PainFDA Approved

Difelikefalin (Korsuva)

Intravenous (post-dialysis)

Overview

A selective kappa-opioid receptor (KOR) agonist peptide that does not cross the blood-brain barrier, providing peripheral analgesia and anti-pruritic effects without central opioid side effects such as euphoria, dysphoria, sedation, or addiction. Difelikefalin activates kappa receptors on peripheral sensory neurons and immune cells to reduce itch signaling and inflammation.

Mechanism of Action

Its restricted CNS penetration is a deliberate design feature to avoid abuse potential..

Research Summary & Key Findings

FDA-approved in 2021 for moderate-to-severe pruritus associated with chronic kidney disease (CKD-associated pruritus) in adults undergoing hemodialysis. KALM-1 and KALM-2 trials demonstrated significant reduction in itch intensity vs. placebo, with >40% of patients achieving clinically meaningful itch reduction (Fishbane et al., NEJM, 2020). Oral formulation under development for CKD-associated pruritus in non-dialysis patients and pruritus in liver disease.

Clinical Status

FDA Approved

Difelikefalin (Korsuva) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.

Administration Routes

Intravenous (post-dialysis)

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Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol.