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Exelixis (EXEL)
NASDAQ:EXEL
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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Pembrolizumab, Xb010
Locally Advanced Or Metastatic Solid Tumors, Nsclc (Non-Small Cell Lung Cancer), Head And Neck Squamous Cell Cancer, Triple Negative Breast Cancer (Tnbc), Hormone-Receptor-Positive Breast Cancer, Esophageal Squamous Cell Cancer
Phase I
Recruiting
Study of XB010 in Subjects With Solid Tumors
Jul 29, 2024
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Zanzalintinib, Nivolumab, Ab521
Advanced Clear Cell Renal Cell Carcinoma Or Other Advanced Solid Tumors
Phase I
Terminated
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)
Dec 19, 2023
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Zanzalintinib, Pembrolizumab
Head And Neck Squamous Cell Carcinoma
Phase II/III
Active Not Recruiting
Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Oct 09, 2023
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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 (EXEL) have in its pipeline
EXEL is currently developing the following drugs: Xb371, Belzutifan, Zanzalintinib, Zanzalintinib. These drug candidates are in various stages of clinical development as the company works toward FDA approval.