Infigratinib is an orally active, selective fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor and active pharmaceutical ingredient used in oncology. It primarily targets FGFR2 alterations associated with certain cancers.
Infigratinib has the molecular formula C26H31Cl2N7O3 and a molecular weight of approximately 560.48 g/mol. Its CAS Number is 872511-34-7.
Infigratinib is a small-molecule targeted anticancer agent that selectively inhibits FGFR1, FGFR2 and FGFR3 signaling. Aberrant FGFR signaling can promote cancer-cell proliferation, survival and tumor progression.
The API has been developed particularly for cancers containing specific FGFR2 gene fusions or rearrangements, including certain advanced or metastatic cholangiocarcinomas.
Infigratinib inhibits the tyrosine kinase activity of FGFR1, FGFR2 and FGFR3. By blocking FGFR-mediated signaling pathways, it reduces downstream cellular signaling involved in proliferation, differentiation and survival.
Its activity is particularly relevant to tumors driven by activating FGFR alterations.
Infigratinib API is used in the development and manufacture of:
Infigratinib is manufactured through controlled chemical synthesis followed by purification, crystallization and drying. Pharmaceutical quality control typically evaluates identity, assay, related substances, residual solvents, water content and elemental impurities.
Infigratinib is generally supplied as a white to off-white solid or crystalline powder. It is a small-molecule pharmaceutical API with limited aqueous solubility.
Infigratinib should be stored in a tightly closed container under controlled conditions and protected from excessive moisture, heat and direct light. Storage conditions should follow the manufacturer's current CoA, SDS and validated stability requirements.
Depending on the intended pharmaceutical application, documentation may include:
Infigratinib is a selective FGFR tyrosine kinase inhibitor used in targeted oncology. Its activity against FGFR signaling, particularly in tumors with specific FGFR2 alterations, makes it an important API for precision cancer-treatment formulations.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | Approximately 218–220°C |