A Study to Evaluate the Effectiveness and Safety of Ibrexafungerp in Patients with Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment


About this study

The purpose of this study is to see how well study drug works at treating people with fungal diseases that are refractory to or intolerant of Standard Antifungal Treatment.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Must have a documented eligible invasive and/or severe fungal disease that is refractory or intolerant to Standard-of-Care treatment. A summary of eligible fungal diseases is listed below:
    • Acute or chronic invasive candidiasis, including candidemia;
    • Acute or chronic severe mucocutaneous candidiasis, including:
    • Esophageal candidiasis, Oropharyngeal candidiasis, Chronic mucocutaneous candidiasis, Vulvovaginal candidiasis;
    • Disseminated/invasive dimorphic fungi: Coccidioidomycosis, Histoplasmosis, Blastomycosis;
    • Chronic Pulmonary Aspergillosis;
    • Allergic Bronchopulmonary Aspergillosis;
    • Invasive Pulmonary Aspergillosis;
    • Other emerging fungi including yeasts and molds (e.g., saccharomycetes, scopulariopsis).
  • Be able to tolerate medication orally or through a nasogastric (NG) tube or  percutaneous endoscopic gastrostomy (PEG) tube.
  • Be able to understand and sign a written informed consent form (ICF), which must be obtained prior to treatment and any study-related procedures.
  • Be able to understand and sign a consent or authorization form which shall permit the use, disclosure and transfer of the subject's personal health information. (e.g., in  the U.S. HIPAA Authorization form). 
  • Be able to understand and follow all study-related procedures including study drug  administration.  
  • Agree to use a medically acceptable method of contraception while receiving  protocol-assigned product.  

Exclusion Criteria:

  • An invasive fungal disease with CNS involvement.
  • Subject has an inappropriately controlled fungal disease source (e.g., persistent  catheters that cannot be removed and are likely the source of infection).
  • Subject is hemodynamically unstable, requiring vasopressor medication for blood  pressure support.  
  • A life expectancy < 30 days.
  • Subject with abnormal liver test parameters: aspartate aminotransferase (AST), alanine  aminotransferase (ALT) > 10 x the upper limit of normal (ULN), and/or total bilirubin > 5 x ULN.
  • Subject is pregnant or lactating.
  • Subject has used an investigational drug within 30 days prior to the baseline visit.

Eligibility last updated 9/13/21. Questions regarding updates should be directed to the study team contact.



Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Paschalis Vergidis, M.D.

Closed for enrollment

Contact information:

Department of Medicine - Clinical Trials Unit

(507) 266-1944


More information


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