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Invasive Mold InfectionsPhase 3NCT06925321

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

A Phase 3 study testing Fosmanogepix IV infusion and Fosmanogepix oral tablet in people with Invasive Mold Infections, run by Basilea Pharmaceutica at 90 sites in 15 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Invasive Mold Infections
What is being tested?
Fosmanogepix IV infusion and Fosmanogepix oral tablet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
234 participants
Where
90 sitesin 15 countries
Study dates
26 Aug 2025to Feb 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

90 sites in 15 countries. Contact the study team or a site near you to ask about taking part.

Alison Kuchta, MD contact

+41616061243

kuchtaa@basileapharma.com

Marc Engelhardt, MD contact

+41797010551

marc.engelhardt@basilea.com

90 sites in 15 countries

United States20 sites, 19 recruiting

  • University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center

    Ann Arbor, Michigan, 48109-5000

    Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21231

    Recruiting

  • University of Alabama at Birmingham School of Medicine, Department of Medicine

    Birmingham, Alabama, 35294-0006

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

    Recruiting

  • Rush University Medical Center, Division of Infectious Diseases

    Chicago, Illinois, 60612

    Recruiting

  • Karmanos Cancer Institute - Detroit

    Detroit, Michigan, 48201

    Terminated

  • City of Hope

    Duarte, California, 91010

    Recruiting

  • Duke University Medical Center, Duke Infectious Diseases

    Durham, North Carolina, 27710

    Recruiting

  • Memorial Healthcare System

    Hollywood, Florida, 33021

    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 Kentucky Medical Center, Division of Infectious Diseases

    Lexington, Kentucky, 40506

    Recruiting

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095-1690

    Recruiting

  • University of Minnesota, M Health Fairview Medical Center

    Minneapolis, Minnesota, 55455

    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 Pennsylvania School of Medicine

    Philadelphia, Pennsylvania, 19104-6243

    Recruiting

  • UC Davis Medical Center

    Sacramento, California, 95817

    Recruiting

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

    Recruiting

  • Washington University School of Medicine, Infectious Diseases Clinical Research Unit

    St Louis, Missouri, 63110

    Recruiting

Other trials in United States

Taiwan8 sites, 8 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807377

    Recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833401

    Recruiting

  • China Medical University Hospital

    Taichung, 404327

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 407219

    Recruiting

  • National Taiwan University Hospital

    Taipei, 100226

    Recruiting

  • Taipei Medical University Hospital

    Taipei, 110301

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112201

    Recruiting

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333

    Recruiting

Other trials in Taiwan

Australia7 sites, 7 recruiting

  • Monash Medical Center Clayton

    Clayton, 3168

    Recruiting

  • The Alfred Hospital

    Melbourne, 3004

    Recruiting

  • Peter MacCallum Cancer Center

    Melbourne, 3050

    Recruiting

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

    Recruiting

  • Royal Melbourne Hospital

    Parkville, 3050

    Recruiting

  • Westmead Hospital

    Westmead, 2145

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, 4102

    Recruiting

Other trials in Australia

Canada7 sites, 7 recruiting

  • University of Alberta

    Edmonton, Alberta, T6G 2R3

    Recruiting

  • Juravinski Hospital - Hamilton Health Sciences

    Hamilton, Ontario, L8V 1C3

    Recruiting

  • London Health Sciences Center - University Hospital

    London, Ontario, N6A 5A5

    Recruiting

  • Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

    Recruiting

  • Toronto General Hospital, The Transplant Infectious Diseases Clinic

    Toronto, Ontario, M5G 2C4

    Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

    Recruiting

  • Vancouver Coastal Health Research Institute (VCHRI)

    Vancouver, V5Z 1M9

    Recruiting

Other trials in Canada

Brazil6 sites, 6 recruiting

  • HC-UFPR

    Curitiba, Paraná, 80060-900

    Recruiting

  • Hospital Our Lady of Grace

    Curitiba, Paraná, 80810-040

    Recruiting

  • Porto Alegre Clinical Hospital (HCPA)

    Porto Alegre, 90035-903

    Recruiting

  • Paulista School of Medicine at Federal University of Sao Paulo, UNIFESP

    São Paulo, São Paulo, 04023-900

    Recruiting

  • Hospital A.C.Camargo ("Antonio Prudente" Foundation)

