Zanzalintinib, Mk-34574, Xl092
Colorectal Cancer
Phase III
Not Yet Recruiting
Zanzalintinib Alone or in Combination With Pembrolizumab and Berahyaluronidase Alfa in Participants With Colorectal Cancer With Molecular Residual Disease
Aug 03, 2026
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Zanzalintinib
Hepatic Impairment, Moderate Hepatic Impairment
Phase I
Recruiting
Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)
Apr 30, 2025
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Xb628
Solid Tumor, Metastatic Solid Tumor, Advanced Solid Tumor, Immune Sensitive Tumor
Phase I
Recruiting
A Study of XB628 in Participants With Recurrent Advanced or Metastatic Solid Tumors
Apr 23, 2025
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Xl495, Adc Cytotoxic Agents
Metastatic Solid Tumor, Locally Advanced Solid Tumor, Solid Tumor Cancer, Solid Cancers, Solid Tumor Malignancy, Urothelial Cancer (Urinary Bladder, Ureters, Or Renal Pelvis Cancer), Urothelial Cancer Of Renal Pelvis
Phase I
Terminated
A Dose-escalation, Dose-finding, and Expansion Study of XL495 in Participants With Locally Advanced or Metastatic Solid Tumors
Oct 04, 2024
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Exelixis (EX9) have in its pipeline
EX9 is currently developing the following drugs: Zanzalintinib, Mk-34574, Xl092, Belzutifan, Zanzalintinib, Xl092, Zanzalintinib, Xl092. These drug candidates are in various stages of clinical development as the company works toward FDA approval.