COMETRIQ (cabozantinib s-malate)
COMETRIQ (cabozantinib s-malate) is a kinase inhibitor approved for the treatment of medullary thyroid cancer (MTC). The medication is specifically indicated for patients whose MTC is characterized as progressive and metastatic. It serves as a targeted therapeutic option for managing this specific form of thyroid malignancy.
How COMETRIQ Works
Cabozantinib inhibits the tyrosine kinase activity of multiple receptors, including RET, MET, VEGFR-1, -2, and -3, as well as KIT, TRKB, and FLT-3. It also targets AXL, ROS1, TYRO3, MER, and TIE-2, which are involved in both normal cellular functions and pathologic processes. By inhibiting these receptor tyrosine kinases, the drug interferes with oncogenesis, metastasis, tumor angiogenesis, and the maintenance of the tumor microenvironment. This multi-kinase inhibition also addresses biological pathways associated with drug resistance.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-11-29
- Patent Cliff
- 2032
- Routes
- ORAL
- Dosage Forms
- CAPSULE
COMETRIQ Approval History
What COMETRIQ Treats
1 indicationsCOMETRIQ is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Medullary Thyroid Cancer
COMETRIQ 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.
COMETRIQ 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 COMETRIQ
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
39 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04310007 | NCI-2020-01541 NCI-2020-01541, EA5191 | Ph 2 | active not recruiting | Testing the Addition of the Pill Chemotherapy, Cabozantinib, to the Standard Immune Therapy Nivolumab Compared to Standard Chemotherapy for Non-small Cell Lung Cancer |
| NCT04071223 | NCI-2019-05619 NCI-2019-05619, A031801 | Ph 2 | active not recruiting | Testing the Addition of a New Anti-cancer Drug, Radium-223 Dichloride, to the Usual Treatment (Cabozantinib) for Advanced Renal Cell Cancer That Has Spread to the Bone, RadiCaL Study |
| NCT05111574 | NCI-2021-11794 NCI-2021-11794, A091903 | Ph 2 | recruiting | Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery |
| NCT02496208 | NCI-2014-02379 NCI-2014-02379, 15-C-0160 | Ph 1 | active not recruiting | Cabozantinib S-malate and Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Genitourinary Tumors |
| NCT05136196 | NCI-2021-12653 NCI-2021-12653, S2101 | Ph 2 | recruiting | BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study |
| NCT05691478 | NCI-2022-08567 NCI-2022-08567, AOST2032 | Ph 2, Ph 3 | recruiting | A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma |
| NCT03866382 | NCI-2019-01266 NCI-2019-01266, A031702 | Ph 2 | recruiting | Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors |
| NCT06811116 | NCI-2025-00837 NCI-2025-00837, 25-082 | Ph 1, Ph 2 | recruiting | Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metastatic Liver Cell Cancer With a Change in Genes for the Protein β-Catenin, The SAPHIRE Trial |
| NCT05904080 | NCI-2023-04469 NCI-2023-04469, A092105 | Ph 2 | recruiting | Testing Nivolumab and Ipilimumab Immunotherapy With or Without the Targeted Drug Cabozantinib in Recurrent, Metastatic, or Incurable Nasopharyngeal Cancer |
| NCT05411081 | NCI-2022-04668 NCI-2022-04668, S2200 | Ph 2 | active not recruiting | Testing Cabozantinib With or Without Atezolizumab in Patients With Advanced Papillary Kidney Cancer, PAPMET2 Trial |
| NCT05092958 | NCI-2021-11166 NCI-2021-11166, A032001 | Ph 3 | active not recruiting | Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study |
| NCT04339738 results posted | NCI-2020-02153 NCI-2020-02153, A091902 | Ph 2 | active not recruiting | Testing the Addition of Nivolumab to Chemotherapy in Treatment of Soft Tissue Sarcoma |
| NCT03375320 results posted | NCI-2017-02297 NCI-2017-02297, A021602 | Ph 3 | active not recruiting | Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors |
| NCT01708954 results posted | NCI-2012-01938 NCI-2012-01938, ECOG-E1512 | Ph 2 | active not recruiting | Erlotinib Hydrochloride and Cabozantinib-s-Malate Alone or in Combination as Second or Third Line Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer |
| NCT04878029 | STUDY00002329 NCI-2021-01365, STUDY00002329 | Ph 1 | recruiting | Cabozantinib in Combination With Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer |
| NCT03367741 results posted | NCI-2017-02211 NCI-2017-02211, PHL-099 | Ph 2 | active not recruiting | Cabozantinib S-malate and Nivolumab in Treating Patients With Advanced, Recurrent, or Metastatic Endometrial Cancer |
| NCT02243605 results posted | NCI-2014-01927 NCI-2014-01927, CABONE | Ph 2 | active not recruiting | Cabozantinib S-malate in Treating Patients With Relapsed Osteosarcoma or Ewing Sarcoma |