    São Paulo, 01509-900

    Recruiting

  • "Santa Marcelina" Hospital

    São Paulo, 08270-070

    Recruiting

Other trials in Brazil

Italy6 sites, 6 recruiting

  • IRCCS Policlinic Hospital San Martino

    Genova, 16132

    Recruiting

  • Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda

    Milan, 20122

    Recruiting

  • University Polyclinic Hospital of Modena

    Modena, 41124

    Recruiting

  • Polyclinic San Matteo, IRCCS

    Pavia, 27100

    Recruiting

  • University Hospital of Pisa

    Pisa, 56126

    Recruiting

  • Giuliano Isontina University Health Authority

    Trieste, 34125

    Recruiting

Other trials in Italy

Spain6 sites, 6 recruiting

  • University Hospital Cruces

    Barakaldo, 48903

    Recruiting

  • Hospital del Mar, Department of Infectious Diseases

    Barcelona, Catalonia, 08003

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08041

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

    Recruiting

  • University Hospital Ramon y Cajal, Department of Infectious Diseases

    Madrid, 28034

    Recruiting

  • University Hospital Virgen Macarena

    Seville, Andalusia, 41009

    Recruiting

Other trials in Spain

Belgium5 sites, 5 recruiting

  • General Hospital Saint-Jan

    Bruges, 8000

    Recruiting

  • Charleroi Grand Hospital (GHDC) - Les Viviers Site

    Charleroi, 6000

    Recruiting

  • Jessa Hospital

    Hasselt, 3500

    Recruiting

  • University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology

    Leuven, 3000

    Recruiting

  • UCL Mont-Godinne University Hospitals

    Yvoir, 5530

    Recruiting

Other trials in Belgium

France4 sites, 4 recruiting

  • Nantes University Hospital Center - Hotel Dieu Hospital, Department of Infectious and Tropical Diseases

    Nantes, 44000

    Recruiting

  • Necker Children's Hospital, Department of Infectious and Tropical Diseases

    Paris, 75015

    Recruiting

  • Rennes University Hospital Center - Pontchaillou Site

    Rennes, 35000

    Recruiting

  • Strasbourg University Hospitals - Civil Hospital

    Strasbourg, 67091

    Recruiting

Other trials in France

Germany4 sites, 4 recruiting

  • University Hospital Cologne, Internal Medicine I - Oncology, Hematology, Clinical Infectiology, Clinical Immunology, Hemostaseology, Internal Intensive Care Medicine, Clinical Study Centre II for Infectious Diseases

    Cologne, North Rhine-Westphalia, 50937

    Recruiting

  • Frankfurt University Clinic

    Frankfurt, 60590

    Recruiting

  • University Medical Center of Johannes Gutenberg University Mainz

    Mainz, Rhineland-Palatinate, 55131

    Recruiting

  • University Hospital Ulm, Comprehensive Infectious Diseases Center Ulm (CIDCU)

    Ulm, Baden-Wurttemberg, 89081

    Recruiting

Other trials in Germany

Greece4 sites, 4 recruiting

  • "LAIKO" General Hospital

    Athens, 115 27

    Recruiting

  • General Hospital of Athens "Evangelismos"

    Athens, PC 10676

    Recruiting

  • University General Hospital "Attikon", 2nd Department of Internal Medicine, Propaedeutic, Hematology Unit

    Athens, PC 12462

    Recruiting

  • General Hospital of Thessaloniki "Ippokratio"

    Thessaloniki, 54642

    Recruiting

Other trials in Greece

Israel4 sites, 4 recruiting

  • Rambam Health Care Campus, Institute of Infectious Diseases

    Haifa, 3109601

    Recruiting

  • Chaim Sheba Medical Center, Department of Infectious Diseases

    Ramat Gan, 52621

    Recruiting

  • The Tel Aviv Sourasky Medical Center, Infectious Diseases Unit

    Tel Aviv, 6423906

    Recruiting

  • Shamir Medical Center, Department of Infectious Diseases

    Tsrifin, 7033001

    Recruiting

Other trials in Israel

Thailand4 sites, 4 recruiting

  • Faculty of Medicine, Siriraj Hospital

    Bangkok, 10700

    Recruiting

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200

    Recruiting

  • Songklanagarind Hospital

    Hat Yai, 90110

    Recruiting

  • Srinagarind Hospital

    Khon Kaen, 40002

    Recruiting

Other trials in Thailand

Netherlands3 sites, 3 recruiting

  • Radboud University Medical Center (Radboudumc), Department of Intensive Care

    Nijmegen, 6525GA

    Recruiting

  • Erasmus Medical Center, Deoartment of Infectious Diseases

    Rotterdam, 3015 GD

    Recruiting

  • UMC Utrecht, Department of Rheumatology & Clinical Immunology

    Utrecht, 3584 CX

    Recruiting

Other trials in Netherlands

Austria2 sites, 2 recruiting

  • Kepler University Hospital GmbH, Department of Internal Medicine IV - Pulmonology

    Linz, 4021

    Recruiting

  • Medical University Vienna, Department of Internal Medicine I, Clinical Department of Infections and Tropical Medicine

    Vienna, 1090

    Recruiting

Other trials in Austria

About this study

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

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:

Read more

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.

Being tested
Fosmanogepix IV infusion, Standard of care antifungal therapy, Fosmanogepix oral tablet
Keywords
Fungal infection, Antifungal, Mold infection, Rare molds, Multidrug resistant mold, Aspergillus spp., Fusarium spp., Lomentospora prolificans, Mucorales fungi, Scedosporium spp.
Medical subject headings
Mycoses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fosmanogepix IV infusionDrug

    Fosmanogepix will be administered IV

  • Standard of care antifungal therapyDrug

    Standard of care antifungal therapy will be administered in accordance with their respective product labels and/or standard practice guidelines

  • Fosmanogepix oral tabletDrug

    Fosmanogepix will be administered orally.

Study groups in NCT06925321
Study groupRoleWhat they receive
Cohort A: Experimental TreatmentExperimentalPatients will receive the study drug. Fosmanogepix will be administered as an Intravenous (IV) infusion or in oral form.
Receives: Drug: Fosmanogepix IV infusion; Drug: Fosmanogepix oral tablet
Cohort A: Comparator Antifungal TreatmentActive comparatorBest available therapy (BAT) administered as IV or orally per standard guidelines.
Receives: Drug: Standard of care antifungal therapy
Cohort BExperimentalPatients will receive the study drug. Fosmanogepix will be administered as an Intravenous (IV) infusion or in oral form.
Receives: Drug: Fosmanogepix IV infusion; Drug: Fosmanogepix oral tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Day 42 all-cause mortality rate

    Measured: Day 42

Secondary outcomes (11)

  1. Proportion of patients with overall response of treatment success

    Measured: Day 42, Day 84 and up to 180 days

  2. Proportion of patients with clinical response of treatment success

    Measured: Day 42, Day 84 and up to 180 days

  3. Proportion of patients with mycological response of eradication or presumed eradication

    Measured: Day 42, Day 84 and up to 180 days

  4. Proportion of patients with radiological response of complete response or partial response

    Measured: Day 42, Day 84 and up to 180 days

  5. All-cause mortality rate at Day 84

    Measured: Day 84

  6. 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

    Measured: Screening up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)

  7. Number of patients with clinically significant laboratory abnormalities

    Measured: Up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)

  8. Number of patients with abnormal neurological examination findings

    Measured: Up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)

  9. Assessment of 12-lead electrocardiogram corrected QT (Fridericia method) Interval (ECG QTcF Interval)

    Measured: Up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)

  10. Plasma concentrations versus time of fosmanogepix (prodrug) and manogepix (active moiety) following IV administration

    Measured: 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)

  11. Plasma concentrations versus time of fosmanogepix (prodrug) and manogepix (active moiety) following oral administration

    Measured: On days 7, 14, 28, and 42. Post-dose plasma samples will also be collected: 72 hrs and 192 hrs after last dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2025
  2. Study start26 Aug 2025
  3. Primary completionFeb 2028 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
An open-label, 2-cohort study
Masking
None (open label)
Enrolment
234 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06925321
Sponsor's protocol ID
FMGX-CS-302
Other IDs
75A50124C00033, 2024-516216-16-00
Status last verified
Oct 2026
First submitted
27 Mar 2025
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fosmanogepix IV infusion and Fosmanogepix oral tablet in people with Invasive Mold Infections, run by Basilea Pharmaceutica at 90 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States, Taiwan, Australia, Canada, Brazil and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alison Kuchta, MD (+41616061243, kuchtaa@basileapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Day 42 all-cause mortality rate (time frame: Day 42). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06925321.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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