Cometriq

(Cabozantinib S-malate)

Phase 3

EExelixis

Cometriq is one of 84 small molecule programs targeting Osteosarcoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

OsteosarcomaRecruiting

MelanomaActive, not recruiting

Clinical Stage III Cutaneous Melanoma AJCC V8Recruiting

Recurrent Lung Non-Small Cell CarcinomaActive, not recruiting

Advanced Renal Cell CarcinomaActive, not recruiting

Metastatic Lung Non-Squamous Non-Small Cell CarcinomaActive, not recruiting

Functioning Pancreatic Neuroendocrine TumorActive, not recruiting

Bladder AdenocarcinomaRecruiting

OsteosarcomaPreclinical

Recruiting

MelanomaPhase 2

Active, not recruiting

Clinical Stage III Cutaneous Melanoma AJCC V8Phase 2

Recruiting

Recurrent Lung Non-Small Cell CarcinomaPhase 2

Active, not recruiting

Advanced Renal Cell CarcinomaPhase 2

Active, not recruiting

Metastatic Lung Non-Squamous Non-Small Cell CarcinomaPhase 2

Active, not recruiting

Functioning Pancreatic Neuroendocrine TumorPhase 3

Active, not recruiting

Bladder AdenocarcinomaPhase 2

Recruiting

Competition

Competitive Landscape

947 competitors in Melanoma

#DrugCompanyPhaseTrials

Leukine

Sanofi

Phase 3

21 2

Tecentriq

Roche

Phase 3

11 3

Proleukin

IIovance Biotherapeutics, Inc.

Phase 3

27 4

Libtayo

Regeneron

Phase 3

6 5

Imjudo

AstraZeneca

Phase 3

2 6

Tuoyi

SSun Yat-sen University

Phase 3

4 7

Incomplete Freund's Adjuvant

EEastern Cooperative Oncology Group

Phase 3

20 8

Cometriq

EExelixis

Phase 3

1 9

Deltavit

HHyundai Pharmaceutical Co., LTD.

Epacadostat

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

Timeline

Expected Milestones

Q3 2026

Phase 3Active, not recruiting

Functioning Pancreatic Neuroendocrine Tumor

NCT03375320

Phase 2Active, not recruiting

Melanoma

NCT05111574

Q4 2026

Phase 2Active, not recruiting

Advanced Renal Cell Carcinoma

NCT04071223

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 2Recruiting

Bladder Adenocarcinoma

NCT03866382

Clinical

Trials by Indication[1]

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

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

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

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

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

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

3 more indications

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

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

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

Regulatory

FDA Approval Timeline[4]

Nov 29, 2012

COMETRIQ

NDA NDA203756

Apr 25, 2016

CABOMETYX

NDA NDA208692

Sources

References

[1]
ClinicalTrials.gov — 8 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

Aug 14, 2026

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]

Bladder Adenocarcinoma1 trial

Osteosarcoma1 trial

Clinical Stage III Cutaneous Melanoma AJCC v81 trial

Recurrent Lung Non-Small Cell Carcinoma1 trial

Functioning Pancreatic Neuroendocrine Tumor1 trial

Metastatic Lung Non-Squamous Non-Small Cell Carcinoma1 trial

Melanoma1 trial

Advanced Renal Cell Carcinoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Related News