Cabozantinib
Small molecule targets AXL, FLT3, KDR, KIT, MET, RET, ROS1, TYRO3 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (7) | US (FDA) | CABOMETYX | — | 2017-12-19 – 2025-09-10 | fda.gov ↗ |
| Label expansion | US (FDA) | COMETRIQ | — | 2016-05-20 | fda.gov ↗ |
| Approved | EU (EMA) | Cometriq | — | 2014-03-21 | europa.eu ↗ |
| Approved | US (FDA) | COMETRIQ | — | 2012-11-29 | fda.gov ↗ |
Trials 238 · started per year
Also used as a comparator or background therapy in 24 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT05122546 Background | Nov 2021 → Jan 2027 expected | clear cell renal carcinoma, papillary renal cell carcinoma, sarcomatoid renal cell carcinoma | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03798626 Background | May 2019 → Mar 2023 | colorectal cancer, gastroesophageal cancer, renal cell carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02293980 Background | Nov 2014 → Jan 2017 overdue | clear cell renal carcinoma | Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02071862 Background | Feb 2014 → Mar 2019 | gastrointestinal stromal tumor, mesothelioma, non-small cell lung carcinoma, renal cell carcinoma +1 | Calithera Biosciences, Inc | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT07077161 Comparator | Jan 2026 → Sep 2027 expected | renal cell carcinoma | dr. Tom van der Hulle | Recruiting | No outcome recorded |
| Phase 2 | NCT05773274 Comparator | Jan 2024 → Apr 2029 expected | digestive system neuroendocrine tumor, grade 1/2 | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT05673824 Background | Jan 2023 → Sep 2025 | poisoning | Fudan University | Completed | No outcome recorded |
| Phase 2 | NCT05012371 Comparator | Feb 2022 → Oct 2027 expected | clear cell renal carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03428217 Background | Apr 2018 → Aug 2020 | clear cell renal carcinoma | Calithera Biosciences, Inc | Completed | No outcome recorded |
| Phase 2 | NCT01835158 Comparator | Jul 2013 → Apr 2016 | clear cell renal carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 310 trials | ||||||
| Phase 3 | NCT07383441 Background | Jun 2026 → Jan 2033 expected | clear cell renal carcinoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase 3 | NCT07620574 Background | May 2026 → May 2030 expected | colorectal cancer, differentiated thyroid carcinoma, hepatocellular carcinoma, pancreatic neuroendocrine tumor +2 | Exelixis | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07405164 Background | Mar 2026 → Jan 2034 expected | cancer, von Hippel-Lindau disease | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT07227402 Comparator | Nov 2025 → Feb 2032 expected | renal cell carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT07011719 Background | Sep 2025 → Apr 2028 expected | clear cell renal carcinoma | Arcus Biosciences, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06726421 Background | Sep 2024 → Sep 2030 expected | renal cell carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 3 | NCT04760288 Comparator | Nov 2023 → Oct 2027 | medullary thyroid gland carcinoma | Hoffmann-La Roche | Withdrawn | No outcome recorded |
| Phase 3 | NCT04586231 Comparator | Feb 2021 → Feb 2026 overdue | renal cell carcinoma | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04211337 Comparator | Feb 2020 → May 2023 overdue | medullary thyroid gland carcinoma | Loxo Oncology, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03729245 Comparator | Dec 2018 → Jan 2022 | renal cell carcinoma | Nektar Therapeutics | Terminated | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07028125 Background | Oct 2025 → Oct 2028 expected | renal cell carcinoma | Centre Francois Baclesse | Recruiting | No outcome recorded |
