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Fosmanogepix treatment for adults with invasive mold infections

An Interventional Phase 3, Open-label, Two-cohort Study to Investigate the Efficacy and Safety of Fosmanogepix in Adult Patients With Invasive Mold Infections Caused by Aspergillus Spp., Fusarium Spp., Lomentospora Prolificans, Mucorales Fungi, or Other Multidrug Resistant Molds

Phase 3 Interventional Basilea Pharmaceutica · NCT06925321

This trial tests whether fosmanogepix (given IV or as a pill) is safe and works to treat adults with invasive mold infections, either compared with usual antifungals or as a salvage option after other treatments fail.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment234 (estimated)
Ages18 Years and up
SexAll
SponsorBasilea Pharmaceutica Industry-sponsored
Locations49 sites (Birmingham, Alabama and 48 other locations)
Trial IDNCT06925321 on ClinicalTrials.gov

What this trial studies

Adults with proven or probable invasive mold infections (including Aspergillus with limited options, Fusarium, Lomentospora prolificans, Mucorales, or other multidrug-resistant molds) are enrolled and assigned to one of two cohorts. Cohort A (primary therapy) receives either fosmanogepix or the site’s standard antifungal regimen, while Cohort B (salvage therapy) receives fosmanogepix after prior treatment failure or intolerance. Fosmanogepix is given intravenously or orally for a target of 84 days (which can be extended to 180 days) within a total study duration of about 8 months including follow-up. The primary outcome compares all-cause mortality at Day 42 against a fixed threshold to determine efficacy and safety.

Who should consider this trial

Good fit: Adults with proven or probable invasive mold infections caused by Aspergillus (with limited options), Fusarium, Lomentospora, Mucorales, or other multidrug-resistant molds who can undergo infection source control and meet other eligibility criteria.

Not a fit: Patients with refractory hematologic malignancy, chronic aspergillosis or aspergilloma, COVID-19–associated mucormycosis, those requiring dialysis, or with very poor performance status (Karnofsky <20) are excluded or unlikely to benefit.

Why it matters

Potential benefit: If successful, fosmanogepix could provide a new treatment option for invasive and drug-resistant mold infections and potentially reduce deaths in these high-risk patients.

How similar studies have performed: Earlier phase trials and compassionate-use reports have shown promising antifungal activity of fosmanogepix against a range of molds, but large phase 3 evidence for invasive mold infections remains limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Main Inclusion Criteria:

1. Diagnosis of proven or probable Invasive mold infection (IMI) defined in accordance with the Revision and Update of the Consensus Definitions of Invasive Fungal Disease from the EORTC/MSGERC as adapted for this study and caused by Aspergillus spp. (in patients with limited treatment options), Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multi-drug resistant molds.
2. Patient's condition allows for appropriate infection source control measures.

Main Exclusion Critera:

1. Refractory hematologic malignancy.
2. Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
3. Coronavirus disease 2019 (COVID-19) associated mucormycosis.
4. Invasive fungal disease caused by more than one fungal pathogen is not permitted in Cohort A but is permitted in Cohort B.
5. Patients with a Karnofsky Performance Status \< 20 at Screening.
6. Requirement, or anticipated requirement, for hemodialysis, peritoneal dialysis, or hemofiltration.
7. Patients with known human immunodeficiency virus infection.
8. Ongoing neurological disorders.
9. Patients receiving hospice/comfort care only.
10. Other medical or psychiatric condition.
11. Current use of any prohibited concomitant medication(s).
12. Current/ previous administration of an investigational drug within 30 days.
13. Prior enrollment in this or any previous study of fosmanogepix.
14. Moderate or severe hepatic impairment.
15. Patient who is pregnant or lactating.
16. Known hypersensitivity to fosmanogepix, manogepix, or any of their excipients.

Where this trial is running

Birmingham, Alabama and 48 other locations

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 Mold InfectionsFungal infectionAntifungalMold infectionRare moldsMultidrug resistant moldAspergillus spp.Fusarium spp.
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.