
Phase 1/2 NCT06746961 Jan 2025 → Jul 2026 overdue esophageal squamous cell carcinoma The First Affiliated Hospital of Zhengzhou University Not yet recruiting No outcome recorded
Phase 2301 trials · 8 met primary · 4 missed
Phase 2 NCT07256223 Dec 2026 → Nov 2027 expected clear cell renal carcinoma Fudan University Not yet recruiting No outcome recorded
Phase 2 NCT07843901 Nov 2026 → Aug 2028 expected parathyroid gland carcinoma Yonsei University Not yet recruiting No outcome recorded
Phase 2 NCT07847359 Oct 2026 → Dec 2028 expected cutaneous melanoma Sun Yat-sen University Recruiting No outcome recorded
Phase 2 NCT07776080 Oct 2026 → Oct 2027 expected hepatocellular carcinoma Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting No outcome recorded
Phase 2 NCT07827807 Sep 2026 → May 2029 expected hepatocellular carcinoma Chang Gung Memorial Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07680088 Sep 2026 → Sep 2028 expected anal squamous cell carcinoma University of Texas Southwestern Medical Center Not yet recruiting No outcome recorded
Phase 2 NCT07829874 Sep 2026 → Sep 2028 expected biliary tract cancer Fudan University Not yet recruiting No outcome recorded
Phase 2 NCT07801287 Sep 2026 → Aug 2028 expected hepatocellular carcinoma Tianjin Medical University Cancer Institute and Hospital Recruiting No outcome recorded
Phase 2 NCT07594015 Aug 2026 → Aug 2031 expected endometrial cancer University of Miami Recruiting No outcome recorded
Phase 2 NCT07686926 Aug 2026 → Jul 2028 expected esophageal squamous cell carcinoma Tianjin Medical University Cancer Institute and Hospital Not yet recruiting No outcome recorded
Show all 301 trials opens the full record — a long page
Phase 2/39 trials · 1 met primary
Phase 2/3 NCT07177716 Oct 2025 → Dec 2028 expected cervical cancer L & L Bio Co., Ltd., Ningbo, China Not yet recruiting No outcome recorded
Phase 2/3 NCT05250843 May 2022 → Dec 2023 hepatocellular carcinoma Third Affiliated Hospital, Sun Yat-Sen University Unknown No outcome recorded
Phase 2/3 NCT05322187 Apr 2022 → Sep 2023 childhood malignant neoplasm, hepatoblastoma, transitional cell neoplasm RenJi Hospital Unknown No outcome recorded
Phase 2/3 NCT05001724 Oct 2021 → Feb 2023 non-small cell lung carcinoma Jiangsu Alphamab Biopharmaceuticals Co., Ltd Terminated No outcome recorded
Phase 2/3 NCT04669496 Jan 2021 → Apr 2025 overdue intrahepatic cholangiocarcinoma Shanghai Zhongshan Hospital Active not recruiting Met primary
Phase 2/3 NCT04909866 Jan 2021 → Sep 2022 hepatocellular carcinoma Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Unknown No outcome recorded
Phase 2/3 NCT04319484 May 2020 → Jan 2025 hepatocellular carcinoma, portal vein thrombosis RenJi Hospital Unknown No outcome recorded
Phase 2/3 NCT04168944 Nov 2019 → Sep 2022 hepatocellular carcinoma RenJi Hospital Unknown No outcome recorded
Phase 2/3 NCT04044651 Oct 2019 → Mar 2021 hepatocellular carcinoma Shi Ming Withdrawn No outcome recorded
Phase 352 trials · 6 met primary · 11 missed
Phase 3 NCT07809256 Sep 2026 → Aug 2028 expected non-small cell lung carcinoma EuroCityClinic LLC Recruiting No outcome recorded
Phase 3 NCT07691515 Jul 2026 → Jan 2030 expected intrahepatic cholangiocarcinoma Zhejiang Cancer Hospital Not yet recruiting No outcome recorded
Phase 3 NCT07537946 May 2026 → May 2031 expected hepatocellular carcinoma, metastatic neoplasm Tongji Hospital Not yet recruiting No outcome recorded
Phase 3 NCT07475026 May 2026 → Jan 2030 expected hepatocellular carcinoma Tianjin Medical University Cancer Institute and Hospital Not yet recruiting No outcome recorded
Phase 3 NCT06841172 Jul 2025 → Jul 2027 expected hepatocellular carcinoma Shandong Cancer Hospital and Institute Recruiting No outcome recorded
Phase 3 NCT06371157 Aug 2024 → Oct 2025 overdue hepatocellular carcinoma Akeso Recruiting No outcome recorded
Phase 3 NCT06492395 Aug 2024 → Jul 2026 overdue hepatocellular carcinoma Second Affiliated Hospital of Guangzhou Medical University Recruiting No outcome recorded