| Phase 4 | NCT06903312 Comparator | Jun 2025 → Oct 2027 expected | renal cell carcinoma | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02592356 Background | Nov 2015 → Mar 2024 | malignant adrenal gland pheochromocytoma, medullary thyroid gland carcinoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT01683110 Background | — | medullary thyroid gland carcinoma | Exelixis | Approved for marketing | No outcome recorded |
Press releases naming this drug 36 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-07-24 | Ipsen | Cabometyx® approved in the EU for previously treated advanced neuroendocrine tumors ipsen.com ↗ |
| 2025-06-20 | Ipsen | Ipsen receives positive CHMP opinion for Cabometyx® in previously treated advanced neuroendocrine tumors ipsen.com ↗ |
| 2024-09-16 | Ipsen | Final results from CABINET Phase III trial reinforce efficacy benefits of Cabometyx® in advanced neuroendocrine tumors ipsen.com ↗ |
| 2024-07-02 | Ipsen | Ipsen expands collaboration and license agreement for development of Cabometyx® in advanced neuroendocrine tumors based on positive CABINET Phase III trial ipsen.com ↗ |
| 2024-01-22 | Ipsen | Latest Phase III trial data investigating Cabometyx® in combination with immunotherapy to be presented at ASCO GU 2024 ipsen.com ↗ |
| 2023-08-23 | Ipsen | Ipsen joins clinical collaboration to evaluate cabozantinib (CABOMETYX®) plus atezolizumab in metastatic non-small cell lung cancer and metastatic castration-resistant prostate cancer ipsen.com ↗ |
| 2023-08-23 | Ipsen | Ipsen announces publication of first matching-adjusted indirect comparison of Cabometyx® (cabozantinib) versus regorafenib in advanced hepatocellular carcinoma in Advances in Therapy ipsen.com ↗ |
| 2023-08-22 | Ipsen | European Commission approves Cabometyx® in combination with Opdivo® as a first-line treatment for patients living with advanced renal cell carcinoma ipsen.com ↗ |
| 2023-08-21 | Ipsen | Exelixis and Ipsen Announce Positive Results from Phase 3 CONTACT-02 Pivotal Trial Evaluating Cabozantinib in Combination with Atezolizumab in Metastatic Castration-Resistant Prostate Cancer ipsen.com ↗ |
| 2023-08-17 | Ipsen | Cabometyx® in combination with Opdivo® demonstrated continued survival and quality of life benefits with over two years of follow-up in the Phase III CheckMate -9ER trial ipsen.com ↗ |
| 2023-08-15 | Ipsen | Ipsen receives positive CHMP opinion for Cabometyx® in radioactive iodine-refractory differentiated thyroid cancer ipsen.com ↗ |
| 2023-02-13 | Ipsen | Cabometyx® in combination with nivolumab shows durable survival benefits at over three-years’ follow-up in first-line advanced renal cell carcinoma ipsen.com ↗ |
| 2022-12-08 | Ipsen | Ipsen provides update on Phase III CONTACT-01 trial evaluating cabozantinib in combination with atezolizumab in patients with metastatic non-small cell lung cancer previously treated with immunotherapy and chemotherapy ipsen.com ↗ |
| 2022-05-27 | Ipsen | ASCO 2022: New Cabometyx® data show encouraging results in monotherapy and in combination across different tumor types including metastatic non-small cell lung cancer ipsen.com ↗ |
| 2022-05-03 | Ipsen | European Commission approves Cabometyx® as a second-line treatment for people living with radioactive iodine-refractory differentiated thyroid cancer ipsen.com ↗ |
| 2022-03-25 | Ipsen | Ipsen receives positive CHMP opinion for Cabometyx® in radioactive iodine-refractory differentiated thyroid cancer ipsen.com ↗ |
| 2022-02-15 | Ipsen | Cabometyx® in combination with Opdivo® demonstrated continued survival and quality of life benefits with over two years of follow-up in the Phase III CheckMate -9ER trial ipsen.com ↗ |
| 2021-09-18 | Ipsen | ESMO 2021: Cabometyx® demonstrates sustained 78% reduction in risk of disease progression or death in people living with uncommon form of thyroid cancer ipsen.com ↗ |
