Peptide
Difelikefalin (Korsuva)
Difelikefalin is a peripherally-restricted selective kappa opioid receptor (KOR) agonist peptide. FDA-approved August 2021 as first treatment for moderate-to-severe CKD-associated pruritus in hemodialysis patients. KALM trials: 51% achieved ≥3-point itch reduction vs 28% placebo. No abuse potential. Administered IV 0.5 mcg/kg post-dialysis.
- Updated
- How we grade
- 42 studies cited
Research notice. This page is for education and research. Peptides may not be FDA-approved for human use and may only be legally available for research. Talk to a qualified clinician before considering any peptide.
- Best evidence
- Grade A
- Conditions studied
- 1
- Outcomes
- 7
- Graded outcomes
- 3220
Evidence by condition
- Strong
- Moderate
- Limited
- Very limited
General
Key findings
- Itch-Related Quality of LifeImproves (the measure goes down)
- Itch Intensity ReductionImproves (the measure goes down)
- Sleep ImprovementImproves (the measure goes up)
Studies cited
42 studies from PubMed
- The efficacy and safety of intravenous difelikefalin for the treatment of pruritus in patients undergoing hemodialysis: a systematic review and meta-analysis of randomized controlled trials.
- Systemic Inflammatory Markers Correlate with Chronic Kidney Disease-Associated Pruritus and Response to Treatment.
- Cost-utility analysis of difelikefalin for the treatment of moderate to severe Chronic Kidney Disease associated-Pruritus (CKD-aP) in adult patients receiving haemodialysis in Spain.
- The efficacy and safety of kappa opioid receptor (KOR) agonists in patients with uraemic pruritus: a systematic review and network meta-analysis.
- Difelikefalin for CKD-aP: real world evidence of efficacy and safety in Italian patients.
- Real-world safety of difelikefalin for chronic kidney disease-associated pruritus: initial insights from a European managed access programme.
- Real-world effectiveness and tolerability of difelikefalin over 12 months for hemodialysis-associated pruritus.
- Nanoliposome-sericin hydrogel microneedle patches effectively alleviate inflammation and scavenge ROS for the treatment of CKD-aP.
- Anti-inflammatory and renoprotective effects of difelikefalin, a kappa opioid receptor agonist, in a rat model of renal ischemia-reperfusion-induced acute kidney injury.
- Long-term efficacy of difelikefalin in hemodialysis patients with pruritus: KALM-1 and KALM-2 extension studies
- Impact of Difelikefalin on the Health-Related Quality of Life of Haemodialysis Patients with Moderate-To-Severe Chronic Kidney Disease-Associated Pruritus: A Single-Arm Intervention Trial.
- Efficacy and safety of difelikefalin in the treatment of hemodialysis patients with pruritus: A meta-analysis and systematic review.
- Efficacy and safety of different systemic drugs in the treatment of uremic pruritus among hemodialysis patients: a network meta-analysis based on randomized clinical trials.
- The efficacy and safety of difelikefalin for pruritus in hemodialysis patients: a systematic review and meta-analysis of randomized controlled trials.
- Pathways for Diagnosing and Treating CKD-Associated Pruritus: A Narrative Review.
- Chronic kidney disease-associated pruritus and quality of life with difelikefalin treatment: a post hoc analysis of phase 3 data using the Skindex-10 questionnaire.
- Difelikefalin in the treatment of hemodialysis patients with pruritus: a systematic review and meta-analysis.
- Difelikefalin: A New κ-Opioid Receptor Agonist for the Treatment of Hemodialysis-Dependent Chronic Kidney Disease-Associated Pruritus
- Difelikefalin for the treatment of moderate-to-severe pruritus associated with chronic kidney disease on hemodialysis
- A Benefit/Risk Assessment of Intrathecal Difelikefalin in Chronic Kidney Disease-Associated Pruritus
- Ocular surface itch and pain: key differences and similarities between the two sensations.
- Cost Effectiveness of Difelikefalin Compared to Standard Care for Treating Chronic Kidney Disease Associated Pruritus (CKD-aP) in People with Kidney Failure Receiving Haemodialysis.
- Difelikefalin for the treatment of moderate-to-severe pruritus associated with chronic kidney disease on hemodialysis.
- The first real-world experience of IV difelikefalin to treat chronic kidney disease-associated pruritus in haemodialysis patients.
- A phase 2 study of oral difelikefalin in subjects with chronic kidney disease and moderate-to-severe pruritus.
- Difelikefalin suppresses itch and reduces scratching independent of inflammation in a murine model of atopic dermatitis.
- Oral difelikefalin reduces moderate to severe pruritus and expression of pruritic and inflammatory biomarkers in subjects with atopic dermatitis.
- Phase 2 Trial of Difelikefalin in Notalgia Paresthetica.
- Efficacy of Difelikefalin for the Treatment of Moderate to Severe Pruritus in Hemodialysis Patients: Pooled Analysis of KALM-1 and KALM-2 Phase 3 Studies
- Safety and Tolerability of Difelikefalin for the Treatment of Moderate to Severe Pruritus in Hemodialysis Patients: Pooled Analysis From the Phase 3 Clinical Trial Program
- Difelikefalin (Korsuva) for chronic kidney disease-associated pruritus.
- Pruritus in chronic kidney disease.
- Difelikefalin in the Treatment of Chronic Kidney Disease-Associated Pruritus: A Systematic Review.
- Difelikefalin for pruritus associated with renal disease.
- Efficacy and Safety of Difelikefalin in Japanese Patients With Moderate to Severe Pruritus Receiving Hemodialysis: A Randomized Clinical Trial.
- Safety and Effectiveness of Difelikefalin in Patients With Moderate-to-Severe Pruritus Undergoing Hemodialysis: An Open-Label, Multicenter Study.
- Effect of oral difelikefalin on uremic pruritus in subjects undergoing hemodialysis: a randomized, placebo-controlled, phase 2 study
- Difelikefalin: A Review in Moderate-to-Severe Pruritus in Adults Undergoing Haemodialysis
- An evaluation of difelikefalin as a treatment option for moderate-to-severe pruritus in end stage renal disease.
- A Phase 3 Trial of Difelikefalin in Hemodialysis Patients with Pruritus
- Peripheral kappa opioid receptor agonism and chronic pruritus
- The opioid crisis: a 21st century pain.