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Comparing olorofim to AmBisome for invasive aspergillosis treatment

Phase III, Adjudicator-blinded, Randomised Study to Evaluate Efficacy and Safety of Treatment With Olorofim Versus Treatment With AmBisome® Followed by Standard of Care in Patients With Invasive Fungal Disease Caused by Aspergillus Species

Phase 3 Interventional F2G Biotech GmbH · NCT05101187

This study is testing a new antifungal called olorofim to see if it works better than AmBisome for treating invasive aspergillosis in patients who haven't had success with other treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment225 (estimated)
Ages18 Years and up
SexAll
SponsorF2G Biotech GmbH Industry-sponsored
Locations140 sites (Birmingham, Alabama and 139 other locations)
Trial IDNCT05101187 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy, safety, and tolerability of olorofim compared to AmBisome® followed by standard of care in patients suffering from invasive aspergillosis. The trial focuses on patients who have not responded to or cannot tolerate azole therapy, addressing a critical gap in treatment options for this high-mortality condition. Olorofim is a novel antifungal with a unique mechanism of action that may be effective against resistant strains of Aspergillus. The study will involve patients over 18 years old with proven or probable lower respiratory tract disease caused by Aspergillus species.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with proven invasive aspergillosis who require antifungal therapy other than azoles.

Not a fit: Patients who are pregnant or breastfeeding will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with invasive aspergillosis who are resistant to current therapies.

How similar studies have performed: Other studies have shown promise with novel antifungal agents, but this specific approach with olorofim is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male and female patients ages over 18 years and weighing more than 30 kg
2. Patients with proven IA at any site or probable LRTD IA per EORTC/MSG 2019 criteria as adapted for this study and where the duration of specific therapy for this episode of IA has been ≤ 28 days. For purposes of this inclusion, the duration of specific therapy includes any mould-active therapy given for this episode of IA whether subsequently judged potentially effective or not.
3. Patients requiring therapy with an antifungal agent other than a mould-active azole, and who have had ≤ 96 hours of potentially effective prior therapy. Potentially effective prior therapy includes any agent to which the infecting strain of Aspergillus is likely to be susceptible. There are no exclusions or limitations on such agents (eg, AmBisome® is permitted) other than their duration.
4. AmBisome® is an appropriate therapy for the patient.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.
2. Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug
3. Patients with only chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
4. Suspected mucormycosis (zygomycosis).
5. Patients with a known active second fungal infection of any type, other than candidiasis that can be treated with fluconazole.
6. The requirement for ongoing use of echinocandin as Candida prophylaxis.
7. Microbiological findings (eg, bacteriological, virological) or other potential conditions that are temporally related and suggest a different aetiology for the clinical features.
8. Human immunodeficiency virus (HIV) infection but not currently receiving antiretroviral therapy.
9. Patients with a baseline prolongation of QT using Fridericia's Correction Formula (QTcF) ≥ 500 msec, or at high risk for QT/QTc prolongation.
10. Evidence of hepatic dysfunction.

Where this trial is running

Birmingham, Alabama and 139 other locations

+90 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Invasive AspergillosisInvasive fungal diseaseAspergillus speciesOlorofimNon-azole antifungalAzole resistance
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.