DNDi aims to develop a less than six-month oral, daily treatment for eumycetoma for all patients in all regions, with high efficacy and no need to monitor for safety.

Target product profile for eumycetoma (fungal mycetoma)

Target populationAdults and children aged ≥5
Immunocompetent or immunocompromised
Pregnant and lactating
Geographic distributionAll regions including IndiaWest and East Africa
Treatment regimenOnce daily
<6 months without surgery
Twice daily
6 months with surgery
6-12 months without surgery
FormulationOralOral or intramuscular injection
Monitoring and efficacyClinical 6 weeksClinical 6 weeks
EfficacyCure rate of >90%
No need for surgery (as in actinomycetoma)
Cure defined as: complete disappearance of mass, closure of sinuses. Skin returned to normal.
Acceptable ≥ketoconazole and cure ≥75%
Tolerability/safetyNo need for monitoringLiver function monitoring (every 6 weeks) – no more discontinuation due to liver enzyme increase than with ketoconazole (est. 5%)
Drug-drug interactionsNoneAdequate with ACTs or forgiveness and usual antibiotic treatments – contraception
ContraindicationsNonePregnant & lactating women
CostNot more than for actinomycetoma or Buruli treatment – acceptable for Essential Medicines ListUSD 200 (based on actinomycetoma cost in Sudan)