The non-profit medical research organization Drugs for Neglected Diseases initiative (DNDi) welcomes new financial support of approximately JPY 778 million (approximately EUR 4.2 million) from the Global Health Innovative Technology (GHIT) Fund to advance the development of DNDI‑6174, in collaboration with Eisai Co., Ltd.
DNDI-6174 is a novel oral drug candidate with a unique mode of action, showing activity not only against visceral leishmaniasis (VL) but also against a broad range of kinetoplastid parasites, including cutaneous leishmaniasis (CL) and Chagas disease. The objective of this project is to advance DNDI‑6174 through a first‑in‑human Phase I clinical trial and to generate key data on safety and pharmacokinetics.
Leishmaniasis is a major global health challenge. Each year, an estimated 50,000 to 90,000 new cases of VL and around 600,000 cases of CL occur worldwide. Today, 73% of VL cases are concentrated in Eastern Africa, with nearly half affecting children under the age of 15. In 2024, the World Health Organization (WHO) and endemic countries in Eastern Africa launched a new framework aimed at eliminating VL as a public health problem in the region. However, significant treatment challenges remain, including safety concerns, long treatment durations, the need for hospitalization, and cold chain logistics. In addition, differences in parasite species and drug resistance make VL more difficult to treat in Eastern Africa than in other regions.
DNDI‑6174 is being developed to address these challenges. It targets the parasite through a novel mechanism of action and has demonstrated strong efficacy and a favourable safety profile in pre-clinical studies, with the potential for a sterile cure. As an oral treatment with the potential for low-dose, short-course administration, it is well-suited for use in resource-limited settings. It is also considered a promising candidate for combination with other new chemical entities in the research pipeline.
Under this project, activities will include pharmaceutical development and the supply of investigational products, as well as the implementation of a Phase I clinical trial using a single-ascending-dose design in healthy adult volunteers. The trial is planned to be conducted at Ampang Hospital in Malaysia, pending regulatory and ethical approvals. Additionally, the project will use bioanalytical methods to measure and analyse drug concentrations in biological samples, and modelling approaches to predict pharmacokinetics and inform dose selection, to better understand drug exposure and to support dose selection in future clinical studies.
If proven safe and effective, DNDI‑6174 could support WHO elimination goals by providing a short-course, oral treatment option. This will improve the patient experience by reducing lengthy hospital stays and their associated burden on families, allowing parents to return to work and children to return to school faster. It will also allow patients to receive care in primary healthcare facilities closer to their homes. With potential activity against multiple parasitic diseases, DNDI-6174 may also contribute to sustainable access and supply.
Under the partnership, DNDi will lead overall project coordination and act as sponsor of the clinical trial, overseeing medical, regulatory, and scientific activities. Eisai will be responsible for pharmaceutical development and the supply of investigational products.
For more information about visceral leishmaniasis (VL) and cutaneous leishmaniasis (CL) and DNDi’s work on the diseases, please visit: Visceral leishmaniasis | DNDi, and Cutaneous leishmaniasis | DNDi.
About DNDi
The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit medical research organization that discovers, develops, and delivers safe, effective, and affordable treatments for neglected populations. DNDi is developing medicines for sleeping sickness, leishmaniasis, Chagas disease, parasitic worm diseases, mycetoma, dengue, paediatric HIV, cryptococcal meningitis, and hepatitis C. Its research priorities include children’s health; gender equity and gender-responsive R&D; and diseases impacted by climate change. Since its creation in 2003, DNDi has collaborated with public and private partners worldwide to deliver new treatments for six deadly diseases, saving millions of lives. Acoziborole is the 14th treatment delivered by DNDi. dndi.org
Media contacts
Yoko Noda (DNDi Tokyo)
ynoda@dndi.org
Phone: +81 70 4465 5453
Frédéric Ojardias (DNDi Geneva)
fojardias@dndi.org
Phone: +41 79 431 6216
Photo credit: Lameck Ododo, DNDi
