EXELIXIS, INC. (EXEL)
Exelixis, Inc. operates as a biotechnology firm dedicated to combating cancer, primarily focusing on the identification, advancement, and marketing of novel oncological treatments within the United States. Its portfolio of commercially available therapeutics includes CABOMETYX tablets, prescribed for individuals with advanced renal cell carcinoma who have previously undergone anti-angiogenic treatment, and COMETRIQ capsules, utilized for managing progressive and metastatic medullary thyroid cancer. Both CABOMETYX and COMETRIQ originate from cabozantinib, a compound that inhibits several tyrosine kinases such as MET, AXL, RET, and VEGF receptors. Additionally, Exelixis offers COTELLIC, an MEK inhibitor employed in combination therapies for advanced melanoma, and MINNEBRO, an orally administered, non-steroidal selective mineralocorticoid receptor blocker, approved for hypertension treatment in Japan. The company's developmental pipeline features several promising candidates, such as XL092, an oral tyrosine kinase inhibitor designed to target VEGF receptors, MET, AXL, MER, and other kinases crucial for cancer proliferation; XB002, an antibody-drug conjugate containing a human monoclonal antibody against tissue factor (TF), intended for advanced solid tumors and non-Hodgkin's lymphoma; and XL102, an orally available cyclin-dependent kinase 7 (CDK7) inhibitor being developed for advanced or metastatic solid tumors. Exelixis, Inc. maintains extensive research partnerships and licensing arrangements with numerous pharmaceutical and biotechnology entities, including Ipsen Pharma SAS, Takeda Pharmaceutical Company Ltd., F. Hoffmann-La Roche Ltd., Redwood Bioscience, Inc., R.P. Scherer Technologies, LLC, Catalent Pharma Solutions, Inc., NBE Therapeutics AG, Aurigene Discovery Technologies Limited, Iconic Therapeutics, Inc., Invenra, Inc., StemSynergy Therapeutics, Inc., Genentech, Inc., Bristol-Myers Squibb Company, and Daiichi Sankyo Company, Limited. Established in 1994, the company originally operated as Exelixis Pharmaceuticals, Inc. before rebranding to Exelixis, Inc. in February 2000. Its corporate headquarters are located in Alameda, California.
Sector: Biological Products, (No Diagnostic Substances)
Industry: Biotechnology
Exelixis, Inc.
- zanzalintinibPDUFApreviously treated metastatic colorectal cancer
- zanzalintinibPDUFAmetastatic colorectal cancer
- zanzalintinibREADOUT
Trials need funding. See this company's dilution risk and cash position.
- Phase 4Active, not recruiting
A Study of Two Different Doses of Cabozantinib (XL184) in Progressive, Metastatic Medullary Thyroid Cancer
Cabozantinib (XL184) 140 mg, Cabozantinib (XL184) 60 mg
Medullary Thyroid Cancer
NCT01896479Enrollment247StartFeb 2015Primary CompletionJul 2020CompletionJan 2035est. - Phase 3Completed
Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer
XL184, Placebo
Thyroid Cancer
NCT00704730Enrollment330StartJun 2008Primary CompletionOct 2011CompletionSep 2020 - Phase 3Terminated
Study of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer
cabozantinib, mitoxantrone
Prostate Cancer, Castration Resistant Prostate Cancer +2
NCT01522443Enrollment119StartMar 2012Primary CompletionOct 2014CompletionJan 2015 - Phase 3Completed
Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100
cabozantinib, prednisone
Prostate Cancer, Castration Resistant Prostate Cancer +2
NCT01605227Enrollment1,028StartJul 2012Primary CompletionSep 2014CompletionMar 2015 - Phase 3Completed
