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A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.
NCT06925321 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to evaluate the efficacy and safety of fosmanogepix (administered IV or oral) for the treatment of adult patients with invasive mold infections. The study is looking for patients who have been diagnosed with invasive mold infections. The maximum study duration will be approximately 8 months, including a target study treatment duration of 84 days which can be extended up to 180 days and follow-up period. The patient will be assigned to one of two treatment cohorts: Cohort A (primary therapy): Patients will receive either the study drug or institutional standard of care antifungal treatment. Cohort B (salvage treatment; i.e. treatment given after patients did not respond to previous treatments or did not tolerate them): Patients will receive the study drug The primary aim is to compare the all cause mortality with a fixed threshold at Day 42.
Conditions Studied
Interventions
- DRUG Fosmanogepix IV infusion
- DRUG Standard of care antifungal therapy
- DRUG Fosmanogepix oral tablet
Study Locations (20)
Other
- Peter MacCallum Cancer Center — Melbourne
- Princess Alexandra Hospital — Woolloongabba
- Kepler University Hospital GmbH, Department of Internal Medicine IV - Pulmonology — Linz
- Medical University Vienna, Department of Internal Medicine I, Clinical Department of Infections and Tropical Medicine — Vienna
- University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology — Leuven
- Nantes University Hospital Center - Hotel Dieu Hospital, Department of Infectious and Tropical Diseases — Nantes
California
- David Geffen School of Medicine at UCLA — Los Angeles
- UC Davis Medical Center — Sacramento
Michigan
- University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center — Ann Arbor
- Karmanos Cancer Institute - Detroit — Detroit
North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill
- Duke University Medical Center, Duke Infectious Diseases — Durham
Alabama
- University of Alabama at Birmingham School of Medicine, Department of Medicine — Birmingham
Kentucky
- University of Kentucky Medical Center, Division of Infectious Diseases — Lexington
Maryland
- Johns Hopkins Hospital — Baltimore
Minnesota
- University of Minnesota, M Health Fairview Medical Center — Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2025-08-26 |
| Est. Completion | 2028-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06925321
The ClinicalTrials.gov registry entry for NCT06925321 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 219 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Basilea Pharmaceutica, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Invasive Mold Infections appearing as the primary indexed condition, and to 3 interventions — of which Fosmanogepix IV infusion is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06925321 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, California, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06925321 about?
NCT06925321 is a clinical study titled "A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.". The purpose of this study is to evaluate the efficacy and safety of fosmanogepix (administered IV or oral) for the treatment of adult patients with invasive mold infections. The study is looking for patients who have been diagnosed with invasive mold infections. The maximum study duration will be ap...
What is the current status of trial NCT06925321?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 219 participants. The study started on 2025-08-26. Estimated completion is 2028-02.
What conditions does trial NCT06925321 study?
This clinical trial studies the following conditions: Invasive Mold Infections. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06925321?
The interventions under investigation include: Fosmanogepix IV infusion (DRUG), Standard of care antifungal therapy (DRUG), Fosmanogepix oral tablet (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06925321?
This trial is sponsored by Basilea Pharmaceutica, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06925321 being conducted?
This trial has 20 study locations across Alabama, California, Kentucky, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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