Pain · FDA Approved
Difelikefalin (Korsuva)
FDA-approved
01 · Overview
A peripherally restricted, selective kappa-opioid receptor (KOR) agonist peptide developed to reduce itch (PMID 31702883). Its limited central nervous system penetration is intended to avoid the central effects of opioids.
In a study of recreational drug users, supratherapeutic doses produced only small, brief drug-liking effects, much lower than pentazocine, indicating low abuse potential (PMID 34708917).
02 · Research summary & key findings
FDA-approved in 2021 (Korsuva) for moderate-to-severe pruritus associated with chronic kidney disease in adults on hemodialysis. In the KALM-1 trial, 49.1% of patients on intravenous difelikefalin vs. 27.9% on placebo had at least a 3-point improvement in itch intensity, with better itch-related quality of life (Fishbane et al., NEJM, 2020) (PMID 31702883). A pooled analysis of KALM-1 and KALM-2 (851 patients) confirmed the benefit (51.1% vs. 35.2%) (PMID 36016762). Diarrhea, dizziness and vomiting were more common than with placebo (PMID 31702883). An oral formulation reduced itch in a phase 2 study of non-dialysis chronic kidney disease (PMID 37059302).
03 · Regulatory status
Difelikefalin (Korsuva) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.
Difelikefalin (Korsuva) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.
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04 · Administration routes
- Intravenous (post-dialysis)
References
- [1]A Phase 3 Trial of Difelikefalin in Hemodialysis Patients with Pruritus N Engl J Med, 2020. PMID 31702883
- [2]Evaluation of the abuse potential of difelikefalin, a selective kappa-opioid receptor agonist, in recreational polydrug users Clin Transl Sci, 2022. PMID 34708917
- [3]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 Kidney Med, 2022. PMID 36016762
- [4]A phase 2 study of oral difelikefalin in subjects with chronic kidney disease and moderate-to-severe pruritus J Am Acad Dermatol, 2023. PMID 37059302
Primary literature
- PubMed: "Difelikefalin"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "Difelikefalin"
Registered interventional and observational studies, including status and phase.
- PubChem: "Difelikefalin"
Chemical structure, molecular properties, and bioactivity data.
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Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol. See our editorial policy for how this content is produced and reviewed. Clinicians: join the network.