Phase 3 NCT06364631 Apr 2024 → May 2032 expected clear cell renal carcinoma Gustave Roussy, Cancer Campus, Grand Paris Recruiting No outcome recorded
Phase 3 NCT05910970 Feb 2024 → Dec 2025 hepatocellular carcinoma Guangxi Medical University Unknown No outcome recorded
Phase 3 NCT06089382 Nov 2023 → Nov 2024 overdue hepatocellular carcinoma Tongji Hospital Not yet recruiting No outcome recorded
Phase 411 trials
Phase 4 NCT07160361 Oct 2025 → Dec 2028 expected hepatocellular carcinoma Second Affiliated Hospital of Xi'an Jiaotong University Not yet recruiting No outcome recorded
Phase 4 NCT07010393 Jul 2025 → Dec 2027 expected thyroid tumor Fujian Medical University Not yet recruiting No outcome recorded
Phase 4 NCT06499610 Jul 2024 → Oct 2027 expected gastric cancer First Affiliated Hospital Xi'an Jiaotong University Not yet recruiting No outcome recorded
Phase 4 NCT06417606 May 2024 → Apr 2025 intrahepatic cholangiocarcinoma Zhiyong Huang Unknown No outcome recorded
Phase 4 NCT06311916 May 2024 → Dec 2027 expected hepatocellular carcinoma Chen Xiaoping Not yet recruiting No outcome recorded
Phase 4 NCT06311929 Apr 2024 → Dec 2027 expected hepatocellular carcinoma Chen Xiaoping Recruiting No outcome recorded
Phase 4 NCT06003673 Jul 2023 → Jul 2024 hepatocellular carcinoma First Affiliated Hospital of Fujian Medical University Unknown No outcome recorded
Phase 4 NCT04297254 Feb 2021 → Jul 2023 hepatocellular carcinoma Eisai Inc. Completed No outcome recorded
Phase 4 NCT06195228 Jan 2020 → Dec 2026 expected — Fudan University Recruiting No outcome recorded
Phase 4 NCT04127396 Sep 2019 → Aug 2021 hepatocellular carcinoma, portal vein thrombosis Beijing Ditan Hospital Unknown No outcome recorded
Phase not applicable29 trials
— NCT07535840 May → Dec 2026 expected hepatocellular carcinoma Tongji Hospital Not yet recruiting No outcome recorded
— NCT07480382 Apr 2026 → Dec 2027 expected hepatocellular carcinoma Hong Wu Not yet recruiting No outcome recorded
— NCT07077798 Aug 2025 → Aug 2026 overdue hepatocellular carcinoma Wan-Guang Zhang Not yet recruiting No outcome recorded
— NCT07188311 Apr 2025 → Apr 2027 expected childhood malignant neoplasm, hepatoblastoma Sun Yat-sen University Recruiting No outcome recorded
— NCT07408804 Apr 2025 → Sep 2026 overdue hepatocellular carcinoma Bangladesh Medical University Recruiting No outcome recorded
— NCT06740370 Dec 2024 → Dec 2025 overdue hepatocellular carcinoma Sun Yat-sen University Recruiting No outcome recorded
— NCT06609850 Oct 2024 → Oct 2026 expected hepatocellular carcinoma Sun Yat-sen University Recruiting No outcome recorded
— NCT06622031 Oct 2024 → Dec 2026 expected hepatocellular carcinoma, portal vein thrombosis Sun Yat-sen University Recruiting No outcome recorded
— NCT06519721 Aug 2024 → Dec 2025 overdue hepatocellular carcinoma RenJi Hospital Active not recruiting No outcome recorded
— NCT06463548 Jul 2024 → Dec 2025 overdue biliary tract cancer Yunpeng Liu Not yet recruiting No outcome recorded
Phase not stated2 trials
— NCT03533361 — thyroid cancer Eisai Inc. Approved for marketing No outcome recorded
— NCT02211222 ? → Aug 2015 differentiated thyroid carcinoma Eisai Inc. Approved for marketing No outcome recorded
Comparator or background therapy68 trials
Phase 0 NCT05007587 Background Jul 2021 → Jun 2022 hepatocellular carcinoma Zhejiang Cancer Hospital Unknown No outcome recorded
Phase 0 NCT06327269 Comparator Apr 2021 → Dec 2024 overdue — Chang Gung Memorial Hospital Recruiting No outcome recorded
Phase 1 NCT06858813 Comparator Apr 2025 → Sep 2030 expected hepatocellular carcinoma, non-small cell squamous lung carcinoma AbbVie Recruiting No outcome recorded
Phase 1 NCT06363006 Background Mar 2024 → Jan 2026 overdue hepatocellular carcinoma Peking Union Medical College Hospital Recruiting No outcome recorded
Phase 1 NCT04522323 Background Aug 2020 → Sep 2025 overdue renal cell carcinoma MedImmune LLC Active not recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 178

