REZZAYO (rezafungin acetate)
REZZAYO is indicated for the treatment of Candidemia; Invasive Candidiasis; Osteomyelitis; Meningitis.
How REZZAYO Works
Rezafungin is an echinocandin antifungal drug. It acts by inhibiting the synthesis of 1,3-β-D-glucan, an essential component of the fungal cell wall, which is absent in mammalian cells. This leads to osmotic instability and cell death in susceptible *Candida* species.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-03-22
- Patent Cliff
- 2038
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
REZZAYO Approval History
What REZZAYO Treats
4 indicationsREZZAYO is approved for 4 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Candidemia
- Invasive Candidiasis
- Osteomyelitis
- Meningitis
REZZAYO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to REZZAYO
3 of 18FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06774144 | STUDY24080165 | Ph 3 | enrolling by invitation | Rezafungin Prophylaxis in Liver Transplant |
| NCT06794554 | MR907-2502 | Ph 2 | active not recruiting | Rezafungin for Treatment of Chronic Pulmonary Aspergillosis (CPA) in Adults With Limited Treatment Options |
| NCT05534529 | MR907-1501 | Ph 1 | terminated | Rezafungin Paediatric PK Study in Paediatric Subjects From Birth to <18 Years of Age |
| NCT06329518 | HHC-2024-0064 | Ph 1 | withdrawn | Rezafungin Pharmacokinetics in Patients on ECMO |
| NCT04117607 results posted | 17-0088 HHSN272201500007I | Ph 1 | terminated | Safety and Pharmacokinetics of Rezafungin |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
REZZAYO FDA Label Details
Indications & Usage
FDA Label (PDF)REZZAYO is indicated for the treatment of Candidemia; Invasive Candidiasis; Osteomyelitis; Meningitis.
REZZAYO Patents & Exclusivity
Patents (7 active)
Exclusivity
Pro Intelligence Preview
Deep insights for REZZAYO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 7 active patents
Trial Analysis
- • 6 total trials
- • Stage: Stable
Competitive Landscape
- • 18 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment