# 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).

> **NCT06997159** · PHASE2 · NOT_YET_RECRUITING · sponsor: **Drugs for Neglected Diseases** · enrollment: 250 (estimated)

## Conditions studied

- Localized Cutaneous Leishmaniasis

## Interventions

- **DRUG:** LXE408
- **DRUG:** Miltefosine 50 MG Oral Capsule [Impavido]
- **DRUG:** Placebo to LXE408

## Key facts

- **NCT ID:** NCT06997159
- **Lead sponsor:** Drugs for Neglected Diseases
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** NOT_YET_RECRUITING
- **Start date:** 2026-06-15
- **Primary completion:** 2028-04-05
- **Final completion:** 2028-04-05
- **Target enrollment:** 250 (ESTIMATED)
- **Last updated:** 2026-05-05

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06997159

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06997159, "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).". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT06997159. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*