Is Difelikefalin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Difelikefalin, including Korsuva (50 µ/ml, Solution for injection, SAR 487.70).

Is Difelikefalin approved by the US FDA?

Drugs@FDA lists 2 application product lines for Difelikefalin, including KORSUVA (Prescription); DIFELIKEFALIN ACETATE (Prescription).

Is Difelikefalin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Difelikefalin: Kapruvia.

Active substance

Difelikefalin

SFDA 2
US FDA 2
EMA 1
Health Canada 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Korsuva	50 µ/ml	Solution for injection · Intravenous use	3 Vial	SAR 487.70	NCE · Prescription	Vifor Fresenius Medical Care Renal Pharma	Valid
Korsuva	50 µ/ml	Solution for injection · Intravenous use	12 Vial	SAR 1950.85	NCE · Prescription	Vifor Fresenius Medical Care Renal Pharma	Valid

Indications — CHI Daman Drug Formulary

CHRONIC KIDNEY DISEASE-ASSOCIATED PRURITIS

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
KORSUVA	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	solution · intravenous	VIFOR INTL	Prescription	23 Aug 2021
DIFELIKEFALIN ACETATE	EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)	solution · intravenous	QILU PHARM HAINAN	Prescription	31 Aug 2026

EMA European Union — centrally authorised medicines

Kapruvia Vifor Fresenius Medical Care Renal Pharma France · Authorised · authorised 25 Apr 2022 · ATC V03AX

Therapeutic indication (EMA)

Kapruvia is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis (see section 5.1).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
KORSUVA	02529688	50 MCG / ML	SOLUTION · INTRAVENOUS	VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.