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Phase 2 EL219 Versus Liposomal Amphotericin B or Voriconazole for Early Antifungal Therapy

NCT07215273 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-06

No results posted yet for this study

Summary

The purpose of this study is to determine if EL219 is safe and effective compared to liposomal amphotericin B (LAmB) or voricanozole for early treatment of invasive mould infections

Conditions

  • Invasive Mould Infection

Interventions

DRUG

EL219

EL219 is specifically being developed for early antifungal therapy (EAT), when infection is suspected due to highly suggestive signs and symptoms of disease; in high-risk people, antifungals are recommended even before confirmation of the microbial cause of infection, because delayed therapy is associated with poor outcomes in those who lack adequate immune responses. EL219 may provide a once-weekly alternative to LAmB and other polyenes that could also reduce the toxicities that often limit the frequency and duration of administration for these highly efficacious antifungals.

DRUG

Active Comparator- IV Antifungal (LAmB or voriconazole)

LAmB has broad-spectrum activity but its use is limited by toxicity and once-daily IV administration. It is not administered outside of the monitored setting given risks for electrolyte disturbances and cardiac arrhythmias. Voriconazole is a first-line therapy for IA and the most common azole used in the US and globally but does not have activity against many non-Aspergillus moulds.

Sponsors & Collaborators

  • Elion Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Taylor G. Sandison, MD · Sponsor: Elion Therapeutics, Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-13
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07215273 on ClinicalTrials.gov