Invasive Fungal InfectionsNCT06433128
Expanded Access to Fosmanogepix for Patients With Serious or Life-threatening Invasive Fungal Infections
A study testing Fosmanogepix solution for infusion and Fosmanogepix 400 mg tablets in people with Invasive Fungal Infections, run by Basilea Pharmaceutica.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Invasive Fungal Infections
- What is being tested?
- Fosmanogepix solution for infusion and Fosmanogepix 400 mg tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- Child, Adult, Older adult
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 locations and contacts
No sites are listed yet.
WEP-Clinical Pharmaceutical Services Provider contact
About this study
Official title: Expanded Access to Fosmanogepix for Patients With Serious or Life-threatening Invasive Fungal Infections Who Have no Other Treatment Options
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.
- Conditions
- Invasive Fungal Infections
- Being tested
- Fosmanogepix solution for infusion, Fosmanogepix 400 mg tablets
- Keywords
- Fungal infection, Candida, Anti-fungal, Yeast, Mold, Rare mold
- Medical subject headings
- Invasive Fungal Infections, Mycoses, Torulopsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosmanogepix solution for infusionDrug
Fosmanogepix solution for infusion, 20 mg/mL for intravenous administration
Fosmanogepix 400 mg tabletsDrug
Fosmanogepix 400 mg tablets for oral administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Fungal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Basilea Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433128
- Sponsor's protocol ID
- EAP to Fosmanogepix
- Status last verified
- Jul 2025
- First submitted
- 22 May 2024
- Last updated
- 24 Jul 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access to Fosmanogepix for Patients With Serious or Life-threatening Invasive Fungal Infections Who Have no Other Treatment Options
- ClinicalTrials.gov ID
- NCT06433128
- Acronym / sponsor ID
- EAP to Fosmanogepix
- Conditions
- Invasive Fungal Infections
- Keywords
- Fungal infection, Candida, Anti-fungal, Yeast, Mold, Rare mold
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fosmanogepix solution for infusionFosmanogepix solution for infusion, 20 mg/mL for intravenous administration | Drug | – |
| Fosmanogepix 400 mg tabletsFosmanogepix 400 mg tablets for oral administration | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
WEP-Clinical Pharmaceutical Services Provider contact
Questions about this trial
What is this clinical trial studying?
A study testing Fosmanogepix solution for infusion and Fosmanogepix 400 mg tablets in people with Invasive Fungal Infections, run by Basilea Pharmaceutica.
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: status not confirmed, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact WEP-Clinical Pharmaceutical Services Provider (fosmanogepixeap@wepclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 24 Jul 2025.