NDAORALCAPSULEPriority Review
Approved
Mar 2014
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
7
Mechanism of Action
anti-leishmanial agent [see Clinical Pharmacology ( )] .
Pharmacologic Class:
Antileishmanial
Clinical Trials (5)
A Clinical Trial to Investigate Efficacy, Safety and Pharmacokinetics (PK) of Two LXE408 Oral Regimens and Oral Miltefosine as Active Control in Participants Aged ≥ 18 Years Old With Localized Cutaneous Leishmaniasis in the Region of the Americas (AMR).
Started Nov 2025
250 enrolled
Localized Cutaneous Leishmaniasis
Dedicated QT Study in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis
Started Dec 2015
42 enrolled
Mucocutaneous Leishmaniasis
Treatment of Leishmaniasis With Impavido® (Miltefosine): Higher-Weight Patient Registry
Started Jul 2015
0Leishmaniasis
Spermiogram Assessment in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis
Started Jul 2015
55 enrolled
Mucocutaneous Leishmaniasis
Treatment of Leishmaniasis With Impavido® (Miltefosine): Pregnancy Registry
Started Jul 2015
0Leishmaniasis or Other Uses of Miltefosine