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New hope against deadly mold infections enters final testing

NCT ID NCT06925321

Disease control Sponsor: Basilea Pharmaceutica Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 6 times

Summary

This study tests a new medicine called fosmanogepix for adults with serious mold infections that are hard to treat. About 234 people will join, receiving either the new drug or standard care. The main goal is to see if fewer people die by day 42. The study is currently recruiting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 234 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

fungal infectious disease fusariosis invasive aspergillosis Zygomycosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Invasive mold infections

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    83 sites in 15 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • "LAIKO" General Hospital

    RECRUITING

    Athens, 115 27, Greece

  • "Santa Marcelina" Hospital

    RECRUITING

    São Paulo, 08270-070, Brazil

  • Chaim Sheba Medical Center, Department of Infectious Diseases

    RECRUITING

    Ramat Gan, 52621, Israel

  • Charleroi Grand Hospital (GHDC) - Les Viviers Site

    RECRUITING

    Charleroi, 6000, Belgium

  • China Medical University Hospital

    RECRUITING

    Taichung, 404327, Taiwan

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • David Geffen School of Medicine at UCLA

    RECRUITING

    Los Angeles, California, 90095-1690, United States

  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Duke University Medical Center, Duke Infectious Diseases

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Erasmus Medical Center, Deoartment of Infectious Diseases

    RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • Faculty of Medicine, Siriraj Hospital

    RECRUITING

    Bangkok, 10700, Thailand

  • Frankfurt University Clinic

    RECRUITING

    Frankfurt, 60590, Germany

  • General Hospital of Athens "Evangelismos"

    RECRUITING

    Athens, PC 10676, Greece

  • General Hospital of Thessaloniki "Ippokratio"

    RECRUITING

    Thessaloniki, 54642, Greece

  • Giuliano Isontina University Health Authority

    RECRUITING

    Trieste, 34125, Italy

  • HC-UFPR

    RECRUITING

    Curitiba, Paraná, 80060-900, Brazil

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

    RECRUITING

    São Paulo, 01509-900, Brazil

  • Hospital Our Lady of Grace

    RECRUITING

    Curitiba, Paraná, 80810-040, Brazil

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, Catalonia, 08041, Spain

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, 08025, Spain

  • Hospital del Mar, Department of Infectious Diseases

    RECRUITING

    Barcelona, Catalonia, 08003, Spain

  • IRCCS Policlinic Hospital San Martino

    RECRUITING

    Genova, 16132, Italy

  • Jessa Hospital

    RECRUITING

    Hasselt, 3500, Belgium

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21231, United States

  • Juravinski Hospital - Hamilton Health Sciences

    RECRUITING

    Hamilton, Ontario, L8V 1C3, Canada

  • Kaohsiung Chang Gung Memorial Hospital

    RECRUITING

    Kaohsiung City, 833401, Taiwan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    RECRUITING

    Kaohsiung City, 807377, Taiwan

  • Karmanos Cancer Institute - Detroit

    TERMINATED

    Detroit, Michigan, 48201, United States

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

    RECRUITING

    Linz, 4021, Austria

  • Linkou Chang Gung Memorial Hospital

    RECRUITING

    Taoyuan, 333, Taiwan

  • Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda

    RECRUITING

    Milan, 20122, Italy

  • Maharaj Nakorn Chiang Mai Hospital

    RECRUITING

    Chiang Mai, 50200, Thailand

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

    RECRUITING

    Vienna, 1090, Austria

  • Memorial Healthcare System

    RECRUITING

    Hollywood, Florida, 33021, United States

  • Monash Medical Center Clayton

    RECRUITING

    Clayton, 3168, Australia

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

    RECRUITING

    Nantes, 44000, France

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100226, Taiwan

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

    RECRUITING

    Paris, 75015, France

  • Ottawa Hospital

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

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

    RECRUITING

    São Paulo, São Paulo, 04023-900, Brazil

  • Peter MacCallum Cancer Center

    RECRUITING

    Melbourne, 3050, Australia

  • Polyclinic San Matteo, IRCCS

    RECRUITING

    Pavia, 27100, Italy

  • Porto Alegre Clinical Hospital (HCPA)

