DNDi aims to develop a topical or oral treatment for all species of leishmania causing cutaneous or mucocutaneous leishmaniasis that is safe and effective for all patients and does not require a cold chain.

Target product profile for cutaneous leishmaniasis

Target speciesOne treatment for all species of Leishmania L. tropica or L. braziliensis
Safety/tolerabilityWell tolerated
All adverse reactions (AR)s ≤ grade 1
Safety monitoring at primary health care (PHC) level.
No major safety concerns:
Well tolerated in >95% of patients treated.
Systemic AR ≤ Grade 3 in <5%.
Local AR ≤ grade 2 in <30%
No treatment-induced mortality
ContraindicationsNoneCan be assessed at primary health care level.
Efficacy>95% patients with complete clinical cure, defined as 100% epithelialization/flattening of lesion(s) at 3 months from treatment onset

Minimal scar
No relapse or development of Leishmania recidivans or mucocutaneous leishmaniasis (MCL)
Parasitological endpoint not required
60% epithelialization/flattening of lesion(s) for L. tropica and 70% for L. braziliensis patients with complete cure

Scar no worse than natural healing
<5% rate of relapse or development of Leishmania recidivans or MCL at 1 year
FormulationTopical / oral Non-parenteral,
or few doses if parenteral
Treatment regimenTopical ≤ 14 days
Oral < 7 days
Topical: 28 days
Oral: twice daily for 28 days
Parenteral ≤ 3 injections
Target populationNo restrictions>9 months of age
No efficacy in immune-compromised patients
Not for use in pregnancy (category B*)
StabilityNo cold chain
At least 3 years at 37º C
2 years at 4-8º C
CostTo be definedTo be defined

* No signs of risk in animal studies, but no adequate studies in humans