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

May 19, 2026 updated by: Basilea Pharmaceutica

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

234

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Clayton, Australia, 3168
        • Recruiting
        • Monash Medical Center Clayton
      • Melbourne, Australia, 3004
        • Recruiting
        • The Alfred Hospital
      • Melbourne, Australia, 3050
        • Recruiting
        • Peter MacCallum Cancer Center
      • Parkville, Australia, 3050
        • Recruiting
        • Royal Melbourne Hospital
      • Woolloongabba, Australia, 4102
        • Recruiting
        • Princess Alexandra Hospital
  • Austria
      • Linz, Austria, 4021
        • Recruiting
        • Kepler University Hospital GmbH, Department of Internal Medicine IV - Pulmonology
      • Vienna, Austria, 1090
        • Recruiting
        • Medical University Vienna, Department of Internal Medicine I, Clinical Department of Infections and Tropical Medicine
  • Belgium
      • Charleroi, Belgium, 6000
        • Recruiting
        • Charleroi Grand Hospital (GHDC) - Les Viviers Site
      • Leuven, Belgium, 3000
        • Recruiting
        • University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology
      • Yvoir, Belgium, 5530
        • Recruiting
        • UCL Mont-Godinne University Hospitals
  • Canada
      • Vancouver, Canada, V5Z 1M9
        • Recruiting
        • Vancouver Coastal Health Research Institute (VCHRI)
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2R3
        • Recruiting
        • University of Alberta
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
        • Recruiting
        • Juravinski Hospital - Hamilton Health Sciences
  • France
      • Nantes, France, 44000
        • Recruiting
        • Nantes University Hospital Center - Hotel Dieu Hospital, Department of Infectious and Tropical Diseases
  • Germany
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Recruiting
        • University Medical Center of Johannes Gutenberg University Mainz
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus, Institute of Infectious Diseases
      • Ramat Gan, Israel, 52621
        • Recruiting
        • Chaim Sheba Medical Center, Department of Infectious Diseases
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • The Tel Aviv Sourasky Medical Center, Infectious Diseases Unit
      • Ẕerifin, Israel, 7033001
        • Recruiting
        • Shamir Medical Center, Department of Infectious Diseases
  • Italy
      • Milan, Italy, 20122
        • Recruiting
        • Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
      • Modena, Italy, 41124
        • Recruiting
        • University Polyclinic Hospital of Modena
      • Pavia, Italy, 27100
        • Recruiting
        • Polyclinic San Matteo, IRCCS
      • Pisa, Italy, 56126
        • Recruiting
        • University Hospital of Pisa
      • Trieste, Italy, 34125
        • Recruiting
        • Giuliano Isontina University Health Authority
  • Netherlands
      • Nijmegen, Netherlands, 6525GA
        • Recruiting
        • Radboud University Medical Center (Radboudumc), Department of Intensive Care
      • Rotterdam, Netherlands, 3015 GD
        • Recruiting
        • Erasmus Medical Center, Deoartment of Infectious Diseases
  • Spain
      • Barakaldo, Spain, 48903
        • Recruiting
        • University Hospital Cruces
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
      • Madrid, Spain, 28034
        • Recruiting
        • University Hospital Ramon y Cajal, Department of Infectious Diseases
    • Andalusia
      • Seville, Andalusia, Spain, 41009
        • Recruiting
        • University Hospital Virgen Macarena
    • Catalonia
      • Barcelona, Catalonia, Spain, 08041
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Catalonia, Spain, 08003
        • Recruiting
        • Hospital del Mar, Department of Infectious Diseases
  • Taiwan
      • Kaohsiung City, Taiwan, 807377
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine, Siriraj Hospital
      • Chiang Mai, Thailand, 50200
        • Recruiting
        • Maharaj Nakorn Chiang Mai Hospital
      • Hat Yai, Thailand, 90110
        • Recruiting
        • Songklanagarind Hospital
      • Khon Kaen, Thailand, 40002
        • Recruiting
        • Srinagarind Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0006
        • Recruiting
        • University of Alabama at Birmingham School of Medicine, Department of Medicine
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
      • Los Angeles, California, United States, 90095-1690
        • Recruiting
        • David Geffen School of Medicine at UCLA
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center, Division of Infectious Diseases
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • Recruiting
        • University of Kentucky Medical Center, Division of Infectious Diseases
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Recruiting
        • Johns Hopkins Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5000
        • Recruiting
        • University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute - Detroit
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota, M Health Fairview Medical Center
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine, Infectious Diseases Clinical Research Unit
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • University of North Carolina at Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center, Duke Infectious Diseases
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • UT MD Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center at Houston, Department of Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A: Experimental Treatment

