Drugs / Zanzalintinib
Zanzalintinib
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | colorectal cancer | 2026-01-07 | “submitted a New Drug Application to the U.S. Food & Drug Administration for zanzalintinib for the treatment of patients with previously treated metastatic colorectal cancer” exelixis.com ↗ “In February 2026, Exelixis announced that the FDA accepted its NDA for zanzalintinib as a treatment for patients with previously treated metastatic CRC” exelixis.com ↗ “its New Drug Application (NDA) for zanzalintinib, in combination with atezolizumab (Tecentriq®), has been accepted for review in the U.S.” exelixis.com ↗ “accepted the company’s New Drug Application for zanzalintinib, in combination with atezolizumab (Tecentriq®)” exelixis.com ↗ “U.S. FDA accepted its NDA for zanzalintinib as a treatment for patients with metastatic CRC” exelixis.com ↗ “the U.S. FDA accepted the company’s NDA for zanzalintinib, in combination with atezolizumab” exelixis.com ↗ “accepted the company’s New Drug Application for zanzalintinib” exelixis.com ↗ |
Trials 48
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials | ||||||
| Phase 1 | NCT06968988 | Jan 2026 → Feb 2029 | soft tissue sarcoma | Washington University School of Medicine | Suspended | No outcome recorded |
| Phase 1 | NCT06957431 | Oct 2025 → May 2031 expected | leiomyosarcoma, liposarcoma | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 1 | NCT06795009 | Oct 2025 → Nov 2029 expected | endometrial cancer | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 1 | NCT06912087 | Sep 2025 → Jun 2027 expected | head and neck neoplasm, metastatic neoplasm, squamous cell carcinoma | University of Chicago | Recruiting | No outcome recorded |
| Phase 1 | NCT06902376 | Jun 2025 → Mar 2028 expected | thyroid gland undifferentiated (anaplastic) carcinoma | UNC Lineberger Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06962332 | May → Dec 2025 overdue | — | Exelixis | Recruiting | No outcome recorded |
| Phase 1 | NCT06952010 | May 2025 → May 2027 expected | cancer, metastatic neoplasm | Exelixis | Recruiting | No outcome recorded |
| Phase 1 | NCT06191796 | Jan 2024 → May 2025 | clear cell renal carcinoma | Exelixis | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT05176483 | Dec 2021 → Jan 2027 expected | castration-resistant prostate carcinoma, clear cell renal carcinoma, colorectal cancer, head and neck squamous cell carcinoma +3 | Exelixis | Recruiting | No outcome recorded |
| Phase 1 | NCT03845166 | Mar 2019 → Aug 2026 overdue | castration-resistant prostate carcinoma, colorectal cancer, hormone receptor-positive breast cancer, renal cell carcinoma | Exelixis | Active not recruiting | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT07042919 | Mar 2026 → Mar 2029 expected | cirrhosis of liver, hepatocellular carcinoma | Devalingam Mahalingam | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06937866 | Nov 2025 → Mar 2030 expected | germ cell tumor | Indiana University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07049926 | Jul 2025 → Oct 2031 expected | renal cell carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03337698 | Dec 2017 → Oct 2025 | non-small cell lung carcinoma | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 227 trials | ||||||
| Phase 2 | NCT07714551 | Jan 2027 → Jan 2031 expected | paraganglioma, pheochromocytoma | Dana-Farber Cancer Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07845786 | Dec 2026 → Jun 2028 expected | non-small cell squamous lung carcinoma | Exelixis | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07578025 | Nov 2026 → Jun 2028 expected | clear cell renal carcinoma | City of Hope Medical Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07691476 | Oct 2026 → Oct 2028 expected | nonpapillary renal cell carcinoma | Yonsei University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07527169 | Oct 2026 → Jul 2028 expected | olfactory neuroblastoma | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07608718 | Oct 2026 → May 2029 expected | prostate carcinoma | Pedro Barata, MD, MSc | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07682675 | Oct 2026 → Apr 2029 expected | metastatic neoplasm, salivary gland adenoid cystic carcinoma | UNICANCER | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07185945 | Oct 2026 → Jun 2027 expected | urothelial carcinoma | Guru Sonpavde | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07470489 | Sep 2026 → Sep 2030 expected | thyroid gland undifferentiated (anaplastic) carcinoma | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07623460 | Sep 2026 → Sep 2028 expected | castration-resistant prostate carcinoma | Stuthi Perimbeti | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07484139 | Sep 2026 → May 2028 expected | oral cavity squamous cell carcinoma | UNC Lineberger Comprehensive Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07677579 | Aug 2026 → Aug 2028 expected | malignant colon neoplasm | Northwell Health | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07218666 | Jul 2026 → Jul 2028 expected | prostate carcinoma | Deepak Kilari | Recruiting | No outcome recorded |