| 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 |
| NCT03914300 results posted | NCI-2019-02220 NCI-2019-02220, OSU-19088 | Ph 2 | active not recruiting | Testing the Combination of Cabozantinib, Nivolumab, and Ipilimumab (CaboNivoIpi) for Advanced Differentiated Thyroid Cancer |
| NCT04079712 results posted | NCI-2019-05864 NCI-2019-05864, 10315 | Ph 2 | active not recruiting | Testing the Combination of XL184 (Cabozantinib), Nivolumab, and Ipilimumab for Poorly Differentiated Neuroendocrine Tumors |
| NCT04514484 | NCI-2020-05956 NCI-2020-05956, 2020-12258 | Ph 1 | active not recruiting | Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV |
| NCT05122546 | 21133 NCI-2021-05559, 21133 | Ph 1 | active not recruiting | CBM588 in Combination With Nivolumab and Cabozantinib for the Treatment of Advanced or Metastatic Kidney Cancer |
| NCT06006013 | STUDY00005532 NCI-2023-04952, STUDY00005532 | Ph 2 | recruiting | Cabozantinib in Combination With Pembrolizumab for the Treatment of Patients With Locally Advanced, Metastatic, or Unresectable Adrenal Cortical Cancer |
| NCT05092373 | 2021-0299 NCI-2021-11360, 2021-0299 | Ph 1 | recruiting | Phase I Study of Tumor Treating Fields (TTF) in Combination With Cabozantinib or With Pembrolizumab and Nab-Paclitaxel in Patients With Advanced Solid Tumors Involving the Abdomen or Thorax |
| NCT01935934 results posted | NCI-2013-00890 NCI-2013-00890, PHL-086 | Ph 2 | completed | Cabozantinib S-Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer |
| NCT02302833 results posted | 2014-0081 NCI-2014-02607, 2014-0081 | Ph 2 | completed | Cabozantinib S-malate in Treating Patients With Metastatic Pheochromocytomas or Paragangliomas That Cannot Be Removed by Surgery |
| NCT04220229 results posted | RG1003562 NCI-2019-08661, 10051 | Ph 1, Ph 2 | terminated | Cabozantinib With Radiation Therapy for the Treatment of Sarcomas of the Extremities |
| NCT05168618 AtezoCab | HCI143814 NCI-2021-13110, HCI143814 | Ph 2 | recruiting | Cabozantinib and Atezolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer |
| NCT02761057 results posted | NCI-2015-01707 NCI-2015-01707, S1500 | Ph 2 | completed | Testing Cabozantinib, Crizotinib, Savolitinib and Sunitinib in Kidney Cancer Which Has Progressed |
| NCT01709435 results posted | NCI-2012-01890 NCI-2012-01890, P121149 | Ph 1 | completed | Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors |
| NCT04442581 results posted | RG1007034 NCI-2020-03968, 10548 | Ph 2 | terminated | Cabozantinib and Pembrolizumab for the First-Line Treatment of Advanced Liver Cancer |
| NCT01822522 results posted | NCI-2013-00740 NCI-2013-00740, AMC-087 | Ph 1 | completed | Cabozantinib S-Malate in Treating Patients With Advanced Solid Tumors and Human Immunodeficiency Virus |
| NCT05327738 | STUDY00023365 NCI-2022-01840, STUDY00023365 | Ph 2 | withdrawn | Yttrium Y 90 Glass Microspheres, Atezolizumab, and Cabozantinib for the Treatment of Unresectable or Locally Advanced Hepatocellular Carcinoma |
| NCT01835145 results posted | NCI-2013-00821 NCI-2013-00821, CALGB-A091201 | Ph 2 | completed | Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed by Surgery |
| NCT01835158 results posted | NCI-2013-00820 NCI-2013-00820, A031203 | Ph 2 | completed | Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer |
| NCT02315430 results posted | NCI-2014-02411 NCI-2014-02411, NRG-GY001 | Ph 2 | completed | Cabozantinib-S-Malate in Treating Patients With Recurrent or Progressive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer |
| NCT01716715 results posted | NCI-2012-02058 NCI-2012-02058, GOG-0186K | Ph 2 | completed | Cabozantinib or Paclitaxel in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer |
| NCT01866410 results posted | NCI-2013-01085 NCI-2013-01085, PHII-125 | Ph 2 | completed | Cabozantinib-S-Malate and Erlotinib Hydrochloride in Treating Patients With Previously Treated Metastatic Non-Small Cell Lung Cancer |
| NCT01811212 results posted | NCI-2013-00554 NCI-2013-00554, 2012C0101 | Ph 2 | completed | Cabozantinib-S-Malate in Treating Patients With Refractory Thyroid Cancer |
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.
COMETRIQ FDA Label Details
Indications & Usage
FDA Label (PDF)COMETRIQ is indicated for the treatment of Medullary Thyroid Cancer.
COMETRIQ Patents & Exclusivity
Patents (8 active)
Pro Intelligence Preview
Deep insights for COMETRIQ
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 32 active patents
Trial Analysis
- • 40 total trials
- • Stage: Growth
Competitive Landscape
- • 3 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
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