| 2021-06-28 | Ipsen | Exelixis and Ipsen Announce Cabozantinib in Combination with an Immune Checkpoint Inhibitor Significantly Improved Progression-Free Survival in Phase 3 COSMIC-312 Pivotal Trial in Patients with Previously Untreated Advanced Liver Cancer ipsen.com ↗ |
| 2021-06-07 | Ipsen | Exelixis and Ipsen Announce Detailed Results from Phase 3 COSMIC-311 Pivotal Trial of Cabozantinib in Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer Presented at ASCO 2021 ipsen.com ↗ |
| 2021-05-11 | Ipsen | Ipsen opts-in to join Exelixis with ongoing development of Cabometyx® for people living with a form of thyroid cancer, based on promising interim results ipsen.com ↗ |
| 2021-03-31 | Ipsen | European Commission approves Cabometyx® in combination with Opdivo® as a first-line treatment for patients living with advanced renal cell carcinoma ipsen.com ↗ |
| 2021-02-26 | Ipsen | Ipsen receives positive CHMP opinion recommending Cabometyx® in combination with Opdivo® as first-line treatment for patients living with advanced renal cell carcinoma ipsen.com ↗ |
| 2021-02-08 | Ipsen | New data from pivotal Phase III CheckMate -9ER trial of Cabometyx® in combination with Opdivo® showed significantly improved QoL benefits and sustained superior efficacy versus sunitinib in patients living with aRCC ipsen.com ↗ |
| 2020-09-19 | Ipsen | ESMO 2020: Cabometyx® (cabozantinib) in combination with Opdivo® (nivolumab) demonstrates significant survival benefits in patients with advanced renal cell carcinoma in pivotal Phase III CheckMate -9ER trial ipsen.com ↗ |
| 2020-07-02 | Ipsen | Ipsen joins clinical collaboration to evaluate cabozantinib (CABOMETYX®) plus atezolizumab in metastatic non-small cell lung cancer and metastatic castration-resistant prostate cancer ipsen.com ↗ |
| 2020-05-19 | Ipsen | Ipsen announces publication of first matching-adjusted indirect comparison of Cabometyx® (cabozantinib) versus regorafenib in advanced hepatocellular carcinoma in Advances in Therapy ipsen.com ↗ |
| 2020-04-20 | Ipsen | Ipsen announces positive topline results from pivotal Phase III CheckMate -9ER trial evaluating CABOMETYX® (cabozantinib) in combination with Opdivo® (nivolumab) in previously untreated advanced renal cell carcinoma ipsen.com ↗ |
| 2018-12-05 | Ipsen | Exelixis and Ipsen initiate phase 3 pivotal trial (COSMIC-312) of cabozantinib in combination with atezolizumab versus sorafenib in previously untreated advanced hepatocellular carcinoma ipsen.com ↗ |
| 2018-11-15 | Ipsen | European Commission approves Ipsen’s Cabometyx® (cabozantinib) for the treatment of hepatocellular carcinoma in adults previously treated with sorafenib ipsen.com ↗ |
| 2018-09-21 | Ipsen | Ipsen receives positive CHMP opinion for Cabometyx® (cabozantinib) for the second-line treatment of patients with hepatocellular carcinoma (HCC) ipsen.com ↗ |
| 2018-05-17 | Ipsen | European Commission approves Ipsen’s Cabometyx® (cabozantinib) for the first-line treatment of adults with intermediate- or poor- risk advanced renal cell carcinoma ipsen.com ↗ |
| 2018-03-28 | Ipsen | Ipsen announces EMA validation of filing of a new application for additional indication for Cabometyx®, for patients with previously treated advanced Hepatocellular Carcinoma (HCC). ipsen.com ↗ |
| 2018-03-23 | Ipsen | Ipsen receives positive CHMP opinion for Cabometyx® (cabozantinib) for the first-line treatment of adults with intermediate- or poor- risk advanced renal cell carcinoma ipsen.com ↗ |
| 2018-01-16 | Ipsen | Ipsen and Exelixis announce phase 3 trial results of cabozantinib demonstrating significant overall survival benefit in patients with previously treated advanced hepatocellular carcinoma ipsen.com ↗ |
