Zanzalintinib

Phase 3Small molecule

Merck & Co.

Zanzalintinib is one of 472 small molecule programs targeting Clear Cell Renal Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

471

Competitors

Pipeline

Status by Indication[3][1]

Indication

Clear Cell Renal CarcinomaActive, not recruiting

LeiomyosarcomaActive, not recruiting

Kidney CancerActive, not recruiting

Adenoid Cystic CarcinomaNot yet recruiting

Pancreatic Neuroendocrine TumorRecruiting

Uterine CancerActive, not recruiting

Liver CancerActive, not recruiting

MeningiomaActive, not recruiting

Bone SarcomaActive, not recruiting

Neuroendocrine NeoplasmActive, not recruiting

Clear Cell Renal CarcinomaPhase 2

Active, not recruiting

LeiomyosarcomaPhase 2

Active, not recruiting

Kidney CancerPhase 3

Active, not recruiting

Adenoid Cystic CarcinomaPhase 2

Not yet recruiting

Pancreatic Neuroendocrine TumorPreclinical

Recruiting

Uterine CancerPhase 1

Active, not recruiting

Liver CancerPhase 1/Phase 2

Active, not recruiting

MeningiomaPhase 2

Active, not recruiting

Bone SarcomaPhase 2

Active, not recruiting

Neuroendocrine NeoplasmPhase 2

Active, not recruiting

Showing 10 of 28 indications

Competition

Competitive Landscape

1399 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Zanzalintinib

Merck & Co.

Phase 3

32 2

Mekinist

Novartis

Preclinical

3 3

Viagra

VViatris Specialty LLC

Preclinical

1 4

Ranexa

MMenarini International Operations Luxembourg SA

Preclinical

1 5

Prednisone/prednisolone

Roche

Preclinical

3 6

Triptorelin Pamoate

Ipsen

Preclinical

2 7

Osmitrol

BB. Braun Medical Inc.

Preclinical

—8

Xylocaine

CCitius Pharmaceuticals, Inc.

Preclinical

—9

Naropin

FFresenius Kabi Oncology Ltd.

Preclinical

—10

Therapeutic Hydrocortisone

EEastern Cooperative Oncology Group

Preclinical

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

Timeline

Expected Milestones

Q2 2027

Phase 2Recruiting

Hepatocellular Carcinoma

NCT06698250

Phase 1Recruiting

Pembrolizumab

NCT06912087

Q3 2027

Phase 2Not yet recruiting

Hepatocellular Cancer

NCT07226063

Q4 2027

Phase 1Recruiting

Solid Tumor

NCT06952010

Q4 2028

Phase 2Not yet recruiting

Colon Cancer Metastatic

NCT07677579

Clinical

Trials by Indication[1]

Renal Cell Carcinoma5 trials

Study of Zanzalintinib (XL092) + AB521 and Zanzalintinib + AB521 + Nivolumab in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Other Advanced Solid Tumors (STELLAR-009)

Terminated·EExelixis·Phase 1·NCT06191796·25 enrolled

Neoadjuvant Zanzalintinib Plus Nivolumab in Patients With Locally Advanced and/or Inoperable Clear Cell Renal Cell Carcinoma With or Without Non-measurable Metastasis

Recruiting·QQian Qin·Phase 2·NCT06794229·69 enrolled

Zanzalintinib for Metastatic Clear Cell Renal Cell Carcinoma With Bone Metastases

Not yet recruiting·KKelly Fitzgerald, MD·Phase 2·NCT07043608·20 enrolled

Show 2 more trials

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)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT07227402·904 enrolled

A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (KEYMAKER-U03): Substudy 03C in Participants With Recurrent Disease During or After Anti-PD-(L)1 Adjuvant Therapy

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT07049926·140 enrolled

Thyroid Cancer2 trials

A Multi-Center Single-Arm Phase 2 Trial Of Zanzalintinib In Combination With Cemiplimab In BRAF Wild-Type Anaplastic Thyroid Cancer: The ZEPHYR Trial

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07470489·12 enrolled

Zanzalintinib for the Treatment of Advanced Thyroid Cancer Before Surgery

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06959511·45 enrolled

Leiomyosarcoma2 trials

Zanzalintinib Combined With Eribulin in Advanced Liposarcoma and Leiomyosarcoma

Recruiting·WWashington University School of Medicine·Phase 1·NCT06957431·18 enrolled

XL092 (Zanzalintinib) for the Treatment of Patients With Metastatic or Unresectable Leiomyosarcoma

Recruiting·NNorthwestern University·Phase 2·NCT06571734·29 enrolled

Metastatic Soft-tissue Sarcoma2 trials

Phase 2 Trial of Zanzalintinib and Pembrolizumab in Select Subtypes of Advanced/Metastatic Soft-tissue Sarcoma

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07283731·20 enrolled

Phase I Study With Expansion Cohort of Zanzalintinib in Combination With Ipilimumab and Nivolumab in Patients With Metastatic Soft Tissue Sarcoma

Recruiting·WWashington University School of Medicine·Phase 1·NCT06968988·18 enrolled

Neuroendocrine Neoplasm1 trial

Zanzalintinib Maintenance in Patients With High Grade Neuroendocrine Neoplasms (HG-NENs)

Recruiting·WWashington University School of Medicine·Phase 2·NCT06926634·32 enrolled

20 more indications

Hepatocellular Cancer1 trial

Maintenance Zanzalintinib and Durvalumab in Participants With Advanced Hepatocellular Cancer

Not yet recruiting·AAmit Mahipal·Phase 2·NCT07226063·16 enrolled

AIN1 trial

Maintenance Zanzalintinib With Etoposide After HDCT in GCT

Recruiting·IIndiana University·Phase 1/2·NCT06937866·38 enrolled

Uterine Cancer1 trial

Zanzalintinib in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer

Recruiting·WWashington University School of Medicine·Phase 1·NCT06795009·36 enrolled

