A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.
Public ClinicalTrials.gov record NCT06925321. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06925321
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 234 participants
Conditions and interventions
Conditions
Interventions
- Fosmanogepix IV infusion Drug
- Standard of care antifungal therapy Drug
- Fosmanogepix oral tablet Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 25, 2025
- Primary completion
- Jan 31, 2028
- Completion
- Jan 31, 2028
- Last update posted
- Aug 16, 2026
2025 – 2028
United States locations
- U.S. sites
- 20
- U.S. states
- 13
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham School of Medicine, Department of Medicine | Birmingham | Alabama | 35294-0006 | Recruiting |
| City of Hope | Duarte | California | 91010 | Recruiting |
| David Geffen School of Medicine at UCLA | Los Angeles | California | 90095-1690 | Recruiting |
| UC Davis Medical Center | Sacramento | California | 95817 | Recruiting |
| Memorial Healthcare System | Hollywood | Florida | 33021 | Recruiting |
| Rush University Medical Center, Division of Infectious Diseases | Chicago | Illinois | 60612 | Recruiting |
| University of Kentucky Medical Center, Division of Infectious Diseases | Lexington | Kentucky | 40506 | Recruiting |
| Johns Hopkins Hospital | Baltimore | Maryland | 21231 | Recruiting |
| University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center | Ann Arbor | Michigan | 48109-5000 | Recruiting |
| Karmanos Cancer Institute - Detroit | Detroit | Michigan | 48201 | Terminated |
| University of Minnesota, M Health Fairview Medical Center | Minneapolis | Minnesota | 55455 | Recruiting |
| Washington University School of Medicine, Infectious Diseases Clinical Research Unit | St Louis | Missouri | 63110 | Recruiting |
| Weill Cornell Medical College - NewYork-Presbyterian Hospital | New York | New York | 10021 | Recruiting |
| David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Recruiting |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | Recruiting |
| Duke University Medical Center, Duke Infectious Diseases | Durham | North Carolina | 27710 | Recruiting |
| University of Pennsylvania School of Medicine | Philadelphia | Pennsylvania | 19104-6243 | Recruiting |
| The University of Texas Health Science Center at Houston, Department of Internal Medicine | Houston | Texas | 77030 | Recruiting |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 62 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06925321, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 16, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06925321 live on ClinicalTrials.gov.