Mycetoma
Target product profile for mycetoma
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)
Ideal | Acceptable | |
---|---|---|
Target population | Adults and children aged ≥5 Immunocompetent or immunocompromised Pregnant and lactating | Adults Immunocompetent |
Geographic distribution | All regions including India | West and East Africa |
Treatment regimen | Once daily <6 months without surgery | Twice daily 6 months with surgery 6-12 months without surgery |
Formulation | Oral | Oral or intramuscular injection |
Monitoring and efficacy | Clinical 6 weeks | Clinical 6 weeks |
Efficacy | Cure 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/safety | No need for monitoring | Liver function monitoring (every 6 weeks) – no more discontinuation due to liver enzyme increase than with ketoconazole (est. 5%) |
Drug-drug interactions | None | Adequate with ACTs or forgiveness and usual antibiotic treatments – contraception |
Contraindications | None | Pregnant & lactating women |
Cost | Not more than for actinomycetoma or Buruli treatment – acceptable for Essential Medicines List | USD 200 (based on actinomycetoma cost in Sudan) |
Making medical history for neglected patients
We develop urgently needed treatments for neglected patients and ensure they’re affordable, available, and adapted to the communities who need them
Stay connected
Get our latest news, personal stories, research articles, and job opportunities.