| 2017-01-31 | Takeda | EXELIXIS AND TAKEDA ENTER INTO EXCLUSIVE LICENSING AGREEMENT TO COMMERCIALIZE AND DEVELOP NOVEL CANCER THERAPY CABOZANTINIB IN JAPAN takeda.com ↗ |
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 265 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cabozantinib | “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 ↗256“Treatment period: Therapeutic agents were selected according to clinical routine, including but not limited to Sorafenib, Lenvatinib, Donafenib, Regorafenib, Apatinib and Cabozantinib.” NCT05673824 ↗ “In this study, Cabozantinib (VEGF inhibitor) and Dostarlimab (immunotherapeutic drug) will be admnistered as a combination to patients with recurrent gynecologic carcinosarcoma.” NCT05559879 ↗ “Safety Study of XL184 (Cabozantinib) in Combination With Temozolomide and Radiation Therapy in the Initial Treatment of Adults With Glioblastoma” NCT00960492 ↗ “XL184 (cabozantinib) is a potent inhibitor of MET, vascular endothelial growth factor receptor 2 (VEGFR2), and RET” PMID 21606412 ↗ May 2011 “A Study of XL184 (Cabozantinib) With or Without Erlotinib in Subjects With Non-Small Cell Lung Cancer (NSCLC)” NCT00596648 ↗ “Treatment with tyrosine kinase inhibitors consists of standard-of-care Lenvatinib or Cabozantinib.” NCT05620771 ↗ “A phase I study of cabozantinib (XL184) in patients with renal cell cancer.” PMID 24827131 ↗ May 2014 “Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer” NCT00704730 ↗ “MET Inhibitors (Crizotinib 250 mg 2/d, or Cabozantinib 60mg/d)” NCT05063058 ↗ “CB-839 in combination with standard dose cabozantinib” NCT02071862 ↗ “Cabozantinib 60 mg once a day for 4 weeks” NCT04644432 ↗ “Cabazitaxel Cabozantinib Carfilzomib” NCT02551718 ↗ “cabozantinib 60 mg orally once daily” NCT03463681 ↗ |
| Known as | BMS-907351 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01018745 ↗ |
| Known as | BMS-907351 FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105717 ↗ |
| Known as | Cabo | “Cabozantinib (Cabo)” NCT04300140 ↗ |
| Known as | Cabometyx | “cabozantinib tablets (Cabometyx®) once daily until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw for a maximum duration of 2 years.” NCT03729297 ↗3“Cabozantinib is the generic for the trade chemotherapy drug CABOMETYX™ (cabozantinib).” NCT06377722 ↗ “Cabozantinib (Cabometyx) 60, 40 and 20 mg” NCT06535737 ↗ |
| Known as | CABOZANTINIB (BMS-907351) | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105717 ↗ |
| Known as | Cabozantinib malate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105717 ↗ |
| Known as | Cabozantinib S-malate | “Cabozantinib S-malate is a vascular endothelial growth factor receptor 2, c-MET, and RET multitargeted tyrosine kinase inhibitor that has antiangiogenic and antitumorigenic...” PMID 25427282 ↗ Feb 201516“I. Compare the progression-free survival rate at 4 months (PFS4) of patients with ocular melanoma treated with cabozantinib-s-malate (cabozantinib) or temozolomide (or dacarbazine).” NCT01835145 ↗ “safety of cabozantinib S-malate (cabozantinib) in combination with atezolizumab in patients with mCRPC with non-measurable disease” NCT05168618 ↗ “cabozantinib s-malate (cabozantinib) combined with nivolumab and ipilimumab in the first or second-line (and beyond) setting” NCT03866382 ↗ “To evaluate the effect of cabozantinib (cabozantinib S-malate) in combination with avelumab on overall survival (OS)” NCT05092958 ↗ “To evaluate the antitumor activity of cabozantinib s-malate (cabozantinib) for Ewing sarcomas” NCT02243605 ↗ “cabozantinib (cabozantinib S-malate) can significantly improve progression-free survival” NCT03375320 ↗ “Patients receive cabozantinib s-malate orally (PO) once daily (QD) on days 1-28.” NCT01935934 ↗ “Patients receive cabozantinib-s-malate orally (PO) daily on days 1-28.” NCT01811212 ↗ “cabozantinib S-malate (cabozantinib) orally (PO) once daily (QD)” NCT05327738 ↗ “XL184 (cabozantinib) (cabozantinib S-malate)” NCT01709435 ↗ “cabozantinib S-malate (cabozantinib)” NCT05136196 ↗ “cabozantinib S-malate (cabozantinib)” NCT05691478 ↗ “Drug: Cabozantinib S-malate” NCT01822522 ↗ “Drug: Cabozantinib S-malate” NCT06006013 ↗ |
