Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rezafungin · 1 trial · 2 indications
Incidence of proven and probable IFIs within 90 days post-transplant
Incidence of breakthrough IFI while on specific antifungal prophylaxis
| Arm | Type | Description |
|---|---|---|
| Prospective Intervention Cohort | EXPERIMENTAL | Rezafungin 400 mg IV once within 24 hours of liver transplant, followed by 200 mg IV once weekly for a total duration of 4 weeks |
| Prospective Control Cohort | ACTIVE_COMPARATOR | Patients who receive fluconazole/voriconazole or no antifungal prophylaxis as part of UPMC's risk-based antifungal prophylaxis standard of care after liver transplant |
| Historical Control Group | ACTIVE_COMPARATOR | Patients at risk for IFI who received fluconazole/voriconazole for antifungal prophylaxis after liver transplant in the two years preceding the study |
| Name | Type | Description |
|---|---|---|
| Rezafungin | DRUG | Rezafungin 400 mg IV once within 24 hours of liver transplant, followed by 200 mg IV weekly for 4 weeks. |
| Standard of care antifungal prophylaxis | DRUG | UPMC uses a tiered approach to antifungal prophylaxis, based on risk factors for IFI. Fluconazole is used for recipients with risk factors for yeast infections: choledochojejunostomy, prolonged transplant time, receipt of \>40 units of blood products within 24 hours of transplant, and Candida colonization or infection within 3 months prior to transplant. Voriconazole is used for recipients with risk factors for mould infections: re-transplantation, renal failure requiring renal replacement therapy, fulminant hepatic failure as indication for transplant, intra-abdominal/thoracic re-exploration within the first month after transplant. No prophylaxis is given if there are no risk factors for yeast or mould infections. |
Inclusion Criteria: * Liver transplant recipient * 18 years of age or older * ≥1 risk factor(s) for IFI: living donor transplant, retransplantation, complicated operations (based on duration of transplant and number of blood products required in the peri-transplant period), choledochojejunostomy an...
Rezafungin is an investigational small molecule being studied for the prophylaxis of fungal infection in liver transplant patients. It is currently in Phase 3 clinical development for this indication, with a trial evaluating its use in preventing infections in this patient population.
Rezafungin is a small molecule antifungal agent. It works by inhibiting the synthesis of an essential component of the fungal cell wall, leading to fungal cell death. This mechanism makes it potentially useful for preventing fungal infections in immunocompromised patients, such as those undergoing liver transplantation.
Rezafungin is being developed by CorMedix Inc., a biopharmaceutical company. CorMedix is publicly traded on the NYSE American under the ticker symbol CRMD.
Rezafungin is in Phase 3 clinical development for the prevention of fungal infection in liver transplant patients. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is actively enrolling participants by invitation.
Rezafungin is being studied in a Phase 3 clinical trial with the identifier NCT06774144, titled 'Rezafungin Prophylaxis in Liver Transplant'. This active, controlled trial is enrolling 385 participants aged 18 years and older in the United States to evaluate the drug's efficacy in preventing fungal infections.
Rezafungin is a distinct investigational drug and is not known to be the same as any other approved medication. It is a novel echinocandin-class antifungal agent being developed specifically for prophylaxis in liver transplant recipients.