Infigratinib API is a synthetic small-molecule fibroblast growth factor receptor (FGFR) kinase inhibitor used in targeted oncology drug development. Infigratinib inhibits FGFR signaling, particularly FGFR1, FGFR2 and FGFR3, which are involved in cellular proliferation and tumor development.
The pharmaceutical form associated with the marketed product is Infigratinib Phosphate, also known as BGJ-398 phosphate. The phosphate salt has a molecular formula of C₂₆H₃₁Cl₂N₇O₃·H₃PO₄ and molecular weight of 658.47 g/mol.
Infigratinib was granted accelerated FDA approval in 2021 for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement. However, the FDA states that this approval was withdrawn on May 16, 2024 following the sponsor's voluntary withdrawal request.
Infigratinib is an orally active targeted anticancer compound that inhibits FGFR tyrosine kinase activity. By blocking FGFR signaling, Infigratinib can interfere with signaling pathways involved in cancer-cell proliferation, survival and angiogenesis.
Swapnroop Drugs and Pharmaceuticals provides Infigratinib API / Infigratinib Phosphate for qualified pharmaceutical manufacturing, formulation development and research requirements.
Infigratinib is a specialized oncology API relevant to FGFR-targeted drug development and pharmaceutical formulation applications.
Infigratinib selectively inhibits the kinase activity of FGFR1, FGFR2 and FGFR3. Abnormal FGFR signaling caused by mutations, amplifications or gene fusions can contribute to uncontrolled cellular growth. Inhibiting this signaling pathway may reduce tumor-cell proliferation.
Infigratinib is associated with:
| Parameter | Specification |
|---|---|
| Appearance | White to off-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% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |