LXE408

DRUG5 trials

Sponsors

Drugs for Neglected Diseases, Novartis Pharmaceuticals

Conditions

Chagas DiseaseLocalized Cutaneous LeishmaniasisPrimary Visceral LeishmaniasisVisceral Leishmaniasis

Phase 1

A First-in-human, Safety, Tolerability, and Pharmacokinetics Study of LXE408 in Healthy Subjects

CompletedNCT07809919

Novartis PharmaceuticalsVisceral Leishmaniasis, Chagas Disease

Start: 2018-12-21End: 2021-09-27Updated: 2026-09-09

Phase 2

A Phase II, Multicentre, Randomized, Two-arm Blinded Study to Assess the Efficacy and Safety of Two LXE408 Regimens for Treatment of Patients With Primary Visceral Leishmaniasis

CompletedNCT05593666

Drugs for Neglected DiseasesPrimary Visceral Leishmaniasis

Start: 2022-12-27End: 2025-12-22Updated: 2026-04-30

LXE408 for Treatment of Visceral Leishmaniasis in Ethiopia, a Proof of Concept Study

CompletedNCT05957978

Drugs for Neglected DiseasesPrimary Visceral Leishmaniasis

Start: 2024-03-29End: 2025-11-13Updated: 2025-12-18

A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease.

RecruitingNCT06632600

Novartis PharmaceuticalsChagas Disease

Start: 2025-04-28End: 2031-01-21Target: 130Updated: 2026-08-19

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).

Not yet recruitingNCT06997159

Drugs for Neglected DiseasesLocalized Cutaneous Leishmaniasis

Start: 2026-06-15End: 2028-04-05Target: 250Updated: 2026-05-05