Table 2.

TPP for new clinical entities against VL (as monotherapy)^*.

	Optimal target profile	Minimal target profile
Target label	VL and PKDL	VL
Species	All species	Leishmania donovani
Distribution	All areas	Either India or Africa
Target population	Immunocompetent and immunosuppressed	Immunocompetent
Clinical efficacy	> 95%	> 90%
Resistance	Active against resistant strains
Safety and tolerability	No AEs requiring clinical monitoring	One clinical monitoring visit in mid/end point
Contraindications	None	Pregnancy/lactation
Interactions	None – compatible for combination therapy	None for malaria, TB and HIV concomitant therapies
Formulation	Oral/i.m. depot	Oral/i.m. depot
Treatment regimen	1/day for 10 days p.o./3 shots over 10 days‡	b.i.d. for < 10 days p.o.; or > 3 shots over 10 days
Stability	3 years in zone 4	Stable under conditions that can be reasonably achieved in the target region (> 2 years)
Cost	< US$10/course	< US$125/course

*Developed by and reproduced with permission by DNDi.

‡For primary VL only. PKDL, HIV co-infection and relapse case treatments may require longer treatment durations.

DNDi: Drugs for Neglected Diseases initiative; PKDL: Post-kala azar dermal leishmaniasis; TPP: Target product profile; VL: Visceral leishmaniasis.