LXE408

Phase 2Small molecule

Novartis

LXE408 is one of 14 small molecule programs targeting Visceral Leishmaniasis. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Visceral LeishmaniasisCompleted

Cutaneous LeishmaniasisNot yet recruiting

Visceral LeishmaniasisPhase 2

Completed

Cutaneous LeishmaniasisPhase 2

Not yet recruiting

Competition

Competitive Landscape

15 competitors in Cutaneous Leishmaniasis

#DrugCompanyPhaseTrials

Abelcet

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Garamycin

Levaquin

Impavido

KKnight Therapeutics (USA) Inc

Phase 3

12 5

Trental

VValidus Pharmaceuticals

Phase 3

3 6

Flagyl

DDePuy Orthopaedics

Phase 2

1 7

Meglumine Antimoniate

UUniversity of Brasilia

Phase 3

14 8

Fusidic Acid

Roche

Phase 3

1 9

Arnica Tincture

UUniversidad de Antioquia

Phase 3

2 10

Zyloprim

Jazz Pharmaceuticals

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Phase 2Not yet recruiting

Cutaneous Leishmaniasis

NCT06997159

Q1 2031

Phase 2Recruiting

Chagas Disease

NCT06632600

Clinical

Trials by Indication[1]

Visceral Leishmaniasis3 trials

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

Active, not recruiting·DDrugs for Neglected Diseases·Phase 2·NCT05593666·101 enrolled

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

Completed·DDrugs for Neglected Diseases·Phase 2·NCT05957978·52 enrolled

A First-in-human, Randomized, Subject Blinded, Placebo Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of LXE408 in Healthy Subjects

Completed· Novartis logo

Novartis·Phase 1·NCT07809919·88 enrolled

Cutaneous Leishmaniasis1 trial

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 recruiting·DDrugs for Neglected Diseases·Phase 2·NCT06997159·250 enrolled

Chagas disease1 trial

A Randomized, Participant- and Investigator-blinded, Controlled, Parallel Group Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LXE408 in Participants With Chronic Chagas Disease Without Severe Organ Dysfunction.

Recruiting· Novartis logo

Novartis·Phase 2·NCT06632600·130 enrolled

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for LXE408. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — LXE408 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for LXE408. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Novartis

LXE408

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q1 2031

Trials by Indication[1]

Visceral Leishmaniasis3 trials

Cutaneous Leishmaniasis1 trial

Chagas disease1 trial

References

Drug Info

Quick Facts

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