FGFR1-3 Inhibitor Infigratinib Phosphate | CAS 1310746-10-1

NVP-BGJ398 Phosphate More Info

NVP-BGJ398 Phosphate is the phosphate salt form of a selective, small molecule ATP-competitive inhibitor of fibroblast growth factor receptor tyrosine kinases, with the CAS Registry Number 1310746-10-1. Its molecular structure is engineered for high potency and selectivity against FGFR1, FGFR2, and FGFR3, designed to fit precisely into the ATP-binding pocket of these receptors. The phosphate salt formation enhances the compound's solubility and stability for pre-clinical and experimental pharmaceutical development, facilitating its use in research and early-phase clinical studies.

The primary mechanism of action involves the potent and selective inhibition of FGFR signaling. By binding to the intracellular kinase domain, it blocks autophosphorylation and activation of the receptor, thereby disrupting downstream pro-survival and proliferative pathways such as RAS-MAPK and PI3K-AKT. This action is particularly effective in cancer cells exhibiting FGFR pathway dysregulation due to genetic alterations like amplifications, activating mutations, or gene fusions, which render them dependent on this signaling for growth and survival.

This compound was developed as a clinical candidate for the treatment of advanced solid tumors characterized by FGFR alterations. It has been investigated in Phase I and II clinical trials for malignancies such as cholangiocarcinoma (especially tumors with FGFR2 fusions), urothelial carcinoma, squamous non-small cell lung cancer, and breast cancer with FGFR1 amplification. Its development represents a targeted therapeutic approach aimed at tumors with specific, actionable molecular drivers, aligning with the principles of precision oncology.

NVP-BGJ398 was administered orally in clinical trials, typically in a continuous daily dosing regimen or on a schedule of several weeks on treatment followed by a short break. Its pharmacokinetic profile showed dose-dependent exposure, and it is metabolized primarily by hepatic enzymes. A key aspect of its clinical pharmacology is the development of hyperphosphatemia as a direct, on-target pharmacodynamic biomarker, reflecting effective systemic inhibition of FGFR signaling, which was used to guide dose escalation in early trials.

The safety profile observed in clinical studies was defined by both on-target and off-target effects. The most common adverse events included hyperphosphatemia, fatigue, gastrointestinal disturbances, and electrolyte abnormalities. On-target toxicities also encompassed nail disorders, stomatitis, and dry eye. More serious risks involved retinal pigment epithelial detachment and potential liver enzyme elevations. While demonstrating proof-of-concept for FGFR inhibition, its clinical development was eventually discontinued in favor of next-generation FGFR inhibitors with potentially improved efficacy and tolerability profiles. It remains a historically important compound in the field of targeted FGFR therapy.

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