    RECRUITING

    Porto Alegre, 90035-903, Brazil

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, 4102, Australia

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

    RECRUITING

    Nijmegen, 6525GA, Netherlands

  • Rambam Health Care Campus, Institute of Infectious Diseases

    RECRUITING

    Haifa, 3109601, Israel

  • Rennes University Hospital Center - Pontchaillou Site

    RECRUITING

    Rennes, 35000, France

  • Royal Melbourne Hospital

    RECRUITING

    Parkville, 3050, Australia

  • Rush University Medical Center, Division of Infectious Diseases

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Shamir Medical Center, Department of Infectious Diseases

    RECRUITING

    Ẕerifin, 7033001, Israel

  • Songklanagarind Hospital

    RECRUITING

    Hat Yai, 90110, Thailand

  • Srinagarind Hospital

    RECRUITING

    Khon Kaen, 40002, Thailand

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, 407219, Taiwan

  • Taipei Medical University Hospital

    RECRUITING

    Taipei, 110301, Taiwan

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 112201, Taiwan

  • The Alfred Hospital

    RECRUITING

    Melbourne, 3004, Australia

  • The Tel Aviv Sourasky Medical Center, Infectious Diseases Unit

    RECRUITING

    Tel Aviv, 6423906, Israel

  • The University of Texas Health Science Center at Houston, Department of Internal Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • UC Davis Medical Center

    RECRUITING

    Sacramento, California, 95817, United States

  • UCL Mont-Godinne University Hospitals

    RECRUITING

    Yvoir, 5530, Belgium

  • UMC Utrecht, Department of Rheumatology & Clinical Immunology

    RECRUITING

    Utrecht, 3584 CX, Netherlands

  • UT MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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

    RECRUITING

    Athens, PC 12462, Greece

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

    RECRUITING

    Cologne, North Rhine-Westphalia, 50937, Germany

  • University Hospital Cruces

    RECRUITING

    Barakaldo, 48903, Spain

  • University Hospital Ramon y Cajal, Department of Infectious Diseases

    RECRUITING

    Madrid, 28034, Spain

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

    RECRUITING

    Ulm, Baden-Wurttemberg, 89081, Germany

  • University Hospital Virgen Macarena

    RECRUITING

    Seville, Andalusia, 41009, Spain

  • University Hospital of Pisa

    RECRUITING

    Pisa, 56126, Italy

  • University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology

    RECRUITING

    Leuven, 3000, Belgium

  • University Medical Center of Johannes Gutenberg University Mainz

    RECRUITING

    Mainz, Rhineland-Palatinate, 55131, Germany

  • University Polyclinic Hospital of Modena

    RECRUITING

    Modena, 41124, Italy

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

    RECRUITING

    Birmingham, Alabama, 35294-0006, United States

  • University of Alberta

    RECRUITING

    Edmonton, Alberta, T6G 2R3, Canada

  • University of Kentucky Medical Center, Division of Infectious Diseases

    RECRUITING

    Lexington, Kentucky, 40506, United States

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

    RECRUITING

    Ann Arbor, Michigan, 48109-5000, United States

  • University of Minnesota, M Health Fairview Medical Center

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • University of Pennsylvania School of Medicine

    RECRUITING

    Philadelphia, Pennsylvania, 19104-6243, United States

  • University of Texas Health Science Center at San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Vancouver Coastal Health Research Institute (VCHRI)

    RECRUITING

    Vancouver, V5Z 1M9, Canada

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

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medical College - NewYork-Presbyterian Hospital

    RECRUITING

    New York, New York, 10021, United States

  • Westmead Hospital

    RECRUITING

    Westmead, 2145, Australia