To develop LXE408 as a potential new oral treatment for visceral leishmaniasis
current phase of drug development
updated 15 Feb 2023
DNDi and Novartis initiated a collaboration and licence agreement in early 2020 to jointly develop LXE408 – a first-in-class compound, discovered at Novartis with financial support from Wellcome – as a potential new oral treatment for visceral leishmaniasis.
Project updates
2022
The Phase I clinical study report was completed in August 2022, with the results supporting continuation to Phase II. All regulatory approvals for the Phase II study in India were received and the site initiation visit took place in November 2022. The first patient was enrolled in December 2022. In parallel, preparations continued for a separate Phase II clinical trial in Ethiopia, with enrolment expected to begin in early 2023.
2021
A Phase I multiple ascending dose study of LXE408 was completed in September 2021, when the last visit of the last participant was completed. All results are expected in the first quarter of 2022. The compound showed good tolerability in Phase I, supporting the continuation of the clinical study to Phase II. Preparation is underway to initiate a Phase II study with participants with visceral leishmaniasis in India in 2022.
2020
A Phase I multiple ascending dose study of LXE408 began in 2020 but faced delays due to the COVID-19 pandemic. Results are expected in mid-2021. Planning is underway for a Phase II study to commence in India in 2022.
News & resources
Clinical trials documents
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DNDi-LXE408-01-VL / CLXE408A12201R
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DNDi-LXE408-02-VL / CLXE408A12202R
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