DateIssuerRelease
2026-09-28 Eisai Inc. Regulatory U.S. FDA Approves WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) for Certain Previously Treated Adult Patients With Advanced Renal Cell Carcinoma With a Clear Cell Component (ccRCC) Approval based on results from the Phase 3 LITESPARK-011 trial evaluating WELIREG in combination with LENVIMA compared to cabozantinib for the treatment of patients with advanced ccRCC following treatment with a PD-1/PD-L1 inhibitor WELIREG plus LENVIMA is the first approved combination of a HIF-2 alpha inhibitor and a multi-targeted VEGFR-TKI for these patients eisai.com ↗
2026-06-11 Ono Pharmaceutical Co., Ltd. Results Ono Pharma Submits a Supplemental Application in Japan to Expand the Use of OPDIVO for the Treatment of Unresectable Anaplastic Thyroid Cancer ono-pharma.com ↗
The results of this study showed an objective response rate of 47.6% (95% confidence interval, 33.4 to 62.3%), thus meeting the primary endpoint.
2026-06-09 Medivir Results Positive results for fostrox + lenvatinib published in Clinical Cancer Research medivir.com ↗
The results showed promising preliminary efficacy and tolerability in the post-immunotherapy setting, supporting further investigation as a second-line option in advanced liver cancer.
2026-06-01 AstraZeneca Results Imfinzi plus Imjudo combined with lenvatinib and TACE reduced the risk of disease progression or death by 30% in embolisation-eligible unresectable liver cancer in EMERALD-3 Phase III trial astrazeneca.com ↗
The median PFS was 13.0 months for this regimen versus 9.8 months for TACE.
2026-05-22 AstraZeneca Results AstraZeneca to showcase Phase III data in liver, breast and bladder cancers and potential first-in-class rare disease therapy at ASCO 2026 astrazeneca.com ↗
CARES Phase III results will demonstrate highly clinically meaningful benefit of anti-fibril therapy, anselamimab, for kappa light chain amyloidosis
2026-04-21 Merck Sharp & Dohme LLC Results Merck and Eisai Provide Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced Renal Cell Carcinoma (RCC) merck.com ↗
At a pre-specified interim analysis, the combination regimens did not meet the dual primary endpoints of progression-free survival (PFS) and overall survival (OS) for the first-line treatment of patients with RCC compared to KEYTRUDA plus LENVIMA.
2026-04-21 Eisai Inc. Results Merck & Co., Inc., Rahway, NJ, USA and Eisai Provide Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced Renal Cell Carcinoma (RCC) eisai.com ↗
At a pre-specified interim analysis, the combination regimens did not meet the dual primary endpoints of progression-free survival (PFS) and overall survival (OS) for the first-line treatment of patients with RCC compared to KEYTRUDA plus LENVIMA.
2026-04-02 AstraZeneca Results Imfinzi plus Imjudo combined with lenvatinib and TACE demonstrated a statistically significant and clinically meaningful improvement in progression-free survival in embolisation-eligible unresectable liver cancer in EMERALD-3 Phase III trial astrazeneca.com ↗
2026-03-27 Eisai Inc. Regulatory Application Submitted for LENVIMA® (lenvatinib) in Japan Seeking Approval of Additional Dosage and Administration for Combination with WELIREG® (belzutifan) for Renal Cell Carcinoma that has Progressed After Chemotherapy eisai.com ↗
2026-03-02 Eisai Inc. Results WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) Reduced the Risk of Disease Progression or Death by 30% Compared to Cabozantinib in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC) This is the first positive Phase 3 trial of a multi-targeted tyrosine kinase inhibitor in combination with a HIF-2 alpha inhibitor, the first for patients with RCC whose disease progressed on or after treatment with anti-PD-1/L1 therapy, and the first to improve PFS compared to a modern tyrosine kinase inhibitor Based on these data, the U.S. FDA accepts for review two supplemental New Drug Applications for WELIREG plus LENVIMA in certain previously treated patients with advanced RCC eisai.com ↗
2026-02-28 Merck Sharp & Dohme LLC Results WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) Reduced the Risk of Disease Progression or Death by 30% Compared to Cabozantinib in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC) merck.com ↗
2026-02-12 Merck Sharp & Dohme LLC Results Merck Advances Treatment of Bladder and Kidney Cancers with New Data at 2026 ASCO GU Cancers Symposium merck.com ↗
New LITESPARK-022 and LITESPARK-011 data highlight the disease-free survival benefit of WELIREG ® (belzutifan) plus KEYTRUDA and progression-free survival benefit of WELIREG in combination with LENVIMA ® (lenvatinib), respectively

