Drug

Cabozantinib

Approved · EMA

Emerging researchLate-stage developmentRising momentum

Also known as Cabometyx, Cometriq.

RxNorm1363268 ChEMBLCHEMBL2105717 ATCL01EX07UNII1C39JW444G

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 2 Open-Label Study of Nivolumab Combined With Cabozantinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma (CA209-9KU)

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

NET RETREAT: A Phase II Study of 177 Lutetium-DOTATATE Retreatment vs. Everolimus or Sunitinib or Cabozantinib in Metastatic/Unresectable Gastroenteropancreatic Neuroendocrine Tumours

Clinical trial2026-07-28Results expected Q2 2029 · ClinicalTrials.gov

A Phase 2 Study of Cabozantinib and Nivolumab in Metastatic Castration Resistant Prostate Cancer

Clinical trial2026-07-12Primary completion · ClinicalTrials.gov

A Multicenter, Open-label, Phase 3 Extension Study to Evaluate the Long-term Efficacy and Safety in Participants Who Are Currently on Treatment in a Belzutifan Study (LITESPARK-043)

Clinical trial2026-07-10Results expected Q1 2034 · ClinicalTrials.gov

A Phase 3, Randomized, Open-label Study of Belzutifan + Zanzalintinib Versus Cabozantinib in Participants With Advanced RCC Who Experienced Disease Recurrence During or After Prior Adjuvant Anti-PD-1/L1 Therapy (LITESPARK-033)

Clinical trial2026-07-10Results expected Q1 2032 · ClinicalTrials.gov

Exelixis’ Cabometyx successor fails primary endpoint in colorectal cancer trial amid FDA review

Regulatory2026-06-22Regulatory news · Fierce Biotech

Phase 3 Trial of Cabozantinib to Treat Advanced Neuroendocrine Tumors.

Research2024-09-16The New England journal of medicine

Final Results From a Phase I Trial and Expansion Cohorts of Cabozantinib and Nivolumab Alone or With Ipilimumab for Advanced/Metastatic Genitourinary Tumors.

Research2024-07-02Journal of clinical oncology : official journal of the American Society of Clinical Oncology

CONTACT-01: A Randomized Phase III Trial of Atezolizumab + Cabozantinib Versus Docetaxel for Metastatic Non-Small Cell Lung Cancer After a Checkpoint Inhibitor and Chemotherapy.

Research2024-03-29Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Pralsetinib in Patients with Advanced/Metastatic Rearranged During Transfection (RET)-Altered Thyroid Cancer: Updated Efficacy and Safety Data from the ARROW Study.

Research2024-01-01Thyroid : official journal of the American Thyroid Association

Accelerated approval: Cabometyx (EMA)

Regulatory2016-09-09EMA

Approval: Cometriq (EMA)

Regulatory2014-03-21EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Cabozantinib

Aliases & brands

CabometyxCometriq

RxNorm CUI

1363268

ChEMBL ID

CHEMBL2105717

ATC codes

L01EX07

UNII

1C39JW444G

Regulatory jurisdictions

ema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2014-03-21

Latest approval

2016-09-09

Authorities

EMA

Total events

emaEuropean Medicines Agency· 2 events

2016-09-09Accelerated approval

Accelerated approval: Cabometyx (EMA)

Indication: Renal Cell Carcinoma (RCC) Cabometyx is indicated as monotherapy for advanced renal cell carcinoma as first-line treatment of adult patients with intermediate or poor risk, in… Show full indication

Renal Cell Carcinoma (RCC) Cabometyx is indicated as monotherapy for advanced renal cell carcinoma as first-line treatment of adult patients with intermediate or poor risk, in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. Cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. Hepatocellular carcinoma (HCC)Cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.Differentiated thyroid carcinoma (DTC)Cabometyx is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy.Neuroendocrine Tumours (NET)Cabometyx is indicated for the treatment of adult patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues.

