Sunitinib is a synthetic, orally active multi-targeted receptor tyrosine kinase inhibitor (TKI) and an important antineoplastic active pharmaceutical ingredient. It is used in targeted cancer therapy because of its ability to inhibit several receptor tyrosine kinases involved in tumor proliferation and angiogenesis.
FDA GSRS identifies Sunitinib with CAS No. 557795-19-4, molecular formula C₂₂H₂₇FN₄O₂, and FDA UNII V99T50803M. The WHO ATC classification for Sunitinib is L01XE04.
Sunitinib is chemically distinct from Sunitinib Maleate. The marketed SUTENT product contains the maleate salt, which has a molecular weight of 532.6 Da and the molecular formula C₂₂H₂₇FN₄O₂·C₄H₆O₅.
The chemical name of Sunitinib is N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide.
Sunitinib is also known as SU-11248, SU011248, SU-011248, NSC-736511 and NSC-750690. FDA GSRS identifies the substance as Sunitinib and provides the CAS Registry Number 557795-19-4.
Sunitinib is a small-molecule kinase inhibitor containing a substituted pyrrole carboxamide and fluorinated indolinone structural system. ChEBI identifies Sunitinib as an antineoplastic agent, angiogenesis inhibitor, receptor protein-tyrosine kinase inhibitor and vascular endothelial growth factor receptor antagonist.
The free-base Sunitinib has an average molecular mass of approximately 398.47 g/mol.
Sunitinib is an antineoplastic API used in targeted cancer treatment. Its pharmaceutical applications include the development of medicines for:
Sunitinib's therapeutic activity is associated with inhibition of multiple receptor tyrosine kinases involved in tumor growth and angiogenesis.
Sunitinib inhibits multiple receptor tyrosine kinases, including VEGFR, PDGFR and KIT, together with other kinase targets.
By inhibiting VEGF receptor signaling, Sunitinib interferes with angiogenesis and reduces signaling involved in the development of tumor-associated blood vessels. Inhibition of PDGFR and KIT further interferes with cellular signaling involved in tumor proliferation and survival.
ChEBI specifically classifies Sunitinib as a receptor protein-tyrosine kinase inhibitor and VEGFR antagonist.
Sunitinib is a specialized oncology API. The Indian Pharmacopoeia Commission has listed Sunitinib Maleate and Sunitinib Capsules among the proposed IP 2026 chemical monographs, indicating current pharmacopoeial development for the maleate form and dosage form.
The free-base Sunitinib should not be assigned the specifications of Sunitinib Maleate. Therefore, numerical assay, impurity and water limits should only be entered where they are supported by the applicable specification for the exact API form.
Sunitinib API manufacturing involves controlled chemical synthesis followed by purification, isolation and drying. Manufacturing controls should address chemical identity, assay, related substances, residual solvents, moisture, stereochemical/structural integrity and physical characteristics.
Validated chromatographic and spectroscopic methods can be used for identity, assay, impurity profiling and stability testing.
Sunitinib is a solid crystalline material. FDA GSRS identifies its formula as C₂₂H₂₇FN₄O₂, while ChEBI reports an average mass of 398.47380.
Published reference data report different melting-point values depending on the material/form and test source. Therefore, melting point should not be treated as a universal pharmaceutical release criterion for Sunitinib without reference to the exact material specification.
Sunitinib should be stored in suitable pharmaceutical-grade, tightly closed packaging that protects the API from moisture, contamination and environmental exposure.
Storage conditions should ultimately be established from validated stability data for the manufactured API.
Typical Sunitinib API documentation may include:
A qualified Sunitinib API manufacturer should maintain controlled chemical synthesis, validated analytical procedures and complete batch traceability.
Particular attention should be given to identity, assay, related substances, residual solvents, elemental impurities and physical properties to ensure consistent pharmaceutical-grade material.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Individual Impurity | NMT 0.10% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 5.0% |