Difelikefalin-The first FDA-approved drug for the treatment of chronic kidney disease (CKD)-related pruritus-Difelikefalin injection

I. Basic information

Generic name: Difelikefalin

CAS number: 1024828-77-0; 1024829-44-4

Chemical structure:

Dosage form and specifications: Injection: 0.065mg/1.3mL (0.05mg/mL)

Indications: It is suitable for the treatment of moderate to severe pruritus (CKD-aP) associated with chronic kidney disease in adults receiving hemodialysis (HD).

Patent: The compound patent expires in 2027.

Registration category: Chemical Class 4

II. Reference preparation selection

This variety was first launched in the United States, and then in the European Union and Japan

III. Domestic and foreign listing information

Currently, this variety has been approved for marketing in the United States, Japan, Europe and other places, but with different specifications.

IV. Project advantages

The approval of Difelikefalin is an important milestone in the clinical treatment of chronic kidney disease-related pruritus.

Good compliance: At the end of each hemodialysis treatment, the intravenous push administration method through the venous line of the dialysis circuit can ensure the patient's medication compliance, which will be a novel, safe and effective treatment option for patients with moderate to severe chronic kidney disease-related pruritus.

Definite efficacy: Effectively reduce the severity and duration of pruritus in hemodialysis patients with moderate to severe chronic kidney disease-related pruritus, and improve sleep, mood and social function and other pruritus-related quality of life.

High safety: Abuse and dependence are a major problem for all opioids, and difacillin mainly acts on peripheral KOR and has limited penetration into the central nervous system, which can minimize this risk.

Large market size: At present, there are more than 840,000 hemodialysis patients (MHD) nationwide, more than 42% of patients have moderate to severe pruritus, and more than 73% of patients said that skin itching affects their normal life. The market size is expected to reach 2 billion yuan.