Patients will receive the study drug.

Fosmanogepix will be administered as an Intravenous (IV) infusion or in oral form.
Drug: Fosmanogepix IV infusion
Fosmanogepix will be administered IV
Drug: Fosmanogepix oral tablet
Fosmanogepix will be administered orally.
Active Comparator: Cohort A: Comparator Antifungal Treatment
Best available therapy (BAT) administered as IV or orally per standard guidelines.
Drug: Standard of care antifungal therapy
Standard of care antifungal therapy will be administered in accordance with their respective product labels and/or standard practice guidelines
Experimental: Cohort B

Patients will receive the study drug.

Fosmanogepix will be administered as an Intravenous (IV) infusion or in oral form.
Drug: Fosmanogepix IV infusion
Fosmanogepix will be administered IV
Drug: Fosmanogepix oral tablet
Fosmanogepix will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Day 42 all-cause mortality rate
Time Frame: Day 42
Day 42

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with overall response of treatment success
Time Frame: Day 42, Day 84 and up to 180 days
Day 42, Day 84 and up to 180 days
Proportion of patients with clinical response of treatment success
Time Frame: Day 42, Day 84 and up to 180 days
Day 42, Day 84 and up to 180 days
Proportion of patients with mycological response of eradication or presumed eradication
Time Frame: Day 42, Day 84 and up to 180 days
Day 42, Day 84 and up to 180 days
Proportion of patients with radiological response of complete response or partial response
Time Frame: Day 42, Day 84 and up to 180 days
Day 42, Day 84 and up to 180 days
All-cause mortality rate at Day 84
Time Frame: Day 84
Day 84
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), treatment-related AEs, adverse events of special interest (AESI), and AEs leading to discontinuation
Time Frame: Screening up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)
Screening up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)
Number of patients with clinically significant laboratory abnormalities
Time Frame: Up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)
Up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)
Number of patients with abnormal neurological examination findings
Time Frame: Up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)
Up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)
Assessment of 12-lead electrocardiogram corrected QT (Fridericia method) Interval (ECG QTcF Interval)
Time Frame: Up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)
Up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)
Plasma concentrations versus time of fosmanogepix (prodrug) and manogepix (active moiety) following IV administration
Time Frame: Pre-dose, 3,6, and 9 hours post-start of the 3-hour IV infusion on Day 3, and at 24 hours (prior to Day 4 dosing)
Pre-dose, 3,6, and 9 hours post-start of the 3-hour IV infusion on Day 3, and at 24 hours (prior to Day 4 dosing)
Plasma concentrations versus time of fosmanogepix (prodrug) and manogepix (active moiety) following oral administration
Time Frame: On days 7, 14, 28, and 42. Post-dose plasma samples will also be collected: 72 hrs and 192 hrs after last dose.
On days 7, 14, 28, and 42. Post-dose plasma samples will also be collected: 72 hrs and 192 hrs after last dose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Basilea Pharmaceutica

Collaborators

Biomedical Advanced Research and Development Authority

Investigators

  • Study Director: Alison Kuchta, MD, Basilea Pharmaceutica International Ltd, Allschwil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

March 27, 2025

First Submitted That Met QC Criteria

April 11, 2025

First Posted (Actual)

April 13, 2025

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMGX-CS-302
  • 2024-516216-16-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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