ArticleCancer chemotherapy and pharmacology2026
A novel cabozantinib formulation with improved safety and bioavailability: preclinical validation in rats.
Article in Cancer chemotherapy and pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
purposeThis study aims to compare the safety and tolerability of CABOMETYX® (commercial name of the marketed cabozantinib tablets) with a novel cabozantinib formulation, referred to hereafter as HND-039 (HP), in Wistar rats.
methodsThe research comprised several studies: a single-dose pharmacokinetic (PK) study comparing CABOMETYX® (R) to two versions of HP (T1 and T2) formulations; a dose tolerance study investigating various doses of CABOMETYX® in terms of adverse effects; and a safety and tolerability study comparing HP at 5 mg/kg/day to CABOMETYX® at 10 mg/kg/day and 7.5 mg/kg/day. Analytical methods included LC-MS/MS for sample analysis, non-compartmental analysis for pharmacokinetics, Kaplan-Meier plots for survival, and standard statistical tests for safety endpoints.
resultsIn the single-dose PK study, the HP formulation demonstrated area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUCt) and maximum observed plasma concentration (Cmax) values approximately 50% higher than those of CABOMETYX®, indicating significantly enhanced bioavailability. The dose tolerance study revealed that doses ≥ 12 mg/kg/day of CABOMETYX® resulted in severe adverse effects and high mortality, while doses ≤ 6 mg/kg/day caused minimal adverse reactions. In the safety and tolerability study, HP demonstrated significantly lower incidence of diarrhea and mortality compared to both CABOMETYX® groups. Additionally, rats treated with HP exhibited attenuated body weight loss and a less pronounced reduction in food intake, along with favorable blood pressure measurements and organ weights.
conclusionThe HP exhibits enhanced bioavailability and superior safety and a favorable safety and tolerability profile in preclinical settings. These findings support further clinical development as a potentially safer alternative to CABOMETYX®, that may reduce treatment-limiting adverse events.
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