Expanded Access to Fosmanogepix for Patients With Serious or Life-threatening Invasive Fungal Infections

NCT ID: NCT06433128

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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Conditions

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Invasive Fungal Infections

Interventions

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Fosmanogepix solution for infusion

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

Intervention Type DRUG

Fosmanogepix 400 mg tablets

Fosmanogepix 400 mg tablets for oral administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Basilea Pharmaceutica

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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WEP-Clinical Pharmaceutical Services Provider

Role: CONTACT

Marc Engelhardt

Role: CONTACT

+41 79 701 0551

Other Identifiers

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EAP to Fosmanogepix

Identifier Type: -

Identifier Source: org_study_id

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