Difelikefalin
Other Therapeutic Products
Sold as Korsuva · Kapruvia
- Drug class
- Other Therapeutic Products
- Availability
- Prescription only
- Routes
- Intravenous
- Markets covered
- 4
- Products on record
- 4
- FDA reports (12 mo)
- 64
Overview
Plain-language summary, compiled from the cited regulatory records
Difelikefalin is an active pharmaceutical ingredient classified as Other Therapeutic Products (V03AX) [1]. It is approved for the treatment of moderate-to-severe pruritus, also known as itching, associated with chronic kidney disease (CKD-aP) in adults who are undergoing hemodialysis [1].
This medication is available under the brand name Korsuva [1]. In the past 12 months, there have been 64 adverse event reports associated with this active ingredient [2]. The most frequently reported adverse events include death, delirium, dizziness, falls, and cerebral infarction [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 1 | August 26, 2025 |
| EU European Union | EMA | 1 | June 1, 2026 |
| GB United Kingdom | MHRA | 1 | May 15, 2026 |
| CA Canada | Health Canada | 1 | March 22, 2025 |
USUnited States· FDA
1 product
Uses
1 INDICATIONS AND USAGE KORSUVA is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD). KORSUVA is a kappa opioid receptor agonist indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).
( 1 ) Limitation of Use Korsuva has not been studied in patients on peritoneal dialysis and is not recommended for use in this population. ( 1 ) Limitations of Use KORSUVA has not been studied in patients on peritoneal dialysis and is not recommended for use in this population.
How to take
EUEuropean Union· EMA
1 product
Uses
1).
How to take
GBUnited Kingdom· MHRA
1 product
Uses
1).
How to take
CACanada· Health Canada
1 product
Uses
KORSUVA (difelikefalin) is indicated for: the treatment of moderate to severe pruritus associated with chronic kidney disease in adult patients on hemodialysis (HD). 1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics Geriatrics (≥ 65 years of age): Evidence from clinical studies suggests that use in the geriatric population is associated with differences in safety. 4 Geriatrics.
How to take
Sources & citations
- [1]FDA DailyMed · 0c7b81f2-0fd3-47… · revised August 26, 2025 [PDF]
- [2]European Medicines Agency · EMEA/H/C/005612 · revised June 1, 2026
- [3]MHRA (UK) · PLGB507840009 · revised May 15, 2026
- [4]Health Canada (DPD) · 02529688 · revised March 22, 2025
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.