NCT06433128

Brief Summary

The EAP is intended to provide a treatment option for patients with proven or probable serious or life-threatening invasive fungal infection (in accordance with the EORTC-MSGERC criteria) who have exhausted their treatment options, primarily due to an infection with a resistant fungal pathogen, and for whom no other treatment options are available through marketed drugs or investigational agents in clinical studies ongoing in the respective indication.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2024

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

First QC Date

May 22, 2024

Last Update Submit

July 23, 2025

Conditions

Keywords

Fungal infectionCandidaAnti-fungalYeastMoldRare mold

Interventions

Fosmanogepix solution for infusion, 20 mg/mL for intravenous administration

Fosmanogepix 400 mg tablets for oral administration

Eligibility Criteria

Age12 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
The EAP is intended to provide a treatment option for patients with proven or probable serious or life-threatening invasive fungal infection (in accordance with the EORTC-MSGERC criteria) who have exhausted their treatment options, primarily due to an infection with a resistant fungal pathogen, and for whom no other treatment options are available through marketed drugs or investigational agents in clinical studies ongoing in the respective indication.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Invasive Fungal InfectionsMycosesTorulopsis

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Central Study Contacts

WEP-Clinical Pharmaceutical Services Provider

CONTACT

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2024

First Posted

May 29, 2024

Last Updated

July 24, 2025

Record last verified: 2025-07