Evidence ↗

2014-03-21Approval

Approval: Cometriq (EMA)

Indication: Treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

194 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

194

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 194

Early Phase 11Phase 131Phase 1 / 217Phase 2116Phase 324Phase 44Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Randomized, Double-blind Study To Evaluate the Efficacy and Safety of Cabozantinib (XL184) at 60 mg/Day Compared to a 140 mg/Day in Progressive, Metastatic Medullary Thyroid Cancer Patients

Active, not recruitingPH IVExelixisn=2472035

A Multicenter Prospective-Retrospective Real-World Study Evaluating Conversion-to-Surgery and Survival After Genotype-Matched Neoadjuvant Systemic Therapy in Locally Advanced Thyroid Carcinoma

Not yet recruitingPH IVFujian Medical Universityn=3352028

Cabozantinib and Nivolumab Among Older Patients With Renal-cell Carcinoma, a Prospective Cohort With Geriatric, Pharmacologic and Patient-reported-outcome Evaluation

RecruitingPH IVGustave Roussy, Cancer Campus, Grand Parisn=502028

CLERANCE HCC, Cabozantinib toLERANCE Study in HepatoCellular Carcinoma

CompletedPH IVHospices Civils de Lyonn=1102021

A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for Treatment of RET-Mutated Medullary Thyroid Cancer.

WithdrawnPH IIIHoffmann-La Roche2035

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase I Study of Cabozantinib and Pamiparib to Evaluate Triple Inhibition of PARP, VEGFR and c-MET in Advanced Homologous Recombination Deficient Malignancies

CompletedPH IM.D. Anderson Cancer Centern=442026

A National Phase I Study of Cabozantinib in Combination With 13-cis-Retinoic Acid in Children With Relapsed or Refractory Solid Tumors

CompletedPH IPeter Zagen=152026

A Phase II, Multicentre, Open-label Study of Cabozantinib as 2nd Line Treatment in Subjects With Unresectable, Locally Advanced or Metastatic Renal Cell Carcinoma With a Clear-Cell Component Who Progressed After 1st Line Treatment With Checkpoint Inhibitors.

CompletedPH IIIpsenn=1272026

Biomarker Phase II Study Of Cabozantinib In Advanced Radioactive-Iodine Refractory Differentiated Thyroid Cancer.

CompletedPH IIGrupo Espanol de Tumores Neuroendocrinosn=412025

A Phase 1b Clinical Trial of Cabozantinib and Abiraterone With Checkpoint Inhibitor Immunotherapy in Metastatic Hormone Sensitive Prostate Cancer (CABIOS Trial)

CompletedPH IWashington University School of Medicinen=182025

A Phase II of Single Agent Cabozantinib in Patients With Locally Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma Post Immunotherapy or Who Are Unsuitable for Immunotherapy (ANZUP1802)

CompletedPH IIAustralian and New Zealand Urogenital and Prostate Cancer Trials Groupn=352025

Research activity

13 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20132025

Most influential

Cabozantinib in Patients with Advanced and Progressing Hepatocellular Carcinoma.

The New England journal of medicine · 2018 · 1,808 cites

Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma.

The New England journal of medicine · 2021 · 1,297 cites

Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma.

The New England journal of medicine · 2015 · 890 cites

Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trial.

The Lancet. Oncology · 2016 · 701 cites

Molecular targeted and immune checkpoint therapy for advanced hepatocellular carcinoma.

Journal of experimental & clinical cancer research : CR · 2019 · 162 cites

Phase 3 Trial of Cabozantinib to Treat Advanced Neuroendocrine Tumors.

The New England journal of medicine · 2025 · 78 cites

Related diseases

2 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Approved indications

Carcinoma, Renal Cell3

Active research areas

Kidney Neoplasms3

Related drugs

8 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Atezolizumab

Studied across 6 of the same disease areas as Cabozantinib in the shared literature.

6 shared diseases1 shared paper

Ipilimumab

Studied across 4 of the same disease areas as Cabozantinib in the shared literature.

4 shared diseases1 shared paper

Lenvatinib

Studied across 4 of the same disease areas as Cabozantinib in the shared literature.

4 shared diseases1 shared paper

Sunitinib

Studied across 4 of the same disease areas as Cabozantinib in the shared literature.

4 shared diseases1 shared paper

Docetaxel

Studied across 2 of the same disease areas as Cabozantinib in the shared literature.

2 shared diseases1 shared paper

Everolimus

Studied across 2 of the same disease areas as Cabozantinib in the shared literature.

2 shared diseases1 shared paper

Pralsetinib

Studied across 2 of the same disease areas as Cabozantinib in the shared literature.

2 shared diseases1 shared paper

Regorafenib

Studied across 2 of the same disease areas as Cabozantinib in the shared literature.

2 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.