A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma
Cabozantinib tablets, Everolimus (Afinitor) tablets
Renal Cell Carcinoma
NCT01865747Enrollment658StartJun 2013Primary CompletionMay 2015CompletionJan 2021 - Phase 3Completed
Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib
Cabozantinib tablets, Placebo tablets
Hepatocellular Carcinoma
NCT01908426Enrollment707StartSep 2013Primary CompletionOct 2017CompletionJan 2021 - Phase 3Active, not recruiting
A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy
Cabozantinib, Placebo
Differentiated Thyroid Cancer
NCT03690388Enrollment187StartOct 2018Primary CompletionAug 2020CompletionJul 2027est. - Phase 3Active, not recruiting
Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy
Cabozantinib, Cabozantinib
Hepatocellular Carcinoma
NCT03755791Enrollment837StartJun 2018Primary CompletionNov 2021CompletionJul 2026est. - Phase 3Active, not recruiting
Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
Cabozantinib, Nivolumab
Renal Cell Carcinoma
NCT03937219Enrollment855StartJun 2019Primary CompletionJan 2022CompletionJan 2027est. - Phase 3Active, not recruiting
Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC
Cabozantinib, Atezolizumab
Metastatic Prostate Cancer, Prostate Adenocarcinoma
NCT04446117Enrollment575StartOct 2020Primary CompletionApr 2024CompletionOct 2026est. - Phase 3Active, not recruiting
Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer
XL092, Atezolizumab
Colorectal Cancer
NCT05425940Enrollment901StartSep 2022Primary CompletionJun 2026CompletionJan 2027est. - Phase 3Active, not recruiting
Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma
XL092, Nivolumab
Non-Clear Cell Renal Cell Carcinoma
NCT05678673Enrollment317StartJan 2023Primary CompletionDec 2026est.CompletionJun 2028est. - Phase 3Enrolling by invitation
Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study
Cabozantinib, Zanzalintinib
Cancer, Renal Cell Carcinoma (RCC) +7
NCT07620574Enrollment5,000StartJul 2026Primary CompletionMay 2030est.CompletionMay 2030est. - Phase 3Recruiting
Zanzalintinib Alone or in Combination With Pembrolizumab and Berahyaluronidase Alfa in Participants With Colorectal Cancer With Molecular Residual Disease
Zanzalintinib, Pembrolizumab (+) Berahyaluronidase alfa
Colorectal Cancer
NCT07750158Enrollment600StartAug 2026est.Primary CompletionApr 2030est.CompletionApr 2030est. - Phase 2/3Active, not recruiting
Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Zanzalintinib, Zanzalintinib-matched Placebo
Head and Neck Squamous Cell Carcinoma
NCT06082167Enrollment600StartJun 2024Primary CompletionAug 2028est.CompletionMar 2029est. - Phase 2/3Recruiting
Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
Zanzalintinib, Everolimus
Pancreatic Neuroendocrine Tumor (pNET), Extra-Pancreatic Neuroendocrine Tumor (epNET)
NCT06943755Enrollment440StartJul 2025Primary CompletionJun 2029est.CompletionJun 2029est. - Phase 2Completed
A Phase 2 Study of XL820 in Adults With Advanced GIST Resistant to Imatinib and/or Sunitinib
XL820, XL820
Gastrointestinal Stromal Tumors, Gastrointestinal Neoplasms
NCT00570635Enrollment16StartDec 2007Primary CompletionMay 2009CompletionMay 2009 - Phase 2Completed
Study of XL184 (Cabozantinib) in Adults With Glioblastoma Multiforme
XL184
Glioblastoma Multiforme
NCT00704288Enrollment222StartMay 2008Primary CompletionJun 2012CompletionDec 2012 - Phase 2Completed
