Cometriq

(Cabozantinib S-malate)

Phase 3

EExelixis

Cometriq is one of 101 small molecule programs targeting Advanced Renal Cell Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

100

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Advanced Renal Cell CarcinomaActive, not recruiting

OsteosarcomaRecruiting

MelanomaActive, not recruiting

Functioning Pancreatic Neuroendocrine TumorActive, not recruiting

Advanced Breast CarcinomaRecruiting

Adrenal Cortical CarcinomaActive, not recruiting

Advanced Hepatocellular CarcinomaRecruiting

Differentiated Thyroid Gland CarcinomaActive, not recruiting

Metastatic Large Cell Neuroendocrine CarcinomaActive, not recruiting

Metastatic Papillary Renal Cell CarcinomaActive, not recruiting

Advanced Renal Cell CarcinomaPhase 2

Active, not recruiting

OsteosarcomaPreclinical

Recruiting

MelanomaPhase 2

Active, not recruiting

Functioning Pancreatic Neuroendocrine TumorPhase 3

Active, not recruiting

Advanced Breast CarcinomaPhase 1

Recruiting

Adrenal Cortical CarcinomaPhase 2

Active, not recruiting

Advanced Hepatocellular CarcinomaPreclinical

Recruiting

Differentiated Thyroid Gland CarcinomaPhase 2

Active, not recruiting

Metastatic Large Cell Neuroendocrine CarcinomaPhase 2

Active, not recruiting

Metastatic Papillary Renal Cell CarcinomaPhase 2

Active, not recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

191 competitors in Melanoma

#DrugCompanyPhaseTrials

Opdivo

Mekinist

45 3

Keytruda

Merck & Co.

Phase 3

95 4

Cotellic

Roche

Phase 3

21 5

Zelboraf

CConrado Roberto Hoffmann Filho

Phase 3

39 6

Taxol

Teva

Phase 3

13 7

Tecentriq

Roche

Phase 3

11 8

Proleukin

IIovance Biotherapeutics, Inc.

Phase 3

28 9

Libtayo

Regeneron

Phase 3

6 10

Opdualag

Bristol-Myers Squibb

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 1Active, not recruiting

Bladder Small Cell Neuroendocrine Carcinoma

NCT02496208

Q4 2026

Phase 2Active, not recruiting

Advanced Renal Cell Carcinoma

NCT04071223

Phase 2Active, not recruiting

Differentiated Thyroid Gland Carcinoma

NCT03914300

Phase 2Active, not recruiting

Metastatic Lung Non-Squamous Non-Small Cell Carcinoma

NCT04310007

Q1 2027

Phase 2Recruiting

Clinical Stage III Cutaneous Melanoma AJCC V8

NCT05136196

Phase 2Active, not recruiting

Skin Angiosarcoma

NCT04339738

Clinical

Trials by Indication[1]

Clinical Stage III Cutaneous Melanoma AJCC v81 trial

Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726) (BiCaZO) - A Phase II Study of Combining Cabozantinib and Nivolumab in Participants With Advanced Solid Tumors (IO Refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05136196·150 enrolled

Bladder Adenocarcinoma1 trial

A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03866382·314 enrolled

Metastatic Nasopharyngeal Carcinoma1 trial

Randomized Phase 2 Study of Nivolumab and Ipilimumab With or Without Cabozantinib in Patients With Advanced Nasopharyngeal Carcinoma That Have Progressed After Platinum Treatment and Immunotherapy

Suspended·NNational Cancer Institute (NCI)·Phase 2·NCT05904080·50 enrolled

Bladder Small Cell Neuroendocrine Carcinoma1 trial

A Phase 1 Study of Cabozantinib Plus Nivolumab (CaboNivo) Alone or in Combination With Ipilimumab (CaboNivoIpi) in Patients With Advanced/Metastatic Urothelial Carcinoma and Other Genitourinary Tumors

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT02496208·152 enrolled

Metastatic Lung Non-Squamous Non-Small Cell Carcinoma1 trial

A Randomized Phase II Trial of Cabozantinib and Cabozantinib Plus Nivolumab Versus Standard Chemotherapy in Patients With Previously Treated Non-Squamous NSCLC

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04310007·117 enrolled

14 more indications

Recurrent Lung Non-Small Cell Carcinoma1 trial

A Randomized Phase II Trial of Erlotinib, Cabozantinib, or Erlotinib Plus Cabozantinib as 2nd or 3rd Line Therapy in Patients With EGFR Wild-Type NSCLC

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT01708954·125 enrolled

Advanced Endometrial Carcinoma1 trial

A Randomized Phase 2 Study of Cabozantinib in Combination With Nivolumab in Advanced, Recurrent Metastatic Endometrial Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03367741·82 enrolled

