RESNIBEN (cabozantinib)
RESNIBEN is indicated for the treatment of Medullary Thyroid Cancer.
How RESNIBEN Works
Cabozantinib is a potent multi-kinase inhibitor that targets the tyrosine kinase activity of RET, MET, and VEGFR-1, -2, and -3. Additionally, it inhibits several other kinases involved in tumor pathogenesis, including KIT, TRKB, FLT-3, AXL, ROS1, TYRO3, MER, and TIE-2. Through the inhibition of these receptors, cabozantinib disrupts signaling pathways essential for oncogenesis, tumor angiogenesis, metastasis, and the maintenance of the tumor microenvironment, thereby addressing mechanisms of tumor growth and drug resistance.
Development Insights
Details
- Status
- Prescription
- First Approved
- N/A
- Routes
- ORAL
- Dosage Forms
- TABLET
RESNIBEN Approval History
What RESNIBEN Treats
1 indicationsRESNIBEN is approved for 1 conditions . These indications span multiple therapeutic areas including oncology, immunology, and more.
- Medullary Thyroid Cancer
RESNIBEN Target & Pathway
ProTarget
Receptors on blood vessel cells that respond to VEGF signals to form new blood vessels. Cancer cells exploit this pathway to ensure blood supply for tumor growth. Blocking VEGFRs prevents tumor angiogenesis and limits cancer progression.
Pathway Context
VEGFR on blood vessels is activated by VEGF to promote angiogenesis
A signaling protein that stimulates the formation of new blood vessels (angiogenesis). Tumors need blood supply to grow, so they secrete VEGF to create new vessels. Blocking VEGF starves tumors of oxygen and nutrients, inhibiting their growth.
RESNIBEN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to RESNIBEN
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
168 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05773274 | NCI-2023-00118 NCI-2023-00118, CCTG-NE1 | Ph 2 | recruiting | Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial |
| NCT07293351 | CA266-0008 2025-523637-26, U1111-1327-6332 | Ph 1, Ph 2 | recruiting | A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208) |
| NCT03793166 | NCI-2018-03694 NCI-2018-03694, A031704 | Ph 3 | active not recruiting | Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study |
| NCT06900595 | NCI-2025-02021 NCI-2025-02021, A092204 | Ph 2 | recruiting | Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescents and Adults With Advanced Adrenocortical Cancer |
| NCT03816345 | NCI-2019-00241 NCI-2019-00241, 10204 | Ph 1 | recruiting | Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO |
| NCT07405164 | 6482-043 U1111-1325-4582, 2025-524160-38-00 | Ph 3 | recruiting | Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) |
| NCT07227402 LITESPARK-033 | 6482-033 U1111-1311-6892, 2024-517136-21 | Ph 3 | recruiting | A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033) |
| NCT05038839 | 2020-0308 NCI-2021-03248, 2020-0308 | Ph 1 | completed | Cabozantinib and Pamiparib for the Treatment of Advanced of Refractory Solid Tumors |
| NCT06475989 | EA3231 NCI-2024-03023, EA3231 | Ph 3 | recruiting | Study of Targeted Therapy vs. Chemotherapy in Patients With Thyroid Cancer |
| NCT04586231 | 6482-011 MK-6482-011, jRCT2031210311 | Ph 3 | active not recruiting | A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011) |
| NCT04022343 results posted | IRB00110583 NCI-2019-02253, Winship4643-19 | Ph 2 | active not recruiting | Neoadjuvant Cabozantinib in Treating Patients With Locally Advanced Kidney Cancer |
| NCT05663710 | 2021-0911 NCI-2022-10595, CDMRP-KC210253 | Ph 1, Ph 2 | recruiting | Phase 1b/2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCC |
| NCT06835972 | 24-126 | Ph 1, Ph 2 | recruiting | A Study of Abemaciclib and Cabozantinib in People With Clear Cell Renal Cell Carcinoma (ccRCC) |
| NCT05327686 SAMURAI | NRG-GU012 NCI-2022-02189, NRG-GU012 | Ph 2 | recruiting | Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial |
| NCT05660954 CABOTHYROID | GETNE-T2216 | Ph 2 | completed | Cabozantinib In Advanced Radioactive-Iodine Refractory Differentiated Thyroid Cancer. |
| NCT04631744 results posted | 19-04020287 | Ph 2 | terminated | Cabozantinib in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC) |
| NCT04200443 results posted | 20664 STU00210699, NU 19S01 | Ph 2 | active not recruiting | Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma |
| NCT05536141 ARC-20 | ARC-20 2024-519142-70-00 | Ph 1 | recruiting | A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors |
| NCT04472767 | 20205807 UCI 19-49 | Ph 2 | recruiting | Cabozantinib Combined With Ipilimumab/Nivolumab and TACE in Patients With Hepatocellular Carcinoma |
| NCT03768063 IMbrella B | BO40729 2023-506184-34-00 | Ph 3 | active not recruiting | A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study |
| NCT07011719 | PEAK-1 2024-515023-11-00 | Ph 3 | recruiting | Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma |
| NCT05361720 | VICCURO21103 NCI-2022-03150, VICCURO21103 | Ph 2 | recruiting | Genetic Testing to Select Therapy for the Treatment of Advanced or Metastatic Kidney Cancer, OPTIC RCC Study |
| NCT04116541 MegaMOST | ET19-073 (MegaMOST) 2023-510567-35-00, 2019-001494-88 | Ph 2 | recruiting | A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors. |
| NCT04868773 | 20216481 UCI 20-134 | Ph 1 | completed | Study of Cabozantinib Plus TAS102 in mCRC as Salvage Therapy |
| NCT05836571 | NCI-2023-03149 NCI-2023-03149, 001704 | Ph 2 | active not recruiting | Testing Ipilimumab and Nivolumab Combination With or Without Cabozantinib in People >= 18 Years Old With Advanced Soft Tissue Sarcoma |
| NCT05019703 | 2021-0409 NCI-2021-06970, 2021-0409 | Ph 2 | recruiting | Atezolizumab and Cabozantinib for the Treatment of Adolescents and Young Adults With Recurrent or Metastatic Osteosarcoma, TACOS Study |
| NCT06026410 FIT-001 | KO-2806-001 | Ph 1 | recruiting | KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors |
| NCT02867592 results posted | NCI-2016-01258 NCI-2016-01258, ADVL1622 | Ph 2 | active not recruiting | Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors |
| NCT05249114 | 2022000050 | Ph 1 | active not recruiting | Study of Cabozantinib With Lu-177 in Patients With Somatostatin Receptor 2 Positive Neuroendocrine Tumors |
| NCT05048212 | 2021-0520 NCI-2021-10708 | Ph 2 | recruiting | A Phase II Study of Nivolumab With Ipilimumab and Cabozantinib in Patients With Untreated Renal Cell Carcinoma Brain Metastases |
| NCT05048901 | T2221 | Ph 1, Ph 2 | recruiting | Cabozantinib and Lanreotide as Treatment for Gastroenteropancreatic Neuroendocrine Tumors |
| NCT04412629 | 202007173 | Ph 2 | active not recruiting | Cabozantinib in High Grade Neuroendocrine Neoplasms |
| NCT03899155 | CA209-8TT 2018-004362-34 | Ph 2 | recruiting | Pan Tumor Rollover Study |
| NCT03798626 | CVPM087A2101 2018-003952-19 | Ph 1 | completed | Gevokizumab With Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers |
| NCT04963283 | 21-2687.cc P30CA046934 | Ph 2 | active not recruiting | Study of Cabozantinib and Nivolumab in Refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer |
| NCT06341712 CabOSTar | CLIN-60000-461 2023-506229-12-00 | Ph 2 | terminated | Effects of Maintenance Cabozantinib+BSC Versus BSC in Children and AYA With Osteosarcoma |
| NCT04338269 CONTACT-03 results posted | WO41994 | Ph 3 | terminated | A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment |
| NCT04211337 LIBRETTO-531 results posted | 17478 J2G-MC-JZJB, 2019-001978-28 | Ph 3 | active not recruiting | A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer |
| NCT07194044 METTSEO | MCC-23281 | Ph 1 | recruiting | Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes |
| NCT03945773 CaboPoint results posted | F-FR-60000-023 2018-002820-18 | Ph 2 | completed | Study of Cabozantinib as 2nd Line Treatment in Subjects With Locally Advanced or Metastatic Renal Cell Carcinoma (RCC) With a Clear-Cell Component Who Progressed After 1st Line Treatment With Checkpoint Inhibitors |
| NCT05425004 | 2020-KOT-002 | Ph 2 | recruiting | Cabozantinib for Patients With Recurrent or Progressive Meningioma |
| NCT05012371 | 2021-0400 NCI-2021-07429, 2021-0400 | Ph 2 | active not recruiting | Lenvatinib With Everolimus Versus Cabozantinib for Second-Line or Third-Line Treatment of Metastatic Renal Cell Cancer |
| NCT04588051 | HCC063 | Ph 2 | active not recruiting | Cabozantinib in Hepatocellular Carcinoma |
| NCT04091750 results posted | STUDY00000904 | Ph 2 | active not recruiting | Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma |
| NCT01068782 results posted | XL184-205 | Ph 2 | terminated | Multiple Doses and Regimens of Cabozantinib in Subjects With Grade IV Astrocytic Tumors in First or Second Relapse |
| NCT06716853 TEM-GU | TEM-GU 2024-512898-27-00 | Ph 1, Ph 2 | terminated | A Clinical Gene Therapy Study With Hematopoietic Stem Cells for the Treatment, With Single Dose of Temferon, of Patients Suffering From Metastatic Renal Cell Carcinoma |
| NCT07383441 | S2419 NCI-2026-00080, S2419 | Ph 3 | not yet recruiting | Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer |
| NCT03957551 results posted | 201904712 | Ph 1, Ph 2 | terminated | Cabozantinib and Pembrolizumab for Advanced Metastatic Melanoma |
| NCT07077161 SKIPPY 2 | SKIPPY2 2025-522962-58-00 | Ph 2 | recruiting | Cabozantinib Dose Skipping as an Alternative to Dose Reductions |
| NCT03468218 results posted | IRB00100269 NCI-2017-02419, Winship4234-17 | Ph 2 | active not recruiting | Pembrolizumab & Cabozantinib in Patients With Head and Neck Squamous Cell Cancer |
Showing 50 of 168 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RESNIBEN FDA Label Details
Indications & Usage
RESNIBEN is indicated for the treatment of Medullary Thyroid Cancer.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment