ArticleClinical and translational science2026
Translational Pharmacokinetic-Pharmacodynamic Modeling and Efficacious Human Dose Prediction of DNDI-6148 for the Treatment of Cutaneous Leishmaniasis.
Article in Clinical and translational science, 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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8 authors.
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Abstract
Cutaneous leishmaniasis is a neglected tropical disease with only one oral treatment option. DNDI-6148 is an orally bioavailable compound with potent antiparasitic activity in preclinical studies. Establishing skin target-site pharmacokinetic/pharmacodynamic (PK/PD) relationships is essential to enable its clinical development. The objective was to characterize the target-site PK and PD of DNDI-6148 in a murine L. major model and to predict a human efficacious dose. A nonlinear mixed-effects PK/PD model was developed using data from L. major-infected BALB/c mice orally administered DNDI-6148 (6.25-50 mg/kg, bid). The murine PD components and skin distribution characteristics were used jointly with allometrically scaled human PK parameters to predict a clinically efficacious dose. DNDI-6148 PK in mice was described by a one-compartment model with dose-dependent bioavailability, saturable clearance, and a skin-to-plasma ratio of 0.56 [95% CI, 0.49-0.68] for both infected and non-infected skin. Parasite clearance at the infection site followed a sigmoidal E
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