Study of Cabozantinib (XL184) in Adults With Advanced Malignancies
Cabozantinib, Placebo
Solid Tumors, Cancer
NCT00940225Enrollment730StartSep 2009Primary CompletionMay 2013CompletionJun 2014 - Phase 2Terminated
Multiple Doses and Regimens of Cabozantinib in Subjects With Grade IV Astrocytic Tumors in First or Second Relapse
Cabozantinib
Astrocytic Tumors
NCT01068782Enrollment19StartApr 2010Primary CompletionMay 2011CompletionOct 2013 - Phase 2Terminated
Combo of Cabozantinib With Abiraterone in Chemotherapy-Naïve Subjects With Bone-Metastatic CRPC
cabozantinib, abiraterone
Prostate Cancer, Castration Resistant Prostate Cancer +1
NCT01995058Enrollment54StartFeb 2014Primary CompletionNov 2014CompletionNov 2014 - Phase 2Recruiting
A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma
Zanzalintinib
Meningioma
NCT07428616Enrollment100StartMay 2026Primary CompletionFeb 2028est.CompletionSep 2029est. - Phase 2Not yet recruiting
Zanzalintinib and Pembrolizumab in First-Line Maintenance for Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
Carboplatin, Paclitaxel
Squamous Non-Small Cell Lung Cancer (NSCLC)
NCT07845786Enrollment60StartDec 2026est.Primary CompletionJun 2028est.CompletionJun 2030est. - Phase 1/2Completed
A Study of XL184 (Cabozantinib) With or Without Erlotinib in Subjects With Non-Small Cell Lung Cancer (NSCLC)
XL184, erlotinib
Carcinoma, Non-Small-Cell Lung
NCT00596648Enrollment92StartFeb 2008Primary CompletionAug 2012CompletionAug 2012 - Phase 1Completed
Study of XL820 in Adults With Solid Tumors
XL820
Cancer
NCT00129571Enrollment-StartAug 2005Primary Completion-Completion-
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 4 | Active, not recruiting | Cabozantinib (XL184) 140 mg, Cabozantinib (XL184) 60 mg | NCT01896479 |
| Phase 3 | Completed | XL184, Placebo | NCT00704730 |
| Phase 3 | Terminated | cabozantinib, mitoxantrone | NCT01522443 |
| Phase 3 | Completed | cabozantinib, prednisone | NCT01605227 |
| Phase 3 | Completed | Cabozantinib tablets, Everolimus (Afinitor) tablets | NCT01865747 |
| Phase 3 | Completed | Cabozantinib tablets, Placebo tablets | NCT01908426 |
| Phase 3 | Active, not recruiting | Cabozantinib, Placebo | NCT03690388 |
| Phase 3 | Active, not recruiting | Cabozantinib, Cabozantinib | NCT03755791 |
| Phase 3 | Active, not recruiting | Cabozantinib, Nivolumab | NCT03937219 |
| Phase 3 | Active, not recruiting | Cabozantinib, Atezolizumab | NCT04446117 |
| Phase 3 | Active, not recruiting | XL092, Atezolizumab | NCT05425940 |
| Phase 3 | Active, not recruiting | XL092, Nivolumab | NCT05678673 |
| Phase 3 | Enrolling by invitation | Cabozantinib, Zanzalintinib | NCT07620574 |
| Phase 3 | Recruiting | Zanzalintinib, Pembrolizumab (+) Berahyaluronidase alfa | NCT07750158 |
| Phase 2/3 | Active, not recruiting | Zanzalintinib, Zanzalintinib-matched Placebo | NCT06082167 |
| Phase 2/3 | Recruiting | Zanzalintinib, Everolimus | NCT06943755 |
| Phase 2 | Completed | XL820, XL820 | NCT00570635 |
| Phase 2 | Completed | XL184 | NCT00704288 |
| Phase 2 | Completed | Cabozantinib, Placebo | NCT00940225 |
| Phase 2 | Terminated | Cabozantinib | NCT01068782 |
| Phase 2 | Terminated | cabozantinib, abiraterone | NCT01995058 |
| Phase 2 | Recruiting | Zanzalintinib | NCT07428616 |
| Phase 2 | Not yet recruiting | Carboplatin, Paclitaxel | NCT07845786 |
| Phase 1/2 | Completed | XL184, erlotinib | NCT00596648 |
| Phase 1 | Completed | XL820 | NCT00129571 |
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