Is Difelikefalin legal in the US?

Yes, FDA approved for itching in adults on kidney dialysis.

AStrong human evidenceFDA approvedas of 2026-10-26

Approved. Difelikefalin is sold as Korsuva, approved by the FDA in August 2021 for moderate-to-severe pruritus (itch) associated with chronic kidney disease in adults on hemodialysis. It is given intravenously through the dialysis circuit. ²

Yes. Korsuva (difelikefalin) was approved in 2021 for moderate-to-severe itch linked to chronic kidney disease in adults on hemodialysis. Staff give it intravenously during dialysis. Patients do not self-inject it. ²

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Citations

Fishbane 2020, NEJM: A phase 3 trial of difelikefalin in hemodialysis patients with pruritus (KALM-1) doi.org
Korsuva (difelikefalin) prescribing information drugs.com

Reference information only, not medical advice. Drawn from the Difelikefalin article, fact-checked against the cited sources. No dosing anywhere on this site.