Abstract
Difelikefalin acetate （product name：KORSUVAⓇ IV Injection Syringe for Dialysis 17.5μg, 25.0μg, and 35.0μg） is a novel intravenously administered κ-opioid receptor agonist developed by Cara Therapeutics, Inc. in the United States. In Japan, Maruishi Pharmaceutical Co., Ltd. initiated its domestic development in April 2013, and subsequently, clinical trials were conducted jointly with Kissei Pharmaceutical Co., Ltd. starting in March 2017. Based on the confirmed efficacy and safety demonstrated in a domestic Phase III clinical trial targeting hemodialysis patients with pruritus refractory to existing treatments, a marketing authorization application was submitted. In September 2023, approval was granted for the indication “improvement of pruritus in hemodialysis patients （limited to cases where existing treatments are insufficiently effective）,” followed by inclusion in the National Health Insurance drug price list in November and commercial launch in December of the same year. Since the drug is a prefilled syringe formulation that is administered via the venous line of the dialysis circuit at the time of blood return upon completion of dialysis, its administration is not affected by fluid intake restrictions or impaired swallowing function, and can be performed under the supervision of a physician.
