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Home > Research and development > Portfolio

Visceral leishmaniasis 

DNDI-8526 (S07 series)

objective

Progress a lead compound from the S07 series into clinical development as a potential new treatment for leishmaniasis

project start
2020

current phase of drug development

Discovery project phase
Drug Discovery
Translation project phase
Translational research
clinical trials icon
Clinical trials
Treatment Access
Registration & access

updated 24 Feb 2025

This project stems from DNDi’s successful NTD Drug Discovery Booster programme. Through continued collaboration with Takeda Pharmaceutical Company Limited to discover and develop new compounds targeting visceral leishmaniasis, the S07 lead chemical series has demonstrated promising efficacy and safety. DNDi and Takeda have been working together on the medicinal chemistry optimization of S07 lead compounds, with the goal of advancing at least one optimized compound to the pre-clinical candidate stage for visceral leishmaniasis. This work was supported by funding from Japan’s Global Health Innovative Technology Fund (GHIT Fund).

Project updates

2024

The nominated pre-clinical candidate for visceral leishmaniasis, DNDI-8526, has shown promise, but several challenges and risks (such as solubility, pharmacokinetics, and species variability) have been identified that need to be addressed before advancing to pre-clinical studies. Given that this compound is positioned as a backup new chemical entity in the leishmaniasis portfolio as a proteasome inhibitor (behind two other compounds, LXE408 and GSK245), the project was placed on hold pending the availability of resources for further development and testing. The project is considered successful thus far, with a clearly defined plan in place for its next steps.

2023

Exploratory toxicology studies for the two selected optimized leads were performed and finalized at Accelera. While a no-observed-adverse-effect level (NOAEL) for one of the leads could not be determined, the second optimized lead fulfills the criteria of the target candidate profile for visceral leishmaniasis. The putative mechanism of action of parasite proteasome inhibition and selectivity against the human target were also confirmed for both S07 series compounds.

2022

Scale-up of the two selected optimized leads was completed. Exploratory toxicity study activities began at Accelera, and bioanalytical method transfer and validation were completed. In-vivo studies with scaled-up lead compounds were initiated in January 2023.

2021

Two optimized leads were identified that will move forward into exploratory toxicology studies before pre-candidate nomination. The current priority is synthesis route optimization and scale-up of the two optimized leads.  

2020

The NTD Drug Discovery Booster identified two lead compounds from the S07 hit series that demonstrated efficacy in a leishmaniasis infection model. These two compounds advanced through to lead optimization and, in collaboration with Takeda, are now being further characterized.

Recent data suggest that these two lead compounds have the same mechanism of action as two other compounds currently in Phase I clinical trials: GSK3494245/DDD1305143, a compound being jointly developed by DNDi and GlaxoSmithKline.

News & resources

  • 6 October 2021 – Projets de l’année 2021 de DNDi : des partenaires et des collègues récompensés pour le travail accompli dans la mise au point de nouveaux traitements de la leishmaniose viscérale et de la maladie du sommeil
  • 6 October 2021 – DNDi 2021 Projects of the Year recognize partners and colleagues for their work in developing new treatments for visceral leishmaniasis and sleeping sickness

Partners

  • Epichem, Australia
  • Monash University, Centre for Drug Candidate Optimisation (CDCO), Australia
  • Takeda Pharmaceutical Company Limited, Japan
  • University of Antwerp, Laboratory of Microbiology, Parasitology, and Hygiene (LMPH), Belgium
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  • Epichem
  • ,Australia
  • Monash University, Centre for Drug Candidate Optimisation (CDCO)
  • ,Australia
  • Takeda Pharmaceutical Company Limited
  • ,Japan
  • University of Antwerp, Laboratory of Microbiology, Parasitology, and Hygiene (LMPH)
  • ,Belgium
  • Takeda Pharmaceutical Company Limited, Japan
  • Epichem, Australia
  • University of Antwerp, Laboratory of Microbiology, Parasitology, and Hygiene (LMPH), Belgium
  • Monash University, Centre for Drug Candidate Optimisation (CDCO), Australia

Funding

  • Japan - Global Health Innovative Technology Fund (GHIT Fund)
  • Switzerland - Swiss Agency for Development and Cooperation (SDC)
  • UK - UK International Development
​
  • Médecins Sans Frontières International
  • Other private foundations and individuals
​

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