DNDi and our partners are working to develop safe, affordable treatments to prevent devastating amputation and disability – and to improve access for all people in need. With evidence from our Phase II trial showing the efficacy of treatment with itraconazole and fosravuconazole, the latter having practical advantages, we are now working to help facilitate access to the two treatments and close epidemiological knowledge gaps in key endemic countries.
Our progress in 2025 includes:

Drug discovery
MycetOS: The evaluation of Series 1 fenarimols concluded, and results were published in RSC Medicinal Chemistry in September. Series 2, 5, and 6 have been evaluated thanks to significant donations of compounds and expertise from the open science community.

Clinical trials
Fosravuconazole: Following completion of the Phase II randomized controlled trial, DNDi and Eisai initiated an early access cohort protocol in Kassala, Sudan to provide fosravuconazole under controlled conditions for eumycetoma patients, bridging treatment gaps while generating real-world safety and efficacy data to inform policy and accelerate access. Concurrently, partners finalized the regulatory dossier for submission to Sudan’s National Medicines and Poisons Board and advanced global regulatory engagement for fosravuconazole registration in eumycetoma-endemic regions. Preparations are underway for feasibility assessments for a multi-country Phase III trial of the treatment.

Registration & access
New treatments for mycetoma: DNDi completed retrospective data collection of mycetoma cases from 2014–2023 in India and Senegal, providing critical insights into disease burden and treatment patterns. In Ethiopia, field surveys concluded across four regions (Afar, Amhara, Southern Nations, and Tigray), screening households and referring people with suspected eumycetoma for diagnosis and care. Additionally, DNDi finalized a socio-behavioral study in Kenya that captured patient and community perspectives on treatment access, adherence, and stigma. These datasets will inform risk mapping, policy guidance, and operational planning for future interventions, including clinical trials and integrated strategies to address neglected tropical diseases in endemic countries.
Photo credit: Kumerra Gemechu-DNDi