DNDI-6148 Chagas disease
To develop an oxaborole for Chagas disease
current phase of drug development
updated 21 Feb 2025
There is an urgent need for new treatments that can be used for both the acute and chronic stages of Chagas disease and that are safer and more effective than current treatment regimens, which use benznidazole and nifurtimox.
The oxaborole DNDI-6148 has emerged as a promising lead candidate for visceral leishmaniasis and cutaneous leishmaniasis; it has also shown efficacy against Chagas disease in an in vivo model and its potential for further development is being assessed.
Project updates
2024
Activities related to the clinical development of DNDI-6148 remain on hold.
2023
The development of DNDI-6148 has been paused pending further studies to determine the potential for reproductive toxicity. Due to their potential teratogenic effects, current treatments for Chagas disease – benznidazole and nifurtimox – cannot be used by pregnant women or women who may become pregnant. Together with partners, DNDi is currently conducting pre-clinical assessments of a number of oxaboroles to select the best candidate for further development.
2022
The last cohort of the first-in-human study was completed in the first quarter of 2022. DNDI-6148 was shown to be safe and well tolerated after a single oral dose. Preparation for the Phase I multiple ascending dose study in India was initiated in parallel with additional reproductive toxicology investigations.
2021
After a delay due to the COVID-19 pandemic, a Phase I single ascending dose study of DNDI-6148 progressed in 2021 and will be completed in the first quarter of 2022. Preliminary results support progression to a multiple ascending dose study, which will be initiated in 2022.
2020
A full analysis of the pharmacokinetic, pharmacodynamic, and modelling data to determine the potential for further development of DNDI-6148 was conducted, following its nomination as a clinical candidate for Chagas disease in 2020. Once data is available from Phase I studies in humans (delayed by the COVID-19 pandemic), the analysis will be finalized.
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