NDAORALTABLETPriority Review
Approved
Apr 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CABOMETYX (cabozantinib) is an oral small-molecule tyrosine kinase inhibitor approved in 2016 for multiple cancer indications including renal cell carcinoma, hepatocellular carcinoma, and medullary thyroid cancer. It works by inhibiting multiple receptor tyrosine kinases involved in tumor growth and angiogenesis. The drug is currently at peak commercial performance with $1.1B in Part D spending.
$1.1BPart D
Peak6.8 years to LOECABOMETYX maintains peak commercial performance with substantial Part D utilization, indicating a mature, stable franchise supporting established brand and medical affairs teams.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Study of Cabozantinib With Selumetinib for Plexiform Neurofibromas
Started Aug 2026
30 enrolled
Neurofibromatosis 1Plexiform Neurofibroma
Modulation of the Bone Immune Microenvironment Following Cabozantinib Treatment of Bone Metastatic Clear Cell Renal Cell Carcinoma: Proof of Concept Study
Started Feb 2026
16 enrolled
Clear Cell Renal Cell Carcinoma
Study of Cabozantinib in Participants With Neuroendocrine Tumors Who Have Already Received Prior Treatment
Started Dec 2025
150 enrolled
Neuroendocrine Tumors
Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
Started Sep 2025
720 enrolled
Metastatic Clear Cell Renal Cell CarcinomaAdvanced Clear Cell Renal Cell Carcinoma
Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma
Started May 2025
50 enrolled
Kidney CancerRenal Cell Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.