• Target disease: Visceral leishmaniasis (VL)
  • Main partners (since project start): Takeda Pharmaceutical Company Ltd., Japan
  • Project start: 2017
  • Funding (since project start): Department for International Development (DFID), UK; Global Health Innovative Technology (GHIT) Fund, Japan.


Overall Objective:

  • Progress DNDi-5561, a selected aminopyrazole compound, to Phase I clinical trials and realize some activities including formulation development, drug product manufacture and start single ascending dose stage of first-in-human.


This project is the continuation of the optimization of the aminopyrazole series for visceral leishmaniasis project. DNDi and Takeda worked with the objective of delivering an anti-parasitic aminopyrazole drug that could meet the Target Product Profile (TPP) published by DNDi. A lead second generation compound DNDI-5561 and several additional advanced, and differentiated, second generation leads have been identified that could provide differentiated back-ups. DNDI-5561 is the most advanced compound of the aminopyrazole series.


The pre-clinical trial application package studies to enable a first-in-human study (Phase I) should start early 2019 and should be completed by the end of 2019.

Following positive results of efficacy and safety studies in animal model, DNDI-5561 was selected as pre-clinical candidate in October 2017.


Last update: February 2019