Trials Sponsors Conditions Drugs Pricing

Conditions

Invasive Mold Infections Invasive mold infections caused by Aspergillus spp., Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multidrug resistant molds

Keywords

Fungal infectionAntifungalMold infectionRare moldsMultidrug resistant moldAspergillus spp.Fusarium spp.Lomentospora prolificansMucorales fungiScedosporium spp.

Outcome Measures

Primary Outcomes (1)

Day 42 all-cause mortality rate
Day 42

Secondary Outcomes (11)

Proportion of patients with overall response of treatment success
Day 42, Day 84 and up to 180 days
Proportion of patients with clinical response of treatment success
Day 42, Day 84 and up to 180 days
Proportion of patients with mycological response of eradication or presumed eradication

Study Arms (3)

Cohort A: Experimental Treatment

EXPERIMENTAL

Patients will receive the study drug. Fosmanogepix will be administered as an Intravenous (IV) infusion or in oral form.

Drug: Fosmanogepix IV infusionDrug: Fosmanogepix oral tablet

Cohort A: Comparator Antifungal Treatment

ACTIVE COMPARATOR

Best available therapy (BAT) administered as IV or orally per standard guidelines.

Drug: Standard of care antifungal therapy

Cohort B

EXPERIMENTAL

Interventions

Fosmanogepix IV infusionDrug

Fosmanogepix will be administered IV

Cohort A: Experimental TreatmentCohort B

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

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Fosmanogepix
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record
Formulated product
Fosmanogepix
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry record
Formulated product
Fosmanogepix oral tablet
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Fosmanogepix
Named ingredient: Fosmanogepix
View registry record
Fosmanogepix
Named ingredient: Fosmanogepix
View registry record
Fosmanogepix oral tablet
Named ingredient: Fosmanogepix
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Biomedical Advanced Research and Development Authority
US federal agencycollaborator
Basilea Pharmaceutica
Industrylead

Study Sites (90)

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

Birmingham, Alabama, 35294-0006, United States

RECRUITING

City of Hope

Duarte, California, 91010, United States

RECRUITING

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095-1690, United States

RECRUITING

UC Davis Medical Center

MeSH Terms

Conditions

Mycoses

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

Alison Kuchta, MD
Basilea Pharmaceutica International Ltd, Allschwil
STUDY DIRECTOR

Central Study Contacts

Alison Kuchta, MD

CONTACT

+41616061243 kuchtaa@basileapharma.com

Marc Engelhardt, MD

CONTACT

+41797010551

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR
Expanded Access: Yes

Study Record Dates

First Submitted

March 27, 2025

First Posted

April 13, 2025

Study Start

August 26, 2025

Actual (reported)

Primary Completion

February 2028

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (3)

Cohort A: Experimental Treatment

Cohort A: Comparator Antifungal Treatment

Cohort B

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (90)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (3)

Cohort A: Experimental Treatment

Cohort A: Comparator Antifungal Treatment

Cohort B

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (90)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Source records

Locations