All press releases naming this drug 231 releases

DateIssuerRelease
Show all 231 releases opens the full record — a long page

Evidence & citations 20 cited values

Every value below carries the sentence it was read from. 582 sources stand behind the page.

FieldValueCited text
Known as lenvatinib “IBI318, 300 mg, administered by intravenous infusion on the first day of each cycle, 1 cycle every 2 weeks (Q2W), continuous medication; lenvatinib 8 mg, orally, continued...” NCT04777084 ↗
569

“Taken together, we hypothesize that combining pembrolizumab with lenvatinib in metastatic UM may target essential cellular oncogenic pathways while normalizing tumor...” NCT05282901 ↗

“Drugs may include all or a subset of the following which each may be tested as single agents or in any number of combinations including, but not limited to: Lenvatinib,...” NCT05553782 ↗

“Successful organoids undergo drug sensitivity testing against a predefined panel of drugs (Gemcitabine + Cisplatin,Gemcitabine + Oxaliplatin,Durvalumab + Gemcitabine +...” NCT07351591 ↗

“This study is a single-arm, prospective Phase II clinical trial designed to evaluate the efficacy and safety of Sinibolimab in combination with Lenvatinib as a neoadjuvant...” NCT06848920 ↗

“Medical therapy is the continuation of the immune-based combo for mRCC including one of the available options among axitinib + pembrolizumab or cabozantinib + nivolumab or...” NCT06903312 ↗

“Eligible participants will receive QL1706 at 5.0 mg/kg intravenously every 3 weeks, lenvatinib at 8 mg orally once daily every 3 weeks, oxaliplatin at 85 mg/m², and gemcitabine...” NCT06892925 ↗

“combinations such as atezolizumab plus bevacizumab, tremelimumab plus durvalumab, or monotherapies such as lenvatinib, sorafenib, tislelizumab, durvalumab, or pembrolizumab, at...” NCT06841172 ↗

“The first-line targeted-immunotherapy regimens consisted of tislelizumab combined with one of the first-line evidence-based tyrosine kinase inhibitors (TKIs), including...” NCT07463248 ↗

“Lenvatinib (bodyweight ≥ 60 kg, 12 mg; \< 60 kg, 8 mg) was given orally daily every 3 weeks until documented disease progression, development of unacceptable toxicity,...” NCT05098847 ↗

“TKI (Sorafenib 400mg, bid, po or Lenvatinib 8mg, qd, po if bodyweight less than 60 kg,12mg, qd, po if bodyweight more than 60kg or Donafenib:200mg, bid, po) +...” NCT06041490 ↗

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Known as E-7080 MESYLATE ChEMBL registry synonym — accepted as the source's own label CHEMBL1289601 ↗
Known as E7080 “UPCC 36315 A Phase II Study Of Everolimus (RAD001) And Lenvatinib (E7080) In Patients With Metastatic Differentiated Thyroid Cancer Who Have Progressed on Lenvatinib Alone” NCT03139747 ↗
8

“Pharmacokinetic Study of E7080/Lenvatinib in Chinese Patients With Unresectable Hepatocellular Carcinoma (HCC)” NCT02953743 ↗