Urothelial Carcinoma1 trial

Zanzalintinib for Advanced Urothelial Carcinoma Progressing After Prior Therapy

Not yet recruiting·GGuru Sonpavde·Phase 2·NCT07185945·44 enrolled

Moderate Hepatic Impairment1 trial

Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)

Recruiting·EExelixis·Phase 1·NCT06962332·20 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Active, not recruiting·EExelixis·Phase 2/3·NCT06082167·600 enrolled

Hepatocellular Carcinoma1 trial

Zanzalintinib (XL-092) Plus Durvalumab and Tremelimumab in Unresectable Hepatocellular Carcinoma (ZENOBIA)

Recruiting·AAnwaar Saeed·Phase 2·NCT06698250·40 enrolled

Pembrolizumab1 trial

Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC

Recruiting·UUniversity of Chicago·Phase 1·NCT06912087·36 enrolled

Meningioma1 trial

A Phase 2, Single-Arm, Multicenter, Open-Label Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma

Recruiting·EExelixis·Phase 2·NCT07428616·100 enrolled

Carcinoma, Renal Cell1 trial

A Phase 3, Randomized, Double-blind, Study of Belzutifan + Zanzalintinib Versus Belzutifan + Placebo in Participants With Advanced RCC Who Have Progressed on or After Both PD-1/L1 and VEGF-TKI Therapies in Sequence or in Combination (LITESPARK-034)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT07489495·758 enrolled

Clear Cell Renal Cell Carcinoma1 trial

A Phase 2 Multicenter Single-Arm Clinical Trial of Zanzalintinib and Pembrolizumab in Subjects With Resectable Clear Cell Renal Cell Carcinoma

Not yet recruiting·YYonsei University·Phase 2·NCT07691476·48 enrolled

Pancreatic Neuroendocrine Tumor1 trial

A Phase 2/3, Multicenter, Randomized Open-Label Study of Zanzalintinib vs Everolimus in Participants With Previously Treated, Unresectable, Locally Advanced or Metastatic Neuroendocrine Tumors

Recruiting·EExelixis·Preclinical·NCT06943755·440 enrolled

Adenoid Cystic Carcinoma1 trial

ZANACC: Phase 2 Non-randomized Single Arm Study Evaluating Zanzalintinib in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma of the Head and Neck

Not yet recruiting·UUNICANCER·Phase 2·NCT07682675·51 enrolled

Colon Cancer Metastatic1 trial

NIMBLE-CRC: NeoImmunoModulation Before Leveraging Excision in Colorectal Rectal Cancer

Not yet recruiting·NNorthwell Health·Phase 2·NCT07677579·26 enrolled

Aggressive Variant Prostate Carcinoma1 trial

Phase II Study of Zanzalintinib in Men With Aggressive Variant Prostate Cancer (NAPOLEON Study)

Not yet recruiting·DDeepak Kilari·Phase 2·NCT07218666·30 enrolled

Differentiated Thyroid Gland Carcinoma1 trial

A Phase 2 Open Label Study of XL092 as First Line Therapy in Radioiodine Refractory Differentiated Thyroid Cancer

Recruiting·NNorthwestern University·Phase 2·NCT06959641·33 enrolled

Advanced Hepatocellular Carcinoma1 trial

A Phase Ib/II Study of Zanzalintinib in Second Line and Beyond for the Treatment of Advanced Hepatocellular Carcinoma

Recruiting·NNorthwestern University·Preclinical·NCT07042919·59 enrolled

Solid Tumor1 trial

A Phase 1 Dose Escalation and Expansion Study of XB628 as a Single Agent and in Combination With Zanzalintinib in Participants With Advanced or Metastatic Solid Tumors

Recruiting·EExelixis·Phase 1·NCT06952010·303 enrolled

Bone Sarcoma1 trial

A Phase 2 Trial of Zanzalintinib in Advanced/Metastatic Bone Sarcomas (ZAMBONE)

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07193550·70 enrolled

Renal Cell Carcinoma (RCC)1 trial

A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors

Recruiting·EExelixis·Phase 1·NCT05176483·1,314 enrolled

Sources

References

[1]
ClinicalTrials.gov — 32 trial records for Zanzalintinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Zanzalintinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Zanzalintinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Merck & Co. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Merck & Co.

Zanzalintinib

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2027

Q4 2027

Q4 2028

Trials by Indication[1]

Renal Cell Carcinoma5 trials

Thyroid Cancer2 trials

Leiomyosarcoma2 trials

Metastatic Soft-tissue Sarcoma2 trials

Neuroendocrine Neoplasm1 trial

Hepatocellular Cancer1 trial

AIN1 trial

Uterine Cancer1 trial

Urothelial Carcinoma1 trial

Moderate Hepatic Impairment1 trial

Head and Neck Squamous Cell Carcinoma1 trial

Hepatocellular Carcinoma1 trial

Pembrolizumab1 trial

Meningioma1 trial

Carcinoma, Renal Cell1 trial

Clear Cell Renal Cell Carcinoma1 trial

Pancreatic Neuroendocrine Tumor1 trial

Adenoid Cystic Carcinoma1 trial

Colon Cancer Metastatic1 trial

Aggressive Variant Prostate Carcinoma1 trial

Differentiated Thyroid Gland Carcinoma1 trial

Advanced Hepatocellular Carcinoma1 trial

Solid Tumor1 trial

Bone Sarcoma1 trial

Renal Cell Carcinoma (RCC)1 trial

References

Drug Info

Quick Facts

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