| Known as | CABOZANTINIBCT-XL184COMETRIQXL184C3627 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105717 ↗ |
| Known as | COMETRIQ | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105717 ↗ |
| Known as | NSC #761968 | “A Phase II Trial of Cabozantinib (XL-184) (NSC #761968) in Women With Recurrent, Clear Cell Carcinoma of the Ovary, Fallopian Tube, or Peritoneum” NCT02315430 ↗ |
| Known as | XL-184 FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105717 ↗ |
| Known as | XL184 | “A Phase II, Randomized, Open-label Study to Assess the Efficacy, Safety, and Pharmacokinetics (PK) of Maintenance Cabozantinib (XL184) Plus Best Supportive Care (BSC) Versus...” NCT06341712 ↗22“The purpose of this phase II study is to find out what effects cabozantinib (XL184) has, good and/or bad, in patients whose tumors one of the following gene changes RET, ROS1,...” NCT01639508 ↗ “A Phase 3, Randomized, Double-blind, Controlled Trial of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic...” NCT01522443 ↗ “Cabozantinib (XL184) is a potent inhibitor of multiple receptor tyrosine kinases (RTKs) known to play important roles in tumor cell proliferation and/or tumor neovascularization.” NCT05052723 ↗ “A Phase I Trial of Cabozantinib (XL184) in Combination With High-dose Ifosfamide in Adults and Children With Relapsed/Refractory Sarcomas (CaIRS Trial)” NCT06156410 ↗ “An Open-Label, Expanded Access Study of Cabozantinib (XL184) in Subjects With Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer” NCT01683110 ↗ “A Phase II Trial of Cabozantinib (XL-184) (NSC #761968) in Women With Recurrent, Clear Cell Carcinoma of the Ovary, Fallopian Tube, or Peritoneum” NCT02315430 ↗ “A Phase 2 Study of Cabozantinib (XL184), a Dual Inhibitor of MET and VEGFR, in Patients With Metastatic Refractory Soft Tissue Sarcoma” NCT01755195 ↗ “Activity of XL184 (Cabozantinib), an oral tyrosine kinase inhibitor, in patients with medullary thyroid cancer.” PMID 21606412 ↗ May 2011 “Niraparib in Combination with Cabozantinib (XL184) in Patients with Advanced Urothelial Cancer (NICARAGUA)” NCT03425201 ↗ “A Phase II Study of Cabozantinib (XL184) in Patients With Advanced/Metastatic Urothelial Carcinoma” NCT01688999 ↗ “Cabozantinib (XL184) 140 mg as capsules and placebo tablets administered orally once a day.” NCT01896479 ↗ “The names of the study interventions involved in this study are: * Cabozantinib (XL184)” NCT02260531 ↗ “A phase I study of cabozantinib (XL184) in patients with renal cell cancer.” PMID 24827131 ↗ May 2014 “Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer” NCT00704730 ↗ “Cabozantinib (XL184) Capsules” NCT01761773 ↗ “Cabozantinib (XL184)” NCT01866293 ↗ “BMS-907351 (XL184)” NCT01018745 ↗ “XL184” NCT05904080 ↗ |
| Known as | XL184,BMS-907351 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105717 ↗ |
| Action | Inhibit | “XL184 (cabozantinib) is a potent inhibitor of MET, vascular endothelial growth factor receptor 2 (VEGFR2), and RET” PMID 21606412 ↗ May 2011 |
| Modality | Small molecule | “XL184 (Cabozantinib), an oral tyrosine kinase inhibitor” PMID 21606412 ↗ May 2011 |
| Route | Oral | “XL184 Administered Orally” NCT00215605 ↗ |
| Target | MET | “XL184 (cabozantinib) is a potent inhibitor of MET, vascular endothelial growth factor receptor 2 (VEGFR2), and RET” PMID 21606412 ↗ May 2011 |
| Target | RET | “XL184 (cabozantinib) is a potent inhibitor of MET, vascular endothelial growth factor receptor 2 (VEGFR2), and RET” PMID 21606412 ↗ May 2011 |