“A Trial of Lenvatinib (E7080) in Radioiodine (131 I)-Refractory Differentiated Thyroid Cancer in China” NCT02966093 ↗

NCT00121680 ↗

NCT03477175 ↗

NCT00832819 ↗

NCT01268293 ↗

NCT01728623 ↗

NCT00280397 ↗

Known as ER-203492-00 ChEMBL registry synonym — accepted as the source's own label CHEMBL1289601 ↗
Known as Kisplyx ChEMBL registry synonym — accepted as the source's own label CHEMBL1289601 ↗
Known as Len “Patients in the neoadjuvant therapy group received Lenvatinib before surgery(Len was started before HAIC treatment, discontinued during HAIC treatment, and discontinued...” NCT06420440 ↗
5

“Patients with advanced intrahepatic cholangiocarcinoma who was initially evaluated unsuitable for the radical therapy and received combined DEB-TACE plus lenvatinib (Len) and...” NCT06192784 ↗

“A phase 3, multinational, randomized, non-inferiority trial (REFLECT) compared the efficacy and safety of lenvatinib (LEN) and sorafenib (SOR) in patients with unresectable...” PMID 31720835 ↗ Nov 2019

“After enrollment, patients will immediately begin treatment with Lenvatinib (Len) and Pucotenlimab (Puco).” NCT06524466 ↗

“received combined HAIC plus lenvatinib (Len) and pucotenlimab” NCT06192797 ↗

“Lenvatinib (LEN) is a first-line therapy” PMID 35921605 ↗ Aug 2022

Known as Lenvanib “Lenvanib (Lenvatinib)” NCT07683949 ↗
Known as Lenvatinib (Lenvima, Eisai China) “Lenvatinib (Lenvima, Eisai China)” NCT03895970 ↗
Known as Lenvatinib mesilate ChEMBL registry synonym — accepted as the source's own label CHEMBL1289601 ↗
Known as Lenvatinib mesylate “lenvatinib mesylate capsule, 12 mg (body weight ≥ 60 kg) or 8 mg (body weight \< 60 kg), oral once a day” NCT04273100 ↗
3

“Lenvatinib mesylate capsule, 8mg (body weight ≤60kg) or 12mg (body weight \>60kg), orally, once daily.” NCT05617859 ↗

“Drug: Lenvatinib Mesylate” NCT02973997 ↗

NCT04929392 ↗

Known as Lenvatinib mesylate (USAN) “Lenvatinib mesylate (USAN)” NCT07571551 ↗
Known as Lenvatinib methanesulfonate ChEMBL registry synonym — accepted as the source's own label CHEMBL1289601 ↗
Known as LENVIMA “Lenvatinib (Lenvima, Eisai China) is a novel angiogenesis inhibitor which targets vascular endothelial growth factor 1-3, fibroblast growth factor receptor 1-4,...” NCT04444193 ↗
3

“Participants will receive approximately six, 28-day cycles of lenvatinib (LENVIMA®, Eisai Inc., Woodcliff Lake, NJ).” NCT05171335 ↗

“Lenvatinib 4 MG Oral Capsule [Lenvima]” NCT05056337 ↗

“Lenvima” NCT04008797 ↗

Known as Lenvima/MK-7902/E7080 (Lenvatinib) “Lenvima/MK-7902/E7080 (Lenvatinib)” NCT05832827 ↗
Known as Ramvatinib mesylate “Ramvatinib mesylate is a class of multi-target receptor tyrosine kinase inhibitors, which can block a series of regulatory factors including VEGFR1-3, KIT and RET in tumor...” NCT04909866 ↗
Action Inhibit “Lenvatinib (E7080), an oral multi-kinase inhibitor, has inhibitory action on tumor cell proliferation and tumor angiogenesis in preclinical models.” PMID 25047123 ↗ Jul 2014
Modality Small molecule “the multitargeted tyrosine kinase inhibitor, lenvatinib” PMID 32265508 ↗ Apr 2020
Route Oral “Oral.” NCT00121680 ↗
Target KIT “Lenvatinib is an oral inhibitor of vascular endothelial growth factor receptor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor alpha, RET, and KIT.” PMID 27704266 ↗ Oct 2016
Target RET “Lenvatinib is an oral inhibitor of vascular endothelial growth factor receptor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor alpha, RET, and KIT.” PMID 27704266 ↗ Oct 2016