DIFELIKEFALIN ACETATE · QILU PHARM HAINAN
DIFELIKEFALIN ACETATE is FDA-approved to treat 2 conditions (same as KORSUVA).
Details
- Status
- Prescription
- First Approved
- 2021-08-23
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
DIFELIKEFALIN ACETATE Approval History
What DIFELIKEFALIN ACETATE Treats
2 indicationsDIFELIKEFALIN ACETATE is approved for 2 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pruritus
- Chronic Kidney Disease
Same approved indications as KORSUVA (same active ingredient).
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.
DIFELIKEFALIN ACETATE FDA Label Details
Indications & Usage
DIFELIKEFALIN ACETATE is FDA-approved to treat 2 conditions — same approved indications as KORSUVA.
Looking for the branded version?
KORSUVA
Full clinical data, patents, trials, and competitive landscape for difelikefalin acetate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.