Last reviewed 2026-04-20 · How we verify

Sunitinib Malate (sunitinib-malate)

Sunitinib is a small molecule that inhibits multiple receptor tyrosine kinases, including PDGFRα, PDGFRβ, VEGFR1, VEGFR2, VEGFR3, KIT, FLT3, CSF-1R, and RET.

Sunitinib Malate, developed by Pfizer Inc., is a small molecule that inhibits multiple receptor tyrosine kinases. It is primarily used to treat gastrointestinal stromal tumor, pancreatic neuroendocrine tumor, and renal cell carcinoma. Sunitinib's mechanism of action involves the inhibition of platelet-derived growth factor receptors, vascular endothelial growth factor receptors, and other kinases. This leads to the inhibition of tumor growth, angiogenesis, and metastatic progression. Sunitinib has demonstrated clinical differentiation in experimental models of cancer and has shown commercial significance with revenue of $63.6B. The drug's pipeline developments are not specified in the provided information.

At a glance

Mechanism of action

Sunitinib works by blocking the activity of various kinases that are involved in tumor growth and angiogenesis. This is achieved through the inhibition of platelet-derived growth factor receptors, vascular endothelial growth factor receptors, and other kinases. The primary metabolite of sunitinib also exhibits similar potency in biochemical and cellular assays.

Approved indications

• Gastrointestinal stromal tumor
• Pancreatic Neuroendocrine Tumor
• Renal cell carcinoma

Boxed warnings

• WARNING: HEPATOTOXICITY Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue sunitinib malate capsules as recommended [see Warnings and Precautions ( 5.1 )] . WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity may be severe, and in some cases fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue sunitinib malate capsules as recommended [see Warnings and Precautions ( 5.1) ].

Common side effects

• Diarrhea
• Mucositis/stomatitis
• Constipation
• Anorexia
• Asthenia
• Skin discoloration
• Rash
• Hand-foot syndrome
• Altered taste
• Hypertension
• Myalgia/limb pain
• Fatigue

Drug interactions

• High Risk QT Prolonging Agents
• P-glycoprotein Substrates
• boceprevir
• conivaptan
• fosphenytoin
• mibefradil
• posaconazole
• primidone
• telaprevir
• telithromycin
• troleandomycin
• voriconazole

Key clinical trials

• Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors (PHASE1)
• Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial (PHASE2)
• Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial (PHASE1)
• A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours (PHASE2)
• Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (PHASE2)
• Testing Sunitinib as Potentially Targeted Treatment in Cancers With cKIT Genetic Changes (MATCH - Subprotocol V) (PHASE2)
• Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (PHASE2)
• Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors (PHASE1, PHASE2)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Sunitinib Malate CI brief — competitive landscape report
• Sunitinib Malate updates RSS · CI watch RSS
• Pfizer portfolio CI