Difelikefalin dosage in published studies and labels

These are the doses used for Difelikefalin in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.

Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.

Last checked against primary sources: November 7, 2026

Studied regimens and sources

Difelikefalin has an FDA-approved human dosage, as Korsuva, for moderate-to-severe itch caused by chronic kidney disease in adults on hemodialysis. The label's recommended dose is 0.5 mcg/kg given as an intravenous bolus into the venous line of the dialysis circuit at the end of each hemodialysis session.

FDA Approved

Dosage evidence summary for Difelikefalin
Human dosing established	Yes
Studied dose range	0.5 mcg/kg after each hemodialysis session (FDA label)
Route	Intravenous
Frequency	At the end of each hemodialysis treatment (three times a week in the pivotal trials)
Duration studied	Ongoing; the pivotal trials lasted 12 weeks
Half-life	23–31 hours in hemodialysis patients before dialysis
Evidence level	FDA Approved
Last reviewed	2026-11-07

Research-reported dosing

Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.

Research-reported dosing for Difelikefalin, one row per studied regimen
Study / context	Population	Dose	Route	Frequency	Duration	Outcome studied	Source
FDA label — Korsuva, CKD-associated pruritusFDA-approved label · FDA prescribing information	Adults with moderate-to-severe pruritus associated with chronic kidney disease who are on hemodialysis	0.5 mcg/kg (dry body weight in the trials)	Intravenous bolus into the venous line of the dialysis circuit	At the end of each hemodialysis treatment	Ongoing; a missed dialysis session means resuming at the end of the next one	In the label's two 12-week trials, 40% and 37% had a 4-point or greater fall in worst-itch score versus 21% and 26% with placebo	KORSUVA (difelikefalin) injection — FDA prescribing information, DailyMed
KALM-1 — phase 3, NEJM 2020 (NCT03422653)Clinical trial · Randomised, double-blind, placebo-controlled phase 3 trial	Adults on hemodialysis with moderate-to-severe pruritus (n=378)	0.5 mcg/kg or placebo	Intravenous	Three times weekly	12 weeks	At least a 3-point fall in worst-itch score in 51.9% versus 30.9% with placebo (observed data); diarrhea, dizziness and vomiting were more common with difelikefalin	A Phase 3 Trial of Difelikefalin in Hemodialysis Patients with Pruritus. N Engl J Med. 2020.

Where sources disagree

Difelikefalin is a peripherally acting kappa opioid receptor agonist. The label warns about dizziness, sleepiness, mental status changes and gait problems, including falls, and advises against driving or operating machinery until its effect is known.
The label says it has not been studied in people on peritoneal dialysis and is not recommended for them. Safety and effectiveness in children have not been established.