| Phase 2 | NCT07283731 | Jun 2026 → Nov 2028 expected | metastatic malignant neoplasm, soft tissue sarcoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07043608 | May 2026 → Feb 2029 expected | clear cell renal carcinoma, metastatic carcinoma in the bone | Kelly Fitzgerald, MD | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07428616 | May 2026 → Feb 2028 expected | meningioma | Exelixis | Recruiting | No outcome recorded |
| Phase 2 | NCT07226063 | May 2026 → Feb 2028 expected | hepatocellular carcinoma | Amit Mahipal | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07511504 | Apr 2026 → Aug 2027 expected | hepatocellular carcinoma | OHSU Knight Cancer Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06863311 | Mar 2026 → Dec 2027 expected | clear cell renal carcinoma | Karie Runcie | Recruiting | No outcome recorded |
| Phase 2 | NCT06926634 | Dec 2025 → Dec 2034 expected | neuroendocrine neoplasm | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT07193550 | Dec 2025 → Oct 2029 expected | bone sarcoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06794229 | Oct 2025 → Jun 2028 expected | renal cell carcinoma | Qian Qin | Recruiting | No outcome recorded |
| Phase 2 | NCT06959511 | Jul 2025 → Mar 2028 expected | thyroid cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06959641 | Jun 2025 → Sep 2028 expected | poorly differentiated thyroid gland carcinoma, thyroid carcinoma, nonmedullary, with or without cell oxyphilia, thyroid gland follicular carcinoma, thyroid gland papillary carcinoma | Jochen Lorch | Recruiting | No outcome recorded |
| Phase 2 | NCT06698250 | Dec 2024 → Dec 2026 expected | hepatocellular carcinoma | Anwaar Saeed | Recruiting | No outcome recorded |
| Phase 2 | NCT06568562 | Dec 2024 → Dec 2026 expected | castration-resistant prostate carcinoma | University of Utah | Recruiting | No outcome recorded |
| Phase 2 | NCT06571734 | Sep 2024 → Jul 2028 expected | Ewing sarcoma, bone sarcoma, leiomyosarcoma, osteosarcoma +1 | Northwestern University | Recruiting | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06943755 | Jul 2025 → Jun 2029 expected | pancreatic neuroendocrine tumor | Exelixis | Recruiting | No outcome recorded |
| Phase 2/3 | NCT06082167 | Jun 2024 → Aug 2028 expected | head and neck squamous cell carcinoma | Exelixis | Active not recruiting | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT07750158 | Aug 2026 → Apr 2030 expected | colorectal cancer | Exelixis | Recruiting | No outcome recorded |
| Phase 3 | NCT07489495 | Apr 2026 → Nov 2030 expected | renal cell carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT07227402 | Nov 2025 → Feb 2032 expected | renal cell carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT05678673 | Jan 2023 → Jul 2025 overdue | renal cell adenocarcinoma | Exelixis | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05425940 | Sep 2022 → Jun 2026 overdue | colorectal cancer | Exelixis | Active not recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT07620574 Background | May 2026 → May 2030 expected | colorectal cancer, differentiated thyroid carcinoma, hepatocellular carcinoma, pancreatic neuroendocrine tumor +2 | Exelixis | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
All press releases naming this drug 23 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 50 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Zanzalintinib | “H&N NEO-COMBAT XL: Neoadjuvant XL-092 (Zanzalintinib) and Pembrolizumab (Keytruda) in Surgically Resectable, HPV Negative Oral Cavity Squamous Cell Carcinoma (OCSCC)” NCT07484139 ↗44“The TKI zanzalintinib (XL092) targets VEGFR, MET and TAM kinases, proteins that are involved in tumor growth, angiogenesis, metastasis and immunosuppression.” PMID 39041200 ↗ Jul 2024 “Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC” NCT06863311 ↗ “STELLAR-304: a phase III study of zanzalintinib (XL092) plus nivolumab in advanced non-clear cell renal cell carcinoma.” PMID 40008409 ↗ Feb 2025 |
| Known as | XL-092 FUMARATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314428 ↗ |
| Known as | XL092 | “H&N NEO-COMBAT XL: Neoadjuvant XL-092 (Zanzalintinib) and Pembrolizumab (Keytruda) in Surgically Resectable, HPV Negative Oral Cavity Squamous Cell Carcinoma (OCSCC)” NCT07484139 ↗8“The TKI zanzalintinib (XL092) targets VEGFR, MET and TAM kinases, proteins that are involved in tumor growth, angiogenesis, metastasis and immunosuppression.” PMID 39041200 ↗ Jul 2024 “Trial of Zanzalintinib (XL092) in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC” NCT06863311 ↗ “STELLAR-304: a phase III study of zanzalintinib (XL092) plus nivolumab in advanced non-clear cell renal cell carcinoma.” PMID 40008409 ↗ Feb 2025 |
| Known as | ZANZALINTINIB FUMARATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314428 ↗ |
| Known as | Zanzalintinib hemifumarate | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314428 ↗ |
| Action | Inhibit | “It works by blocking certain proteins that play important roles in the development, growth and spread of cancer.” PMID 39041200 ↗ Jul 2024 |
| Modality | Small molecule | “The TKI zanzalintinib (XL092) targets VEGFR, MET and TAM kinases” PMID 39041200 ↗ Jul 2024 |
| Route | Oral | “XL092 is administered orally once a day on Day 1 to Day 21 of a 21 day cycle.” NCT03337698 ↗ |