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Home > Scientific articles
Nov 2025

Safety, tolerability and pharmacokinetics of DNDI-6148, a novel agent for leishmaniasis: A randomized, controlled, single ascending dose study in healthy participants

British Journal of Clinical Pharmacology

by Gillon J-Y, Delhomme S, Launay D, Blesson S, Braillard S, Maghdooni P, Assmus F, Hoglund R, Tarning J, Loyau S, Arana B, Latreille-Barier M, Donazzolo Y. British Journal of Clinical Pharmacology 2025;1-11. doi: 10.1002/bcp.70328

Summary: The benzoxaborole derivative DNDI-6148 is an antiparasitic agent with activity against multiple Leishmania protozoan species, including L. infantum and L. donovani, which cause visceral leishmaniasis. The authors of this manuscript investigated the safety, tolerability and pharmacokinetics of single oral doses of DNDI-6148 in a randomized, parallel-group, placebo-controlled, first-in-human study. No major safety concerns were identified in 64 healthy male participants exposed to an oral suspension of DNDI-6148 at single doses up to 380 mg, or placebo, and the PK profile was favourable. These data support further clinical development.

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Clinical trials Visceral leishmaniasis

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