An update on the clinical pharmacology of miltefosine in the treatment of leishmaniasis

Miltefosine is an alkylphosphocholine agent with a broad spectrum of antiparasitic properties. For over two decades now, miltefosine remains the first and only oral drug licensed and used in treatment of the neglected tropical disease leishmaniasis. An extensive review on the pharmacology of miltefosine was last published in 2012, while additional data on the clinical pharmacokinetics (PK) and pharmacodynamics (PD) of miltefosine became available in the past decade, along with ongoing and future studies in this area. Miltefosine PK are characterized by slow absorption and elimination resulting in accumulation of drug in plasma until the end of treatment. Several recent studies established exposure-response relationships for various treatment regimens of miltefosine in the treatment of visceral and cutaneous leishmaniasis, leading to the identification of PK parameters predictive of clinical relapse and outcome. This review provides an update on the most recent developments in the area of clinical pharmacology of miltefosine, including a discussion of the current dosing regimens.