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Treatment of serious fungal infections with Fosmanogepix

An Interventional Efficacy and Safety Phase 3 Double-blind 2-arm Study to Investigate IV Followed by Oral Fosmanogepix Compared With IV Caspofungin Followed by Oral Fluconazole in Adult Participants With Candidemia and/or Invasive Candidiasis

Phase 3 Interventional Basilea Pharmaceutica · NCT05421858

This study is testing if a new treatment called Fosmanogepix can help people with serious fungal infections like candidemia and invasive candidiasis do better than the usual treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment450 (estimated)
Ages18 Years and up
SexAll
SponsorBasilea Pharmaceutica Industry-sponsored
Locations138 sites (Birmingham, Alabama and 137 other locations)
Trial IDNCT05421858 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of Fosmanogepix for treating candidemia and invasive candidiasis, which are severe fungal infections caused by Candida species. Participants will be randomly assigned to receive either Fosmanogepix via intravenous infusion followed by oral tablets or a standard treatment regimen of caspofungin followed by fluconazole. The study aims to determine how well Fosmanogepix works compared to the standard of care in managing these life-threatening infections. Patients will be monitored for safety and treatment outcomes throughout the trial.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with candidemia and/or invasive candidiasis.

Not a fit: Patients with existing infections that are not candidemia or invasive candidiasis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for patients suffering from life-threatening fungal infections.

How similar studies have performed: Previous studies have shown promising results with similar antifungal approaches, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patients ≥ 18 years (or the minimum country-specific age of consent if \> 18) at Screening who have provided signed informed consent indicating that they understand the purpose of, and procedures required for, the study, and are willing to participate in the study. If the patient is unable to consent for himself/herself, a legally authorized representative must provide informed consent on his/her behalf.
2. Diagnosis of candidemia and/or invasive candidiasis based on a blood or non-blood specimen obtained within ≤ 96 hours (4 days) before randomization, and on clinical criteria judged attributable to candidemia/invasive candidiasis occurring at any time from ≤ 12 hours prior to the qualifying positive index culture being taken through to randomization.
3. Patient's condition allows for appropriate infection source control measures, including removal of pre-existing intravascular catheters and devices, if necessary.

Exclusion Criteria:

1. Existing infection

   1. Infection known to be due to Candida krusei, in blood or any other normally sterile site.
   2. Inappropriate fungal infection source control.
   3. Diagnosis of certain deep-seated Candida infections.
2. Life expectancy of \< 72 hours in the opinion of the investigator.
3. Requirement, or expected requirement, for hemodialysis, peritoneal dialysis, or hemofiltration.
4. Ongoing neurological disorders, including specified conditions presenting with a CTCAE Grade ≥ 2 (neurological symptoms that are considered to be a consequence of the current episode of candidemia / invasive candidiasis are not exclusionary).
5. Patients with known human immunodeficiency virus infection, who have CD4+ count \< 200/mm3 or viral load \> 400 copies/mL), or who have had an active opportunistic infection within 6 months prior to Screening.
6. Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the patient inappropriate for the study.
7. Current use of any prohibited concomitant medications or those unwilling/unable to use a permitted concomitant medication.
8. Received \> 2 days (\> 48 hours) equivalent of prior systemic antifungal treatment at approved doses and frequency to treat the current episode of candidemia and/or invasive candidiasis (e.g., \> 2 doses of a once daily antifungal agent or \> 4 doses of a twice daily antifungal agent), within the 96 hours prior to randomization (except for non-susceptible Candida spp. and for patients who develop candidemia or invasive candidiasis while on prophylaxis with an azole or amphotericin B).
9. Previous administration with an investigational drug or investigational vaccine within 30 days or 5 half-lives preceding the first dose of study drug used in this study (whichever is longer).
10. Prior participation in this or any previous study of fosmanogepix.
11. Moderate or severe hepatic impairment, known active viral hepatitis B or C, ALT or AST ≥ 5 × ULN or total bilirubin \> 3 × ULN unless this is due to isolated hyperbilirubinemia or documented Gilbert's syndrome.
12. Female patient is pregnant or lactating.
13. Known hypersensitivity to fosmanogepix, manogepix, caspofungin, any echinocandin, fluconazole or to any of their excipients.
14. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and Sponsor and Sponsor delegate employees directly involved in the conduct of the study and their family members.

Where this trial is running

Birmingham, Alabama and 137 other locations

+88 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions CandidemiaCandidiasis, InvasiveFungal infectionCandidaAnti-fungalYeast
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.