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Home > Research and development > Portfolio

Filaria: river blindness 

Emodepside

Home > Research and development > Portfolio

Filaria: river blindness

Emodepside

objective

Advance the clinical development of emodepside as an anti-parasitic macrofilaricidal treatment

project start
2013

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 21 Feb 2025

Emodepside, an antihelminthic veterinary drug for cats and dogs, was originated by the Japanese pharmaceutical company Astellas and then developed and commercialized by Bayer Animal Health. DNDi, in collaboration with Bayer AG, is evaluating emodepside as a potential anti-parasitic macrofilaricidal treatment for onchocerciasis in humans.

Under a joint development agreement, Bayer AG provides the active ingredient emodepside to DNDi, who is responsible for its clinical development; Bayer AG is responsible for pre-clinical and pharmaceutical development, as well as registration, manufacturing, and distribution of the drug.

First-in-human Phase I studies for emodepside in healthy volunteers have successfully been completed, including both a single ascending dose study in 2017 and a multiple ascending dose study in 2018. Emodepside is orally bioavailable, and a tablet that could be commercialized has been developed.

DNDi’s Phase II proof-of-concept clinical trial to investigate the safety and efficacy of emodepside for people living with onchocerciasis was initiated in 2021.

Project updates

2024

By the third quarter of 2024, all enrolled patients had completed treatment and follow-up in part 1 of the Phase II study testing the safety and efficacy of emodepside in treating onchocerciasis, and data and monitoring activities were finalized. Initial findings from part 1 of the Phase II study showed a favourable safety profile and initial proof of concept.

2023

By April 2023, Phase II trial recruitment was finalized and all study participants in Ghana and the Democratic Republic of the Congo had completed treatment. Initial findings are expected to be released in the third quarter of 2024. Emodepside’s notable efficacy in individuals with Trichuris trichiura and hookworm infections, as demonstrated by our partners Swiss TPH and Bayer, positions it as a promising candidate for pan-nematode treatment.

2022

The Phase II clinical trial testing the safety and efficacy of emodepside in patients with Onchocerca volvulus continued recruitment at one site in Ghana and two sites in the Democratic Republic of the Congo. Three safety review committee meetings were held, and no safety concerns were noted. Over 50% of targeted patient enrollment was reached by December 2022. 

2021

In 2021, clinical trial sites were established, and staff were trained on all aspects of clinical trial conduct, including good clinical practice based on International Conference on Harmonization (ICH) standards. The Phase II clinical trial testing the safety and efficacy of emodepside in patients infected with Onchocerca volvulus was successfully initiated. 

2020

In 2020, DNDi laid the groundwork for a Phase II proof-of-concept clinical trial in Hohoe, Ghana, that will investigate the safety and efficacy of emodepside for people living with onchocerciasis. DNDi has also completed the renovation of the clinical trial site. 

2019

With Phase I studies complete, preparations are underway to run a Phase II clinical trial (including safety and dose response and regimen selection) in Hohoe, Ghana. DNDi  is renovating the site and will identify an additional site in the country for this study. 

2018

First-in-human studies for emodepside in healthy volunteers have successfully been completed, both a single ascending dose study in 2017 and a multiple ascending dose study in 2018. As a next step, DNDi  plans to run a Phase II “proof-of-concept” clinical trial in DRC and Ghana, investigating the safety and efficacy of the drug in people living with onchocerciasis.

2017

Phase I studies continued throughout 2017 with 116 healthy volunteers recruited by the end of the year. The single ascending dose study was completed and the multiple ascending dose study will be completed in 2018.

2016

Emodepside entered into healthy volunteer Phase I studies in 2016. The single ascending dose study will be completed in 2017 while the protocols for the multiple dose study will be initiated. The design of two Phase Ib studies to be performed in patients in Africa is also being finalized.

2015

The pre-clinical package to start Phase I studies was completed and recruitment into a single-single-ascending dose study was initiated in December 2015.

