PazSol001

PazSol001 is an investigational, high-solubility oral formulation of pazopanib hydrochloride, the active ingredient in the approved multi-kinase inhibitor Votrient. Developed by the Antoni van Leeuwenhoek Ziekenhuis (Netherlands Cancer Institute), PazSol001 is designed to address the pH-dependent solubility, variable oral bioavailability, and large inter-patient pharmacokinetic variability associated with the standard commercial formulation of pazopanib. It utilizes a solid dispersion formulation, specifically incorporating the polymer excipient Soluplus in an 8:1 ratio with pazopanib hydrochloride, to enhance dissolution and absorption. PazSol001 is being evaluated in a Phase 0 proof-of-principle clinical pharmacokinetic study in adults with locally advanced or metastatic cancer, including renal cell carcinoma, with the goal of achieving therapeutic drug exposure comparable to the standard 800 mg Votrient tablet but at a significantly lower dose (such as 300 mg), thereby reducing the required drug load and potentially minimizing dose-dependent toxicities.