A Phase 3 interventional study of Fosmanogepix IV infusion and Standard of care antifungal therapy in Invasive Mold Infections, sponsored by Basilea Pharmaceutica. Recruiting at 90 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Basilea Pharmaceutica · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of fosmanogepix (administered IV or oral) for the treatment of adult patients with invasive mold infections. The study is looking for patients who have been diagnosed with invasive mold infections. The maximum study duration will be approximately 8 months, including a target study treatment duration of 84 days which can be extended up to 180 days and follow-up period.
The patient will be assigned to one of two treatment cohorts:
Cohort A (primary therapy): Patients will receive either the study drug or institutional standard of care antifungal treatment.
Cohort B (salvage treatment; i.e. treatment given after patients did not respond to previous treatments or did not tolerate them): Patients will receive the study drug
The primary aim is to compare the all cause mortality with a fixed threshold at Day 42.
260 studies on the registry are indexed under Mycoses; 37 are open to participants now.
This study's planned enrollment of 234 is above the median of 68 across 164 interventional studies indexed under Mycoses.
Browse Mycoses studies →Basilea Pharmaceutica is the lead sponsor of 60 studies on the registry; 7 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 15 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Critera:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive the study drug. Fosmanogepix will be administered as an Intravenous (IV) infusion or in oral form.
Drug: Fosmanogepix IV infusion · Drug: Fosmanogepix oral tablet
Best available therapy (BAT) administered as IV or orally per standard guidelines.
Drug: Standard of care antifungal therapy
Patients will receive the study drug. Fosmanogepix will be administered as an Intravenous (IV) infusion or in oral form.
Drug: Fosmanogepix IV infusion · Drug: Fosmanogepix oral tablet
Fosmanogepix will be administered IV
Standard of care antifungal therapy will be administered in accordance with their respective product labels and/or standard practice guidelines
Fosmanogepix will be administered orally.
Day 42 all-cause mortality rate
Time frame: Day 42
Proportion of patients with overall response of treatment success
Time frame: Day 42, Day 84 and up to 180 days
Proportion of patients with clinical response of treatment success
Time frame: Day 42, Day 84 and up to 180 days
Proportion of patients with mycological response of eradication or presumed eradication
Time frame: Day 42, Day 84 and up to 180 days
Proportion of patients with radiological response of complete response or partial response
Time frame: Day 42, Day 84 and up to 180 days
All-cause mortality rate at Day 84
Time frame: Day 84
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), treatment-related AEs, adverse events of special interest (AESI), and AEs leading to discontinuation
Time frame: Screening up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)
Number of patients with clinically significant laboratory abnormalities
Time frame: Up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)
Number of patients with abnormal neurological examination findings
Time frame: Up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)
Assessment of 12-lead electrocardiogram corrected QT (Fridericia method) Interval (ECG QTcF Interval)
Time frame: Up to follow-up 6 weeks after EOST (target duration approximately up to 8 months)
Plasma concentrations versus time of fosmanogepix (prodrug) and manogepix (active moiety) following IV administration
Time frame: Pre-dose, 3,6, and 9 hours post-start of the 3-hour IV infusion on Day 3, and at 24 hours (prior to Day 4 dosing)
Plasma concentrations versus time of fosmanogepix (prodrug) and manogepix (active moiety) following oral administration
Time frame: On days 7, 14, 28, and 42. Post-dose plasma samples will also be collected: 72 hrs and 192 hrs after last dose.
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Started Aug 2025 (actual). Primary completion is estimated for Feb 2028, 30 months after the start.
Of 15 phase 3 interventional studies under Mycoses, half reached primary completion within 68 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 81. This study's planned 30 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Fosmanogepix