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Study identifier: NCT06925321 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.

Condition: Invasive Mold Infections  ·  Sponsor: Basilea Pharmaceutica

PhasePhase 3
Planned participants234
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Alison Kuchta, MD  ·  +41616061243  ·  kuchtaa@basileapharma.com

Marc Engelhardt, MD  ·  +41797010551  ·  marc.engelhardt@basilea.com

Always discuss trial participation with your own doctor first.

Locations (76)

University of Alabama at Birmingham School of Medicine, Department of MedicineBirmingham, Alabama, United StatesRecruiting
City of HopeDuarte, California, United StatesRecruiting
David Geffen School of Medicine at UCLALos Angeles, California, United StatesRecruiting
UC Davis Medical CenterSacramento, California, United StatesRecruiting
Memorial Healthcare SystemHollywood, Florida, United StatesRecruiting
Rush University Medical Center, Division of Infectious DiseasesChicago, Illinois, United StatesRecruiting
University of Kentucky Medical Center, Division of Infectious DiseasesLexington, Kentucky, United StatesRecruiting
Johns Hopkins HospitalBaltimore, Maryland, United StatesRecruiting
University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care CenterAnn Arbor, Michigan, United StatesRecruiting
Karmanos Cancer Institute - DetroitDetroit, Michigan, United StatesRecruiting
University of Minnesota, M Health Fairview Medical CenterMinneapolis, Minnesota, United StatesRecruiting
Washington University School of Medicine, Infectious Diseases Clinical Research UnitSt Louis, Missouri, United StatesRecruiting

+ 64 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06925321