Sutent

(Sunitinib Malate)

Phase 2

CCp Cv

Sutent is one of 49 small molecule programs targeting Malignant Neoplasms of Urinary Tract. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Malignant Neoplasms of Urinary TractActive, not recruiting

Advanced LymphomaActive, not recruiting

Thymic CarcinomaActive, not recruiting

Metastatic Pancreatic Neuroendocrine TumorRecruiting

Malignant Neoplasms of Urinary TractPhase 2

Active, not recruiting

Advanced LymphomaPhase 2

Active, not recruiting

Thymic CarcinomaPhase 2

Active, not recruiting

Metastatic Pancreatic Neuroendocrine TumorPhase 1

Recruiting

Competition

Competitive Landscape

34 competitors in Advanced Lymphoma

#DrugCompanyPhaseTrials

Ibrance

Pfizer

Phase 2

3 2

Mekinist

Novartis

Phase 2

3 3

Adavosertib

AstraZeneca

Phase 2

2 4

Balversa

Johnson & Johnson

Phase 2

2 5

Vitrakvi

Bayer

Phase 2

2 6

Tagrisso

AstraZeneca

Phase 2

2 7

Sutent

Pfizer

Phase 2

2 8

M6620

AstraZeneca

Phase 2

2 9

Mektovi

Pfizer

Phase 2

1 10

Truqap

AstraZeneca

Phase 2

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

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Metastatic Pancreatic Neuroendocrine Tumor

NCT05687123

Phase 2Active, not recruiting

Advanced Lymphoma

NCT02465060

Q2 2027

Phase 2Active, not recruiting

Thymic Carcinoma

NCT03463460

Q3 2027

Phase 2Active, not recruiting

Malignant Neoplasms of Urinary Tract

NCT03541902

Q2 2028

Phase 3Active, not recruiting

Non-Clear Cell Renal Cell Carcinoma

NCT05678673

Clinical

Trials by Indication[1]

Metastatic Pancreatic Neuroendocrine Tumor1 trial

A Phase I Dose Escalation-Expansion Trial of Sunitinib Malate Plus Lutetium Lu 177 Dotatate (Lutathera) in Somatostatin Receptor Positive Pancreatic Neuroendocrine Tumors

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT05687123·24 enrolled

Advanced Lymphoma1 trial

Molecular Analysis for Therapy Choice (MATCH)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02465060·6,452 enrolled

Thymic Carcinoma1 trial

A Multicenter, Phase II Trial of Pembrolizumab and Sunitinib in Refractory Advanced Thymic Carcinoma

Active, not recruiting·DDwight Owen·Phase 2·NCT03463460·9 enrolled

Non-Clear Cell Renal Cell Carcinoma1 trial

A Randomized Open-Label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma

Active, not recruiting·EExelixis·Phase 3·NCT05678673·317 enrolled

Malignant Neoplasms of Urinary Tract1 trial

Cabosun Ii: Cabozantinib Versus Sunitinib for Metastatic Variant Histology Renal Cell Carcinoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03541902·32 enrolled

2 more indications

Stage IIIB Lung Non-Small Cell Cancer AJCC v71 trial

Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #736511) as Maintenance Therapy in Non-progressing Patients Following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB / IV Non-small Cell Lung Cancer

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT00693992·210 enrolled

Clear Cell Renal Cell Carcinoma1 trial

ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT00326898·1,943 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 26, 2006

SUTENT

NDA NDA021938

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for Sunitinib Malate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Sunitinib Malate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Sunitinib Malate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021938). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Cp Cv company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Highest Phase: Phase 2[1]
Company: CCp Cv

Sutent

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Q2 2028

Trials by Indication[1]

Metastatic Pancreatic Neuroendocrine Tumor1 trial

Advanced Lymphoma1 trial

Thymic Carcinoma1 trial

Non-Clear Cell Renal Cell Carcinoma1 trial

Malignant Neoplasms of Urinary Tract1 trial

Stage IIIB Lung Non-Small Cell Cancer AJCC v71 trial

Clear Cell Renal Cell Carcinoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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