News & resources

  • 24 September 2024 – HAT Platform Newsletter No. 23
  • 8 August 2024 – The long and winding road towards new treatments against lymphatic filariasis and onchocerciasis, Trends in Parasitology
  • 30 January 2024 – DNDi receives USD 20 million to develop innovative treatments to further elimination goals for sleeping sickness and river blindness
  • 22 February 2023 – HAT Platform Newsletter No. 22
  • 13 October 2022 – ‘Out of sight’: our work on river blindness featured in German magazine GEO
  • 10 March 2022 – Drug development for the treatment of onchocerciasis: Population pharmacokinetic and adverse events modeling of emodepside, PLOS Neglected Tropical Diseases
  • 28 July 2021 – Evaluation of the in vitro susceptibility of various filarial nematodes to emodepside, International Journal for Parasitology: Drugs and Drug Resistance
  • 22 July 2021 – Development of emodepside as a possible adulticidal treatment for human onchocerciasis—The fruit of a successful industrial–academic collaboration, PLOS Pathogens 
  • 24 March 2021 – Safety, tolerability, and pharmacokinetics of emodepside, a potential novel treatment for onchocerciasis (river blindness), in healthy male subjects, British Journal of Clinical Pharmacology
  • 9 December 2014 – Bayer and DNDi sign first agreement to develop an innovative oral treatment for human river blindness

Clinical trials documents

Partners

  • Bayer Healthcare AG, Germany
  • Hammersmith Medicines Research, UK
  • Imperial College London, UK
  • Kumasi Centre for Collaborative Research in Tropical Medicine (KCCR), Kwame Nkrumah University of Science and Technologyy (KNUST), Ghana
  • Mahidol Oxford Tropical Medicine Research Unit (MORU), Thailand
  • Medicines Development for Global Health, Australia
  • Programme national de lutte contre les maladies tropicales négligées à chimiothérapie préventive (PNLMTN-CTP), DRC
  • The Queen’s University of Belfast, UK
  • University of Bonn, Germany
  • University of Health and Allied Sciences, Ghana
  • Washington University – School of Medicine (Saint Louis), USA
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  • Bayer Healthcare AG
  • ,Germany
  • Hammersmith Medicines Research
  • ,UK
  • Imperial College London
  • ,UK
  • Kumasi Centre for Collaborative Research in Tropical Medicine (KCCR), Kwame Nkrumah University of Science and Technologyy (KNUST)
  • ,Ghana
  • Mahidol Oxford Tropical Medicine Research Unit (MORU)
  • ,Thailand
  • Medicines Development for Global Health
  • ,Australia
  • Programme national de lutte contre les maladies tropicales négligées à chimiothérapie préventive (PNLMTN-CTP)
  • ,DRC
  • The Queen’s University of Belfast
  • ,UK
  • University of Bonn
  • ,Germany
  • University of Health and Allied Sciences
  • ,Ghana
  • Washington University – School of Medicine (Saint Louis)
  • ,USA
  • Bayer Healthcare AG, Germany
  • Hammersmith Medicines Research, UK
  • Imperial College London, UK
  • University of Health and Allied Sciences, Ghana
  • Medicines Development for Global Health, Australia
  • Mahidol Oxford Tropical Medicine Research Unit (MORU), Thailand
  • The Queen’s University of Belfast, UK
  • Kumasi Centre for Collaborative Research in Tropical Medicine (KCCR), Kwame Nkrumah University of Science and Technologyy (KNUST), Ghana
  • Programme national de lutte contre les maladies tropicales négligées à chimiothérapie préventive (PNLMTN-CTP), DRC
  • Washington University – School of Medicine (Saint Louis), USA
  • University of Bonn, Germany

Funding

  • Germany - Federal Ministry of Education and Research (BMBF) through KfW
  • Switzerland - Swiss Agency for Development and Cooperation (SDC)
  • UK - UK International Development
  • USA - United States Agency for International Development (USAID)
​
  • Gates Foundation
  • Médecins Sans Frontières International
  • Other private foundations and individuals
​

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