Skin Angiosarcoma1 trial

A Multicenter Phase II Trial of Paclitaxel With and Without Nivolumab in Taxane Naive, and Nivolumab and Cabozantinib in Taxane Pretreated Subjects With Angiosarcoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04339738·90 enrolled

Osteosarcoma1 trial

A Feasibility and Randomized Phase 2/3 Study of the VEGFR2/MET Inhibitor Cabozantinib in Combination With Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma

Suspended·NNational Cancer Institute (NCI)·Preclinical·NCT05691478·1,122 enrolled

Metastatic Papillary Renal Cell Carcinoma1 trial

A Phase II Randomized Trial of Cabozantinib (NSC #761968) With or Without Atezolizumab (NSC #783608) in Patients With Advanced Papillary Renal Cell Carcinoma (PAPMET2)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05411081·200 enrolled

Advanced Hepatocellular Carcinoma1 trial

A Phase I/II Trial of Sapanisertib in Combination With Cabozantinib in ß-catenin-mutated Hepatocellular Carcinoma (SAPHIRE)

Recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT06811116·92 enrolled

Adrenal Cortical Carcinoma1 trial

Phase 2 Trial of XL184 (Cabozantinib) an Oral Small-Molecule Inhibitor of Multiple Kinases, in Children and Young Adults With Refractory Sarcomas, Wilms Tumor, and Other Rare Tumors

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02867592·109 enrolled

Metastatic Ewing Sarcoma1 trial

A Phase 2 Study of XL184 (Cabozantinib) in Treating Patients With Relapsed Osteosarcomas and Ewing Sarcomas

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02243605·90 enrolled

Functioning Pancreatic Neuroendocrine Tumor1 trial

Randomized, Double-Blinded Phase III Study of CABozantinib Versus Placebo IN Patients With Advanced NEuroendocrine Tumors After Progression on Prior Therapy (CABINET)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT03375320·298 enrolled

Melanoma1 trial

A Randomized Phase II Trial of Adjuvant Nivolumab With or Without Cabozantinib in Patients With Resected Mucosal Melanoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05111574·101 enrolled

Metastatic Large Cell Neuroendocrine Carcinoma1 trial

A Phase 2 Study of XL184 (Cabozantinib) in Combination With Nivolumab and Ipilimumab for the Treatment of Poorly Differentiated Neuroendocrine Carcinomas

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04079712·17 enrolled

Advanced Renal Cell Carcinoma1 trial

A Phase II Randomized Trial of Radium-223 Dichloride and Cabozantinib in Patients With Advanced Renal Cell Carcinoma With Bone Metastasis (RadiCal)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04071223·134 enrolled

Differentiated Thyroid Gland Carcinoma1 trial

Phase II Study of XL184 (Cabozantinib) in Combination With Nivolumab and Ipilimumab (CaboNivoIpi) in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer Whose Cancer Progressed After One Prior VEGFR-Targeted Therapy

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03914300·11 enrolled

Advanced Breast Carcinoma1 trial

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

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT05092373·43 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 29, 2012

COMETRIQ

NDA NDA203756

Apr 25, 2016

CABOMETYX

NDA NDA208692

Sources

References

[1]
ClinicalTrials.gov — 19 trial records for Cabozantinib S-malate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Cabozantinib S-malate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Cabozantinib S-malate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA208692). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Cometriq. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Exelixis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Highest Phase: Phase 3[1]
Company: EExelixis

Patent Landscape[5]

Patent Cliff

Jan 15, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7579473Aug 14, 2026

11091439Jan 15, 2030

11091440Jan 15, 2030

11098015Jan 15, 2030

8877776Oct 8, 2030

6 more patents

10039757Jul 18, 2031

10034873Jul 18, 2031

9717720Feb 10, 2032

12128039Feb 10, 2032

11298349Feb 10, 2032

9724342Jul 9, 2033

Cometriq

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Trials by Indication[1]

Clinical Stage III Cutaneous Melanoma AJCC v81 trial

Bladder Adenocarcinoma1 trial

Metastatic Nasopharyngeal Carcinoma1 trial

Bladder Small Cell Neuroendocrine Carcinoma1 trial

Metastatic Lung Non-Squamous Non-Small Cell Carcinoma1 trial

Recurrent Lung Non-Small Cell Carcinoma1 trial

Advanced Endometrial Carcinoma1 trial

Skin Angiosarcoma1 trial

Osteosarcoma1 trial

Metastatic Papillary Renal Cell Carcinoma1 trial

Advanced Hepatocellular Carcinoma1 trial

Adrenal Cortical Carcinoma1 trial

Metastatic Ewing Sarcoma1 trial

Functioning Pancreatic Neuroendocrine Tumor1 trial

Melanoma1 trial

Metastatic Large Cell Neuroendocrine Carcinoma1 trial

Advanced Renal Cell Carcinoma1 trial

Differentiated Thyroid Gland Carcinoma1 trial

Advanced Breast Carcinoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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