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December 12, 2023

KORSUVA® IV Injection Syringe for Dialysis 17.5μg, 25.0μg and 35.0μg to Launch in Japan for Treatment of Pruritus in Patients Undergoing Hemodialysis

Kissei Pharmaceutical Co., Ltd.
Maruishi Pharmaceutical Co., Ltd.

Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto, Nagano, Japan; Chairman and CEO: Mutsuo Kanzawa; "Kissei") and Maruishi Pharmaceutical Co., Ltd. (Head Office: Tsurumi, Osaka, Japan; Representative Director and President: Katsuhito Inoue; "Maruishi") announced that KORSUVA® IV Injection Syringe for Dialysis 17.5μg, 25.0μg, and 35.0μg (generic name: difelikefalin acetate "KORSUVA®") for the treatment of pruritus in patients undergoing hemodialysis will launch in Japan on December 13, 2023.

KORSUVA® is a kappa opioid receptor agonist originated and developed by Cara Therapeutics, Inc. (Head Office: USA, President and CEO: Christopher Posner; "Cara"). In April 2013, Maruishi acquired certain rights from Cara, and since March 2017, Maruishi and Kissei have been jointly developing KORSUVA® for the indication of uremic pruritus in Japan. On September 25, 2023, Maruishi obtained manufacturing and marketing authorization of KORSUVA® in Japan for the treatment of pruritus in patients undergoing hemodialysis. The product is manufactured by Maruishi and marketed by Kissei in Japan.

KORSUVA® is provided as a pre-filled syringe formulation to facilitate convenience in the medical environment. Through the supply of KORSUVA® Kissei and Maruishi strive to expand treatment options for uremic pruritus and to improve the QOL (Quality of Life) of patients undergoing hemodialysis.

《 Reference 》

Product Summary of KORSUVA® IV Injection Syringe for Dialysis

Brand Name

KORSUVA® IV Injection Syringe 17.5μg

KORSUVA® IV Injection Syringe 25.0μg

KORSUVA® IV Injection Syringe 35.0μg

Generic Name

Difelikefalin acetate (JAN)


Improvement of pruritus in hemodialysis patients (limited to cases in which the effects of existing treatments are insufficient)

Dosage and Administration

Normally, inject difelikefalin with the below table dosage to adults into the venous side of the dialysis circuit during return transfusion at the end of dialysis three times a week.

Dry weight


Under 45 kg

17.5 μg

45 kg or higher but under 65 kg

25.0 μg

65kg or higher but under 85 kg

35.0 μg

85 kg or higher

42.5 μg


Injection (syringe)

NHI price

KORSUVA® 17.5μg 2,971 JPY per syringe
KORSUVA® 25.0μg 3,609 JPY per syringe
KORSUVA® 35.0μg 4,341 JPY per syringe

Manufacturing and Marketing Authorization Holder

Maruishi Pharmaceutical Co., Ltd.


Kissei Pharmaceutical Co., Ltd.

Date of Marketing Approval in Japan

September 25, 2023

Date of Drug Price Listing

November 22, 2023

Date of Launch in Japan

December 13, 2023

Product photo
コルスバ 集合写真 - 上下トリミング.jpg

About uremic pruritus in dialysis patients
Uremic pruritus is a common itching condition in spite of the absence of obvious skin lesion, which occurs in many patients with end-stage renal disease undergoing hemodialysis.
It is reported that long-lasting and intense distressing itching in these patients make their QOL very low and have negative impacts on psychological and physical health such as poor sleep quality, depression, and an increased risk of death.
It is considered that endogenous opioids are related to pruritus as one of the expression mechanisms of pruritus in dialysis patients. KORSUVA® selectively activates kappa opioid receptor which is one of the subtypes of opioid receptors, and exerts its antipruritic action by acting on the kappa opioid receptor.

About Kissei Pharmaceutical Co., Ltd.
Kissei is a Japanese pharmaceutical company based on the management philosophy "contributing to society through high-quality, innovative pharmaceutical products" and "serving society through our employees." As a strong R&D-oriented corporation, it concentrates on providing innovative pharmaceuticals to patients worldwide in the focus fields of urology, nephrology/dialysis, gynecology and rare/intractable diseases.
For more details about Kissei Pharmaceutical Co., Ltd., please visit https://www.kissei.co.jp/.

About Maruishi Pharmaceutical Co., Ltd.
Maruishi is a specialty pharma that has a strong presence in the perioperative and infection control area and is known as a leading producer of Japanese Pharmacopoeia drugs. Making use of the technology, knowledge, and know-how that have been cultivated over 130 years of history, Maruishi continues to contribute to the healthcare and improvement of QOL of the patients.
For more details about Maruishi Pharmaceutical Co., Ltd., please visit https://www.maruishi-pharm.co.jp/.

About Cara Therapeutics, Inc.
Cara Therapeutics (Nasdaq: CARA) is a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus.
For more information, visit https://www.caratherapeutics.com/ and follow the company on X (Twitter), LinkedIn and Instagram.